Анализ сайта qeios.com
Основное Готовность: 85%
Домен
qeios.com
Состояние доменного имени
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Проверяем корректность доменного имени и наличие технических проблем на уровне домена.
Домен второго уровня идеален для продвижения.
Отличный запоминающийся домен.
Ответ сервера
200 Успешный ответ
HTTP-код ответа и цепочка редиректов
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Код 200 — страница доступна. Коды 3xx — редиректы (цепочки замедляют загрузку и размывают ссылочный вес). Коды 4xx/5xx — ошибки, поисковик не сможет проиндексировать страницу.
Кол-во редиректов 3 слишком большое! Проверьте настройки сайта и веб-сервера!
Цепочка редиректов:
http://qeios.com
301 MovedPermanently
http://www.qeios.com/
301 MovedPermanently
https://www.qeios.com/
200 OK
Безопасность
Сайт безопасен
Использование HTTPS и SSL-сертификат
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HTTPS — обязательный стандарт. Google и Яндекс отдают предпочтение защищённым сайтам. Отсутствие SSL или просроченный сертификат ведут к предупреждениям в браузере и снижению позиций.
Не настроен HSTS (Strict-Transport-Security) — рекомендуется включить.
На сайте работает защищенный протокол ssl и сайт открывается по https.
Ssl-сертификат действителен до 18.11.2026 20:26:46.
HTTP автоматически перенаправляется на HTTPS.
Поздравляем! Сайт не содержится в реестре РКН.
Кодировка
utf-8
Кодировка символов страницы
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Стандарт — UTF-8. Неправильная кодировка вызывает нечитаемые символы и мешает поисковику корректно распознать текст страницы.
Указана кодировка на странице utf-8.
Язык
en
Атрибут lang в HTML-теге
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Атрибут lang (<html lang="ru">) сообщает поисковикам и браузерам, на каком языке написана страница. Помогает при ранжировании в региональном поиске.
Язык документа указан явно: en.
Скорость загрузки
~1,86сек
Время отклика сервера (TTFB)
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Time To First Byte — время до получения первого байта от сервера. Норма до 200 мс. Медленный отклик ухудшает пользовательский опыт и ранжирование: Яндекс и Google учитывают скорость страниц.
Скорость загрузки сайта 1,86сек превышает 1 секунду. Желательно улучшить работу сайта!
Объем документа
399Кб
Размер HTML-кода страницы
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Слишком большой HTML замедляет парсинг браузером и сканирование поисковым роботом. Рекомендуется не более 200 Кб.
Объем html-документа 399Кб оптимален.
Структура html-документа корректна.
Ресурсы
Ресурсы: 9
Внешние ресурсы страницы (CSS, JS, изображения)
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Количество и тип подключённых ресурсов влияют на скорость загрузки. Большое число запросов увеличивает время рендеринга страницы.
Кол-во файлов ресурсов 9 достаточно.
Показать полный список ресурсов
| Тип | Название | Значение |
|---|---|---|
| stylesheet | /css/app.css?id=e3ecc7f35e15a71b4f54d93c3674d63f | |
| stylesheet | /css/pages/front_pages/site_teaser.css?id=66a12153e0c066ce79ba21a27b836546 | |
| js | https://www.googletagmanager.com/gtag/js?id=G-DH4JRM4KNN | |
| js | /js/app.js?id=4be253114933d016b6f93c896d4596f4 | |
| js | https://cdnjs.cloudflare.com/ajax/libs/mathjax/2.7.7/MathJax.js?config=TeX-AMS_HTML | |
| js | https://cdn.embedly.com/widgets/platform.js | |
| js | https://www.qeios.com/js/lib/convert-oembed.js | |
| js | https://www.qeios.com/js/lib/jquery-collapser/jquery.collapser.min.js | |
| js | /js/pages/site_teaser.js?id=535e3fd3d8f18b96f961fbb9c5fc0589 |
Серверные заголовки
Кол-во: 4
HTTP-заголовки ответа сервера
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Заголовки сервера передают браузеру и поисковику служебную информацию: кеширование, безопасность (CSP, HSTS), сжатие (gzip). Правильная настройка ускоряет загрузку и повышает защищённость.
Найдены серверные заголовки 4шт. Подробнее про серверные заголовки.
Показать полный список серверных заголовков
| Ключ | Значение |
|---|---|
| Date | Sat, 22 Aug 2026 08:25:25 GMT |
| Server | Apache/2.4.66 |
| Cache-Control | no-cache, private |
| Set-Cookie | XSRF-TOKEN=eyJpdiI6ImN4cCs2aXNUdHp0SktGR09YY0haQUE9PSIsInZhbHVlIjoicjdXYSszZE5EeGRUa3o5WHNoL1JwQ1IvSGFZaVhQdGpCVUhnTllUK0VYbitMQVNZYWRMQ2xWRXdaNGxRcVlFZEhLem93djNmbGMyUFpZWGpPblloVllNK2xHd3pxNDlyekJxODJBTXZha2hoNVVteXhZSmhWOU9HR25MTlpQMGwiLCJtYWMiOiIyYjc2YThkODdmNjFlNWQ5OTVmNjE5ZWEzNTIzZjEyNjc4NzIwNjJkM2Y2OWNkMTYxMTNhNDUzNDQ5YTQ4MzU5IiwidGFnIjoiIn0%3D; expires=Sat, 22 Aug 2026 10:25:25 GMT; Max-Age=7200; path=/; samesite=lax |
CMS
Не определена
Система управления сайтом (движок)
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CMS — это движок, на котором работает сайт (WordPress, 1C-Bitrix, Tilda и др.). Знание CMS помогает понять возможности SEO-оптимизации и подобрать подходящие инструменты. «Не определена» — вероятно, самописный сайт или нестандартная сборка.
CMS не определена. Вероятно, сайт самописный либо движок надёжно скрыт. Это не ошибка.
Веб-сервер
Apache
Программное обеспечение сервера
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Веб-сервер — это ПО, которое отдаёт страницы посетителям (nginx, Apache, IIS, LiteSpeed и др.). Определяется по серверным заголовкам ответа (Server, X-Powered-By и т.п.). «Не определён» — сервер намеренно скрывает эти заголовки, это нормальная практика безопасности.
Сайт работает на веб-сервере Apache.
Мета-теги Готовность: 48%
Title
Qeios - Research you can trust
Заголовок страницы в браузере и поисковой выдаче
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Title — главный SEO-заголовок страницы. Влияет на CTR в поиске и ранжирование. Оптимальная длина: 50–70 символов. Ключевые слова — ближе к началу.
Необходимо увеличить число символов в title (текущее значение: 30, оптимально: от 40 до 45)
Дублей словоформ в title не найдено.
Description
The Open Science platform reshaping scholarly communication.
Описание страницы в поисковой выдаче (сниппет)
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Meta Description — текст под заголовком в выдаче. Напрямую на позиции не влияет, но влияет на CTR. Оптимальная длина: 120–160 символов.
Необходимо увеличить число символов в description (текущее значение мало: 60, минимум: 80, оптимально: от 120 до 130)
Keywords
Список ключевых слов страницы (устаревший тег)
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Meta Keywords не учитывается Яндексом и Google для ранжирования с 2009–2012 годов. Заполнение не обязательно, но не вредит. Конкурент может использовать содержимое для анализа.
Установите мета-тег keywords!
Канонический Url
Указывает поисковику основную версию страницы
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Canonical (rel=canonical) предотвращает проблему дублей страниц. Должен точно совпадать с URL проверяемой страницы. Неправильный canonical может передать ссылочный вес на другую страницу.
Рекомендуем прописать канонический Url.
Robots
Ошибок нет
Директивы для поисковых роботов на уровне страницы
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Meta Robots управляет индексацией конкретной страницы: index/noindex — индексировать ли, follow/nofollow — следовать ли по ссылкам. Noindex полностью исключает страницу из поиска.
Meta-тег robots не указан. Страница свободна для индексации.
Адаптивность
width=device-width, initial-scale=1
Настройка масштабирования на мобильных устройствах
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Тег viewport (<meta name="viewport">) сообщает браузеру, как масштабировать страницу на мобильных. Стандарт: width=device-width, initial-scale=1. Отсутствие — признак отсутствия мобильной версии.
Meta-тег viewport со значением-константой width=device-width задаёт ширину страницы в соответствии с размером экрана.
Meta-тег viewport со значением initial-scale=1.0 определяет масштаб 1:1, т.е. «не масштабировать».
Разметка OpenGraph
Кол-во: 3
Мета-теги для красивых превью в соцсетях
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OpenGraph (og:title, og:description, og:image) управляет тем, как страница выглядит при репосте в социальных сетях и мессенджерах. Отсутствие OG-тегов — невзрачный превью при шеринге.
Разметка OpenGraph задана. Страница оптимизирована под социальные сети.
Показать полный список og мета-тегов
| Тип | Значение |
|---|---|
| og:title | Qeios - Research you can trust |
| og:description | The Open Science platform reshaping scholarly communication. |
| og:image | https://www.qeios.com/images/brand/Qeios_background_blue.png |
Все мета-теги
Кол-во: 9
Полный список мета-тегов страницы
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Таблица всех meta-тегов, включая нестандартные. Позволяет найти опечатки, дубли и лишние теги.
Найдены мета-теги 9шт. Мета-теги не видимы для человека и предназначены для обмена информацией между веб-страницей и поисковыми системами, браузерами и другими веб-службами. С ними роботы 🤖 и устройства ведут себя более ожидаемо.
Показать полный список мета-тегов
| Тип | Название | Значение |
|---|---|---|
| name | viewport | width=device-width, initial-scale=1 |
| name | csrf-token | 9Fb5ykShKPuVGKmMiGtWKtcn6fwmUGYIF1BR9UHR |
| name | app-base-url | https://www.qeios.com |
| name | description | The Open Science platform reshaping scholarly communication. |
| name | twitter:card | summary_large_image |
| name | twitter:site | @qeios |
| property | og:title | Qeios - Research you can trust |
| property | og:description | The Open Science platform reshaping scholarly communication. |
| property | og:image | https://www.qeios.com/images/brand/Qeios_background_blue.png |
Оптимизация Готовность: 77%
Структура
Ошибок нет
Семантические HTML-элементы страницы
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Проверяет наличие основных структурных элементов: nav, header, footer, main. Корректная семантическая структура помогает поисковику понять архитектуру страницы.
Структура документа корректна (теги <html> и <body> присутствуют в единственном экземпляре).
Контент
Есть ошибки
Объём и качество текстового содержимого
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Анализирует объём полезного текста на странице. Слишком мало — страница может считаться малополезной. Слишком много — ухудшается читаемость и восприятие.
Кол-во слов 209 слишком мало. Добавьте больше текста (минимум 400 слов)!
Слова из title 4 встречаются в тексте достаточно.
Абзацев с текстом 12 достаточно.
Среднее число слов в абзаце 27 достаточно.
Кол-во знаков контента 1418 на странице оптимально.
Заголовки
Ошибок нет
Иерархия заголовков H1–H6
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H1 должен быть один и содержать ключевой запрос. H2–H6 описывают подразделы. Пропуск уровней (H1 → H3) и несколько H1 — типичные ошибки, снижающие понятность страницы для поисковика.
На странице присутствуют заголовки <h2> 3. Это хорошо.
На странице присутствуют заголовки <h3> 6.
Тошнота
2,45
Насколько одно слово доминирует в тексте
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Классическая тошнота = √(частота самого повторяющегося слова). Норма до 7–8: текст воспринимается естественно. Выше — поисковик может счесть страницу переспамленной.
Тошнота страницы в пределах нормы 3.
Академич. тошнота
13,88%
Насколько текст перенасыщен ключевыми словами
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Академическая тошнота = (частота слова / общее количество слов) × 100%. Показывает долю конкретного слова в тексте. Норма 5–15%.
Академическая тошнота страницы в пределах нормы.
Семантическое ядро
20
Наиболее часто встречающиеся слова на странице
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Топ слов по частоте использования. Показывает, какие слова доминируют в тексте с точки зрения поисковика.
Контент страницы содержит осмысленный текст и слова.
Показать список слов
| Слово | Кол-во | Частота |
|---|---|---|
| articles | 6 | 2,87% |
| research | 5 | 2,39% |
| review | 4 | 1,91% |
| sciences | 4 | 1,91% |
| article | 3 | 1,44% |
| health | 2 | 0,96% |
| domingo | 2 | 0,96% |
| researchers | 2 | 0,96% |
| peer-approved | 1 | 0,48% |
| preprints | 1 | 0,48% |
| archive | 1 | 0,48% |
| ethics | 1 | 0,48% |
| indexed | 1 | 0,48% |
| europe | 1 | 0,48% |
| 1 | 0,48% | |
| scholar | 1 | 0,48% |
| covid-19 | 1 | 0,48% |
| portfolio | 1 | 0,48% |
| reimagined | 1 | 0,48% |
| create | 1 | 0,48% |
Индексация Готовность: 50%
Индексирование
Ошибок нет
Разрешено ли индексирование страницы
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Проверяет, не закрыта ли страница от индексации через robots.txt, meta robots или X-Robots-Tag. Страница, закрытая от индексации, не появится в поисковой выдаче.
Анкоров на странице 26 оптимально. Поисковые роботы обязательно проиндексируют сайт.
Robots.txt
Найден корректный robots.txt
Файл управления сканированием сайта роботами
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Robots.txt указывает поисковым роботам, какие страницы сканировать, а какие — нет. Ошибки в файле могут случайно закрыть важные разделы от индексации.
Кол-во редиректов для файла robots.txt 3 слишком большое! Это может вызывать затруднение при индексации поисковыми роботами!
Проверяемая страница не запрещена в robots.txt.
Robots.txt доступен по постоянному адресу
Цепочка редиректов для файла robots.txt:
http://qeios.com/robots.txt
301 MovedPermanently
http://www.qeios.com/robots.txt
301 MovedPermanently
https://www.qeios.com/robots.txt
200 OK
Показать содержимое robots.txt
User-agent: *
Allow: /register/researcher
Disallow: /register
Sitemap
Кол-во: 0
XML-карта сайта для поисковиков
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Sitemap.xml помогает поисковику быстрее находить и индексировать страницы. Особенно важен для крупных сайтов и новых страниц, на которые ещё нет входящих ссылок.
Robots.txt не содержит ссылку на карту сайта. Рекомендуется добавить карту сайта и указать ссылку на нее в robots.txt.
