Institutional Review Board
 
Am I required to obtain IRB approval for my research proposal? At what point should this be addressed in the proposal process?
 
It is the grantee's responsibility to obtain IRB approval if the grant is to be used in whole or in part for research involving human subjects. If IRB approval is required under the federal guidelines, the applicant needs to obtain it, either from their institution or by contracting with a third-party IRB.
 
While it is preferred that applicants satisfy this requirement at the time of application, it is not required. However, if human subjects are involved, funding will be contingent on satisfying this requirement for IRB review and approval. As a condition of funding, RWJF grantees conducting research involving human subjects are required to certify on a RWJF Letter of Agreement that they will conduct the research in compliance with the ethical standards and the criteria for approval of research set forth in United States Department of Health and Human Services policy for the protection of human research subjects (45 CFP part 46 and related policies and protocols, as amended from time to time).
 
When a proposed research study involves children, IRBs are guided by special regulatory requirements that provide additional protection for the children who would be involved in the research, including requirements for active and/or passive parental consent. We strongly encourage Healthy Eating Research applicants to address IRB issues early in the application development process so that they can incorporate these requirements into their study designs, and proceed in a timely manner with research implementation in the event that they are funded.
 
Because IRB requirements and institutional proposal review meetings vary from one institution to the next, we suggest that you familiarize yourself with your institution's requirements as soon as possible. Below, we have provided a few additional resources and web links on federal requirements for research involving human subjects, and more specifically with research involving children and teens:
 
  • Tutorials, Case Studies, and Training Courses and Other Bioethics Resources on the Web Sponsored by NIH Institutes and offices:  http://bioethics.od.nih.gov/casestudies.html
  • Policy Guidance from the USDHHS Office for Human Research Protections (OHRP) - contains educational resources, online tutorial, information on special issues (e.g., children, HIPAA), and categories of research that may be reviewed through an expedited review procedure: http://www.hhs.gov/ohrp/ 
  • Other federal resources and links to other documents and reports can be found at the following website:  http://bioethics.od.nih.gov/index.html
  • Articles from a recent RWJF-funded workshop on IRB review and consent issues with research involving teens, including:
Diviak KR, Curry SJ, Emery SL, Mermelstein RJ. Human Participants Challenges in Youth Tobacco Cessation Research:  Researchers' Perspectives. ETHICS & BEHAVIOR 2004; 14(4): 321-334.
 
Wagener DK, Sporer AK, Simmerling M, Flome JL, An C, Curry SJ. Human Participants Challenges in Youth-Focused Research: Perspectives and Practices of IRB Administrators. ETHICS & BEHAVIOR 2004; 14(4): 335-349.
 

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