Research Compliance

• Principal Investigator Requirements
• Study Team Member Requirements
• Who is a Meriter Employee? Who needs Health Certification to Enter Meriter Hospital? 
• Mandatory Human Subjects Protection Training

• Is UnityPoint Health - Meriter Part of the UW Health Care Component?
• HIPAA and Preparatory to Research Activities
• HIPAA and Record Review/Data Research
• HIPAA and Subject Recruitment

• Data Sources, Access, and Transferring Meriter PHI for Research
• UW SMPH Access to UnityPoint Health Epic - Describes process, requirements, and contacts

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. Determine if Meriter is engaged in the research or just being used as a study site (see Engagement Worksheet) before submitting your ARROW application.
2. UW-Madison researchers will always start with submitting an ARROW application to UW IRB.
3. You will always submit a Meriter research compliance application regardless of engagement or reviewing IRB. See the UW – Meriter Submission Guidance for details.

Your Meriter submission must demonstrate that all Meriter’s institutional requirements have been met.

When UW-Madison has given an exemption or is the reviewing IRB you’ll be attaching the approved ARROW application listing Meriter as a research site and describing Meriter’s involvement in your Meriter submission.

When the reviewing IRB is another academic institution or commercial IRB you’ll be attaching the UW-IRB customized consent and a study supplement you create to describe Meriter’s involvement in your study.

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

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

• 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

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

• UW-Madison researchers fulfill Meriter and UW training requirement by taking the UW CITI training course(s). If you have identified Meriter as a research site in your ARROW application, Meriter’s Research Compliance Office will be able to confirm your training.
• Meriter employees who perform research tasks such as consenting subjects, designing research, making decisions about inclusion/exclusion criterion for a study, etc. must take the Meriter CITI training.
• Meriter employees who perform study specific tasks should receive protocol specific training from the principal investigator, study coordinator or other qualified study team member.
• External researchers must take the human subjects training offered at their own institution. Meriter Research Compliance may ask you to show proof of your training.

• 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.

21 CFR 50 Protection of Human Subjects

21 CFR 56 Institutional Review Boards

45 CFR 46 Protection of Human Subjects

  Expedited Review Categories