Внутренние ссылки
Кол-во: 15
Ссылки на другие страницы своего сайта
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Внутренние ссылки распределяют ссылочный вес между страницами и помогают поисковику обходить сайт. Пустые анкоры и ссылки на запрещённые robots.txt страницы — типичные ошибки.
Внутренних ссылок на странице 15 оптимально.
Внутренние ссылки не запрещены к индексации в robots.txt.
На странице присутствуют изображения 4.
Показать внутренние ссылки
| Url | Анкор | Состояние | Анализировать |
|---|---|---|---|
| /peer-approved-articles |
Peer-approved
|
|
Анализировать url |
| /preprints |
Preprints
|
|
Анализировать url |
| /archive |
Archive
|
|
Анализировать url |
| /about |
About
|
|
Анализировать url |
| /ethics |
Ethics
|
|
Анализировать url |
| /plans |
Plans
|
|
Анализировать url |
| /login |
Log in
|
|
Анализировать url |
| /indexing |
more
|
|
Анализировать url |
| /article-submission-form |
Submit a paper
|
|
Анализировать url |
| /read/TU6VRN.2 |
<p class="teaser-articles-per-domain__article-category">Research Article</p>
<h4 class="teaser-articles-per-domain__article-title">Impact of the Revised Common Rule on Enhancing Human Research Subject Protections and Reducing Researcher Burdens</h4>
<p class="teaser-articles-per-domain__authors">
Min Fu Tsan
</p>
<publication-rating-overview :publication="{"id":10747,"title":"Impact of the Revised Common Rule on Enhancing Human Research Subject Protections and Reducing Researcher Burdens","qeios_id":"TU6VRN.2","published_at":"2025-03-03T10:09:12.000000Z","created_at":"2025-03-03T10:09:12.000000Z","updated_at":"2026-08-22T08:24:09.000000Z","abstract":"<div class=\"ck-publication-abstract-context\"><p><strong>Objectives:<\/strong> The Common Rule, the U.S. Basic Federal Policy for Protection of Human Research Subjects, was revised extensively in 2018 to modernize the regulations by enhancing protections for human research subjects and reducing unnecessary burden and ambiguity for researchers. It was implemented on January 21, 2019. The purpose of this study was to determine whether the revised Common Rule, in fact, enhanced human research subject protections and reduced burdens on researchers.<\/p><p><strong>Methods:<\/strong> Analysis of data collected on the performance of human research protection programs from 107-109 Department of Veterans Affairs research facilities between 2016 and 2024 was carried out to evaluate the impact of the revised Common Rule at five and a half years after its implementation.<\/p><p><strong>Results: <\/strong>At five and a half years after the implementation of the revised Common Rule, when 77% of all active human research protocols were under the revised Common Rule requirements, there was an increase of 259% in the number of exempt protocols and a reduction of 44% in the number of protocols requiring institutional review board (IRB) continuing reviews. However, analysis of human research subject protection performance metric data during the same period revealed that of the five human research subject protection performance metrics studied, two, i.e., unanticipated, serious, research-related adverse events, and research conducted without IRB approval, remained unchanged, while three, i.e., required informed consent and Health Insurance Portability and Accountability Act authorization not obtained, as well as continued research activities during a lapse in IRB continuing reviews, deteriorated.<\/p><p><strong>Conclusions:<\/strong> The revised Common Rule achieved its objective of reducing the burden of low-risk studies on researchers. However, it appeared to impair, instead of enhance, human research subject protections.<\/p><\/div>","body":"<p><strong>Corresponding author:<\/strong> Min-Fu Tsan, <a href=\"mailto:minfu.tsan@gmail.com\">minfu.tsan@gmail.com<\/a><\/p><h2>Introduction<\/h2><p>The Common Rule, i.e., the U.S. Basic Federal Policy for Protection of Human Research Subjects (45 Code of Federal Regulations 46, Subpart A), which outlined provisions for the institutional review board (IRB), informed consent form, and assurance of compliance, was revised extensively in 2018<sup data-reference-id=\"av5e0esChw8u\" id=\"A0HeE0iEBJW9\"><a href=\"#av5e0esChw8u\">[1]<\/a><\/sup>. From the initial issuance of the Advance Notice of Proposed Rule-Making in 2011 to its final completion in 2018, this revision took 7 years to complete<sup data-reference-id=\"NXgBjmRRIKai\" id=\"aqWeljmukzgI\"><a href=\"#NXgBjmRRIKai\">[2]<\/a><\/sup>. According to the Office for Human Research Protections, the federal office responsible for the implementation and oversight of the Common Rule, the intended purpose of revising the Common Rule was to modernize the regulations by i) enhancing protections for human research subjects, and ii) reducing unnecessary burden and ambiguity for researchers. To accomplish these objectives, the revisions included, but were not limited to, improving informed consent so that potential participants would be better informed when making decisions about whether to participate in particular research studies; reducing the burdens of low-risk studies to allow IRBs and researchers to focus on high-risk studies; and requiring the use of a single-IRB review for multi-site studies in the U.S., eliminating the time and effort associated with multiple IRB reviews and the need for reconciling different IRB determinations and requirements<sup data-reference-id=\"av5e0esChw8u\" id=\"HcX3mzmH5XTp\"><a href=\"#av5e0esChw8u\">[1]<\/a><\/sup><sup data-reference-id=\"oRBRntfbvbAx\" id=\"mTr9cQJW8AWK\"><a href=\"#oRBRntfbvbAx\">[3]<\/a><\/sup>.<\/p><p>To achieve the objective of reducing unnecessary burden and ambiguity for researchers, the revised Common Rule expanded the exempt research categories from 6 to 8, reduced the number of protocols requiring IRB continuing reviews, and required the use of a single-IRB review for multi-site studies<sup data-reference-id=\"av5e0esChw8u\" id=\"oMOx6YTMSMNJ\"><a href=\"#av5e0esChw8u\">[1]<\/a><\/sup><sup data-reference-id=\"oRBRntfbvbAx\" id=\"QeZeGJqtd65h\"><a href=\"#oRBRntfbvbAx\">[3]<\/a><\/sup>. However, the revised Common Rule included no specific provisions that were designed to enhance human research subject protections. This was in part because there were no procedures or interventions that had been shown to improve human research subject protections, as prior to 2018, we didn\u2019t know how to measure human research subject protections<sup data-reference-id=\"KH6mUe8fYXlc\" id=\"xteVvHAanIrS\"><a href=\"#KH6mUe8fYXlc\">[4]<\/a><\/sup>. The proposed new requirements for informed consent may improve the quality of informed consent, leading to potential participants being better informed when making decisions about whether to participate in particular research studies<sup data-reference-id=\"eN19iS7IZsvF\" id=\"sSY7GG152ERH\"><a href=\"#eN19iS7IZsvF\">[5]<\/a><\/sup>. However, whether this improvement will lead to improved human research subject protections is not clear.<\/p><p>The Department of Veterans Affairs (VA) health care system is the largest integrated health care system in the U.S., with 107-109 VA medical centers conducting research involving human subjects. In the current study, data collected on the performance of human research protection programs at these VA research facilities from 2016 through 2024 were analyzed to determine the impact of the revised Common Rule on enhancing human research subject protections and reducing researcher burdens at five and a half years after the implementation of the revised Common Rule.<\/p><h2>Methods<\/h2><h3>Data collection<\/h3><p>Collection of VA human research protection program performance data was carried out as described previously by Tsan and Puglisi<sup data-reference-id=\"AJInDtbiHG9m\" id=\"OdvXvbekZDBq\"><a href=\"#AJInDtbiHG9m\">[6]<\/a><\/sup>. Briefly, as part of a quality assurance program, the VA Office of Research Oversight has collected quality assurance data from all VA human research protection programs each year starting in 2010. The Office of Research Oversight required facility research compliance officers to conduct audits of all informed consent documents annually and regulatory audits of all human research protocols once every three years using auditing tools developed by the Office of Research Oversight (available at <a target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/www.va.gov\/ORO\/orochecklists.asp\">https:\/\/www.va.gov\/ORO\/orochecklists.asp<\/a>). Approximately one third of all active human research protocols were audited each year. For protocols that had been active for more than three years, protocol regulatory audits were limited to the last three years of research. Using a web-based system, results of these audits conducted between June 1 and May 31 of each year were collected from all VA research facilities<sup data-reference-id=\"AJInDtbiHG9m\" id=\"oqOOQ8baWM9M\"><a href=\"#AJInDtbiHG9m\">[6]<\/a><\/sup>.<\/p><p>Data on the numbers of exempt protocols and protocols requiring IRB continuing reviews, as well as human research subject protection performance metrics collected from 2016 through 2024, were analyzed to evaluate the impact of the revised Common Rule. Human research subject protection performance metrics consisted of the following five performance metrics:<\/p><ul style=\"list-style-type:disc;\"><li>Local adverse events (as opposed to external adverse events in a multi-site research protocol) that were determined by IRBs to be serious, unanticipated, and related or probably related to research;<\/li><li>Required informed consent was not obtained from the subjects or subject\u2019s legally authorized representatives;<\/li><li>Required Health Insurance Portability and Accountability Act (HIPAA) authorization was not obtained from subjects or subject\u2019s legally authorized representatives;<\/li><li>Non-exempt research was conducted without IRB review and approval; and<\/li><li>Research activities were continued during a lapse in IRB continuing reviews, except when the IRB determined that it was in the best interest of already enrolled subjects to continue participating in the research<sup data-reference-id=\"AJInDtbiHG9m\" id=\"CY23ZFEjUUBp\"><a href=\"#AJInDtbiHG9m\">[6]<\/a><\/sup>.<\/li><\/ul><p>The revised Common Rule was implemented on January 21, 2019. Data from 3 years between 2016 and 2018 were collected prior to the implementation of the revised Common Rule, while data from 5 years between 2020 and 2024 were collected after its implementation. Twenty nineteen (2019) was a transitional year. It contained approximately 7 months (from June 1, 2018, to January 20, 2019) of pre-implementation data and approximately 5 months (from January 21, 2019, to May 31, 2019) of post-implementation data.<\/p><h3>Protection of human research subjects Statement<\/h3><p>This quality assurance project did not involve human subjects and did not collect individually identifiable information. Therefore, no IRB review and approval was required<sup data-reference-id=\"HqZpX8opL3Mv\" id=\"JN1RbM8tU8HN\"><a href=\"#HqZpX8opL3Mv\">[7]<\/a><\/sup>.<\/p><h3>Data analysis<\/h3><p>We used analysis of ordinal categorical data as described by Agresti<sup data-reference-id=\"QoymTcrhTDi4\" id=\"x0NhQdjbWTCb\"><a href=\"#QoymTcrhTDi4\">[8]<\/a><\/sup>&nbsp;to determine the trend of change of these performance data from 2016 through 2024. This was carried out using JavaStat ordinal contingency table analysis available at <a target=\"_blank\" rel=\"noopener noreferrer\" href=\"http:\/\/www.statpages.info\">www.statpages.info<\/a>. A <i>p <\/i>value of &lt; 0.05 was considered to be statistically significant. For those performance data with statistically significant changes, we also calculated percent changes from 2016 through 2024 using the following formula:<\/p><p>Percent change = [(rate in 2024 \u2013 rate in 2016) \u00f7 rate in 2016] x 100<sup data-reference-id=\"bgXsOLrsGnap\" id=\"PLEPRBMIOUPq\"><a href=\"#bgXsOLrsGnap\">[9]<\/a><\/sup>.<\/p><h2>Results<\/h2><h3>Implementation of the revised Common Rule<\/h3><p>The revised Common Rule requirements applied to human research protocols that were exempt or required to be approved by an IRB on or after January 21, 2019, and those that had been approved by an IRB prior to January 21, 2019, but were determined by an IRB to be transitioned to the revised Common Rule requirements. Protocols that were exempt or approved by an IRB prior to January 21, 2019, continued to be subjected to pre-revised Common Rule requirements, unless they were transitioned to the revised Common Rule requirements as described above<sup data-reference-id=\"av5e0esChw8u\" id=\"CDM0AbgJmetZ\"><a href=\"#av5e0esChw8u\">[1]<\/a><\/sup>.<\/p><p>Table 1 shows data from 2016 through 2024 on the numbers and rates of protocols subjected to the revised Common Rule requirements. As shown here, the rates of protocols subjected to the revised Common Rule requirements increased progressively from 28.7% in 2020 to 77.0% in 2024.