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HRPP Innovation & Demonstration Initiative

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Demonstrations

In 2007, the U-M launched two demonstration projects to provide additional flexibility and reduced administrative burden for certain types of minimal risk research.

Since the U-M has elected to apply its Federalwide Assurance to research sponsored by federal agencies that require adherence to 45 CFR 46, U-M was positioned to create alternative processes and procedures for review of non-federally funded human research. In determining which projects to would qualify for the demonstrations, IRB-HSBS set the following criteria:

  • The research must be determined to pose no more than minimal risk to subjects, and
  • Must not include any of the following:
    • Federal sponsorship, including federal training grants
    • FDA regulated components
    • Sponsor or other contractual restrictions requiring adherence to federal regulations for clinical interventions (including clinical behavioral interventions)
    • Prisoners as subjects
    • NIH-issued Certificate of Confidentiality
The following procedural points were considered:
  • Ease of administration of the new process emphasizing:
    • Compatibility with the current electronic IRB application
    • Ease of training and informing investigators, study teams, and IRB staff
    • Ability to monitor the projects
  • Significance of impact on the research community:
    • Elimination of regulatory excess that is not protective of human subjects
    • Enhanced regulatory outcomes for minimal risk research
    • No increase in effort required for investigators

Demonstration Project for Two Year Approval Periods

Federal regulations require continuing review of research at least annually, depending on the degree of risk to the subjects. For research projects posing no more than minimal risk to subjects, U-M postulated that lengthening the review period beyond one year was unlikely to increase risks to subjects.

In September 2007, IRB Health Sciences and Behavioral Sciences (IRB- HSBS) began issuing two year approvals to projects anticipating the following benefits:

  • Reduction of administrative workload for investigators
  • Reduction of application volume for IRB staff and reviewers

Demonstration of Exemption for Analysis of Identifiable Data (UM Exemption #7)

Federal regulations require annual continuing review for all studies, including minimal risk studies where research activity is limited to analysis of identifiable data. U-M proposed that for research involving no direct interaction or intervention with human subjects, the requirement to submit annual continuing reviews does not enhance subject safety. A new exemption category was created to provide appropriate review and subsequent exemption from regulatory oversight.

In September 2007, IRB-HSBS began issuing UM Exemption #7 to new projects and existing IRB approved projects anticipating the following benefits:

  • Reduction of administrative workload for investigators
  • Reduction of application volume for IRB staff and reviewers
  • Reduced turn-around time for application review

 

Outcomes

To assure that the demonstrations achieved the desired reduction in administrative burden and continued to offer equivalent protections to human subjects, IRB-HSBS requested monitoring of the projects and tracked IRB-HSBS workload.

Post-approval monitoring was conducted by U-M's Office of Human Research Compliance Review (OHRCR) at the two-year anniversary of the initiation of the two demonstration projects resulting in the following assessments:

No increased risk to subjects or non-compliance from demonstrations
After surveying principal investigators receiving a demonstration determination and interviewing selected investigators, OHRCR found:

  • No increased risks to subjects were identified for any projects conducted under a demonstration.
  • Several studies that had obtained federal funding subsequent to receiving a demonstration approval had contacted the IRB to resume an annual review cycle.

Reduction in Workload
Since the introduction of the demonstration projects, the IRB-HSBS has issued:

  • Greater than 900 two year approvals
  • Nearly 300 Exemption #7 determinations

Based upon these results, U-M has adopted the two demonstration projects as permanent processes covered by it HRPP policies. The IRB will continue tracking data into the future to determine trends that may further enhance these projects.

 

Ideas for the Future

Given the success of the current Innovations and demonstrations, U-M is committed to continued exploration of regulatory flexibility to minimize administrative burden while continuing to apply the highest ethical standards for the protection of human subjects. Ideas for future projects include:

  1. Permissible Minor Modifications
    Currently, under federal regulations, any modification to an IRB-approved research protocol or its study materials requires prospective review and approval of an amendment - even in minimal risk research. In some cases, allowing minor changes to be employed immediately instead of waiting for IRB approval may reduce risk to the subjects. Appropriate modifications may also improve the investigator's data collection or contribute to an enriched experience for the subject.

  2. Expansion of existing exemptions or new exemptions for additional categories of research
    Many minimal risk social and behavioral research designs fall outside of the specific exemption criteria outlined in the federal regulations. Expansion or reinterpretation of the exempt review categories for adult participants would result in reduced administrative burden without a negative impact on risk to human subjects.

  3. Exemptions for long-term follow-up on clinical research studies
    Many clinical research projects follow subjects until death after all clinical interventions and all other subject interactions are completed. An exemption category for clinical research protocols in long-term follow-up would reduce the regulatory burden on investigators and the IRB by eliminating the need for annual continuing review.

U-M encourages members of the research community to suggest new innovations and demonstrations. Contact hrppumich@umich.edu with your ideas.