Education and training
Initial education requirement
All individuals who are involved in the design, conduct or management of human subject research within Spectrum Health must complete required human subjects research protections (HSRP) training. The completion of the Basic Couse - Biomedical Research provided by the Collaborative Institutional Training Initiative (CITI) meets this requirement. HIPAA rules as they relate to research activity are included in this module, as well.
Documentation of completed HSRP training must be on file with the Spectrum Health IRB prior to committee consideration of a research submission. IRB submissions will not be processed until the CITI Basic Course is completed by all research personnel listed on the application. This requirement also applies to subcontractors, consultants, students and all other non-Spectrum Health personnel involved in research being conducted at Spectrum Health.
Good Clinical Practice (GCP) training is required for all NIH-supported clinical trials. For clinical trials, it is highly recommended that individuals involved in the conduct, management and/or oversight of a clinical trial complete the GCP CITI Program modules.
- National Institutes of Health policy definition of a clinical trial:
- "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on biomedical or behavioral outcomes."
- NIH Clinical Trial decision tool link
Refresher requirement
All research personnel who remain engaged in human research at Spectrum Health are required to complete continuing education every three years from the date the Basic Couse - Biomedical Research provided by the Collaborative Institutional Training Initiative (CITI) was completed.
An email reminder of upcoming expirations is sent by CITI to the email address specified when originally registering. The email reminder will include a link directly to the CITI Refresher Course.
- Go to the Collaborative Institutional Training Initiative (CITI) website
- Register where indicated
- Affiliate yourself with Spectrum Health by typing "Spectrum Health" into the box under "Search for organization: Enter full or partial name", found within the "Select Your Organization Affiliation" screen. Failure to affiliate with Spectrum Health will prevent access to the correct Spectrum Health education modules. – Continue to step 2
- Enter your name and email address. – Continue to step 3
- Create a user ID and password for ongoing access to the online training courses. Select a security question and give your unique answer in the box below the dropdown list. -- Continue to step 4
- Enter gender, ethnicity and race or select “Prefer not to answer” – Continue to step 5
- Answer the CME/CEU and survey questions. – Continue to step 6
- Complete the required fields in demographic profile and provide accurate contact information to facilitate ongoing communication of continuing education requirements (i.e. CITI Refresher Course). – Continue to step 7
- Select the required Biomedical Research course:
- Question 1: Select "Biomedical Research"
- Question 2: Select "I have not completed the Spectrum Health Basic CITI Course" for the Refresher Course
- Question 3: RCR Course: Select "No Thank You"
- Question 4: Optional Courses: Select "No Thank You". If you are required to complete GCP training, do not select “No Thank You” and instead, select your required course: GCP, HIPS, etc.
- Question 5: Biosafety/Biosecurity Course: Select “Not at this time” – Click “Complete Registration”
- Finalize your registration by clicking “Finalize Registration”
- Begin your Biomedical Research Course by clicking on the link "Biomedical Research" then by completing “The Integrity Assurance Statement”
- Complete all required modules and obtain a cumulative score of 85% or greater. If your cumulative score is less 85%, you will need to retake the modules until your score is at least 85%.
- Once your CITI Basic Biomedical Course is complete, a certificate will generate automatically.
- Retain a copy of the certificate for your records. It is the responsibility of the Principle Investigator to ensure HSRP training is completed and maintained for all study personnel.
- Login to the CITI website using the username and password you created when first registering with CITI.
- If your username and/or password cannot be located, click “Forgot Username or Password” and follow the prompts.
- On your Learner Menu go to "Affiliate with Another Institution" and select "Spectrum Health" from the drop down menu
- Complete the required member information and click “next”.
- If your current training does not meet the Spectrum Health HSRP criteria, you will be required to complete the Biomedical course:
- Question 1: Select "Biomedical Research"
- Question 2: Select "I have not completed the Spectrum Health Basic CITI Course" for the Refresher Course
- Question 3: RCR Course: Select "No Thank You"
- Question 4: Optional Courses: Select "No Thank You". If you are required to complete GCP training, do not select “No Thank You” and instead, select your required course: GCP, HIPS, etc.
- Question 5: Biosafety/Biosecurity Course: Select “Not at this time” – Click “Submit”
- Begin your Biomedical Research Course by clicking on the link "Biomedical Research" then by completing “The Integrity Assurance Statement”
- Any modules not completed at your prior institution that are required by Spectrum Health will appear as “incomplete”
- Complete all required modules
- A completion certificate will generate automatically
- Retain a copy of the certificate for your records. It is the responsibility of the Principle Investigator to ensure HSRP training is completed and maintained for all study personnel.
- Login to the CITI website using the username and password you created when first registering with CITI.
- If your username and/or password cannot be located, click “Forgot Username or Password” and follow the prompts.
- Under 'My Courses select 'Add a Course or Update Your Learner Groups’. This will take you to the course selection page
- Select your courses:
- Question 1: Select "I have completed the Spectrum Health Basic CITI Course"
- Question 2: Select "Biomedical" for the Refresher Course
- Question 3: RCR Course: Select "No Thank You"
- Question 4: Optional Courses: Select "No Thank You". If you are required to complete GCP training, do not select “No Thank You” and instead, select your required course: GCP, HIPS, etc.
- Question 5: Biosafety/Biosecurity Course: Select “Not at this time” – Click “Submit”
- Begin your Biomedical Research Course by clicking on the link "Biomedical Research" then by completing “The Integrity Assurance Statement”
- Once your CITI Biomedical Refresher Course is complete, a certificate will generate automatically.
- Retain a copy of the certificate for your records. It is the responsibility of the Principle Investigator to ensure HSRP training is completed and maintained for all study personnel.
For questions, additional information, or comments regarding the CITI Program please contact the Spectrum Health IRB Analyst at 616.486.2031 or irbassist@corewellhealth.org.
Conflict of interest reporting
Spectrum Health requires, at a minimum, annual disclosures from employees, physicians and affiliates involved in research and/or other sponsored programs overseen and managed by the Spectrum Health Office of the Institutional Review Board (IRB) as well as Spectrum Health’s Office of Sponsored Programs (OSP). Individuals fitting into any of these categories are required to disclose certain financial and other interests on an annual basis.
Completing the required disclosure supports our core value of integrity and fulfills the requirements of the Spectrum Health Conflicts of Interest – Research and Sponsored Programs Policy (SH-ADMIN-RES-020). In addition to an annual disclosure, any new and/or updated financial interests must be disclosed under certain circumstances (refer to "WHEN must disclosures be made?" section of the policy for detailed information on these circumstances).
Note: The IRB cannot process any proposal until all identified personnel have completed and/or are current with COI training and disclosure. Further, the IRB cannot grant final approval to any project where an individual on the project has a positive disclosure until a final determination from the Spectrum Health Conflict of Interest Committee has been reviewed and accepted by the IRB (more detailed information available in the conflict of interest policy).
If you have questions or concerns about the COI process, call 616.486.2060 or contact researchcoi@corewellhealth.org.
Contact Spectrum Health Office of the IRB
For questions about the CITI program or required training.