<\/p><figure class=\"table\"><table><thead><tr><th>&nbsp;<\/th><th>2016<\/th><th>2017<\/th><th>2018<\/th><th>2019<\/th><th>2020<\/th><th>2021<\/th><th>2022<\/th><th>2023<\/th><th>2024<\/th><\/tr><tr><th>Total number of active protocols<\/th><th>15,699<\/th><th>15,279<\/th><th>15,258<\/th><th>15,061<\/th><th>14,637<\/th><th>15,015<\/th><th>14,917<\/th><th>14,685<\/th><th>14,484<\/th><\/tr><\/thead><tbody><tr><td>Protocols Subjected to revised Common Rule requirements<\/td><td>0<\/td><td>0<\/td><td>0<\/td><td>\u2014<sup>1<\/sup><\/td><td>4,201<br>(28.7%)<\/td><td>7,207<br>(48.0%)<\/td><td>9,142<br>(61.3%)<\/td><td>10,465<br>(71.3%)<\/td><td>11,153<br>(77.0%)<\/td><\/tr><\/tbody><\/table><figcaption><strong>Table 1. <\/strong>Implementation of the revised Common Rule<\/figcaption><\/figure><p><sup>1 <\/sup><i>Data not collected<\/i><\/p><h3>Number of exempt protocols and IRB continuing reviews<\/h3><p>The revised Common Rule expanded the exempt categories from 6 to 8, adding Category 7, storage of identifiable private information or identifiable biospecimens for secondary research for which broad consent is required, and Category 8, secondary research using identifiable private information or identifiable biospecimens for which broad consent is required<sup data-reference-id=\"av5e0esChw8u\" id=\"b9AIdmRzTlnW\"><a href=\"#av5e0esChw8u\">[1]<\/a><\/sup>.<\/p><p>Prior to the revision, the Common Rule required IRBs to conduct continuing review of ongoing research at intervals appropriate to the degree of risk, but not less than annually. The revised Common Rule removed the annual IRB continuing review requirements for studies approved using expedited review procedures and for studies merely analyzing study data after completing all study interventions or involving only observational follow-up in conjunction with standard clinical care<sup data-reference-id=\"av5e0esChw8u\" id=\"wTqZOiu9iz36\"><a href=\"#av5e0esChw8u\">[1]<\/a><\/sup><sup data-reference-id=\"oRBRntfbvbAx\" id=\"KzpQddhgLnDP\"><a href=\"#oRBRntfbvbAx\">[3]<\/a><\/sup>.<\/p><p>The above changes in the revised Common Rule requirements should markedly increase the number of exempt protocols and reduce the number of protocols requiring IRB continuing reviews. However, the extent of these changes is not clear.<\/p><p>Table 2 shows data collected from 2016 through 2024 on the total numbers of active protocols each year, numbers and rates of exempt protocols, numbers of protocols audited, and numbers and rates of protocols requiring IRB continuing reviews.<\/p><p>As shown in Table 2, the number of exempt protocols increased from approximately 6% of the total number of active protocols in 2016-18 to 21.9% in 2024, an increase of 259%. In contrast, the number of protocols requiring IRB continuing reviews decreased from 83.2% in 2016 to 46.9% in 2024, a reduction of 44%.<\/p><figure class=\"table\"><table><thead><tr><th>&nbsp;<\/th><th>2016<\/th><th>2017<\/th><th>2018<\/th><th>2019<\/th><th>2020<\/th><th>2021<\/th><th>2022<\/th><th>2023<\/th><th>2024<\/th><th><i>P <\/i>value<sup>1<\/sup><\/th><th>Change (%)<sup>2<\/sup><\/th><\/tr><tr><th>Total number of active protocols&nbsp;<\/th><th>15,699<\/th><th>15,279<\/th><th>15,258<\/th><th>15,061<\/th><th>14,637<\/th><th>15,015<\/th><th>14,917<\/th><th>14,685<\/th><th>14,484<\/th><th>&nbsp;<\/th><th>&nbsp;<\/th><\/tr><\/thead><tbody><tr><td>Exempt protocols<\/td><td>960<br>(6.1%)<sup>3<\/sup><\/td><td>943<br>(6.2%)<\/td><td>946<br>(6.2%)<\/td><td>1,145<br>(7.7%)<\/td><td>1,878<br>(12.8%)<\/td><td>2,379<br>(15.8%)<\/td><td>2,738<br>(18.4%)<\/td><td>3,044<br>(20.7%)<\/td><td>3,170<br>(21.9%)<\/td><td>0.0000<\/td><td>+259%<\/td><\/tr><tr><td>Total number of protocols audited&nbsp;<\/td><td>3,801<\/td><td>3,573<\/td><td>3,564<\/td><td>3,569<\/td><td>3,348<\/td><td>3,540<\/td><td>3,349<\/td><td>3,441<\/td><td>3,201<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Protocols requiring IRB<sup>4 <\/sup>continuing review<\/td><td>3,162<br>(83.2%)<\/td><td>3,094<br>(86.6%)<\/td><td>3,035<br>(85.2%)<\/td><td>2,861<br>(80.2%)<\/td><td>2,547<br>(76.1%)<\/td><td>2,205<br>(62.3%)<\/td><td>1,900<br>(56.7%)<\/td><td>1,606<br>(46.7%)<\/td><td>1,501<br>(46.9%)<\/td><td>0.0000<\/td><td>-44%<\/td><\/tr><\/tbody><\/table><figcaption><strong>Table 2. <\/strong>Impact of revised Common Rule on Exempt protocols and IRB continuing reviews<\/figcaption><\/figure><p><sup>1 <\/sup><i>Determined using analysis of ordered categories for the trend of changes from 2016 through 2024.<\/i><br><sup>2<\/sup><i> Percent change from 2016 to 2024.<\/i><br><sup>3<\/sup><i> The numbers in parentheses were the percentages of the total number of active protocols or protocols audited.<\/i><br><sup>4 <\/sup><i>Abbreviation used: IRB, institutional review board.&nbsp;<\/i><\/p><h3>Protecting human subjects participating in research<\/h3><p>The human research subject protection performance metrics proposed by Tsan &amp; Puglisi<sup data-reference-id=\"AJInDtbiHG9m\" id=\"FR3zicROL63K\"><a href=\"#AJInDtbiHG9m\">[6]<\/a><\/sup>&nbsp;were used to assess the impact of the revised Common Rule on enhancing human research subject protections.<\/p><p><strong>Unanticipated, serious and research-related adverse events: <\/strong>Table 3 shows data from 2016 through 2024 on the numbers and rates of local adverse events that were determined by IRBs to be serious, unanticipated, and related or probably related to research. The numbers of protocols audited each year ranged from 3,201 in 2024 to 3,801 in 2016.<\/p><p>The rates of local adverse events that were determined to be serious, unanticipated, and related or probably related to research were low, ranging from 0.36%, i.e., 0.36 events per 100 protocols, in 2017, to 1.09% in 2018. There was no statistically significant trend of change from 2016 through 2024.<\/p><figure class=\"table\"><table><thead><tr><th>&nbsp;<\/th><th>2016<\/th><th>2017<\/th><th>2018<\/th><th>2019<\/th><th>2020<\/th><th>2021<\/th><th>2022<\/th><th>2023<\/th><th>2024<\/th><th><i>P&nbsp;<\/i>value<sup>1<\/sup><\/th><th>Change (%)<sup>2<\/sup><\/th><\/tr><tr><th>Total number of active protocols&nbsp;<\/th><th>15,699<\/th><th>15,279<\/th><th>15,258<\/th><th>15,061<\/th><th>14,637<\/th><th>15,015<\/th><th>14,917<\/th><th>14,685<\/th><th>14,484<\/th><th>&nbsp;<\/th><th>&nbsp;<\/th><\/tr><\/thead><tbody><tr><td>Total number of protocols audited&nbsp;<\/td><td>3,801<\/td><td>3,573<\/td><td>3,564<\/td><td>3,569<\/td><td>3,348<\/td><td>3,540<\/td><td>3,349<\/td><td>3,441<\/td><td>3,201<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Local adverse events that are serious, unanticipated, and related to research<\/td><td>15<br>(0.39%)<sup>3<\/sup><\/td><td>13<br>(0.36%)<\/td><td>39<br>(1.09%)<\/td><td>15<br>(0.42%)<\/td><td>18<br>(0.54%)<\/td><td>13<br>(0.37%)<\/td><td>19<br>(0.56%)<\/td><td>20<br>(0.58%)<\/td><td>25<br>(0.78%)<\/td><td>0.2763<\/td><td>N\/A<sup>4<\/sup><\/td><\/tr><\/tbody><\/table><figcaption><strong>Table 3.<\/strong>&nbsp;Local adverse events determined to be serious, unanticipated, and related or probably related to research<\/figcaption><\/figure><p><sup>1 <\/sup><i>Determined using analysis of ordered categories for the trend of changes from 2016 through 2024.<\/i><br><sup>2<\/sup><i> Percent change from 2016 to 2024.<\/i><br><sup>3<\/sup><i> The numbers in parentheses were the percentages of the total number of protocols audited.&nbsp;<\/i><br><sup>4<\/sup><i><sup>&nbsp;<\/sup>N\/A denotes not applicable<\/i><\/p><p><strong>Informed consent and HIPAA authorization:<\/strong> Table 4 shows data from 2016 through 2024 on the numbers of informed consent documents audited each year; numbers and rates of informed consent documents that were not obtained; numbers of HIPAA authorizations required; and numbers and rates of these authorizations that were not obtained.<\/p><p>The numbers of informed consent documents audited ranged from 35,323 in 2021 to 90,153 in 2017. The rates of informed consent documents not obtained, which included missing informed consent documents as well as informed consent documents not signed by the subjects or legally authorized representatives, were small, ranging from 0.03% in 2016 to 0.39% in 2021. There was a statistically significant trend of change, increasing from 0.03% in 2016 to 0.12% in 2024, an increase (or deterioration) of 300%.<\/p><p>The numbers of protocols requiring HIPAA authorizations audited ranged from 33,356 in 2021 to 87,045 in 2017. The rates of required HIPAA authorizations not obtained were small, ranging from 0.56% in 2016 to 1.43% in 2021. There was a statistically significant trend of change, increasing from 0.56% in 2016 to 0.85% in 2024, an increase (or deterioration) of 52%.<\/p><figure class=\"table\"><table><thead><tr><th>&nbsp;<\/th><th>2016<\/th><th>2017<\/th><th>2018<\/th><th>2019<\/th><th>2020<\/th><th>2021<\/th><th>2022<\/th><th>2023<\/th><th>2024<\/th><th><i>P&nbsp;<\/i>value<sup>1<\/sup><\/th><th>Change (%)<sup>2<\/sup><\/th><\/tr><tr><th>Total number of active protocols&nbsp;<\/th><th>15,699<\/th><th>15,279<\/th><th>15,258<\/th><th>15,061<\/th><th>14,637<\/th><th>15,015<\/th><th>14,917<\/th><th>14,685<\/th><th>14,484<\/th><th>&nbsp;<\/th><th>&nbsp;<\/th><\/tr><\/thead><tbody><tr><td>Total number of protocols audited&nbsp;<\/td><td>15,629<\/td><td>15,264<\/td><td>15,233<\/td><td>1,892<\/td><td>13,985<\/td><td>12,066<\/td><td>11,584<\/td><td>10,850<\/td><td>11,272<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Total number of ICDs<sup>3<\/sup> audited<\/td><td>89,024<\/td><td>90,153<\/td><td>82,849<\/td><td>73,331<\/td><td>57,827<\/td><td>35,323<\/td><td>52,525<\/td><td>61,237<\/td><td>71,724<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Informed consent not obtained<\/td><td>29<br>(0.03%)<sup>4<\/sup><\/td><td>34<br>(0.04%)<\/td><td>85<br>(0.11%)<\/td><td>74<br>(0.10%)<\/td><td>38<br>(0.07%)<\/td><td>138<br>(0.39%)<\/td><td>33<br>(0.06%)<\/td><td>64<br>(0.10%)<\/td><td>84<br>(0.12%)<\/td><td>0.0000<\/td><td>+300%<\/td><\/tr><tr><td>Total number of HIPAA authorizations required<\/td><td>86,109<\/td><td>87,045<\/td><td>78,372<\/td><td>69,970<\/td><td>52,756<\/td><td>33,356<\/td><td>46,218<\/td><td>55,417<\/td><td>66,185<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>HIPAA authorizations not obtained<\/td><td>486<br>(0.56%)<\/td><td>572<br>(0.66%)<\/td><td>518<br>(0.66%)<\/td><td>529<br>(0.76%)<\/td><td>535<br>(1.01%)<\/td><td>477<br>(1.43%)<\/td><td>337<br>(0.73%)<\/td><td>527<br>(0.95%)<\/td><td>562<br>(0.85%)<\/td><td>0.0000<\/td><td>+52%<\/td><\/tr><\/tbody><\/table><figcaption><strong>Table 4.<\/strong> Informed consent documents and Health Insurance Portability and Accountability Act authorizations&nbsp;<\/figcaption><\/figure><p><sup>1 <\/sup><i>Determined using analysis of ordered categories for the trend of changes from 2016 through 2024.<\/i><br><sup>2<\/sup><i> Percent change from 2016 to 2024.<\/i><br><sup>3<\/sup><i> Abbreviations used: ICD, informed consent document; HIPAA, Health Insurance Portability and Accountability.<\/i><br><sup>4<\/sup><i> The numbers in parentheses were the percentages of the total number of protocols audited or HIPAA authorizations required.<\/i><\/p><p><br><strong>Institutional review board initial and continuing reviews: <\/strong>Table 5 shows data from 2016 through 2024 on the numbers and rates of protocols conducted and completed without IRB review and approval; and the numbers and rates of protocols for which investigators continued research activities during a lapse in required IRB continuing reviews.<\/p><p>The numbers of protocols audited each year ranged from 3,201 in 2024 to 3,801 in 2016. Only one protocol was conducted without IRB approval in 2023. There was no statistically significant trend of change from 2016 through 2024.<\/p><p>The number of protocols requiring IRB continuing reviews ranged from 1,501 in 2024 to 3,162 in 2016. The rates of protocols for which investigators continued research activities during a lapse in IRB continuing reviews were small, ranging from 0.00% to 0.19%. There was a statistically significant trend of change from 0.00% in 2016 to 0.13% in 2024.<\/p><figure class=\"table\"><table><thead><tr><th>&nbsp;<\/th><th>2016<\/th><th>2017<\/th><th>2018<\/th><th>2019<\/th><th>2020<\/th><th>2021<\/th><th>2022<\/th><th>2023<\/th><th>2024<\/th><th><i>P&nbsp;<\/i>value<sup>1<\/sup><\/th><th>Change (%)<sup>2<\/sup><\/th><\/tr><tr><th>Total number of active protocols<\/th><th>15,699<\/th><th>15,279<\/th><th>15,258<\/th><th>15,061<\/th><th>14,637<\/th><th>15,015<\/th><th>14,917<\/th><th>14,685<\/th><th>14,484<\/th><th>&nbsp;<\/th><th>&nbsp;<\/th><\/tr><\/thead><tbody><tr><td>Total number of protocols audited<\/td><td>3,801<\/td><td>3,573<\/td><td>3,564<\/td><td>3,569<\/td><td>3,348<\/td><td>3,540<\/td><td>3,349<\/td><td>3,441<\/td><td>3,201<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Conducted without IRB<sup>3 <\/sup>approval<\/td><td>0&nbsp;<br>(0.00%)<sup>4<\/sup><\/td><td>0&nbsp;<br>(0.00%)<\/td><td>0&nbsp;<br>(0.00%)<\/td><td>0&nbsp;<br>(0.00%)<\/td><td>0&nbsp;<br>(0.00%)<\/td><td>0<br>(0.00%)<\/td><td>0<br>(0.00%)<\/td><td>1<br>(0.03%)<\/td><td>0<br>(0.00%)<\/td><td>0.2316<\/td><td>N\/A<sup>5<\/sup><\/td><\/tr><tr><td>Total number of protocols requiring IRB continuing reviews<\/td><td>3,162<\/td><td>3,094<\/td><td>3,035<\/td><td>2,861<\/td><td>2,547<\/td><td>2,205<\/td><td>1,900<\/td><td>1,606<\/td><td>1,501<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Continued research activities during lapse<\/td><td>0&nbsp;<br>(0.00%)<\/td><td>0<br>(0.00%)<\/td><td>3<br>(0.10%)<\/td><td>0<br>(0.00%)<\/td><td>2<br>(0.08%)<\/td><td>0<br>(0.00%)<\/td><td>2<br>(0.11%)<\/td><td>3<br>(0.19%)<\/td><td>2<br>(0.13%)<\/td><td>0.0106<\/td><td>XX<sup>6<\/sup><\/td><\/tr><\/tbody><\/table><figcaption><strong>Table 5. <\/strong>Institutional review board initial and continuing reviews<\/figcaption><\/figure><p><sup>1&nbsp;<\/sup><i>Determined using analysis of ordered categories for the trend of changes from 2016 through 2024.