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The Michigan Initiative includes two types of process improvements:
- Innovations - Outright changes to institutional policies, processes or procedures
- Demonstrations - Temporary changes to policies, processes or procedures that are piloted to ensure that the change reduces administrative burden without increasing risk or adversely impacting subjects' rights or welfare.
Considerations for Implementing Demonstration Projects
1. Modification/development of policies, procedures, and IRB materials, including but not limited to:
- Standard Operating Procedures
- Guidance and policy materials
- Determination letters to inform PIs about additional responsibilities
2. eResearch system changes/additions, including but not limited to:
- IRB application and workflow
- System notifications (new, reminder)
- Reporting mechanisms for tracking and monitoring
3. Training of IRB staff and IRB membership
4. Education of PIs and study teams
5. Monitoring to assure subject safety and compliance with demonstration partners
6. Informing AAHRPP when submitting any (re)accreditation materials
The Michigan Initiative
The HRPP Policy Innovation & Demonstration Initiative ("Michigan Initiative") is an ongoing effort to review current U-M human subjects protection policies and procedures to reduce administrative burden and streamline processes for investigators and staff. The Michigan Initiative focuses on utilizing the flexibility allowed by federal regulations and identifying standards for areas where these regulations do not apply, while maintaining the ethical standards that form the basis for protecting human subjects in research.
For flexibility initiatives, the HRPP, under the direction of the University of Michigan Office of Research (UMOR), and the U-M IRBs work together to develop institutional approaches to reduce regulatory burdens in human subjects research.
Since U-M elects to apply its Federalwide Assurance to only research sponsored by federal agencies that require adherence to 45 CFR 46, we are positioned to create alternative processes and procedures for review of non-federally funded human research through flexibility initiatives (a.k.a. "innovation or demonstration projects").
Beginning September 2019, the U-M HRPP, IRB Offices, and our partners from ITS-eResearch embarked on a three-year, multi-phase project to redesign the current IRB application (the "HUM") and the IRB review processes.
- Increase quality and efficiency of input by researchers, and improve the researcher's experience with the IRB application and review processes.
- Prioritize capturing the regulatory requirements for determinations, documentation, oversight, and reporting.
- Reduce burden for the researcher, IRB reviewer, and IRB staff.
- Utilize supplemental information (e.g., "help" features) to contribute to the regulatory and procedural knowledge of the study teams.
- Enhance the business intelligence features to improve the reporting of various HRPP indicators, and build flexibility to add indicators as needed.
- Utilize IT design to permit timely updating of IRB application questions.
U-M Research Community Input Needed
The success of this project will depend on input from you, the U-M human subjects research community. The project team plans to offer a variety of opportunities to obtain your feedback throughout the initiative, starting with a short survey planned for mid-November to broadly identify what you like/dislike about the current IRB application.
To learn about additonal opportunities to particpate and for updates on the project, check this webpage frequently.
Innovations U-M has implemented to date include:
- Streamlining the IRB application paths (i.e., types of applications) in eResearch for:
- Secondary use of existing data/records/specimens
- Exempt human subjects research
- Activities not regulated as human subjects research
- Requests for review by a non-UM IRB.
- Updating IRB policies regarding staff roles for:
- Exempt reviews - authorization for IRB staff to make exempt determinations
- Scheduled Continuing Review (SCR) - authorization for qualified IRB-HSBS staff to conduct expedited review of non-federally funded research.
- Implementing U-M guidelines regarding:
- Expanding the interpretation of federal exemption category #5 to cover public benefit and service programs sponsored by the State of Michigan.
HRPP's criteria for demonstration projects includes:
- The research must be determined to pose no more then minimal risk to subjects.
- The research must not include:
- 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 Certificates of Confidentiality
- The project must evaluate the impact of procedural improvements, including the:
- Compatibility with the current electronic IRB application
- Ease of training and informing investigators, study teams, and the IRB staff
- Ability to monitor the projects.
- The project must signify the impact of procedural improvements on the research community, such as:
- 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.
- Extended definition for federal exemption #2 [pre-2018 Common Rule] (proposed by IRB-HSBS, 2013; adopted by all U-M IRBs)
Federal exemption category 2 applies to projects involving educational tests, surveys, interviews, or observation of public behavior. It does not allow for any other research intervention in conjunction with the durvey, etc., regardless of the risk. U-M exemption #2a expands the federal definition to minimal-risk research with adults that involves a non-invasive intervention followed by data collection vai survey, interview (including focus groups) or observation. Examples of non-invasive interventions include, but are not limited to:
- Reading a story or vignette
- Playing an electronic game
- Using a computer program or website
- Watching a video
- Using a robot arm or device
- Being exposed to stimuli, such as color, light or sound (within safe limits)
- Two-year approval periods (proposed by IRB-HSBS, 2007; adopted by IRB-Flint, 2014, IRBMED, 2015)
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 beyone one year was unlikely to increase risks to subjects.
- Exemption for analysis of identifiable data: U-M Exemption #7 [pre-2018 Common Rule] (proposed by IRB-HSBS, 2007; adopted by all U-M IRBs) 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 doesn not enhance subject safety. A new exemption category was created to provide appropriate review and subsequent exemption from regulatory oversight. Anticipated benefits included:
- Reduction of administrative workload for investigators
- Reduction of application volume for IRB staff and reviewers
- Reduced turn-around time for application review of U-M Exemption #7 studies
- Pilot of the 2018 Common Rule for non-federally funded research (June 2018-January 2019)
Pilot to evaluate business process changes, validate burden-reducing efforts, and test changes to the IRB application prior to the implementation of the 2018 Common Rule, including:
- Implementing new and updated exemption categories (except 7 and 8);
- Implementing new exemption review paths, specifically the "system-generated" determination workflow for exemptions 1, 2, and 3; and
- Removing the requirements for continuing review of expedited studies (i.e., minimal risk studies).