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.
NIH introduces three new policies for studies involving a clinical trial. New 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
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 May 25, 2017 receipt dates.
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 (9/6, Kelly, 10.14M) “To Your Health” blog profiles Dr. Eliseo Pérez-Stable, the director of the National Institute on Minority Health and Health Disparities (NIMHD), and his continuing efforts to break down cultural and language barriers that prevent people from accessing healthcare. The article explains that Dr. Pérez-Stable experienced such barriers firsthand while growing up as an immigrant from Cuba in the Miami area and later learned more about the prevalence of such experiences in the Latino community while doing research at the University of California at San Francisco.
Majority of People Would Give Personal Information to Precision Medicine Database. Modern Healthcare (8/18, Castellucci, Subscription Publication, 235K) reports the majority of Americans support the Precision Medicine Initiative Cohort Program and would be willing to participate, according to a new survey conducted by market research firm GfK and published in Plos One. The article explains that the program aims to improve medicine by gathering genetic information, medical histories, and EHRs from over 1 million people and the National Institutes of Health has already awarded almost $55 million in grants to begin recruiting people to participate.
Additional Sources. Fierce Healthcare (8/18, Dvorak, 147K) reports the survey found that almost 80% of Americans support the program and a majority said they would “definitely” or “probably” take part in it. NIH’s deputy director for science, outreach, and policy Kathy L. Hudson said the survey results are “extremely promising.”
Politico (8/18, Geller, 1.95M) adds the survey was supported by the NIH and the results were based on the responses of around 2,600 people.
Analytics, Data Science and EHRS in the New Age. In a nearly 4,000 word article, Healthcare IT News (8/15, Andrews, 1K) reports on how “the rapid advancement of precision medicine” is “continually outstripping” the pace of change in EHRs. The article reports that EHRs are essentially the same as they were in 2004 when the Office of the National Coordinator for Health Information Technology launched the interoperability initiative, but medicine has changed a lot since then. The Office of the National Coordinator for Health IT’s deputy national coordinator Jon White said, “The overarching problem with interoperability is that there is no common data model – not only between vendors, but between instances of a particular vendor. There really needs to be a standard data model for healthcare.”
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.” .
Zika hits Miami: Nation's first local outbreak, health officials confirm. The Centers for Disease Control and Prevention confirmed certain Zika cases in Miami were the first in the continental US to demonstrate the local transmission of the virus. All three network newscasts provided nearly 11 minutes of coverage combined and led with the story, while print and online sources also provide extensive reporting on the announcement. Coverage highlighted the implications of the spread of the Zika virus in the US and suggested that the news will increase pressure on Congress to act on the President’s funding request to fight the disease.
In a nearly 1,700-word article, the Miami Herald (7/29, Chang, 762K) reported that “four people in South Florida – two in Miami-Dade County and two in Broward – have been infected by local mosquitoes, according to Florida Gov. Rick Scott, whose announcement triggered a wave of response from public health agencies and elected officials.” CDC Director Tom Frieden said the agency is not currently advising against travel to Miami, asserting that these cases appear to be “isolated” and an example of what “may be occasional clusters in the United States,” but not the beginning of “widespread transmission.”
On ABC World News Tonight (7/29, lead story, 2:25, Llamas, 14.63M), correspondent Eva Pilgrim added that health officials have tested around 19,000 mosquitoes from the neighborhood, but none have so far tested positive for the virus. Reuters (7/29, Fagenson) said that “many” local residents “viewed the arrival of Zika in Miami as all but inevitable, given the region’s large numbers of tourists and its sweaty summer mosquito season.” On ABC World News Tonight (7/29, story 2, 1:05, Llamas, 14.63M), chief medical editor Dr. Richard Besser praised the CDC for not imposing travel restrictions on Miami, calling the decision “a responsible move,” given the lack of “a widespread outbreak across Miami.”
Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, told NBC Nightly News (7/29, lead story, 2:25, Holt, 16.61M) correspondent Kerry Sanders he thinks “we’re going to see more” incidents of locally transmitted cases and posited, “The critical issue is how do you respond to that?” The Hill (7/29, Sullivan, 884K) added that Fauci “said at an event at the Bipartisan Policy Center Friday that he thinks ‘very aggressive mosquito abatement’ will prevent the virus from becoming ‘sustained’ in the continental United States.”
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.