<\/i><br><sup>2<\/sup><i> Percent change from 2016 to 2024.<\/i><br><sup>3<\/sup><i> Abbreviations used: IRB, institutional review board.<\/i><br><sup>4<\/sup><i> The numbers in parentheses were the percentages of the total number of protocols audited or requiring IRB continuing reviews.<\/i><br><sup>5<\/sup><i><sup>&nbsp;<\/sup>N\/A denotes not applicable.<\/i><br><sup>6<\/sup><i><sup> <\/sup>XX Unable to calculate, because the 2016 value was zero.<\/i><\/p><h2>Discussion<\/h2><p>The results presented in this report demonstrated that at five and a half years after the implementation of the revised Common Rule on January 21, 2019, when 77% of all active human research protocols were under the revised Common Rule requirements, there had been an increase of 259% in the number of exempt protocols and a reduction of 44% in the number of protocols requiring IRB continuing reviews from 2016 to 2024. Thus, the revised Common Rule has achieved its objective of markedly reducing the burden of low-risk studies on researchers.<\/p><p>On the other hand, these results also revealed that there had been no enhancement in human research subject protections. Of the five human research subject protection performance metrics studied, two, i.e., unanticipated, serious, research-related adverse events, and research conducted without IRB approval, remained unchanged, while three, i.e., required informed consent and HIPAA authorization not obtained, as well as continued research activities during a lapse in IRB continuing reviews, deteriorated. These data suggested that instead of enhancing human research subject protections, the implementation of the revised Common Rule appeared to reduce human research subject protections.<\/p><p>Specifically, the revised Common Rule did not affect the rates of unanticipated physical and psychological harms experienced by research participants (the first performance metric). However, it caused a 300% increase and a 52% increase in dignitary harms to research participants due to violations of their autonomy and privacy rights, respectively (the second and third performance metrics). Finally, while there was no change in the rate of research conducted without IRB review and approval (the fourth performance metric), there was a statistically significant increase in the rate of investigators continuing research activities during a lapse in IRB continuing reviews (the fifth performance metric), which placed research subjects at an increased risk of harm in the absence of objective oversight.<\/p><p>The questions are how the implementation of the revised Common Rule, which was intended to enhance human research subject protections, led to increased dignitary harms to research participants, and how the implementation of the revised Common Rule, while markedly reducing the number of protocols requiring IRB continuing reviews, led to more investigators continuing research activities during a lapse in required IRB continuing reviews?<\/p><p>It was disappointing that five and a half years after the implementation of the revised Common Rule, we found that the revised Common Rule actually hindered human research subject protections, instead of enhancing it as the Office for Human Research Protections claimed. However, considering the following observations, this may not be something that is unexpected.<\/p><ul style=\"list-style-type:disc;\"><li>Despite one of the objectives for revising the Common Rule being to enhance human research subject protections, the revised Common Rule didn\u2019t include any provisions that were designed to improve human research subject protections. We knew this was the case because there were no procedures or interventions that had been shown to improve human research subject protections, as prior to 2018, we didn\u2019t know how to measure human research subject protections<sup data-reference-id=\"KH6mUe8fYXlc\" id=\"4xD00eK0Puhl\"><a href=\"#KH6mUe8fYXlc\">[4]<\/a><\/sup>.<\/li><\/ul><ul><li>The revised Common Rule contained provisions designed to improve informed consent so that potential participants would be better informed when making decisions about whether to participate in particular research studies. These included giving prospective participants information a reasonable person would want to know to make a decision about whether to participate in research, providing sufficient detail, reorganizing consent forms to facilitate understanding, and presenting concise and focused key information at the beginning<sup data-reference-id=\"av5e0esChw8u\" id=\"pA1ZO8SbCjQv\"><a href=\"#av5e0esChw8u\">[1]<\/a><\/sup><sup data-reference-id=\"oRBRntfbvbAx\" id=\"YX9R9fVirrNG\"><a href=\"#oRBRntfbvbAx\">[3]<\/a><\/sup>. However, the revised Common Rule didn\u2019t provide sufficient guidelines on how these requirements should be implemented, including what constitutes information a reasonable person would want to know to make a decision about whether to participate in research and what constitutes concise and focused \u201ckey information.\u201d<sup data-reference-id=\"lZpdPg6xPKn6\" id=\"GNIGotzWkjsF\"><a href=\"#lZpdPg6xPKn6\">[10]<\/a><\/sup><sup data-reference-id=\"2WaDAOsJbERT\" id=\"DhPCcoLVPfb7\"><a href=\"#2WaDAOsJbERT\">[11]<\/a><\/sup>&nbsp;As a result, there has been no study demonstrating whether these new requirements have achieved the goal of improving potential participants\u2019 understanding of the informed consent, thereby facilitating their decisions on whether to participate in the research.<\/li><li>The revised Common Rule required the use of a single-IRB review for multi-site studies in the U.S., eliminating the time and effort associated with multiple IRB reviews and the need for reconciling different IRB determinations and requirements.<sup data-reference-id=\"av5e0esChw8u\" id=\"Mmgq1r8MMzxE\"><a href=\"#av5e0esChw8u\">[1]<\/a><\/sup><sup data-reference-id=\"oRBRntfbvbAx\" id=\"EbFLh1Y808F6\"><a href=\"#oRBRntfbvbAx\">[3]<\/a><\/sup>&nbsp;The potential benefits of a single-IRB review for multi-site studies had been previously well documented using the experience of the National Cancer Institute Central IRB.<sup data-reference-id=\"YcLj9rluKAoU\" id=\"leoJ1uEY3Sbg\"><a href=\"#YcLj9rluKAoU\">[12]<\/a><\/sup>&nbsp;However, the implementation of this revised Common Rule requirement for the use of a single-IRB review for all federally funded\/supported multi-site studies is daunting.<sup data-reference-id=\"HBr3L84fzZmq\" id=\"y55TkvUzZHUe\"><a href=\"#HBr3L84fzZmq\">[13]<\/a><\/sup><sup data-reference-id=\"o4lyzMjW9l4A\" id=\"eYU7HRb90UsL\"><a href=\"#o4lyzMjW9l4A\">[14]<\/a><\/sup>&nbsp;In a National Institutes of Health-sponsored workshop in 2022 examining why single-IRB review remained problematic, the workshop participants identified several major barriers such as additional responsibilities for study teams, persistent duplicative review processes, the lack of harmonization of policies and processes across institutions, the absence of additional guidance from federal agencies, and the need for greater flexibility in policy requirements. The workshop recommended additional resources and training for research teams, the commitment of institutional leaders to harmonize practices, and for policy makers to critically evaluate the requirements and provide flexibility in applicability.<sup data-reference-id=\"o4lyzMjW9l4A\" id=\"IYjhJOVAYaao\"><a href=\"#o4lyzMjW9l4A\">[14]<\/a><\/sup><\/li><\/ul><p>It is clear that the implementation of the revised Common Rule is complex. The difficulties and confusions in implementing these revised Common Rule requirements, together with the disruptions caused by the coronavirus disease 2019 (COVID-19) pandemic in the U.S. between 2020 and 2022, might have prevented institutions and investigators from focusing on research and human research subject protections, leading to unfortunate lapses in obtaining informed consent and HIPAA authorization as required and investigators continuing research activities during lapses in IRB continuing reviews, as demonstrated in this study.<\/p><p>In a preliminary analysis of 16 performance metrics related to IRB, Tsan and Van Hook<sup data-reference-id=\"AxwBVV7QgIIe\" id=\"nxAKWvMMZ3Lm\"><a href=\"#AxwBVV7QgIIe\">[15]<\/a><\/sup>&nbsp;reported that two and a half years after the implementation of the revised Common Rule, when 48% of all active protocols were under the revised Common Rule requirement, 4 improved, 4 deteriorated, and 8 remained unchanged from 2016 through 2021. The 4 performance metrics that deteriorated were all related to informed consent documents and HIPAA authorization requirements. It was speculated at that time that the disruptions caused by the COVID-19 pandemic in the U.S. in 2020 and 2021 were largely responsible for the observed deteriorations.<sup data-reference-id=\"AxwBVV7QgIIe\" id=\"jbdITjwRUDdp\"><a href=\"#AxwBVV7QgIIe\">[15]<\/a><\/sup><\/p><p>In view of the continued deterioration of the second and third human research subject protection performance metrics and the development of an increased rate of investigators continuing research activities during a lapse in IRB continuing reviews (the fifth performance metric), when the COVID-19 pandemic was under control in the U.S. after 2022, I would have to conclude that the implementation of the revised Common Rule was largely responsible for the observed deterioration of the second, third, and fifth human research subject protection performance metrics from 2016 through 2024.<\/p><p>As we overcome the difficulties in implementing the revised Common Rule in the coming years, we hope to see human research subject protection performance metrics return to the levels of the pre-implementation years, i.e., 2016-2018. However, as the revised Common Rule didn\u2019t include any specific provisions that would enhance human research subject protections, I don\u2019t expect any improvement in human research subject protections as a result of the revised Common Rule.<\/p><p>It would have been helpful if the Office for Human Research Protections, in its commentary, had indicated explicitly which provisions in the Revised Common Rule were designed to enhance human research subject protections and how protections of human research subjects should be assessed.<sup data-reference-id=\"oRBRntfbvbAx\" id=\"rNuOfKdY6YKz\"><a href=\"#oRBRntfbvbAx\">[3]<\/a><\/sup>&nbsp;Implementation of new regulatory requirements is the best opportunity to find out whether the new requirements lead to improved human research subject protections. Lessons learned from the current revision will undoubtedly guide us for the next revision.<\/p><h2>Conclusion<\/h2><p>At five and a half years after the implementation of the revised Common Rule on January 21, 2019, when 77% of all active human research protocols were under the revised Common Rule requirements, there was an increase of 259% in the number of exempt protocols and a reduction of 44% in the number of protocols requiring IRB continuing reviews from 2016 to 2024. Thus, the revised Common Rule has achieved its objective of markedly reducing the burden of low-risk studies on researchers.<\/p><p>On the other hand, analysis of human research subject protection performance metric data during the same period revealed that there was no enhancement in human research subject protections. Of the five human research subject protection performance metrics studied, two, i.e., unanticipated, serious, research-related adverse events, and research conducted without IRB approval, remained unchanged, while three, i.e., required informed consent and HIPAA authorization not obtained, as well as continued research activities during a lapse in IRB continuing reviews, deteriorated. Thus, instead of enhancing human research subject protections, the implementation of the revised Common Rule appeared to reduce human research subject protections.<\/p><h2>Notes<\/h2><p><strong>Running title: <\/strong>Impact of the Revised Common Rule.<\/p><h2>Statements and Declarations<\/h2><h3>Data Availability<\/h3><p>The dataset used in this study (Office of Research Oversight Facility Director Certification Quality Indicator Data 2016\u20132024) is available by submitting a Freedom of Information Act (FOIA) request to vacofoiase@va.gov.<\/p><h3>Author Contributions<\/h3><p>MFT conceived the idea, conducted the analysis and interpretation of the data, and wrote the manuscript.<\/p><h3>Acknowledgements<\/h3><p>The author thanks Yen B. Nguyen, Pharm.D., and all VA research compliance officers for their contributions to conducting the audits and collecting the data presented in this report.<\/p><section class=\"references-section\"><h2 class=\"references-section__title\">References<\/h2><ol class=\"references-list\"><li class=\"reference\" id=\"av5e0esChw8u\"><sup class=\"reference-markers-links\"><a href=\"#A0HeE0iEBJW9\">a<\/a>,&nbsp;<a href=\"#HcX3mzmH5XTp\">b<\/a>,&nbsp;<a href=\"#oMOx6YTMSMNJ\">c<\/a>,&nbsp;<a href=\"#CDM0AbgJmetZ\">d<\/a>,&nbsp;<a href=\"#b9AIdmRzTlnW\">e<\/a>,&nbsp;<a href=\"#wTqZOiu9iz36\">f<\/a>,&nbsp;<a href=\"#pA1ZO8SbCjQv\">g<\/a>,&nbsp;<a href=\"#Mmgq1r8MMzxE\">h<\/a><\/sup><cite>U.S. Department of Health and Human Services (2018). \"Federal policy for the protection of human subjects: 45 code of Federal Registration (CFR) 46.