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Committee For the Protection of Human Subjects

Multi-site Research


POLICY

When a UTHealth researcher is the lead investigator for a multi-site research study or when a UTHealth researchers is the lead of a data coordinator center, in addition to the criteria for approval outlined in the policy on initial review, IRB reviewers will evaluate whether the research plan addresses additional protections with respect to coordination of communication and flow of information between the various sites.


PROCEDURE

The initial application should include the plan for management of data for multi-site trials when UTHealth researchers are responsible for the data coordinating center. When a UTHealth researcher is responsible for multi-site research, for example, as the holder of an IND with one or more non UTHealth sites, the researcher must submit a plan for management of data including  the mechanism to ensure all the sites have access to the most current version of the protocol documents and consent forms. The researcher should also have a plan for managing safety reports from each site.

The UTHealth researcher responsible for the multi-site research should have a mechanism in place to ensure that each collaborating institution has IRB approval prior to initiating the research at that site.

Community based participatory research: When UTHealth researchers work with community representatives to conduct community based participatory research, they should provide information on the use of community advisory boards, letters of support from community organizations etc. IRB reviewers will consider the plan for community engagement and review the plan for dissemination of results back to the community.

When the IRB is reviewing community based participatory research, if the IRB membership does not include members with expertise and knowledge of community based participatory research, the IRB will invite consultants with expertise in this area.

If you find errors in this document, contact cphs@uth.tmc.edu 

Document Number:

101-C21

Document Name:

Multi-site research led by UTHealth Researchers

Approved by:

Executive Director, Research Compliance

Effective Date:

1 Jun 2016

Revision History:

1 Jun 2016, 1 Jun 2021