Monday, June 18, 2012

Integrating Human Research Protections Into Research Design

As human research protection programs (HRPPs) have evolved and become more sophisticated, researchers have begun integrating human research protections into their research designs. No longer is the protection of human research participants addressed only after a research protocol has been written. Increasingly, researchers are incorporating ethical considerations at the initial stages of research design. HRPP education programs aimed at researchers, and good working relationships between researchers and their IRB, are facilitating the research design process.

Both ethical and practical considerations are driving this trend. The application for grants from the National Institutes of Health and other federal agencies requires a section on human subject protection as part of the research plan. Generally, the research plan must include details about the risks to human participants, adequacy of protections proposed for human participants, potential benefits of the research project, and data and safety monitoring plans. Nearly every professional association whose members conduct human participant research sets guidelines for the ethical conduct of research with human participants. For example, the American Psychological Association and the American Anthropological Association have detailed guidelines.
HRPPs can help researchers by taking several steps:
  • Implement a strong education program that meets the researchers’ needs in terms of scheduling and topics covered, and also provides documentation of s completion of educational requirements.
  • Provide individual consultation for specific research projects on human research protection issues with IRB chairs, members, or staff. Consider instituting a formal consultation program for researchers in the design phase of research that is independent of the IRB.
  • Develop standardized language on the organization’s HRPP to provide to researchers for grant applications. Offer assistance in completing the human participant protection sections of grant applications.
  • Provide timely assistance with documentation such as exempt determinations or letters or approval, including completion and signing of required forms for grant applications.

Integrating human protections in the design of research produces not only better protections for research participants but also higher-quality research. As researchers become more knowledgeable about human research protections, IRB review of their protocols is more efficient. All benefit—research participants, researchers, and HRPPs—when HRPPs help researchers and work with them to integrate human research protections in the research design.


American Psychological Association guidelines:
American Anthropological Association guidelines:

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