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 (date extended)||January 2018|
|Revised Common Rule (45 CFR 46)||January 19, 2018|
The effective date has been extended to September 25, 2017.
Updated FAQs for implementation are available http://osp.od.nih.gov/sites/default/files/sIRB_Extramural_FAQs_0.pdf.
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.)
CNN (3/17, Marsh, 29.79M) reported that on Friday, “the Environmental Protection Agency announced...that it has awarded Michigan $100 million to make upgrades to Flint’s drinking water system.” These “funds will allow Flint to accelerate and expand its work to replace lead service lines and make other critical infrastructure improvements.”
Reuters (3/17, Volcovici) reported that “the EPA will make $31.5 million immediately available...and Michigan will provide a $20 million required match.” The other “$68.5 million will come after the city and Michigan complete additional public comment and technical reviews.”
In a related story, the AP (3/19, Ehrmann) reports, however, that “Flint residents could still be a few years away from drinking unfiltered tap water as the city makes incremental progress on an ambitious – if not overly optimistic – timeframe to replace old water service lines.”
The Washington Post (3/18, Cimons, 11.43M) reported many patients avoid colonoscopies because of the “dreadful” prep required. In total, “about 40 percent of the people who should get a colonoscopy don’t.” However, new products that facilitate the prep procedure may be on the market within two years, and preliminary tests show that patients using the new products “were twice as likely as those who used the standard prep solution to be satisfied and four times as likely to recommend it.” Susan Czajkowski, chief of the health behaviors research branch of the National Cancer Institute said that “Understanding patient motivation...can be important research,” adding that “the easier you make it for people, the more you can improve their adherence.”
The Baltimore Sun (2/13, McDaniels, 714K) reports Lawrence Lacks, the eldest son of Henrietta Lacks, claims “that an agreement the National Institutes of Health made with” Lacks’ family about the use of his mother’s cervical cancer cells was not valid, and is seeking “compensation from Johns Hopkins University and possibly others for the unauthorized use of her cells in research that led to decades of medical advances.” Lacks says the NIH “cut him out of” a 2013 agreement with other family members on how to use the cells, and believes his mother would “be horrified that Johns Hopkins profited while her family to this day has no rights.” The NIH has not responded to the accusation. Johns Hopkins says it did not profit from the cells and has “worked with family members to develop a series of programs to recognize and honor Henrietta Lacks,” Lacks contends “that is not enough to correct the wrong done to Henrietta Lacks.”
The Providence (RI) Business Newss (1/30, Sherman, 27K) reports the National Institutes of Health has awarded a $2.8 million grant to the Miriam Hospital “to study whether weight loss could prevent recurring gestational diabetes.” The study will involved over “250 overweight or obese women with a history of gestational diabetes that plan to have another pregnancy within one to three years."
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.