\" U.S. Department of Health and Human Services. <a href=\"http:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/regulations\/45-cfr-46\/index.html\" target=\"_blank\">http:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/regulations\/45-cfr-46\/index.html<\/a>.<\/cite><\/li><li class=\"reference\" id=\"NXgBjmRRIKai\"><sup class=\"reference-markers-links\"><a href=\"#aqWeljmukzgI\">^<\/a><\/sup><cite>U.S. Department of Health and Human Services (2011). \"Human subjects research protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators.\" <i>Federal Register<\/i>. <b>76<\/b>(143):44512\u201344531.<\/cite><\/li><li class=\"reference\" id=\"oRBRntfbvbAx\"><sup class=\"reference-markers-links\"><a href=\"#mTr9cQJW8AWK\">a<\/a>,&nbsp;<a href=\"#QeZeGJqtd65h\">b<\/a>,&nbsp;<a href=\"#KzpQddhgLnDP\">c<\/a>,&nbsp;<a href=\"#YX9R9fVirrNG\">d<\/a>,&nbsp;<a href=\"#EbFLh1Y808F6\">e<\/a>,&nbsp;<a href=\"#rNuOfKdY6YKz\">f<\/a><\/sup><cite>Menikoff J, Kaneshiro J, Pritchard I (2017). \"The common rule, updated.\" <i>New Engl J Med<\/i>. <b>376<\/b>(7):613\u2013615. doi:<a href=\"https:\/\/doi.org\/10.1056\/NEJMp1700736\" target=\"_blank\">10.1056\/NEJMp1700736<\/a>.<\/cite><\/li><li class=\"reference\" id=\"KH6mUe8fYXlc\"><sup class=\"reference-markers-links\"><a href=\"#xteVvHAanIrS\">a<\/a>,&nbsp;<a href=\"#4xD00eK0Puhl\">b<\/a><\/sup><cite>Tsan MF (2024). \"How well are we protecting human research subjects?\" Qeios. doi:<a href=\"https:\/\/doi.org\/10.32388\/7RS57W\" target=\"_blank\">10.32388\/7RS57W<\/a>.<\/cite><\/li><li class=\"reference\" id=\"eN19iS7IZsvF\"><sup class=\"reference-markers-links\"><a href=\"#sSY7GG152ERH\">^<\/a><\/sup><cite>Yu M, Fischhoff B, Krishnamurti T (2019). \"Implementing a new Common Rule requirement for informed consent: A randomized trial on adult asthma patients.\" <i>MDM Policy &amp; Practice<\/i>. <b>4<\/b>:1\u20136. doi:<a href=\"https:\/\/doi.org\/10.1177\/2381468319839315\" target=\"_blank\">10.1177\/2381468319839315<\/a>.<\/cite><\/li><li class=\"reference\" id=\"AJInDtbiHG9m\"><sup class=\"reference-markers-links\"><a href=\"#OdvXvbekZDBq\">a<\/a>,&nbsp;<a href=\"#oqOOQ8baWM9M\">b<\/a>,&nbsp;<a href=\"#CY23ZFEjUUBp\">c<\/a>,&nbsp;<a href=\"#FR3zicROL63K\">d<\/a><\/sup><cite>Tsan MF, Puglisi JT (2023). \"Protecting human subjects participating in research.\" <i>Am J Transl Res<\/i>. <b>15<\/b>(9):5707\u20135714. <a href=\"http:\/\/www.ajtr.org\/ISSN:1943-8141\/AJTR0151875\" target=\"_blank\">www.ajtr.org\/ISSN:1943-8141\/AJTR0151875<\/a>.<\/cite><\/li><li class=\"reference\" id=\"HqZpX8opL3Mv\"><sup class=\"reference-markers-links\"><a href=\"#JN1RbM8tU8HN\">^<\/a><\/sup><cite>Tsan MF, Puglisi JT (2014). \"Health care operations activities that may constitute research \u2013 The Department of Veterans Affairs\u2019 perspective.\" <i>IRB<\/i>. <b>36<\/b>(1):9\u201311.<\/cite><\/li><li class=\"reference\" id=\"QoymTcrhTDi4\"><sup class=\"reference-markers-links\"><a href=\"#x0NhQdjbWTCb\">^<\/a><\/sup><cite>Agresti A (1984). <i>Analysis of Ordinal Categorical Data<\/i>. 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From the initial issuance of the Advance Notice of Proposed Rule-Making in 2011 to its final completion in 2018, this revision took 7 years to complete<sup data-reference-id=\"NXgBjmRRIKai\" id=\"aqWeljmukzgI\"><a href=\"#NXgBjmRRIKai\">[2]<\/a><\/sup>. According to the Office for Human Research Protections, the federal office responsible for the implementation and oversight of the Common Rule, the intended purpose for revising the Common Rule was to modernize the regulations by i) enhancing protections for human research subjects, and ii) reducing unnecessary burden and ambiguity for researchers. To accomplish these objectives, the revisions included, but were not limited to, improving informed consent so that potential participants would be better informed when making decisions whether to participate in particular research studies; reducing the burdens of low-risk studies to allow IRBs and researchers to focus on high-risk studies; and requiring the use of a single-IRB review for multi-site studies in the U.S., eliminating the time and effort associated with multiple IRB reviews and the need for reconciling different IRB determinations and requirements<sup data-reference-id=\"av5e0esChw8u\" id=\"HcX3mzmH5XTp\"><a href=\"#av5e0esChw8u\">[1]<\/a><\/sup><sup data-reference-id=\"oRBRntfbvbAx\" id=\"mTr9cQJW8AWK\"><a href=\"#oRBRntfbvbAx\">[3]<\/a><\/sup>.<\/p><p>To achieve the objective of reducing unnecessary burden and ambiguity for researchers, the revised Common Rule expanded the exempt research categories from 6 to 8, reduced the number of protocols requiring IRB continuing reviews, and required the use of a single-IRB review for multi-site studies<sup data-reference-id=\"av5e0esChw8u\" id=\"oMOx6YTMSMNJ\"><a href=\"#av5e0esChw8u\">[1]<\/a><\/sup><sup data-reference-id=\"oRBRntfbvbAx\" id=\"QeZeGJqtd65h\"><a href=\"#oRBRntfbvbAx\">[3]<\/a><\/sup>. However, the revised Common Rule included no specific provisions that were designed to enhance human research subject protections. This was in part because there were no procedures or interventions that had been shown to improve human research subject protections, as prior to 2018, we didn\u2019t know how to measure human research subject protections<sup data-reference-id=\"KH6mUe8fYXlc\" id=\"xteVvHAanIrS\"><a href=\"#KH6mUe8fYXlc\">[4]<\/a><\/sup>. The proposed new requirements for informed consent may improve the quality of informed consent, leading to potential participants being better informed when making decisions whether to participate in particular research studies<sup data-reference-id=\"eN19iS7IZsvF\" id=\"sSY7GG152ERH\"><a href=\"#eN19iS7IZsvF\">[5]<\/a><\/sup>. However, whether this improvement will lead to improved human research subject protections is not clear.<\/p><p>The Department of Veterans Affairs (VA) health care system is the largest integrated health care system in the U.S., with 107-109 VA medical centers conducting research involving human subjects. In the current study, data collected on the performance of human research protection programs at these VA research facilities from 2016 through 2024 were analyzed to determine the impact of the revised Common Rule on enhancing human research subject protections and reducing researcher burdens at five and a half years after the implementation of the revised Common Rule.<\/p><h2>Methods<\/h2><h3>Data collection<\/h3><p>Collection of VA human research protection program performance data was carried out as described previously by Tsan and Puglisi<sup data-reference-id=\"AJInDtbiHG9m\" id=\"OdvXvbekZDBq\"><a href=\"#AJInDtbiHG9m\">[6]<\/a><\/sup>. Briefly, as part of a quality assurance program, the VA Office of Research Oversight has collected quality assurance data from all VA human research protection programs each year starting in 2010. The Office of Research Oversight required facility research compliance officers to conduct audits of all informed consent documents annually and regulatory audits of all human research protocols once every three years using auditing tools developed by the Office of Research Oversight (available at <a target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/www.va.gov\/ORO\/orochecklists.asp\">https:\/\/www.va.gov\/ORO\/orochecklists.asp<\/a>). Approximately one third of all active human research protocols were audited each year. For protocols that had been active for more than three years, protocol regulatory audits were limited to the last three years of research. Using a web-based system, results of these audits conducted between June 1 and May 31 of each year were collected from all VA research facilities<sup data-reference-id=\"AJInDtbiHG9m\" id=\"oqOOQ8baWM9M\"><a href=\"#AJInDtbiHG9m\">[6]<\/a><\/sup>.<\/p><p>Data on the numbers of exempt protocols and protocols requiring IRB continuing reviews, as well as human research subject protection performance metrics collected from 2016 through 2024, were analyzed to evaluate the impact of the revised Common Rule. Human research subject protection performance metrics consisted of the following five performance metrics:<\/p><ul style=\"list-style-type:disc;\"><li>Local adverse events (as opposed to external adverse events in a multi-site research protocol) that were determined by IRBs to be serious, unanticipated, and related or probably related to research;<\/li><li>Required informed consent was not obtained from the subjects or subject\u2019s legally authorized representatives;<\/li><li>Required Health Insurance Portability and Accountability Act (HIPAA) authorization was not obtained from subjects or subject\u2019s legally authorized representatives;<\/li><li>Non-exempt research was conducted without IRB review and approval; and<\/li><li>Research activities were continued during a lapse in IRB continuing reviews, except when the IRB determined that it was in the best interest of already enrolled subjects to continue participating in the research<sup data-reference-id=\"AJInDtbiHG9m\" id=\"CY23ZFEjUUBp\"><a href=\"#AJInDtbiHG9m\">[6]<\/a><\/sup>.<\/li><\/ul><p>The revised Common Rule was implemented on January 21, 2019. Data from 3 years between 2016 and 2018 were collected prior to the implementation of the revised Common Rule, while data from 5 years between 2020 and 2024 were collected after its implementation. Twenty nineteen (2019) was a transitional year. It contained approximately 7 months (from June 1, 2018, to January 20, 2019) of pre-implementation data and approximately 5 months (from January 21, 2019, to May 31, 2019) of post-implementation data.<\/p><h3>Protection of human research subjects Statement<\/h3><p>This quality assurance project did not involve human subjects and did not collect individually identifiable information. Therefore, no IRB review and approval was required<sup data-reference-id=\"HqZpX8opL3Mv\" id=\"JN1RbM8tU8HN\"><a href=\"#HqZpX8opL3Mv\">[7]<\/a><\/sup>.<\/p><h3>Data analysis<\/h3><p>We used analysis of ordinal categorical data as described by Agresti<sup data-reference-id=\"QoymTcrhTDi4\" id=\"x0NhQdjbWTCb\"><a href=\"#QoymTcrhTDi4\">[8]<\/a><\/sup>&nbsp;to determine the trend of change of these performance data from 2016 through 2024. This was carried out using JavaStat ordinal contingency table analysis available at <a target=\"_blank\" rel=\"noopener noreferrer\" href=\"http:\/\/www.statpages.info\">www.statpages.info<\/a>. A <i>p <\/i>value of &lt; 0.05 was considered to be statistically significant. For those performance data with statistically significant changes, we also calculated percent changes from 2016 through 2024 using the following formula:<\/p><p>Percent change = [(rate in 2024 \u2013 rate in 2016) \u00f7 rate in 2016] x 100<sup data-reference-id=\"bgXsOLrsGnap\" id=\"PLEPRBMIOUPq\"><a href=\"#bgXsOLrsGnap\">[9]<\/a><\/sup>.<\/p><h2>Results<\/h2><h3>Implementation of the revised Common Rule<\/h3><p>The revised Common Rule requirements applied to human research protocols that were exempt or required to be approved by an IRB on or after January 21, 2019, and those that had been approved by an IRB prior to January 21, 2019, but were determined by an IRB to be transitioned to the revised Common Rule requirements. Protocols that were exempt or approved by an IRB prior to January 21, 2019, continued to be subjected to pre-revised Common Rule requirements, unless they were transitioned to the revised Common Rule requirements as described above<sup data-reference-id=\"av5e0esChw8u\" id=\"CDM0AbgJmetZ\"><a href=\"#av5e0esChw8u\">[1]<\/a><\/sup>.<\/p><p>Table 1 shows data from 2016 through 2024 on the numbers and rates of protocols subjected to the revised Common Rule requirements. As shown here, the rates of protocols subjected to the revised Common Rule requirements increased progressively from 28.7% in 2020 to 77.0% in 2024.<\/p><figure class=\"table\"><table><thead><tr><th>&nbsp;<\/th><th>2016<\/th><th>2017<\/th><th>2018<\/th><th>2019<\/th><th>2020<\/th><th>2021<\/th><th>2022<\/th><th>2023<\/th><th>2024<\/th><\/tr><tr><th>Total number of active protocols<\/th><th>15,699<\/th><th>15,279<\/th><th>15,258<\/th><th>15,061<\/th><th>14,637<\/th><th>15,015<\/th><th>14,917<\/th><th>14,685<\/th><th>14,484<\/th><\/tr><\/thead><tbody><tr><td>Protocols Subjected to revised Common Rule requirements<\/td><td>0<\/td><td>0<\/td><td>0<\/td><td>\u2014<sup>1<\/sup><\/td><td>4,201<br>(28.7%)<\/td><td>7,207<br>(48.0%)<\/td><td>9,142<br>(61.3%)<\/td><td>10,465<br>(71.3%)<\/td><td>11,153<br>(77.0%)<\/td><\/tr><\/tbody><\/table><figcaption><strong>Table 1. <\/strong>Implementation of the revised Common Rule<\/figcaption><\/figure><p><sup>1 <\/sup><i>Data not collected<\/i><\/p><h3>Number of exempt protocols and IRB continuing reviews<\/h3><p>The revised Common Rule expanded the exempt categories from 6 to 8, adding Category 7, storage of identifiable private information or identifiable biospecimens for secondary research for which broad consent is required, and Category 8, secondary research using identifiable private information or identifiable biospecimens for which broad consent is required<sup data-reference-id=\"av5e0esChw8u\" id=\"b9AIdmRzTlnW\"><a href=\"#av5e0esChw8u\">[1]<\/a><\/sup>.