McLaren Health Care
HRPP Education and Training

HRPP Education and Training

Human Research Protection Program (HRPP) education and training in research ethics and regulations are fundamental to the MHC HRPP mission to promote the highest standards in human research protections. One of the primary responsibilities of the HRPP is to ensure that IRB members, IRB staff of the HRPP Office, investigators, members of research teams and those charged with the protection of human research subjects receive and maintain the training and education necessary to fulfill their obligations in the research enterprise.

The MHC HRPP utilizes the Collaborative Institutional Training Initiative (CITI) website for educating and training the research community. CITI Program identifies education and training needs in the communities we serve and provides high quality, peer-reviewed, web-based educational materials to meet those needs.

Required Training for All Key Study Personnel

Basic Human Subjects Research (HSR) Course

All Key Study Personnel at McLaren Health Care must complete human subjects protection training on the Collaborative Institutional Training Initiative (CITI) website. The requirement to complete CITI training applies to Key Study Personnel, all Human Subjects Research, Key Study Personnel, including Exempt, Expedited and Full Board studies. This training must be completed before an individual can be approved as a member of the research team. IRB approval of any individual application is contingent upon the fulfillment of this requirement. 

It is the Principal Investigator’s responsibility to ensure that the list of personnel in the IRB application is current and those listed as Key Study Personnel maintain current CITI Human Subjects Protection Training. HRPP staff and Institutional Officials also must complete CITI training.

MHC Definition of Key Study Personnel (KSP)

Key Study Personnel (KSP) is an A individual listed as study personnel, in the IRB application with full or partial responsibility for the design, conduct, OR reporting of research. KSP includes the Principal Investigator, other investigators and research personnel engaged in the conduct of the research activity such that they directly intervene or interact with human subjects with research participants to obtain consent and/or research data or will have access to participants’ private and identifiable private information during data collection or data analysis. Key Personnel applies to individuals who are not affiliated with MHC or an affiliate institution but, are authorized to participate on study under the supervision of a McLaren PI.

    Key Personnel also include faculty mentors/Academic Advisors who provide direct oversight to Postdoctoral Fellows, Residents and Clinical Fellows on the IRB application.

    There are two educational tracks for the Basic Human Subjects Research Course:

    • Biomedical Research
    • Social and Behavioral Research

    To receive maximal benefit, you should choose the track most closely related to the research in which you are involved. Each track contains up to eleven required modules which take approximately 10 to 30 minutes to complete, as well as several optional modules. The Human Subjects Research training is valid for a 3-year period. There are two training courses: BASIC and REFRESHER.  Basic training must be completed before completing refresher courses.  

    If you have not previously completed the Basic Human Subjects Research Course taking a refresher course will not satisfy the training requirement. If this is your first time taking the course, you must complete it in its entirety.

    Monitoring Required Training

    HRPP has an oversight mechanism to ensure that all individuals are up-to-date with their required training. (You may also print a certificate of completion for your records at the end of the course)

    Refer to the policy MHC_RP0306 Education and Training in Human Subject Research if you would like more details regarding education and training.

    Do I Need Any Other Training Besides CITI Human Subject Research Training?

    Conflicts of Interest Course

    In addition to HSR training, all investigators and co-investigators must complete the CITI Conflicts of Interest Course. GCP training is an additional separate training and is not basic human subjects protection training. This training is valid for a 4-year period.

    Good Clinical Practice Course

    If clinical trial is required to adhere to ICH-GCP E6 guidelines, you must complete Good Clinical Practice (GCP) training is required every three years. GCP training is an additional separate training and is not basic human subjects protection training. GCP principles are specific to clinical trials and include international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials. Refer to clinical trial contract/agreement, sponsor or funding agency to determine if your research protocol is required to adhere to ICH-GCP E6 guidelines. Individuals engaged in the conduct of a clinical trial (per the NIH definition) must complete a Good Clinical Practice (GCP) training.  GCP Course options in CITI Program are:

    • Good Clinical Practice for Clinical Trials with Investigational Drugs and Biologics (US FDA Focus)
    • Good Clinical Practice Social and Behavioral Best Practices for Clinical Research
    • GCP for Clinical Investigations of Devices (formerly called GCP Course for Clinical Trials Involving Investigational Medical Devices (international focus)
    • GCP for Clinical Investigations of Drugs and Biologics (ICH) (formerly called GCP for Clinical Trials Involving Investigational Drugs (international / ICH focus)

    Good Clinical Practice training  is valid for a 3-year period, after which time a Refresher GCP Course must be completed. Alternative GCP training review -  Submit a request for acceptance of alternate GCP training in lieu of the options above and email documentation of past training.

    For more information about good clinical practice and alternative GCP training, see the Application of GCP to the Conduct of Clinical Research Page.

    Community-Engaged Research

    Investigators conducting community engaged research must complete the CITI Engaged and Community-Based Participatory Research. For more information about community-based engaged research see our web page

    Additional Continuing Education

    Frequently Asked Questions

    The CITI Support Center also provides resources and answers to frequently asked questions.