HRPP Education and Training

Who must complete CITI Human Subject Research Training?
Do I Need Any Other Training Besides CITI Human Subject Research Training?
How to Register and Complete a Course?
Refresher Training?
Can I use CITI Training from Another Institution?
Need Help Login to CITI
How to check your CITI Training Records?

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 https://www.mclaren.org/main/community-engaged-research.

Additional Continuing Education

https://www.mclaren.org/main/research-education

Frequently Asked Questions

From the CITI web site click the "Register Here" button. In Step 1, select McLaren Healthcare Corporation as your organization affiliation.
On the CITI site, click the Register button. In Step 1, type in "McLaren Health Care Corporation" as your organization affiliation.
In Step 2, fill in your name and email address, entering the same email you use in iRIS. Your MHC CITI training record is linked to your account in iRIS, the IRB’s online submission system. The two accounts are linked by email address, so your PRIMARY email address in CITI must match your email address in iRIS. If necessary, you can update your email address in CITI or in the "My Account Information" section of iRIS under "My Assistant."
Complete the username and personal profile sections, and specify if you want to receive Continuing Education credits (fee applies)
In steps 3-4, enter a username, password, security question and personal profile info. You also can choose to receive Continuing Education credits, which are available for a fee that is paid by the learner. You only need to answer the required questions in these sections.
Once you are registered, you may begin the training process!

Please see the CITI Program Site for more information at Guide to Getting Started .

CITI Human Subject Research training course taken under a non-McLaren Health Care institution may be accepted. However, we will require affiliation* with McLaren Health Care on the CITI website. CITI will review the modules previously completed and the date(s) taken. CITI will ask the individual to complete any modules required by McLaren Health Care that were not required by your previous institution.

To link your completed modules from another institution to McLaren Health Care:

Log on to your previous CITI account and click on the "Affiliate with another institution" link.
Type "McLaren Health Care Corporation" into the search box then select it from the drop down menu that appears.
When prompted, choose the "Biomedical Research Investigators" or "Social and Behavioral Research Investigators" course; whichever matches the course work that you completed previously.
Scroll to the bottom of the page and select "Submit"

You will then be prompted to complete any modules McLaren Health Care requires that your former institution did not. Course completion will be registered electronically with the MHC Human Research Protections Program.

To view a previously completed course or print a completion certificate; select the “View Previously Completed Coursework" option from your Main Menu.

1. On CITI Program, select “Log In”. You will then be taken to the page shown below where you can enter your Username and Password.

2. Once you have logged in, you will be taken to your homepage. Here you can access your records, one of two ways. You can either select “My Records”.

3. Once you selected “My Records”, you will be brought to the page below. Here you can see what courses you have completed and the date you completed each course.

4. By selecting “View-Print-Share” you can print or save a copy of your completion certificate and your completion report for your records by selecting “View / Print”.

The MHC CITI Human Subjects Protection and Good Clinical Practice Training courses are valid for 3 years. You will receive email reminders from CITI prior to expiration, but also keep track of your training expiration date. After you log into CITI, training (e.g. Stage 2, 3 or 4) will appear in the MHC courses section. Click on the title of the course to begin. Note: Once you have taken all the refresher courses offered by CITI (up to Stage 4), you will be required to take the full course again.

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

McLaren Health Care HRPP Education and Training