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Informed Consent: Additional Resources
- Office for Human Research Protections (OHRP) [hhs.gov]:
The Office for Human Research Protections (OHRP) protects the rights, welfare, and well-being of subjects involved in research conducted or supported by the Department of Health and Human Services (HHS) and helps ensure that such research is carried out in accordance with the regulations described at: Title 45, Part 46 of the Code of Federal Regulations, Protection of Human Subjects; also referred to as 45 CFR 46.
OHRP has tips for informed consent at Tips On Informed Consent [hhs.gov] and at OHRP Informed Consent Frequently Asked Questions [hhs.gov].
- GWAS Policy:
The NIH released the final "Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS)" in the NIH Guide and the Federal Register on August 28, 2007. Under this policy, investigators who are performing whole genome association studies conducted or supported by the NIH are expected to submit their data to the NIH GWAS data repository for broad sharing with the research community.
See: Genome-Wide Association Studies (GWAS) [grants.nih.gov]
- Institutional Review Boards (IRBs):
The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The Office of Human Research Protections (OHRP) has developed an IRB Guidebook to help researchers and IRB members to understand the policies, principles, and issues that pertain to designing and reviewing research proposals.
In addition, the Department of Energy developed a resource book for IRBs to provide updated information to their investigators on many of the topics covered in the IRB guidebook. There is a chapter in this resource that is dedicated to issues pertaining to genetics and genomics research.
As a complement to the NIH GWAS Policy, the NIH has developed a Points to Consider document for IRBs and institutions in their review of data submission plans for institutional certifications under NIH's GWAS policy.
- Human Subject Protection Program, FDA:
The U.S. Food and Drug Administration (FDA), through its Office of Health Affairs, has developed its own set of regulations on the protection of human subjects (Title 21, Parts 50 and 56 of the Code of Federal Regulations; also referred to as 21 CFR 50, 56).
The regulations apply to any clinical trial that involves an investigational drug, biological product, or other device that is regulated by the FDA under the Food, Drug, and Cosmetics Act — regardless of whether or not the trial receives Federal funding. If a trial is supported by the Department of Health and Human Services and involves an FDA-regulated drug or device, then it is subject to both organizations' regulations. (For more information, see Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors).
- Other organizations:
Groups such as Public Responsibility in Medicine and Research (PRIM&R) help to educate medical personnel and the public about the ethical, legal, and policy issues involved in clinical research.
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Last Reviewed: December 18, 2008
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