Protection of Human Subjects in Research

Tips for Applicants:

• Review the Office of Human Research Protections (OHRP) Web site. OHRP provides leadership and oversight on all matters related to the protection of human subjects participating in research conducted or supported by the U.S. Department of Health and Human Services. OHRP helps ensure that such research is carried out with the highest ethical standards and in an environment where all who are involved in the conduct of oversight of human subjects research understand their primary responsibility for protecting the rights, welfare, and well-being of subjects. The OHRP Web site offers much important information and will introduce applicable Federal regulations and guidance. Further, Decision Charts are presented that are helpful in thinking through relevant human subject protections issues.
• Consult with your IRB. When your protocol is ready and you think you have done a thorough and thoughtful job of addressing the Protection of Human Subjects issues, you may want to meet informally with your Institutional Review Board (IRB) chair or administrator. Ask what the IRB has been concerned about lately. Ask for a “quick read” of the Human Subjects Protection section of your protocol. Listen more than you speak. Rework the pertinent sections as necessary!
• Carefully review the PHS 398. The grant application form includes detailed information about human subject participation protections. In particular, see “Part II—Human Subject Protections Supplement.” This section poses 5 questions and describes 6 scenarios for making decisions about the protections—using the same process the IRB will use in reviewing research protocols. Much of the required information on the protection of human subjects in the PHS 398 grant application is identical to information that must be provided about the research protocol for IRB review.
• Determine your own institutional policy regarding when to submit to your IRB. AHRQ no longer requires that IRB approval and certification prior to review. However, it is recommended that you check with your own IRB, academic institution, or sponsor, regarding their policies regarding IRB review and submission. AHRQ permits you to wait until you are notified of funding before submitting the protocol to your IRB. However, any modification of the research plan section of the application required by the IRB or to address human subjects concerns raised during peer review, must be submitted to the Agency for approval before an award will be made. Select for more information about “Just in Time” policies.
• Understand Peer Reviewers’ options with regard to human subject protections. Peer reviewers assess research protocols for issues related to human subject protections and then assign each application a Human Subjects Protection code. The Scientific Review Group will assess the adequacy of safeguards of the rights and welfare of research participants, and the appropriate inclusion of women, minorities, and children, based on the information in the application. They will evaluate the involvement of human subjects and proposed protections according to the following review criteria:
  1. Risk to subjects.
  2. Adequacy of protection against risks.
  3. Potential benefits of the proposed research to the subjects and others.
  4. Importance of the knowledge to be gained.
  5. Data and safety monitoring for clinical trials.

  This evaluation will be part of the Approach criterion and will be factored into the overall score for scientific and technical merit of the application.

• If your application is lacking, in any way, in meeting human subjects protections requirements, the reviewers or Agency staff will assign it a code that negatively affects your award. This may happen for various reasons, some related to the claims about the research protocol (e.g., for exemption or the risk benefit relationship) or the procedures for insuring participant protections (e.g., inadequate procedures to maximize privacy and confidentiality or subjects not adequately informed about risks in the informed consent document). A code 44 means the application is unacceptable due to human subject protections concerns and prevents the Agency from issuing an award. Reflecting a lesser problem, a code 48 puts a restriction on the award that must be addressed before any subjects can be enrolled. The AHRQ Program Officer can work with you to help resolve these issues. When all concerns are resolved, the Agency changes the code to 54—funds may be awarded and you may enroll subjects. Go to more information about the codes.