IRB Fast Facts

IRB Fast Facts for
Residents and Students

What is an IRB? What do they do?

IRB stands for “Institutional Review Board.” The IRB is comprised of physicians, nurses, Spectrum Health staff, business people and community volunteers from the West Michigan area. The IRB’s mission is to cultivate ethical principles for the responsible conduct of human subject research through education, regulatory guidance and quality initiatives. When reviewing a research protocol, the Spectrum Health IRB assesses whether the benefits and knowledge to be gained outweigh any risks to which participants may be exposed. This committee is also responsible for ensuring that research is conducted in agreement with hospital policies, applicable state and federal regulations, and standards of good clinical practice. Research involving human subjects must undergo IRB review prior to beginning any research activities.

How can the IRB help me, the investigator?

The IRB has a staff of 11 people who are committed to working with you throughout the IRB approval process. Three analysts work solely on investigator-initiated, minimal risk research, which is where resident/student research usually falls. They are able to meet with you before or after you submit your project to the IRB and answer questions specific to your project. They can help identify which federal regulations you must comply with, and help you understand your responsibilities as an investigator.

When can I begin working on research at Spectrum Health?

The IRB must approve the addition of research study personnel. It is not permissible for any person who is not approved study personnel to access medical records for research purposes or interact with research participants prior to this approval being granted. First, you must create a personal profile in IRBManager, the online IRB program.
  1. Go to https://login.irbmanager.com/
  2. Enter “newuser” for the user name and “newuser” for the password. 
  3. Enter “spectrumhealth” for the client. 
  4. Click “Login,” then select “Investigator” in the next screen. 
  5. This will take you to a screen to create your profile, including your user name and password. Completely fill out this screen with your address, phone and email. 
Once you have created your profile, the principal investigator (PI) or study coordinator must follow these steps to add you to the research.
  1. Log into the IRBManager website (https://login.irbmanager.com/). 
  2. Select the study that the new personnel will be added to. 
  3. Once in the study screen, select “Start xForm” from the Actions column on the left.
  4. Select the “Modification of Approved Human Research” and follow the onscreen directions to add personnel to the study. 
Upon receiving this request, the IRB staff will verify CITI has been completed and that the individual has completed the Spectrum Health-required credentialing. The request will not be forwarded for IRB approval until all of these requirements have been met. An official IRB approval letter will be sent to the PI and study coordinator. Once this letter has been sent, then the individual can begin study-related activities.

Where can I find more information?

IRB phone number: 616.486.2031
IRB fax number: 616.391.1367
IRB email address for project submissions or questions specific to a submitted project irb@spectrumhealth.org
IRB email address for general questions not related to a specific research project: irbassist@spectrumhealth.org

The Investigator Manual is a great resource for individuals conducting research at Spectrum Health. The manual, along with other IRB forms and templates, can be found here.

Information on how to access and register for CITI, as well as how to affiliate an established CITI account with Spectrum Health can be found here.