MSU HRPP Manual Section 6-2-B

6-2-B, Minimization of Risks: Adequate Resources

Investigators should have adequate resources available to protect human subjects involved in the research. Adequate resources should include both monetary and non-monetary resources as needed (e.g., space, equipment, staff, time, expertise, counseling, medical care).

Investigators should consider, when appropriate, the following types of resources:

  • Adequate qualified staffing (e.g., availability, number, expertise, experience)

  • Process to ensure that all individuals assisting with the research are adequately informed about the protocol and their research related duties

  • Adequate time for the researchers to conduct and complete the research

  • Access to a population that will allow recruitment of necessary number of subjects

  • Psychological, social, or medical services and monitoring, including counseling or social support services that may be required because of research participation

  • Ancillary care

  • Adequate facilities, including equipment needed to protect subjects

  • Resources for subject communication, such as language translation services

  • Reliance on entities within Michigan State University but not under control of the investigator and where protection of subjects requires those entities be prepared for involvement (e.g., student pool, counseling, educational or social services, nursing unit, pathology lab, pharmacy, billing unit, radiology clinic)

During the review process, Institutional Review Board (IRB) members should review applications to determine if each research study has the necessary resources to protect subjects’ rights and welfare.

In the process of evaluating adequate resources, the IRB considers the following:

  • Monetary and non-monetary resources

  • Provisions for monetary resources if the study is unfunded

  • Whether there are adequate staff, including expertise and qualifications to conduct the research

  • Need for and access to counseling, medical, or health care for subjects

  • Safeguards to protect privacy of subjects (e.g., space for consent and process) and confidentiality of data (e.g., physical and electronic records)

  • Whether the resources described are adequate to protect subjects effectively

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 3-9-2008. Revision 2 approved by VP Research & Graduate Studies on 8-22-2011. Revision 3 approved by Assistant VP Regulatory Affairs on 11-23-2015.

Related HRPP Manual Sections

None

Approved PDF Version

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