<\/p><p>Prior to the revision, the Common Rule required IRBs to conduct continuing review of ongoing research at intervals appropriate to the degree of risk, but not less than annually. The revised Common Rule removed the annual IRB continuing review requirements for studies approved using expedited review procedures and for studies merely analyzing study data after completing all study interventions or involving only observational follow-up in conjunction with standard clinical care<sup data-reference-id=\"av5e0esChw8u\" id=\"wTqZOiu9iz36\"><a href=\"#av5e0esChw8u\">[1]<\/a><\/sup><sup data-reference-id=\"oRBRntfbvbAx\" id=\"KzpQddhgLnDP\"><a href=\"#oRBRntfbvbAx\">[3]<\/a><\/sup>.<\/p><p>The above changes in the revised Common Rule requirements should markedly increase the number of exempt protocols and reduce the number of protocols requiring IRB continuing reviews. However, the extent of these changes is not clear.<\/p><p>Table 2 shows data collected from 2016 through 2024 on total numbers of active protocols each year, numbers and rates of exempt protocols, numbers of protocols audited, and numbers and rates of protocols requiring IRB continuing reviews.<\/p><p>As shown in Table 2, the number of exempt protocols increased from approximately 6% of the total number of active protocols in 2016-18 to 21.9% in 2024, an increase of 259%. In contrast, the number of protocols requiring IRB continuing reviews decreased from 83.2% in 2016 to 46.9% in 2024, a reduction of 44%.<\/p><figure class=\"table\"><table><thead><tr><th>&nbsp;<\/th><th>2016<\/th><th>2017<\/th><th>2018<\/th><th>2019<\/th><th>2020<\/th><th>2021<\/th><th>2022<\/th><th>2023<\/th><th>2024<\/th><th><i>P <\/i>value<sup>1<\/sup><\/th><th>Change (%)<sup>2<\/sup><\/th><\/tr><tr><th>Total number of active protocols&nbsp;<\/th><th>15,699<\/th><th>15,279<\/th><th>15,258<\/th><th>15,061<\/th><th>14,637<\/th><th>15,015<\/th><th>14,917<\/th><th>14,685<\/th><th>14,484<\/th><th>&nbsp;<\/th><th>&nbsp;<\/th><\/tr><\/thead><tbody><tr><td>Exempt protocols<\/td><td>960<br>(6.1%)<sup>3<\/sup><\/td><td>943<br>(6.2%)<\/td><td>946<br>(6.2%)<\/td><td>1,145<br>(7.7%)<\/td><td>1,878<br>(12.8%)<\/td><td>2,379<br>(15.8%)<\/td><td>2,738<br>(18.4%)<\/td><td>3,044<br>(20.7%)<\/td><td>3,170<br>(21.9%)<\/td><td>0.0000<\/td><td>+259%<\/td><\/tr><tr><td>Total number of protocols audited&nbsp;<\/td><td>3,801<\/td><td>3,573<\/td><td>3,564<\/td><td>3,569<\/td><td>3,348<\/td><td>3,540<\/td><td>3,349<\/td><td>3,441<\/td><td>3,201<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Protocols requiring IRB<sup>4 <\/sup>continuing review<\/td><td>3,162<br>(83.2%)<\/td><td>3,094<br>(86.6%)<\/td><td>3,035<br>(85.2%)<\/td><td>2,861<br>(80.2%)<\/td><td>2,547<br>(76.1%)<\/td><td>2,205<br>(62.3%)<\/td><td>1,900<br>(56.7%)<\/td><td>1,606<br>(46.7%)<\/td><td>1,501<br>(46.9%)<\/td><td>0.0000<\/td><td>-44%<\/td><\/tr><\/tbody><\/table><figcaption><strong>Table 2. <\/strong>Impact of revised Common Rule on Exempt protocols and IRB continuing reviews<\/figcaption><\/figure><p><sup>1 <\/sup><i>Determined using analysis of ordered categories for the trend of changes from 2016 through 2024.<\/i><br><sup>2<\/sup><i> Percent change from 2016 to 2024.<\/i><br><sup>3<\/sup><i> The numbers in parentheses were the percentages of the total number of active protocols or protocols audited.<\/i><br><sup>4 <\/sup><i>Abbreviation used: IRB, institutional review board.&nbsp;<\/i><\/p><h3>Protecting human subjects participating in research<\/h3><p>The human research subject protection performance metrics proposed by Tsan &amp; Puglisi<sup data-reference-id=\"AJInDtbiHG9m\" id=\"FR3zicROL63K\"><a href=\"#AJInDtbiHG9m\">[6]<\/a><\/sup>&nbsp;were used to assess the impact of the revised Common Rule on enhancing human research subject protections.<\/p><p><strong>Unanticipated, serious and research-related adverse events: <\/strong>Table 3 shows data from 2016 through 2024 on numbers and rates of local adverse events that were determined by IRBs to be serious, unanticipated, and related or probably related to research. The numbers of protocols audited each year ranged from 3,201 in 2024 to 3,801 in 2016.<\/p><p>The rates of local adverse events that were determined to be serious, unanticipated, and related or probably related to research were low, ranging from 0.36%, i.e., 0.36 events per 100 protocols, in 2017, to 1.09% in 2018. There was no statistically significant trend of change from 2016 through 2024.<\/p><figure class=\"table\"><table><thead><tr><th>&nbsp;<\/th><th>2016<\/th><th>2017<\/th><th>2018<\/th><th>2019<\/th><th>2020<\/th><th>2021<\/th><th>2022<\/th><th>2023<\/th><th>2024<\/th><th><i>P&nbsp;<\/i>value<sup>1<\/sup><\/th><th>Change (%)<sup>2<\/sup><\/th><\/tr><tr><th>Total number of active protocols&nbsp;<\/th><th>15,699<\/th><th>15,279<\/th><th>15,258<\/th><th>15,061<\/th><th>14,637<\/th><th>15,015<\/th><th>14,917<\/th><th>14,685<\/th><th>14,484<\/th><th>&nbsp;<\/th><th>&nbsp;<\/th><\/tr><\/thead><tbody><tr><td>Total number of protocols audited&nbsp;<\/td><td>3,801<\/td><td>3,573<\/td><td>3,564<\/td><td>3,569<\/td><td>3,348<\/td><td>3,540<\/td><td>3,349<\/td><td>3,441<\/td><td>3,201<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Local adverse events that are serious, unanticipated, and related to research<\/td><td>15<br>(0.39%)<sup>3<\/sup><\/td><td>13<br>(0.36%)<\/td><td>39<br>(1.09%)<\/td><td>15<br>(0.42%)<\/td><td>18<br>(0.54%)<\/td><td>13<br>(0.37%)<\/td><td>19<br>(0.56%)<\/td><td>20<br>(0.58%)<\/td><td>25<br>(0.78%)<\/td><td>0.2763<\/td><td>N\/A<sup>4<\/sup><\/td><\/tr><\/tbody><\/table><figcaption><strong>Table 3.<\/strong>&nbsp;Local adverse events determined to be serious, unanticipated, and related or probably related to research<\/figcaption><\/figure><p><sup>1 <\/sup><i>Determined using analysis of ordered categories for the trend of changes from 2016 through 2024.<\/i><br><sup>2<\/sup><i> Percent change from 2016 to 2024.<\/i><br><sup>3<\/sup><i> The numbers in parentheses were the percentages of the total number of protocols audited.&nbsp;<\/i><br><sup>4<\/sup><i><sup>&nbsp;<\/sup>N\/A denotes not applicable<\/i><\/p><p><strong>Informed consent and HIPAA authorization:<\/strong> Table 4 shows data from 2016 through 2024 on numbers of informed consent documents audited each year; numbers and rates of informed consent documents that were not obtained; numbers of HIPAA Authorization required; and numbers and rates of these authorizations that were not obtained.<\/p><p>The numbers of informed consent documents audited ranged from 35,323 in 2021 to 90,153 in 2017. The rates of informed consent documents not obtained, which included missing informed consent documents as well as informed consent documents not signed by the subjects or legally authorized representatives, were small, ranging from 0.03% in 2016 to 0.39% in 2021. There was a statistically significant trend of change, increasing from 0.03% in 2016 to 0.12% in 2024, an increase (or deterioration) of 300%.<\/p><p>The numbers of protocols requiring HIPAA authorizations audited ranged from 33,356 in 2021 to 87,045 in 2017. The rates of required HIPAA authorization not obtained were small, ranging from 0.56% in 2016 to 1.43% in 2021. There was a statistically significant trend of change, increasing from 0.56% in 2016 to 0.85% in 2024, an increase (or deterioration) of 52%.<\/p><figure class=\"table\"><table><thead><tr><th>&nbsp;<\/th><th>2016<\/th><th>2017<\/th><th>2018<\/th><th>2019<\/th><th>2020<\/th><th>2021<\/th><th>2022<\/th><th>2023<\/th><th>2024<\/th><th><i>P&nbsp;<\/i>value<sup>1<\/sup><\/th><th>Change (%)<sup>2<\/sup><\/th><\/tr><tr><th>Total number of active protocols&nbsp;<\/th><th>15,699<\/th><th>15,279<\/th><th>15,258<\/th><th>15,061<\/th><th>14,637<\/th><th>15,015<\/th><th>14,917<\/th><th>14,685<\/th><th>14,484<\/th><th>&nbsp;<\/th><th>&nbsp;<\/th><\/tr><\/thead><tbody><tr><td>Total number of protocols audited&nbsp;<\/td><td>15,629<\/td><td>15,264<\/td><td>15,233<\/td><td>1,892<\/td><td>13,985<\/td><td>12,066<\/td><td>11,584<\/td><td>10,850<\/td><td>11,272<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Total number of ICDs<sup>3<\/sup> audited<\/td><td>89,024<\/td><td>90,153<\/td><td>82,849<\/td><td>73,331<\/td><td>57,827<\/td><td>35,323<\/td><td>52,525<\/td><td>61,237<\/td><td>71,724<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Informed consent not obtained<\/td><td>29<br>(0.03%)<sup>4<\/sup><\/td><td>34<br>(0.04%)<\/td><td>85<br>(0.11%)<\/td><td>74<br>(0.10%)<\/td><td>38<br>(0.07%)<\/td><td>138<br>(0.39%)<\/td><td>33<br>(0.06%)<\/td><td>64<br>(0.10%)<\/td><td>84<br>(0.12%)<\/td><td>0.0000<\/td><td>+300%<\/td><\/tr><tr><td>Total number of HIPAA authorization required<\/td><td>86,109<\/td><td>87,045<\/td><td>78,372<\/td><td>69,970<\/td><td>52,756<\/td><td>33,356<\/td><td>46,218<\/td><td>55,417<\/td><td>66,185<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>HIPAA authorization not obtained<\/td><td>486<br>(0.56%)<\/td><td>572<br>(0.66%)<\/td><td>518<br>(0.66%)<\/td><td>529<br>(0.76%)<\/td><td>535<br>(1.01%)<\/td><td>477<br>(1.43%)<\/td><td>337<br>(0.73%)<\/td><td>527<br>(0.95%)<\/td><td>562<br>(0.85%)<\/td><td>0.0000<\/td><td>+52%<\/td><\/tr><\/tbody><\/table><figcaption><strong>Table 4.<\/strong> Informed consent document and Health Insurance Portability and Accountability Act authorization&nbsp;<\/figcaption><\/figure><p><sup>1 <\/sup><i>Determined using analysis of ordered categories for the trend of changes from 2016 through 2024.<\/i><br><sup>2<\/sup><i> Percent change from 2016 to 2024.<\/i><br><sup>3<\/sup><i> Abbreviations used: ICD, informed consent document; HIPAA, Health Insurance Portability and Accountability.<\/i><br><sup>4<\/sup><i> The numbers in parentheses were the percentages of the total number of protocols audited or HIPAA authorization required.<\/i><\/p><p><br><strong>Institutional review board initial and continuing reviews: <\/strong>Table 5 shows data from 2016 through 2024 on numbers and rates of protocols conducted and completed without IRB review and approval; and numbers and rates of protocols for which investigators continued research activities during a lapse in required IRB continuing reviews.<\/p><p>The numbers of protocols audited each year ranged from 3,201 in 2024 to 3,801 in 2016. Only one protocol was conducted without IRB approval in 2023. There was no statistically significant trend of change from 2016 through 2024.<\/p><p>The number of protocols requiring IRB continuing reviews ranged from 1,501 in 2024 to 3,162 in 2016. The rates of protocols for which investigators continued research activities during a lapse in IRB continuing reviews were small, ranging from 0.00% to 0.19%. There was a statistically significant trend of change from 0.00% in 2016 to 0.13% in 2024.<\/p><figure class=\"table\"><table><thead><tr><th>&nbsp;<\/th><th>2016<\/th><th>2017<\/th><th>2018<\/th><th>2019<\/th><th>2020<\/th><th>2021<\/th><th>2022<\/th><th>2023<\/th><th>2024<\/th><th><i>P&nbsp;<\/i>value<sup>1<\/sup><\/th><th>Change (%)<sup>2<\/sup><\/th><\/tr><tr><th>Total number of active protocols<\/th><th>15,699<\/th><th>15,279<\/th><th>15,258<\/th><th>15,061<\/th><th>14,637<\/th><th>15,015<\/th><th>14,917<\/th><th>14,685<\/th><th>14,484<\/th><th>&nbsp;<\/th><th>&nbsp;<\/th><\/tr><\/thead><tbody><tr><td>Total number of protocols audited<\/td><td>3,801<\/td><td>3,573<\/td><td>3,564<\/td><td>3,569<\/td><td>3,348<\/td><td>3,540<\/td><td>3,349<\/td><td>3,441<\/td><td>3,201<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Conducted without IRB<sup>3 <\/sup>approval<\/td><td>0&nbsp;<br>(0.00%)<sup>4<\/sup><\/td><td>0&nbsp;<br>(0.00%)<\/td><td>0&nbsp;<br>(0.00%)<\/td><td>0&nbsp;<br>(0.00%)<\/td><td>0&nbsp;<br>(0.00%)<\/td><td>0<br>(0.00%)<\/td><td>0<br>(0.00%)<\/td><td>1<br>(0.03%)<\/td><td>0<br>(0.00%)<\/td><td>0.2316<\/td><td>N\/A<sup>5<\/sup><\/td><\/tr><tr><td>Total number of protocols requiring IRB continuing reviews<\/td><td>3,162<\/td><td>3,094<\/td><td>3,035<\/td><td>2,861<\/td><td>2,547<\/td><td>2,205<\/td><td>1,900<\/td><td>1,606<\/td><td>1,501<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Continued research activities during lapse<\/td><td>0&nbsp;<br>(0.00%)<\/td><td>0<br>(0.00%)<\/td><td>3<br>(0.10%)<\/td><td>0<br>(0.00%)<\/td><td>2<br>(0.08%)<\/td><td>0<br>(0.00%)<\/td><td>2<br>(0.11%)<\/td><td>3<br>(0.19%)<\/td><td>2<br>(0.13%)<\/td><td>0.0106<\/td><td>XX<sup>6<\/sup><\/td><\/tr><\/tbody><\/table><figcaption><strong>Table 5. <\/strong>Institutional review board Initial and continuing reviews<\/figcaption><\/figure><p><sup>1&nbsp;<\/sup><i>Determined using analysis of ordered categories for the trend of changes from 2016 through 2024.<\/i><br><sup>2<\/sup><i> Percent change from 2016 to 2024.<\/i><br><sup>3<\/sup><i> Abbreviations used: IRB, institutional review board.<\/i><br><sup>4<\/sup><i> The numbers in parentheses were the percentages of the total number of protocols audited or requiring IRB continuing reviews.<\/i><br><sup>5<\/sup><i><sup>&nbsp;<\/sup>N\/A denotes not applicable.<\/i><br><sup>6<\/sup><i><sup> <\/sup>XX Unable to calculate, because the 2016 value was zero.