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Equitable selection of participants (representation of minorities and women in research)

Researcher Help: Equitable selection of participants (representation of minorities and women in research)

Goals of Research

Scientific or Scholarly validity	Information
General Considerations	Researchers should describe the goals of their research, including hypotheses and how the design will address the hypothesis. Scientific or scholarly merit review of the researcher's goals provides information the IRB needs to make required regulatory determinations. The scientific review process evaluates the soundness of the research design and the ability of the research to answer the proposed questions. For example, a study might be designed to show that a new HIV drug is non-inferior to other existing drugs in the same class as part of an application to the FDA for approval of the drug. The application and protocol should address how the design will accomplish this goal. Similarly, a study might be designed to create generalizable data using interviews and surveys to characterize social networks and their impacts on sexual disease transmission. The application and protocol should explain how the survey instruments and interviews will be used to measure network effects.
Required Determinations by the IRB	The IRB must determine: Risks to participants are minimized by using procedures consistent with sound research design and which do not unnecessarily expose participants to risk. Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result. To make these determinations, the scientific or scholarly review must address the following: Does the research use procedures consistent with sound research design? Is the research design sound enough to yield the expected knowledge? At DOH scientific or scholarly review may take place in a program, Office, Bureau or Division, or as part of a grant award process, or by the IRB. If scientific merit reivew is conducted by someone other than the IRB, then these findings should be documented and included as part of the IRB application as information for the IRB to consider. The IRB may not delegate the scientific or scholarly merit determination to an external body. However, the IRB will consider those findings as part of its deliberations. In the absence of external review of scientific or scholarly merit, the IRB will conduct its own review. In all cases the conduct of the scientific or scholarly review requires the reviewers to have the expertise to understand the goals of the research, and the background, aims, and methods of the research to answer the above questions. If the IRB does not have sufficient expertise, it will seek a consultation.
Accreditation Element	Element I.1.B: The Organization has and follows written policies and procedures for reviewing the scientific or scholarly validity of a proposed research study. Such procedures are coordinated with the ethics review process.
Regulations	45 CFR §46.111(a)(1)(i), 45 CFR §46.111(a)(2), 21 CFR §56.111(a)(1)(i), 21 CFR §56.111(a)(2)
Guidance
References	OHRP Institutional Review Board Guidebook, Chapter 4; OHRP Institutional Review Board Guidebook, Chapter 5 Evaluation Instrument for Accreditation, Association for Accreditation of Human Research Protection Program

Process of informed consent

Help for Researchers: The process of informed consent

Confidentiality

Help for Researchers: Confidentiality protections

Adding researchers and study personnel

Help for researchers: How to add researchers and study personnel

Researchers and key study personnel

Help for researchers: Researchers and Key Study Personnel

Research involving FDA-regulated in vitro diagnostic products

In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. [21 CFR 809.3]

Information about in vitro diagnostic products can be found on the FDA Office of In Vitro Diagnostic Device Evaluation and Safety at: http://www.fda.gov/cdrh/oivd/
Researchers planning to conduct research involving IVDs must provide specific information to the IRB.
Researchers should download DOH's Worksheet for Researchers: Research Involving In Vitro Diagnostic Investigations and provide all information required by the worksheet to the IRB using the online application system.
researcher-worksheet-IVD.doc 44.50 kB

Documentation of Informed Consent

Help for investigators: documentation of informed consent

Subject selection and recruitment

Help for researchers: Subject Selection and Recruitment