<p> Local Context Review of International Research</p><p>In accordance with OHRP guidance http://www.hhs.gov/ohrp/humansubjects/guidance/local.htm , when approving international research the BUMC must demonstrate that we possesses sufficient knowledge of the local research context to satisfy the following requirements: "IRBs must also be capable of ensuring that (i) selection of subjects is equitable; (ii) privacy of subjects is protected and confidentiality of data is maintained; (iii) informed consent is sought in language understandable to the subject and under conditions that minimize the possibility of coercion or undue influence; and (iv) appropriate safeguards protect the rights and welfare of vulnerable subjects”</p><p>Ordinarily the IRB meets this standard by obtaining IRB review from a local IRB (as presumably they would have such knowledge). In lieu of obtaining local IRB review, for minimal risk studies, the IRB will accept the necessary information (items i. -iv above) about the local research context from an appropriate consultant. An appropriate consultant would be someone a. who is NOT an investigator on the project or the grant and who has no other conflict of interest b. has knowledge of local context obtained through extended, direct experience with the specific subject populations and their surrounding communities.</p><p>In most instances the BUMC IRB will also require a letter of permission from the appropriate local authority that demonstrates that permission has been granted to conduct research at the specific site. </p><p>Version 4.24.09 Documentation of Local Context Review Form</p><p>Local Context Review: OHRP requires that the IRB consider local context when reviewing international studies. If the study is a minimal risk study and no “non-US” institution is engaged in research, then (local) IRB review may not be required for this study. The BUMC IRB may accept documentation of local context review from an appropriate local consultant and permission from the appropriate authority at the research site. </p><p>A. Permission from the Site: Please attach a letter of permission from the appropriate authority that demonstrates that permission has been given to conduct the research at the specific site </p><p>B. Local Context Review: The Local Consultant must be an INDEPENDENT consultant meaning that he/she may NOT be an investigator on the project or the grant and may not have another conflict of interest related to the project. The Local Consultant must have knowledge of the local context obtained through extended, direct experience with the subject population and/or the community or communities being studied. Please provide in the text box below the name, title and contact information for the local consultant. Please describe the qualifications of the Local Consultant based on the criteria described above. </p><p>C Local Consultant Attestation : The Local Consultant must complete the four questions below to attest to the fact that he/she has reviewed the research project and agrees that : </p><p>1. The selection of subjects is equitable</p><p>2. The research study as plan adequately protects the privacy of subjects and confidentiality of the data </p><p>3. That the plan ensures that informed consent will be sought in language understandable to the subject and under conditions that minimize the possibility of coercion or undue influence. If the plan allows for a waiver of informed consent, that a waiver is appropriate for the population and the site being studied; </p><p>4. That the research plan has in place appropriate safeguards protect the rights and welfare of vulnerable subjects.</p><p>Signature of Local Consultant______Date______</p><p>Please have the Local Consultant complete and sign this form. Alternatively, the Local Consultant can provide a letter or email providing the above information.</p><p>Version 4.24.09</p>