<\/i><\/p><h2>Discussion<\/h2><p>The results presented in this report demonstrated that at five and a half years after the implementation of the revised Common Rule on January 21, 2019, when 77% of all active human research protocols were under the revised Common Rule requirements, there had been an increase of 259% in the number of exempt protocols and a reduction of 44% in the number of protocols requiring IRB continuing reviews from 2016 to 2024. Thus, the revised Common Rule has achieved its objective of markedly reducing the burden of low-risk studies on researchers.<\/p><p>On the other hand, these results also revealed that there had been no enhancement in human research subject protections. Of the five human research subject protection performance metrics studied, two, i.e., unanticipated, serious, research-related adverse events, and research conducted without IRB approval, remained unchanged, while three, i.e., required informed consent and HIPAA authorization not obtained, as well as continued research activities during a lapse in IRB continuing reviews, deteriorated. These data suggested that instead of enhancing human research subject protections, the implementation of the revised Common Rule appeared to reduce human research subject protections.<\/p><p>Specifically, the revised Common Rule did not affect the rates of unanticipated physical and psychological harms experienced by research participants (the first performance metric). However, it caused a 300% increase and a 52% increase in dignitary harms to research participants due to violations of their autonomy and privacy rights, respectively (the second and third performance metrics). Finally, while there was no change in the rate of research conducted without IRB review and approval (the fourth performance metric), there was a statistically significant increase in the rate of investigators continuing research activities during a lapse in IRB continuing reviews (the fifth performance metric), which placed research subjects at an increased risk of harms in the absence of objective oversight.<\/p><p>The questions are how the implementation of the revised Common Rule, which was intended to enhance human research subject protections, led to increased dignitary harms to research participants, and how the implementation of the revised Common Rule, while markedly reducing the number of protocols requiring IRB continuing reviews, led to more investigators continuing research activities during a lapse in required IRB continuing reviews?<\/p><p>It was disappointing that five and a half years after the implementation of the revised Common Rule, we found that the revised Common Rule actually hindered human research subject protections, instead of enhancing it as the Office for Human Research Protections claimed. However, considering the following observations, this may not be something that is unexpected.<\/p><ul style=\"list-style-type:disc;\"><li>Despite one of the objectives for revising the Common Rule being to enhance human research subject protections, the revised Common Rule didn\u2019t include any provisions that were designed to improve human research subject protections. We knew this was the case because there were no procedures or interventions that had been shown to improve human research subject protections, as prior to 2018, we didn\u2019t know how to measure human research subject protections<sup data-reference-id=\"KH6mUe8fYXlc\" id=\"4xD00eK0Puhl\"><a href=\"#KH6mUe8fYXlc\">[4]<\/a><\/sup>.<\/li><\/ul><ul><li>The revised Common Rule contained provisions designed to improve informed consent so that potential participants would be better informed when making decisions whether to participate in particular research studies. These included giving prospective participants information a reasonable person would want to know to make a decision whether to participate in research, providing sufficient detail, reorganizing consent forms to facilitate understanding, and presenting concise and focused key information at the beginning<sup data-reference-id=\"av5e0esChw8u\" id=\"pA1ZO8SbCjQv\"><a href=\"#av5e0esChw8u\">[1]<\/a><\/sup><sup data-reference-id=\"oRBRntfbvbAx\" id=\"YX9R9fVirrNG\"><a href=\"#oRBRntfbvbAx\">[3]<\/a><\/sup>. However, the revised Common Rule didn\u2019t provide sufficient guidelines on how these requirements should be implemented, including what constitutes information a reasonable person would want to know to make a decision whether to participate in research and what constitutes concise and focused \u201ckey information.\u201d<sup data-reference-id=\"lZpdPg6xPKn6\" id=\"GNIGotzWkjsF\"><a href=\"#lZpdPg6xPKn6\">[10]<\/a><\/sup><sup data-reference-id=\"2WaDAOsJbERT\" id=\"DhPCcoLVPfb7\"><a href=\"#2WaDAOsJbERT\">[11]<\/a><\/sup>&nbsp;As a result, there has been no study demonstrating whether these new requirements have achieved the goal of improving potential participants\u2019 understanding of the informed consent, thereby facilitating their decisions on whether to participate in the research.<\/li><li>The revised Common Rule required the use of a single-IRB review for multi-site studies in the U.S., eliminating the time and effort associated with multiple IRB reviews and the need for reconciling different IRB determinations and requirements.<sup data-reference-id=\"av5e0esChw8u\" id=\"Mmgq1r8MMzxE\"><a href=\"#av5e0esChw8u\">[1]<\/a><\/sup><sup data-reference-id=\"oRBRntfbvbAx\" id=\"EbFLh1Y808F6\"><a href=\"#oRBRntfbvbAx\">[3]<\/a><\/sup>&nbsp;The potential benefits of a single-IRB review for multi-site studies had been previously well documented using the experience of the National Cancer Institute Central IRB.<sup data-reference-id=\"YcLj9rluKAoU\" id=\"leoJ1uEY3Sbg\"><a href=\"#YcLj9rluKAoU\">[12]<\/a><\/sup>&nbsp;However, the implementation of this revised Common Rule requirement for the use of a single-IRB review for all federally funded\/supported multi-site studies is daunting.<sup data-reference-id=\"HBr3L84fzZmq\" id=\"y55TkvUzZHUe\"><a href=\"#HBr3L84fzZmq\">[13]<\/a><\/sup><sup data-reference-id=\"o4lyzMjW9l4A\" id=\"eYU7HRb90UsL\"><a href=\"#o4lyzMjW9l4A\">[14]<\/a><\/sup>&nbsp;In a National Institutes of Health-sponsored workshop in 2022 examining why single-IRB review remained problematic, the workshop participants identified several major barriers such as additional responsibilities for study teams, persistent duplicative review processes, the lack of harmonization of policies and processes across institutions, the absence of additional guidance from federal agencies, and the need for greater flexibility in policy requirements. The workshop recommended additional resources and training for research teams, the commitment of institutional leaders to harmonize practices, and policy makers to critically evaluate the requirements and provide flexibility in applicability.<sup data-reference-id=\"o4lyzMjW9l4A\" id=\"IYjhJOVAYaao\"><a href=\"#o4lyzMjW9l4A\">[14]<\/a><\/sup><\/li><\/ul><p>It is clear that the implementation of the revised Common Rule is complex. The difficulties and confusions in implementing these revised Common Rule requirements, together with the disruptions caused by the coronavirus disease 2019 (COVID-19) pandemic in the U.S. between 2020 and 2022, might have prevented institutions and investigators from focusing on research and human research subject protections, leading to unfortunate lapses in obtaining informed consent and HIPAA authorization as required and investigators continuing research activities during lapses in IRB continuing reviews, as demonstrated in this study.<\/p><p>In a preliminary analysis of 16 performance metrics related to IRB, Tsan and Van Hook<sup data-reference-id=\"AxwBVV7QgIIe\" id=\"nxAKWvMMZ3Lm\"><a href=\"#AxwBVV7QgIIe\">[15]<\/a><\/sup>&nbsp;reported that two and a half years after the implementation of the revised Common Rule, when 48% of all active protocols were under the revised Common Rule requirement, 4 improved, 4 deteriorated, and 8 remained unchanged from 2016 through 2021. The 4 performance metrics that deteriorated were all related to informed consent documents and HIPAA authorization requirements. It was speculated at that time that the disruptions caused by the COVID-19 pandemic in the U.S. in 2020 and 2021 were largely responsible for the observed deteriorations.<sup data-reference-id=\"AxwBVV7QgIIe\" id=\"jbdITjwRUDdp\"><a href=\"#AxwBVV7QgIIe\">[15]<\/a><\/sup><\/p><p>In view of the continued deterioration of the second and third human research subject protection performance metrics and the development of an increased rate of investigators continuing research activities during a lapse in IRB continuing reviews (the fifth performance metric), when the COVID-19 pandemic was under control in the U.S. after 2022, I would have to conclude that the implementation of the revised Common Rule was largely responsible for the observed deterioration of the second, third, and fifth human research subject protection performance metrics from 2016 through 2024.<\/p><p>As we overcome the difficulties in implementing the revised Common Rule in the coming years, we hope to see human research subject protection performance metrics return to the levels of the pre-implementation years, i.e., 2016-2018. However, as the revised Common Rule didn\u2019t include any specific provisions that would enhance human research subject protections, I don\u2019t expect any improvement in human research subject protections as a result of the revised Common Rule.<\/p><p>It would have been helpful if the Office for Human Research Protections in its commentary indicated explicitly which provisions in the Revised Common Rule were designed to enhance human research subject protections and how protections of human research subjects should be assessed.<sup data-reference-id=\"oRBRntfbvbAx\" id=\"rNuOfKdY6YKz\"><a href=\"#oRBRntfbvbAx\">[3]<\/a><\/sup>&nbsp;Implementation of new regulatory requirements is the best opportunity to find out whether the new requirements lead to improved human research subject protections. Lessons learned from the current revision will undoubtedly guide us for the next revision.<\/p><h2>Conclusion<\/h2><p>At five and a half years after the implementation of the revised Common Rule on January 21, 2019, when 77% of all active human research protocols were under the revised Common Rule requirements, there was an increase of 259% in the number of exempt protocols and a reduction of 44% in the number of protocols requiring IRB continuing reviews from 2016 to 2024. Thus, the revised Common Rule has achieved its objective of markedly reducing the burden of low-risk studies on researchers.<\/p><p>On the other hand, analysis of human research subject protection performance metric data during the same period revealed that there was no enhancement in human research subject protections. Of the five human research subject protection performance metrics studied, two, i.e., unanticipated, serious, research-related adverse events, and research conducted without IRB approval, remained unchanged, while three, i.e., required informed consent and HIPAA authorization not obtained, as well as continued research activities during a lapse in IRB continuing reviews, deteriorated. Thus, instead of enhancing human research subject protections, the implementation of the revised Common Rule appeared to reduce human research subject protections.<\/p><h2>Notes<\/h2><p><strong>Running title: <\/strong>Impact of the Revised Common Rule.<\/p><h2>Statements and Declarations<\/h2><h3>Data Availability<\/h3><p>The dataset used in this study (Office of Research Oversight Facility Director Certification Quality Indicator Data 2016\u20132024) is available by submitting a Freedom of Information Act (FOIA) request to vacofoiase@va.gov.<\/p><h3>Author Contributions<\/h3><p>MFT conceived the idea, conducted the analysis and interpretation of the data, and wrote the manuscript.<\/p><h3>Acknowledgements<\/h3><p>The author thanks Yen B. Nguyen, Pharm.D., and all VA research compliance officers for their contributions in conducting the audits and collecting the data presented in this report.<\/p><section class=\"references-section\"><h2 class=\"references-section__title\">References<\/h2><ol class=\"references-list\"><li class=\"reference\" id=\"av5e0esChw8u\"><sup class=\"reference-markers-links\"><a href=\"#A0HeE0iEBJW9\">a<\/a>,&nbsp;<a href=\"#HcX3mzmH5XTp\">b<\/a>,&nbsp;<a href=\"#oMOx6YTMSMNJ\">c<\/a>,&nbsp;<a href=\"#CDM0AbgJmetZ\">d<\/a>,&nbsp;<a href=\"#b9AIdmRzTlnW\">e<\/a>,&nbsp;<a href=\"#wTqZOiu9iz36\">f<\/a>,&nbsp;<a href=\"#pA1ZO8SbCjQv\">g<\/a>,&nbsp;<a href=\"#Mmgq1r8MMzxE\">h<\/a><\/sup><cite>U.S. Department of Health and Human Services (2018). \"Federal policy for the protection of human subjects: 45 code of Federal Registration (CFR) 46.\" U.S. Department of Health and Human Services. <a href=\"http:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/regulations\/45-cfr-46\/index.html\" target=\"_blank\">http:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/regulations\/45-cfr-46\/index.html<\/a>.<\/cite><\/li><li class=\"reference\" id=\"NXgBjmRRIKai\"><sup class=\"reference-markers-links\"><a href=\"#aqWeljmukzgI\">^<\/a><\/sup><cite>U.S. Department of Health and Human Services (2011). \"Human subjects research protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators.\" <i>Federal Register<\/i>. <b>76<\/b>(143):44512\u201344531.