About the Author
Proxima CRO Team
Ellie Reynolds, MBE
Senior Quality Assurance & Regulatory Affairs Manager
Ellie has a Masters in Bioengineering, with a focus in Global Medical Innovation, from Rice University and has worked on multiple medical devices from need identification through the entire development process.

Although not specifically discussed in the FDA regulations, requiring the subject to sign a second research consent document for the secondary facility should be avoided when feasible.

In the first (unrelated admission to second institution) and second (reasonably foreseeable admission to second institution) scenarios, research is not being conducted at the second institution and therefore, no research consent is needed for the second facility (however, consent for medical treatment may be required). Since the medical need in the first scenario is unexpected, the informed consent document would not describe such involvement.

In the second scenario, because the second facility’s involvement is planned, the informed consent document should describe the activities to be carried out at the second facility. When some of the research activities are carried out at a secondary location, the investigator and the IRB should consider whether any additional information, such as a local emergency contact number, needs to be included in the informed consent document.

The third scenario (second facility designated as extension of research milieu) is the most complex. Because the second facility is involved in research, the informed consent process should include a description of this activity. As appropriate, this could be included in the consent document presented to all subjects, or a separate informed consent document could be prepared for those subjects entering the second facility. If the original facility’s IRB is accepting responsibility for other sites, it would review and approve the informed consent document(s). If the second facility does not agree to cooperative review, however, the second facility’s IRB may accept the original informed consent document if it adequately describes the involvement of the second facility (i.e. not require a second document). The second facility’s IRB may also decide to develop its own informed consent document. In this case it is important that the subject not receive conflicting information and the two IRBs should work to resolve such issues. If there are two consent documents, generally the original document would cover the overall study and the secondary document would only detail the specific procedures involved while at that facility.

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