Research Compliance
UnityPoint Health - Meriter Research Compliance
Meriter Institutional Review Board (IRB) is made up of scientific and non-scientific members as defined in 45 CFR 46.XXX. The board reviews protocols when Meriter is engaged in the research. Members perform expedited reviews on minimal risk studies as submissions come in. A fully convened board reviews studies that are greater than minimal risk.Meriter Human Research Protection Program (HRPP) focuses on protecting the rights and welfare of the human subjects who participate in research conducted within Meriter facilities. The HRPP ensures when Meriter is not engaged in the research, but is used as a research site the research is conducted under an IRB approval, and all Meriter institutional requirements are met.
Meriter has an agreement with the federal government to comply with the code of federal regulations that protect human subjects. The agreement also binds Meriter to ethical principles described in the Belmont Report.
Research Requirements
UW SMPH Access to UnityPoint Health Epic - Describes process, requirements, and contacts
Supplemental Forms - Additional templates for consent, HIPAA Authorization and more.
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.
Online IRB Submissions
- Visit the Meriter online application site.
- Click the "Request New Account" button below the login block.
- 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.
Study personnel are those who have contact with Meriter patients, patient records or patient specimens for research purposes.
Individuals conducting Quality Assurance or Program Improvement projects do not need a user account. View instructions for submitting a non-regulated project.
- In most cases you'll be submitting and getting UW IRB approval first. Please reference Submission Guidance
- Use the Meriter online IRB application submission system.
- Use the supplemental forms for researchers.
- Contact the Research Compliance Office with questions or concerns.
Liz Michaels, MS, CIP
IRB Coordinator
(608) 417-6411
Single IRB Review
Where do I start?
- UW-Madison Investigators: Regardless of who the Reviewing IRB will be, contact UW Reliance (irbreliance@wisc.edu) to determine next steps.
- UW-Madison Investigators will complete an application at UW first.
- Complete a Study Application at UnityPoint Health - Meriter.
- 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.
- Meriter IRB User Accounts for study team members listed on the Meriter study application.
- 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.
Human Subject Protection Training
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:
- Log in to the CITI website.
- Register
- Choose an institution: UW affiliates choose UW. All others choose Meriter
- Complete Registration Steps
- Sign up for Required Modules
- Email your CITI Transcript to Liz Michaels
- 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.
Supplemental Forms for Researchers
- 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
Regulations and Ethics
21 CFR 50 Protection of Human Subjects
21 CFR 56 Institutional Review Boards
HIPAA and Research Overview
HIPAA Implications of UW - Meriter JOA on Data Sharing
Human Subjects Research vs. Quality Assurance
View this Chart to determine if your project is regulated human subjects research, quality assurance or program improvement.
Follow these directions to submit your quality assurance or program improvement project to Meriter IRB.