Local Context and Consent Language Confirmation Form

When the University of Utah IRB (UU IRB) acts as the Single IRB for Multi-Site Research

An individual who has the appropriate knowledge and expertise should provide this information. This individual may be a representative of your local IRB or HRPP, the site PI, or another qualified individual.

You will only be asked for this information once. The UU IRB will keep it on file and use it for any study performed at your site that uses the UU IRB as the Single IRB. You will have opportunities to update it later.

Name of your site, which is relying on the UU IRB

Name and contact information of the HRPP Primary Contact for this information
Local Context Information:

Local context is information about the site’s community and potential participant population that may need to be considered in order to evaluate the Criteria for IRB approval. This most often includes relevant characteristics of the local population.
What are the characteristics of the local community that may be enrolled at your site?
This will help the IRB ensure appropriate methods are in place for conducting research in your community. This may include the following:
- Cultural, demographic, and economic characteristics
- Languages spoken and local educational and/or literacy concerns
- Religious, social, and political considerations
What are the local laws or policies relevant to research that must be implemented in studies conducted at your site? You can describe this in the text box or attach a document.
The UU IRB helps sites to apply these laws and policies. However, as part of your local review, we ask for you to confirm that these laws and policies are applied; you will use the Local Review Reporting Form for this. Local laws or policies may include the following:
1. Laws or policies about age of majority
2. Laws or policies about who can act as a legally authorized representative
3. Laws or policies about how the consent process or consent document are to be used
4. Laws or policies about privacy and confidentiality

Select the non-IRB and ancillary reviews for research that may occur at your institution (select all that apply):

Confirmation of study team qualifications and human subject research training

Confirmation of adequate resources available to conduct the study

Conflict of Interest review

Safety review(s) (e.g., radiation safety, institutional biosafety, etc.)

Scientific review(s)

Facilities use review(s)

Other (describe below):

Consent Information:

The UU IRB requires the site PI to provide local person to contact consent language on a study-by-study basis. The following information is needed for your site.
Site-specific research related injury language, if applicable

Site-specific IRB or HRPP contact information, if applicable

Other site-specific verbatim language that must be included in the consent form
This may include the following types of information:
- Local law or institutional policy for local reporting of communicable diseases.
- Local requirements for genetic testing and data storage.
- Required conflict of interest disclosure language
HIPAA Authorization Information:

Check here if your site is not required to follow the HIPAA Privacy Rule (i.e., your site is not considered a HIPAA Covered Entity)

Complete the following section if your site must follow the HIPAA Privacy Rule:

Does your site require the use of a HIPAA authorization document that is separate from the consent document?

If Yes, attach the HIPAA authorization document below.

	Yes
	No
Clear

Will your site allow the use of any appropriate Authorization language, so long as the UU IRB determines that it meets the requirements of the HIPAA Privacy Rule?

If No, attach your site's HIPAA authorization language below.

	Yes
	No
Clear

HIPAA Authorization Attachments

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If you have any questions about completing this form, please contact the UU IRB at 801-581-3655 or irb@hsc.utah.edu. We are happy to assist you.


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