Research Involving Human Subjects
About Peer Review
Learn about the review of human subjects during the peer review process. Applicants can get a better idea of what peer reviewers look for in the application and Protection of Human Subjects section. Peer Reviewers can find guidance for reviewing the human subjects research plan.
|Dissemination of NIH-Funded Clinical Trial Information (ClinicalTrial.gov)||January 18, 2017|
|Good Clinical Practice (GCP) Training for NIH CT Awardees||January 1, 2017|
|Single IRB for Multi-Site Research||September 25, 2017|
|Use of Clinical Trial-specific FOA||September 27, 2017|
|Revised Common Rule (45 CFR 46)||January 19, 2018|
OHRP publishes the Revised Common Rule. NEW Policy Announcement
The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight.
The final rule has been published by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-protection-of-human-subjects.
HHS released a Press Release about the final rule that can be accessed at: https://www.hhs.gov/about/news/2017/01/18/final-rule-enhances-protections-research-participants-modernizes-oversight-system.html.
NIH introduces three new policies for studies involving a clinical trial. Policy Announcements
Effective January 18, 2017, the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information states that all clinical trials funded in whole or in part by NIH, regardless of study phase or type of intervention, will be expected to register at ClinicalTrials.gov and report findings. Read the summary.
NIH introduces the Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials. Effective January 1, 2017, all NIH-funded investigators who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP).
Starting with applications for grant or cooperative agreements received on or after September 27, 2017, NIH will require that all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials. The Policy on Funding Opportunity Announcement (FOA) for Clinical Trials can be found here.
Policy on the Use of a Single Institutional Review Board for Multi-Site Research Policy Announcement **Date Extended**
NIH has published a Guide Notice (NOT-OD-16-094) describing the expectation that domestic sites of multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will rely on the use of a single Institutional Review Board (sIRB) of record. The Policy applies to all domestic sites participating in NIH conducted or supported multi-site studies, whether supported through grants, contracts, or the NIH intramural program. While foreign sites in multi-site studies will not be expected to follow this Policy, they may elect to do so. This Policy will go into effect with the September 25, 2017 receipt dates. (New effective date.)
The New York Times (10/29, McNeil, Subscription Publication, 13.42M) reports that genetic sequencing of blood samples from the 1970s has exonerated “Patient Zero” of the Aids epidemic, “French Canadian flight attendant named Gaétan Dugas.” Dugas’s was identified as person who introduced AIDS into the US by journalist Randy Shilts, who also died from AIDS. However, analysis shows that “the strain infecting [Dugas] had circulated among gay men in New York for several years before he arrived here in 1974.” According to the Times, Dugas “did not introduce the virus to North America; he was a victim before he was a vector.” His case, however, “raises a moral question: Is it right to hunt down the first case in any outbreak, to find every Patient Zero?” The Times notes that it is this search that “has become a regular feature of health journalism.”
Edwards was one of 60,000 enlisted men enrolled in a once-secret government program — formally declassified in 1993 — to test mustard gas and other chemical agents on American troops. But there was a specific reason he was chosen: Edwards is African-American. While the Pentagon admitted decades ago that it used American troops as test subjects in experiments with mustard gas, until now, officials have never spoken about the tests that grouped subjects by race. Japanese-American, African-American and Puerto Rican troops were used as test subjects. NPR breaks a two-part story of mustard gas testing on US military members based on race. Part II of the story focuses on the broken promises of treatment by the VA. Click here to read Part I and Part II.
The Washington Post (8/3, Dennis, 9.18M) reports NIH officials announced on Wednesday that they will begin clinical testing of a Zika vaccine in human trials. The initial trial will “involve at least 80 volunteers between ages 18 and 35 at three locations around the United States,” including the NIH Clinical Center in Bethesda. In a statement, National Institute of Allergy and Infectious Diseases director Anthony Fauci said, “A safe and effective vaccine to prevent Zika virus infection and the devastating birth defects it causes is a public health imperative.” In a previous interview with The Washington Post, Fauci said that government researchers had leveraged research on the West Nile and dengue viruses to “quickly create vaccine candidates that target Zika, which currently has no cure or effective treatment.” If the early results are successful, researchers “hope to begin a larger-scale trial in Zika-affected countries in early 2017.”
New Human Subjects Tools
- Human Subjects Infographic - This one-page infographic is a guide to defining human subjects research at the NIH. It summarizes human subjects research, what you will need for your NIH application and what you will need if you are funded.
- Preparing the Human Subjects Section - Are you working on human subjects research or human specimens or data? Should you submit a Data and Safety Monitoring Plan? This 15-slide presentation simplifies the human subjects scenarios found in the Supplemental Grant Application Instructions for NIH applications (http://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf). Find the scenario that best describes your research to determine what supplemental information needs to be submitted with your NIH application.
- Exemptions Infographic - This one-page infographic is a guide to simplify the 3 human subjects research exemptions most commonly used at the NIH. It summarizes Exemptions 1, 2 and 4 providing basic definitions, examples of studies that meet and do not meet the criteria of the exemption, and things one must consider when engaged in exempt human subjects research.