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What must I include in "Protection of Human Subjects"?
When preparing your application, you should know that in addition to the regular review criteria for scientific merit, reviewers use four other criteria to judge human subjects research applications:
Part II: Supplemental
Instructions for Preparing the Protection of Human Subjects Section of
the Research Plan is found in the PHS 398 and the SF424and
can be helpful when writing this section.
It is important that you complete and submit the Targeted/Planned Enrollment Table with your application which indicates the proposed ethnic, racial and gender compositions of your study population.
Reviewers will also evaluate your plans for recruiting and retaining subjects. Trial recruitment that is slower than expected can result in prolonged trial durations, increased costs, uneven workload, and morale problems, both for trial participants and clinical research team members. Furthermore, when recruitment is so poor that it needs to be curtailed before the trial's target sample size is reached, study power is reduced and there may be a need to revise study endpoints. The Office of Research on Women's Health provides pertinent information on the recruitment and retention of women and minorities in clinical research and may be useful as you consider your plans for recruiting these special populations.
It is good to demonstrate that you have access to the population under study and to provide realistic estimates of how many in the population will meet your inclusion/exclusion criteria. If you have done preliminary work with this same population, you may wish to describe successful strategies previously used. You will need to describe which strategies you plan to use for identifying and enrolling participants
Once enrolled into the study it is important that you have strategies outlined for retaining patients. A brief statement as to how you plan to keep patients in the study is desirable.
Women and Minorities
The Office of Research on Women's Health provides a brief history, policy documents and outreach information on inclusion, recruitment and retention of women, men and minorities in clinical research.
Data and Safety Monitoring Plans ( DSMP )
A DSMP is required for every grant application or contract proposal submitted to NHLBI that includes a clinical study. Grants that include multiple clinical research protocols addressing separate research questions in different groups of subjects must have a DSMP for each protocol.
Peer reviewers will gauge the adequacy of your plans to protect subjects from research risk and to include required populations. If your description is inadequate or your application does not comply with requirements, your priority score may suffer and your application may get a Bar to fund . If a grant will be funded by NHLBI, a detailed DSMP must be included as part of the formal protocol that is submitted to NHLBI Program Staff and the applicant’s IRB for approval before accrual of human subjects begins.
All clinical research that entails greater than "minimal risk" requires independent monitoring. "Minimal risk" is defined in 45 CFR 46, Section 102 (i) as: a risk where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than doing so as part of a routine physical examination.
In the Human Subjects section of the grant application, there should be a separate subsection entitled, "Data and Safety Monitoring Plan (DSMP)". The DSMP should provide a general description of the overall framework for data and safety monitoring. It should address the following areas:
Monitoring requirements may differ depending on the type, complexity and phase of your clinical study. A plan may include the following types of monitoring:
You will work with NHLBI to make the final decision about safety monitoring before you begin your study. Please see the NIH Policy for Data and Safety Monitoring and Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials for more information.
The instructions for a non-modular budget can be found in
the SF424 or
PHS 398 or in the instructions in the RFA to which you are
responding. Non-modular budgets require much
more detail about salaries, travel, equipment, patient care
costs and budget justification information, among other things.
Advice to Investigators Submitting Clinical Research Applications sponsored by the Center for Scientific Review. This site gives additional information to assist investigators in writing and submitting applications.
Page Last Updated: February 2011