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 (http://www.hhs.gov/ohrp/)
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 (see http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm)
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 (see http://grants2.nih.gov/grants/funding/phs398/phs398.html)
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. For more information about “Just
in Time” policies, go to: http://grants2.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm
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:
Risk to subjects.
Adequacy of protection against risks.
Potential benefits of the proposed research to the
subjects and others.
Importance of the knowledge to be gained.
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. For more information about the
codes, go to: http://www.niaid.nih.gov/ncn/clinical/humansubjects/human_subject_codes.htm
Current as of June 2005
Internet Citation:
Protection of Human Subjects in Research. June 2005. Agency for Health Care Research and Quality, Rockville, MD. http://www.ahrq.gov/fund/hsubjects.htm
540 Gaither Road Rockville, MD 20850 