<\/cite><\/li><li class=\"reference\" id=\"oRBRntfbvbAx\"><sup class=\"reference-markers-links\"><a href=\"#mTr9cQJW8AWK\">a<\/a>,&nbsp;<a href=\"#QeZeGJqtd65h\">b<\/a>,&nbsp;<a href=\"#KzpQddhgLnDP\">c<\/a>,&nbsp;<a href=\"#YX9R9fVirrNG\">d<\/a>,&nbsp;<a href=\"#EbFLh1Y808F6\">e<\/a>,&nbsp;<a href=\"#rNuOfKdY6YKz\">f<\/a><\/sup><cite>Menikoff J, Kaneshiro J, Pritchard I (2017). \"The common rule, updated.\" <i>New Engl J Med<\/i>. <b>376<\/b>(7):613\u2013615. doi:<a href=\"https:\/\/doi.org\/10.1056\/NEJMp1700736\" target=\"_blank\">10.1056\/NEJMp1700736<\/a>.<\/cite><\/li><li class=\"reference\" id=\"KH6mUe8fYXlc\"><sup class=\"reference-markers-links\"><a href=\"#xteVvHAanIrS\">a<\/a>,&nbsp;<a href=\"#4xD00eK0Puhl\">b<\/a><\/sup><cite>Tsan MF (2024). \"How well are we protecting human research subjects?\" Qeios. doi:<a href=\"https:\/\/doi.org\/10.32388\/7RS57W\" target=\"_blank\">10.32388\/7RS57W<\/a>.<\/cite><\/li><li class=\"reference\" id=\"eN19iS7IZsvF\"><sup class=\"reference-markers-links\"><a href=\"#sSY7GG152ERH\">^<\/a><\/sup><cite>Yu M, Fischhoff B, Krishnamurti T (2019). \"Implementing a new Common Rule requirement for informed consent: A randomized trial on adult asthma patients.\" <i>MDM Policy &amp; Practice<\/i>. <b>4<\/b>:1\u20136. doi:<a href=\"https:\/\/doi.org\/10.1177\/2381468319839315\" target=\"_blank\">10.1177\/2381468319839315<\/a>.<\/cite><\/li><li class=\"reference\" id=\"AJInDtbiHG9m\"><sup class=\"reference-markers-links\"><a href=\"#OdvXvbekZDBq\">a<\/a>,&nbsp;<a href=\"#oqOOQ8baWM9M\">b<\/a>,&nbsp;<a href=\"#CY23ZFEjUUBp\">c<\/a>,&nbsp;<a href=\"#FR3zicROL63K\">d<\/a><\/sup><cite>Tsan MF, Puglisi JT (2023). \"Protecting human subjects participating in research.\" <i>Am J Transl Res<\/i>. <b>15<\/b>(9):5707\u20135714. <a href=\"http:\/\/www.ajtr.org\/ISSN:1943-8141\/AJTR0151875\" target=\"_blank\">www.ajtr.org\/ISSN:1943-8141\/AJTR0151875<\/a>.<\/cite><\/li><li class=\"reference\" id=\"HqZpX8opL3Mv\"><sup class=\"reference-markers-links\"><a href=\"#JN1RbM8tU8HN\">^<\/a><\/sup><cite>Tsan MF, Puglisi JT (2014). \"Health care operations activities that may constitute research \u2013 The Department of Veterans Affairs\u2019 perspective.\" <i>IRB<\/i>. <b>36<\/b>(1):9\u201311.<\/cite><\/li><li class=\"reference\" id=\"QoymTcrhTDi4\"><sup class=\"reference-markers-links\"><a href=\"#x0NhQdjbWTCb\">^<\/a><\/sup><cite>Agresti A (1984). <i>Analysis of Ordinal Categorical Data<\/i>. New York, NY: John Wiley &amp; Sons.<\/cite><\/li><li class=\"reference\" id=\"bgXsOLrsGnap\"><sup class=\"reference-markers-links\"><a href=\"#PLEPRBMIOUPq\">^<\/a><\/sup><cite>Tsan MF, Nguyen Y (2017). \"Effectiveness of human research protection program performance measurements.\" <i>J Emp Res Human Res Ethics<\/i>. <b>12<\/b>(4):217\u2013228. doi:<a href=\"https:\/\/doi.org\/10.1177\/1556264617720387\" target=\"_blank\">10.1177\/1556264617720387<\/a>.<\/cite><\/li><li class=\"reference\" id=\"lZpdPg6xPKn6\"><sup class=\"reference-markers-links\"><a href=\"#GNIGotzWkjsF\">^<\/a><\/sup><cite>Bazzano LA, Durant J, Brantley PR (2021). \"A modern history of informed consent and the role of Key information.\" <i>Ochsner J<\/i>. <b>21<\/b>(1):81\u201385.<\/cite><\/li><li class=\"reference\" id=\"2WaDAOsJbERT\"><sup class=\"reference-markers-links\"><a href=\"#DhPCcoLVPfb7\">^<\/a><\/sup><cite>Gelinas L, Morrell W, Tse T, Glazier A, Zarin DA, Bierer BE (2023). \"Characterization of key information sections in informed consent forms posted on ClinicalTrials.gov.\" <i>J Clin Transl Sci<\/i>. <b>7<\/b>(1):e185. doi:<a href=\"https:\/\/doi.org\/10.1017\/cts.2023.605\" target=\"_blank\">10.1017\/cts.2023.605<\/a>.<\/cite><\/li><li class=\"reference\" id=\"YcLj9rluKAoU\"><sup class=\"reference-markers-links\"><a href=\"#leoJ1uEY3Sbg\">^<\/a><\/sup><cite>Wagner TH, Murray C, Goldberg J, Adler JM, Abrams J (2010). \"Costs and Benefits of the National Cancer Institute Central Institutional Review Board.\" <i>J Clin Oncol<\/i>. <b>28<\/b>(4):662\u2013666. doi:<a href=\"https:\/\/doi.org\/10.1200\/JCO.2009.23.2470\" target=\"_blank\">10.1200\/JCO.2009.23.2470<\/a>.<\/cite><\/li><li class=\"reference\" id=\"HBr3L84fzZmq\"><sup class=\"reference-markers-links\"><a href=\"#y55TkvUzZHUe\">^<\/a><\/sup><cite>Hu A, Holl JL, Raval MV (2022). \"Pediatric specific challenges of the single institutional review board mandate.\" <i>Trials<\/i>. <b>23<\/b>:224. doi:<a href=\"https:\/\/doi.org\/10.1186\/s13063-022-06141-y\" target=\"_blank\">10.1186\/s13063-022-06141-y<\/a>.<\/cite><\/li><li class=\"reference\" id=\"o4lyzMjW9l4A\"><sup class=\"reference-markers-links\"><a href=\"#eYU7HRb90UsL\">a<\/a>,&nbsp;<a href=\"#IYjhJOVAYaao\">b<\/a><\/sup><cite>Green JM, Goodman P, Kirby A, Cobb N, Bierer BE (2023). \"Implementation of single IRB review for multisite human subjects research: Persistent challenges and possible solutions.\" <i>J Clin Transl Sci<\/i>. <b>7<\/b>:e99, 1\u20135. doi:<a href=\"https:\/\/doi.org\/10.1017\/cts.2023.517\" target=\"_blank\">10.1017\/cts.2023.517<\/a>.<\/cite><\/li><li class=\"reference\" id=\"AxwBVV7QgIIe\"><sup class=\"reference-markers-links\"><a href=\"#nxAKWvMMZ3Lm\">a<\/a>,&nbsp;<a href=\"#jbdITjwRUDdp\">b<\/a><\/sup><cite>Tsan MF, Van Hook H (2022). \"Assessing the quality and performance of institutional review boards: impact of the revised Common Rule.\" <i>J Emp Res Human Res Ethics<\/i>. <b>17<\/b>(4):525\u2013532. doi:<a href=\"https:\/\/doi.org\/10.1177\/15562646221094407\" target=\"_blank\">10.1177\/15562646221094407<\/a>.<\/cite><\/li><\/ol><\/section>","abstract":"<div class=\"ck-publication-abstract-context\"><p><strong>Objectives:<\/strong> The Common Rule, the U.S. Basic Federal Policy for Protection of Human Research Subjects, was revised extensively in 2018 to modernize the regulations by enhancing protections for human research subjects and reducing unnecessary burden and ambiguity for researchers. It was implemented on January 21, 2019. The purpose of this study was to determine whether the revised Common Rule, in fact, enhanced human research subject protections and reduced burdens to researchers.<\/p><p><strong>Methods:<\/strong> Analysis of data collected on the performance of human research protection programs from 107-109 Department of Veterans Affairs research facilities between 2016 and 2024 was carried out to evaluate the impact of the revised Common Rule at five and a half years after its implementation.<\/p><p><strong>Results: <\/strong>At five and a half years after the implementation of the revised Common Rule, when 77% of all active human research protocols were under the revised Common Rule requirements, there was an increase of 259% in the number of exempt protocols and a reduction of 44% in the number of protocols requiring institutional review board (IRB) continuing reviews. However, analysis of human research subject protection performance metric data during the same period revealed that of the five human research subject protection performance metrics studied, two, i.e., unanticipated, serious, research-related adverse events, and research conducted without IRB approval, remained unchanged, while three, i.e., required informed consent and Health Insurance Portability and Accountability Act authorization not obtained, as well as continued research activities during a lapse in IRB continuing reviews, deteriorated.<\/p><p><strong>Conclusions:<\/strong> The revised Common Rule achieved its objective of reducing the burden of low-risk studies to researchers. However, it appeared to impair, instead of enhancing, human research subject protections.<\/p><\/div>"},"domain_openalex_id":"https:\/\/openalex.org\/domains\/4","field_openalex_id":"https:\/\/openalex.org\/fields\/27","subfield_openalex_id":"https:\/\/openalex.org\/subfields\/2739","article_category":"Research Article","pre_grammar_correction_grammar_score":null,"grammar_corrected_at":null,"authors_aggregation":"33.0000","presentation_authors":[{"id":93894,"first_name":"Min Fu","last_name":"Tsan","is_researcher":true,"is_super_admin":false,"research_institution_id":33068,"biography":null,"avatar_path":null,"deactivated_at":null,"referrer_id":null,"orcid_id":"0000-0002-0142-1873","is_gold":false,"labarchives_uid":null,"accepts_authoring_request_emails":true,"stripe_id":"cus_RcmZT4L07xP8Wk","pm_type":null,"pm_last_four":null,"trial_ends_at":null,"last_article_publishing_prompt_received_at":"2026-07-18T01:00:20.000000Z","openalex_id":"https:\/\/openalex.org\/A5061961613","h_index_on_openalex":33,"research_field_openalex_id":"https:\/\/openalex.org\/fields\/27","is_admin":true,"affiliation_strings":["Research Service, McGuire Research Institute, United States"],"short_affiliation_strings":["McGuire Research Institute, United States"],"full_name":"Min Fu Tsan","research_field_display_name":"Medicine","is_pro":false,"auth_is_following":false,"avatar_url":null,"is_profile_visitable":true,"profile_url":"https:\/\/www.qeios.com\/profile\/93894","follow_endpoint":"https:\/\/www.qeios.com\/follow\/user\/93894","unfollow_endpoint":"https:\/\/www.qeios.com\/unfollow\/user\/93894","pivot":{"authorable_id":10747,"user_id":93894,"authorable_type":"App\\Models\\Article","created_at":"2025-03-03T10:09:12.000000Z","updated_at":"2025-03-03T10:09:12.000000Z","sort_index":0},"research_institution":{"id":33068,"name":"McGuireWoods","email_domain":null,"country_name":"United States","city_name":"Richmond","website":"https:\/\/www.mcguirewoods.com\/","subscription_expires_at":null,"ror_id":"https:\/\/ror.org\/051cjrp31","has_active_subscription":false},"subscriptions":[{"id":1149,"user_id":93894,"name":"personal_pro","stripe_id":"sub_1RmGVbBj1ubvnKBgaHLZ1qs5","stripe_status":"canceled","stripe_price":"price_1Q0maQBj1ubvnKBgilEbfLIv","quantity":1,"trial_ends_at":"2025-08-17T16:14:13.000000Z","ends_at":"2025-07-30T08:53:20.000000Z","created_at":"2025-07-18T15:47:49.000000Z","updated_at":"2025-07-30T08:53:20.000000Z","items":[{"id":1148,"subscription_id":1149,"stripe_id":"si_ShfrIvyVgLtWp0","stripe_product":"prod_Lp4gwnJFTNGobT","stripe_price":"price_1Q0maQBj1ubvnKBgilEbfLIv","quantity":1,"created_at":"2025-07-18T15:47:49.000000Z","updated_at":"2025-07-18T15:47:49.000000Z"}]},{"id":953,"user_id":93894,"name":"personal_pro","stripe_id":"sub_1QjgecBj1ubvnKBgzwE7RrS8","stripe_status":"canceled","stripe_price":"price_1Q0maQBj1ubvnKBgilEbfLIv","quantity":1,"trial_ends_at":"2025-02-20T12:57:43.000000Z","ends_at":"2025-02-20T12:58:11.000000Z","created_at":"2025-01-21T12:34:06.000000Z","updated_at":"2025-02-20T12:58:11.000000Z","items":[{"id":952,"subscription_id":953,"stripe_id":"si_RcwXMaoCGaW0oI","stripe_product":"prod_Lp4gwnJFTNGobT","stripe_price":"price_1Q0maQBj1ubvnKBgilEbfLIv","quantity":1,"created_at":"2025-01-21T12:34:06.000000Z","updated_at":"2025-01-21T12:34:06.000000Z"}]}]}],"publication_type":"article","version_label":"v1","newer_published_version_exists":false,"is_versionable":true,"is_reviewable":true,"read_url":"https:\/\/www.qeios.com\/read\/TU6VRN.2","doi_url":"https:\/\/doi.org\/10.32388\/TU6VRN.2","doi":"10.32388\/TU6VRN.2","doi_for_altmetric_mentions":"10.32388\/TU6VRN","edit_url":"https:\/\/www.qeios.com\/compose\/edit\/TU6VRN.2","spotify_podcast_url":null,"domain_name":"Health Sciences","field_name":"Medicine","subfield_name":"Public Health, Environmental and Occupational Health","first_non_preprint_version_published_at":"2025-03-03T10:09:12.000000Z","vacant_authors":[],"auth_is_bookmarker":false,"auth_is_admin":false,"auth_can_publish":false,"auth_can_delete":false,"auth_can_quit":false,"auth_can_modify_authorship":false,"auth_can_give_administration":false,"auth_can_create_new_version":false,"all_versions_views_count":6583,"all_versions_downloads_count":1139,"all_versions_average_rating":3.4285714285714284,"all_versions_published_reviewers_count":7,"all_versions_average_subrating_for_clarity":4,"all_versions_average_subrating_for_novelty":3.5714285714285716,"all_versions_average_subrating_for_impact":3.5714285714285716,"is_peer_approved":true,"peer_approval_statement":"'Impact of the Revised Common Rule on Enhancing Human Research Subject Protections and Reducing Researcher Burdens' has been peer-approved following rigorous reviews. Reviewers commended its comprehensive analysis of data from 107-109 VA research facilities, methodological rigour, and clear structure. The study provides valuable insights into the regulatory changes' effects on institutional review practices, highlighting its relevance for evaluating human research protections and researcher workload."}" :is-clickable="false" shorter-version=""></publication-rating-overview>
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Рекомендательные блоки («с этим покупают», «похожие товары» и т.п.) на сайте не обнаружены — требования ст. 10.7 ФЗ-149 к сайту не применяются. Нарушений нет.
ФЗ-38: реклама Готовность: 100%
Нарушения
Не выявлены
Рекламных тематик с обязательными оговорками (медицина, БАД, кредиты и займы, новостройки) на сайте не обнаружено. Нарушений нет.
ФЗ-436: защита детей Готовность: 100%
Нарушения
Не выявлены
Признаков информационной продукции (новости, видео, книги, игры, курсы) не обнаружено — обязательная возрастная маркировка по ФЗ-436 сайту не требуется. Нарушений нет.
Вердикт
Сайт qeios.com не совсем готов к продвижению (процент готовности лишь 65%). Для попадания в ТОПы поисковых систем нужно:
Исправьте ошибки в мета-тегах.
Исправьте ошибки индексации.
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