Research Integrity Office

There are many details to consider when planning research. Please use this list of Meriter Department Contacts to aid in your planning.

• Principal Investigator Requirements
• Study Team Member Requirements
• Who is a Meriter Employee? Who needs Health Verification to Enter Meriter Hospital? 
• 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
• When do I need a data user agreement from UnityPoint Health - Meriter?

 

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

Unit Support – Please collaborate with the Meriter employed unit manager or director on a support letter for your research. Submit the letter with your study application.

Supplemental Forms - Additional templates for Meriter Site Supplement, Permission to Contact form, HIPAA Authorization.

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.

View reporting requirements for Human subjects research, ceded research, exempt research and research when Meriter is not engaged.

UW-Madison Researchers

1. Always start by submitting an application to UW IRB.
2. Determine if Meriter is engaged in your research or you’re just using Meriter as a study site. Do this before submitting your UW application. See Engagement Worksheet.
3. Register your research at Meriter after UW IRB approves your research or cedes review to another IRB.
   1. You will ALWAYS submit an electronic research registration application to Meriter Research Integrity Office if your research takes place at Meriter or you are using data or specimens from Meriter. See the UW – Meriter Submission Guidance for details.
   2. Registering your research at Meriter will make sure it meets all of Meriter’s institutional requirements. You will also be providing our institution with data about research conducted here. View Submission Guidance.

UnityPoint Health – Meriter Researchers

1. Start by contacting the Meriter Research Integrity Office by calling 608-417-6411 or emailing liz.michaels@unitypoint.org. Discuss your research to determine if it’s a non-regulated quality assurance/program improvement study or regulated human subjects research.
2. Regulated human subjects research is registered at Meriter through electronic submission.
3. UnityPoint Health – Meriter cedes review of employee research to UnityPoint Health – Des Moines IRB.

Use the Meriter Engagement Worksheet to find out.

Are Meriter Pharmacists engaged in my drug study at Meriter?

View the UW – Meriter Submission Guidance.

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.

All study personnel listed on the registration application will need a Meriter Research account.

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.

• 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: Submit the UW-IRB approved consent document.
• HIPAA Authorization Form - English
• HIPAA Authorization Form - Spanish available on request - contact office.
• Meriter Site Supplement: Use this for multi-site research or for UW non-protocol based applications to help define what research activities are happening at Meriter.

UnityPoint Health - Meriter requires all researchers to take human subjects protection training.

• UW-Madison researchers fulfill Meriter and UW training requirement by taking the UW CITI training course(s).  
• 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 UnityPoint Health – Des Moines 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 Integrity Office may ask you to show proof of your training.

Follow the steps below:

1. Go to the CITI website.
2. Register (button at top right of website)
3. Select an organization Affiliation – Start typing UnityPoint. Select UnityPoint Health – Des Moines.
4. Complete Registration Steps.
5. What modules do I complete?
   Biomedical Modules: Select this option if you are involved in a biomedical research study where an intervention is being conducted (drug, device, labs, medical testing), or where human subjects will be consented. There are 9 required modules to complete.
   
   Social-Behavioral-Educational Modules: Select this option if you are involved in non-intervention studies, such as retrospective chart reviews, surveys, etc. More than likely, if you are requesting a waiver of informed consent, you can complete these modules. There are 9 required modules to complete.
6. Complete the modules for the course you selected.

• Use multiple login sessions to complete the modules. The CITI system will save your answers to the quizzes at the end of each module.

Technical issues with the CITI Site contact:
Email: support@citiprogram.org
Phone: (888) 529-5929

21 CFR 50 Protection of Human Subjects

21 CFR 56 Institutional Review Boards

45 CFR 46 Protection of Human Subjects

  Expedited Review Categories

HIPAA and Research Overview (US Dept of Health & Human Services)

As part of our assurance, Meriter agrees to follow the ethical principles for human research in the Belmont Report.