NIH has updated its human subjects research decision tool to reflect changes effective in the 2018 Revised Common Rule. Answer a few quick questions to find out if your research could be considered human subjects research or if it may be exempt from federal regulations. Continue reading
On the new Protection of Human Subjects site, you can find useful information about proposing and conducting NIH extramural research involving human subjects, including policies, regulations, training, resources, and updated information on the revised human subject regulation (Common Rule). Continue reading
NIH has issued initial guidance on the implementation of the Revised Common Rule NOT-OD-19-050. The effective date for the amended regulation is January 21, 2019. It applies to studies initiated on or after this date, and ongoing studies that voluntarily transitioned to the Revised Common Rule, including those that implemented the three burden-reducing provisions during the delay period (July 19, 2018 through January 20, 2019). Continue reading
As announced in our previous blog post and policy notice, as of September 26, 2018, NIH is no longer able to offer its Protecting Human Research Participants (PHRP) course and does not plan to provide an alternative course. Although similar courses are available elsewhere, such courses are not affiliated with or endorsed by NIH. Continue reading
We recently released a policy notice announcing that as of September 26, 2018, the NIH will no longer be offering the Protecting Human Research Participants (PHRP) course. It is important to note that investigators are still required to comply with all aspects of the NIH policy Required Education in the Protection of Human Research Participants, and can do so through a different training program or course.
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Informed consent is a critical component of clinical research, but there are often challenges to making the process meaningful and effective. Explore these challenges with experts from diverse perspectives and learn innovative ways to address them at the “Meeting New Challenges in Informed Consent” installment of HHS Office for Human Research Protections (OHRP) Exploratory Workshop, a new initiative to provide a forum for the research community to exchange ideas on important issues related to human subjects protections.The workshop will include discussion on how to lay the groundwork for meaningful informed consent, effectively present information for high-quality decision making, and more! Continue reading
The Glossary of NIH terms now contains definitions for Ancillary Study, Child, Clinical Trial Research Experience, Independent Clinical Trial, and Older Adult. Continue reading
The Human Subjects System (HSS) system was launched in June 2018 and replaced the Inclusion Management System (IMS). Learn about HSS at a glance by viewing the new graphic on the HSS page. The graphic orients users at different stages of the grants process to how and when they can use HSS to update study information on human subjects and clinical trials to NIH. Continue reading
Earlier this year I wrote a post about the 21st Century Cures Act and its changes that directly affect the NIH. One part of this new legislation contains provisions to improve clinical research and privacy through certificates of confidentiality.
Currently, certificates of confidentiality (or “CoCs”) are provided upon request to researchers collecting sensitive information about research participants. Soon, CoCs will be automatically provided for NIH-supported research, as set forth in the 21st Century Cures Act. …. Continue reading
In September Dr. Carrie Wolinetz and I blogged about our policy reforms to build a more robust clinical trials enterprise through greater stewardship and transparency at each phase of the clinical trial journey from conception to sharing of results. We discussed how these efforts promise to improve the quality and efficiency of clinical trials, translating into more innovative and robust clinical trial design, and accelerated discoveries that will advance human health.
Over the past months we have continued to partner with the community to work through the implementation of these new policies, developing responses to frequently asked questions and even reconsidering the timing of our single IRB policy to give our grantees time to work through how to operationalize the change. …. Continue reading