Institutional Review Board (IRB)

• Principal Investigator Requirements
• Study Team Member Requirements
• Mandatory Human Subjects Protection Training

UnityPoint Health – Meriter allows UW-Madison investigators to use research documents that have been translated by UW Health Interpreter Services. Please submit the translated document along with a signed certification of translation.

UW-Madison investigators may use the UW Language Line for interpretation of the spoken word between the research team and research subjects. This can be arranged through the UW Health Interpreter Services Manager 608-265-7423.

Funding for Translation and Language Line Interpreting

• Investigators are responsible for all costs associated with translation and interpretation.
• Meriter Foundation Funding - Please add translation and interpretation for non-English subjects in your grant request budget. The Foundation is willing to fund these costs.

1. Visit the Meriter IRB online application site.
2. Click the "Request New Account" button below the login block.
3. Complete the required fields (view tip sheet).

Accounts are set up during regular business hours, Monday - Friday. You will receive an e-mail notification in 24-72 hours when your account has been activated.

• All study personnel must fulfill the Meriter Human Subject Training Requirement. Compliance with this requirement is tracked through the online submission system.
• Send a recent, dated proof of completion for your human subjects protection training to the UnityPoint Health - Meriter IRB Office.
• Submissions are electronically blocked from reaching the IRB if even one person on a submission fails to have current training associated with their user account.
  
  

• Complete the mandatory human subject protection training. Learn more about Meriter's mandatory training requirements.

• Contact the IRB Office with questions or concerns.

Liz Michaels, MS, CIP

IRB Coordinator

(608) 417-6411

• Use the Meriter online IRB application submission system.
• Use the supplemental forms for researchers.

Where do I start? 

1. UW-Madison Investigators: Regardless of who the Reviewing IRB will be, contact UW Reliance (irbreliance@wisc.edu) to determine next steps.
2. UW-Madison Investigators will complete an application at UW first.
3. Complete a Study Application at UnityPoint Health - Meriter.
4. Do not begin your research until the relying and reviewing IRB institutions approve your research.

What you'll need for Meriter Application

Regardless of whether Meriter is the reviewing or relying IRB.

1. Meriter IRB User Accounts for study team members listed on the Meriter study application.
2. Send IRB Office Human Subjects Protection Training Transcript See Mandatory Training.

• Commercial or sponsored studies
• Multi-site or collaborative research that qualifies for expedited or a convened IRB review.

• Research that meets one of the federal exemptions. Exempt research has no IRB of oversight. There is no reviewing IRB, therefore Meriter cannot cede review.
• UnityPoint Health – Meriter IRB acts on behalf of the institution and has the authority to decline ceding IRB review for any new research if there are extenuating factors (e.g. a conflict of interest, a study that does not fit with Meriter's culture and mission, etc.). Meriter IRB may consult with the institutional official as necessary

Submit a cede application to request Meriter to cede review to another SMART IRB institution. For commercial research, please contact the IRB Office for additional requirements.

UnityPoint Health - Meriter requires all researchers and IRB members to take human subjects protection training every three years.

Meriter accepts CITI training completion reports from UW-Madison and other institutions.

• Follow the steps below:

1. Log in to the CITI website.
2. Register
3. Choose an institution: UW affiliates choose UW. All others choose Meriter
4. Complete Registration Steps
5. Sign up for Required Modules
6. Email your CITI Transcript to Liz Michaels
7. Locate your CITI Transcript

• Use multiple login sessions to complete the modules. The CITI system will save your answers to the quizzes at the end of each module.
• Passing Score - You need an aggregate score of 80% for all the quizzes.

• Permission to use Meriter's PACs for Research form.
• File Sharing Policy: Electronic file transfer must comply with the tools listed.

Meriter Department Letter of Support
Use this to document how UnityPoint Health – Meriter staff will help facilitate your research on our premises. The letter should be signed by a UnityPoint Health - Meriter employed Director or Manager. 

Permission to Contact Form (HIPAA Compliant)

Please use UW-Madison Consent Template 

HIPAA Authorization Form

Meriter Site Supplement

21 CFR 50 Protection of Human Subjects

21 CFR 56 Institutional Review Boards

45 CFR 46 Protection of Human Subjects

  Expedited Review Categories