MSU HRPP Manual Section 8-8

8-8, Flexibility Initative

The Michigan State University (MSU) Human Research Protection Program (HRPP) is identifying existing HRPP policy or process constraints that constitute a burden on investigators and on the institution above and beyond what is reasonable and responsible considering risks to human subjects. The initiative can depart from requirements incorporated in federal regulations and associated guidance by federal regulatory agencies so long as the initiative does not inappropriately increase risks to human subjects or otherwise adversely impact subjects’ rights or welfare and the initiative provides equivalent protections. Each initiative must be approved by the Institutional Official and must be included as a subpart within this section of the HRPP Manual.

The specific initiatives provide narrow circumstances under which the initiative can be applied to the activity. The specific initiatives must meet specific criteria outlined in the section of the manual provided below. In addition, the study cannot include any of the following:

  • Federal funding or federal training grants

  • FDA regulated

  • Sponsor or other contractual restrictions

  • Clinical interventions (including clinical behavioral interventions)

  • Prisoners as subjects

  • Receipt of an NIH issued certificate of confidentiality to protect identifiable research data

  • Be a project for which MSU serves as the IRB of record

Except as specified in the relevant section regarding the initiative, all other federal, state, and local requirements for the protection of human subjects in research and the HRPP Manual sections apply to the activity.

Each initiative will be reviewed periodically to assure compliance with this section and with all other MSU HRPP requirements.

The following HRPP Manual sections provide specific criteria for each initiative:

8-8-A       Exemption Category 7
8-8-B       Exemption Category 8
8-8-C       Continuing Review

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 9-3-2009. Revision 1 approved by VP Research & Graduate Studies on 7-22-2011. Revision 2 approved by VP Research & Graduate Studies on 12-11-2015.

Related HRPP Manual Sections

None

Approved PDF Version

Please note that hyperlinks have been added to the web version of this document for ease of use. View approved PDF version of Section 8-8, Flexibility Initiative.