HRPP Education Resources

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U-M HRPP Key Information | Human Subjects Links | Questions

The University of Michigan offers a variety of educational opportunities and resources for U-M investigators, students and staff involved in human subjects research.

Regulatory Education

HUMAN SUBJECTS PROTECTION TRAINING

The Human Subjects Research Protections e-Learning course in U-M’s Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS) training catalog fulfills the regulatory requirements for human subjects protections training. U-M employees and students have access to the PEERRS menu in U-M’s My LINC training system via their uniqname and UMICH (level 1) password. Completion of this course is a requirement for the IRB approval of regulated human subjects studies.

For more information, review the course details.

GOOD CLINICAL PRACTICE (GCP) TRAINING

    The National Institutes of Health (NIH) requires study team members responsible for the conduct, management, and oversight of NIH-funded clinical trials to complete good clinical practice (GCP) training consistent with the principles of the International Conference on Harmonisation (E6). U-M offers two options for basic good clinical practice (GCP) training for clinical trial study team members:

    1. For biomedical clinical trails, U-M offers GCP training through the CITI Program.  To access the CITI GCP course, you must first create a CITI account (free) and affiliate with the University of Michigan within CITI.  See the CITI step-by-step instructions for details.
    2. For social/behavioral clinical trials, the Michigan Institute for Clinical & Health Research (MICHR) offers the NCATS  Social and Behavioral Best Practices course in My LINC (also available via Wolverine Access).  This course satisifies the NIH requirement for good clinical practice (GCP) training. Access the My LINC training system using your uniqname and UMICH (Level 1) password.  Enter “social and behavioral best practices” in the What would you like to learn today? search bar, or see the My LINC step-by-step instructions for details on how to register for the MICHR GCP course. 

    HRPP EDUCATION POLICY

    HRPP Operations Manual, Part 13

    Need more information about NIH's GCP training policy?

    Read the NIH FAQ

    U-M expectations for fulfilling NIH GCP requirement

    • All study team members involved in the design, conduct, recording, or reporting of an active NIH-funded clinical trial must be GCP certified through a qualifying training provider (e.g., CITI, MICHR/My LINC)
    • Administrative Staff on an NIH-funded clinical trial are not required to complete GCP, unless directed to do so by the principal investigator on a project or per unit-specific (e.g., clinical trial support unit) business process
    • The study team member is responsible for obtaining a GCP certificate displaying the course completion date, and providing that certificate upon request of the research sponsor, the institutional review board (IRB), or other institutional oversight units.
    • GCP training must be renewed every three (3) years upon initial certification expiration, as long as the study team member is involved on an active clinical trial.

    Other qualifying GCP training providers

    U-M accepts GCP training from the following:

    Procedural Education

    The following U-M departments offer courses, seminars, workshops, etc. that cover regulatory overviews and specific human subject protection procedures.  

    CLINICALTRIALS.GOV TRAINING (OPTIONAL)

    Learn the basics about registering a clinical trial and reporting results of that trial through the NIH’s ClinicalTrials.gov online database by taking CITI’s Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov course.  U-M offers this optional training course through its menu on the CITI Program website(link is external).  

    Research Administrators

    • Research Administrators Network (RAN) – mostly applicable to those administrators who work on funding proposals and financial monitoring of awards, but compliance information and processes may be covered.

    FAQs

    Is Good Clinical Practice (GCP, ICH-GCP) training the same as Human Subjects Research Protections training?

    No.  Good Clinical Practice (GCP)(link is external) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical research that involves human participants in research.  A sponsor (e.g., National Institutes of Health) may require that research involving a clinical trial and/or utilizing an FDA-approved protocol follow the International Conference on Harmonization (ICH) Good Clinical Practice guidelines, including ICH-GCP training for investigators.  The biomedical version of GCP focuses on FDA requirements and the application of the informed consent processes for clinical research.  The social-behavioral version of GCP training focuses on the informed consent process for clinical research.

    GCP training is not offered through PEERRS.  For U-M GCP training options, see:  HRPP Education Resources.

    Human Subjects Protections (HSP) training focuses on the U.S. Common Rule(link is external) regulations and requirements, including the ethical principles associated with protecting the human particpants in research and the codified protection methods such as Institutional Review Board (IRB) oversight and criteria for an appropriate informed consent process.  HSP training is required by federal sponsors for human subjects research, including research that qualifies for an IRB exemption.

    GCP training is not offered through PEERRS. For U-M GCP training options, see: HRPP Education Resources.

    Human Subjects Protections (HSP) training focuses on the U.S. Common Rule(link is external) regulations and requirements, including the ethical principles associated with protecting the human particpants in research and the codified protection methods such as Institutional Review Board (IRB) oversight and criteria for an appropriate informed consent process. HSP training is required by federal sponsors for human subjects research, including research that qualifies for an IRB exemption.

    Questions?

    To ask a question, express concerns, or provide suggestions about human research protections at U-M, please send a message to [email protected](link sends e-mail).

    For help with GCP training courses (e.g., registration, navigation):

    Human Subjects Links

    eResearch NextGen: Human Research Application

    OHRP Research Community Forum

    HRPP Policies

    Operations Manual (OM)

    Authorization Agreement Process

    Office of Research Compliance Review (ORCR)

    Single IRB-of Record Process (SIRB)

    Certificate of Confidentiality Process

    HRPP Education Resources

    Information for the Public

    International Research

    IRB HEALTH SCIENCES AND BEHAVIORAL SCIENCES (HSBS)

    IRBMED