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IV.16 |
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Research
Conducted at International Performance Sites |
Objective
It is the
policy of the University of Texas Health Science
Center at
Policy/Procedure
I. CPHS review of international research
A. When the foreign institution or site is a performance site and is actively involved in the research, the following conditions apply.
1. The CPHS will review all international research utilizing human participants/data and/or samples to assure adequate provisions are in place to protect the rights and welfare of the participants.
2. Because UTHSC-H holds an assurance with Office of Human Research Protection (OHRP), the foreign institution or site must also file an Assurance of compliance (FWA) with OHRP.
3. Approval of research is permitted if “the procedures prescribed by the foreign institution afford protections that are at least equivalent to those provided in 45 CFR 46.”
4. The CPHS must receive a copy of the foreign institution or site’s Research Ethics Board (REB)/Independent Ethics Committee (IEC) review and approval of each study prior to the commencement of the research at the foreign institution or site.
B. When the foreign institution or site is a performance site that is not actively involved in the research, the CPHS approval to conduct research at the foreign institution or site is conditioned upon receiving documentation of the performance site’s REB/IEC determination, or letter of cooperation, as described below.
1. When the foreign institution or site has an established REB/IEC, the principal investigator (PI) must obtain, and provide to the CPHS, approval to conduct the research at the "not engaged" site from the site’s REB/IEC or provide documentation that the site’s IRB/IEC has determined that approval is not necessary for the PI to conduct the proposed research at the site.
2. When the foreign institution or site does not have an established REB/IEC, a letter of cooperation must be obtained demonstrating that the appropriate institutional or oversight officials are permitting the research to be conducted at the performance site.
3. It is the responsibility of the UTHSC-H PI and the foreign institution or site to assure that the resources and facilities are appropriate for the nature of the research.
4. It is the responsibility of the UTHSC-H PI and the foreign institution or site to notify the CPHS promptly if a change in research activities alters the performance site’s engagement in the research (e.g., performance site “not engaged” begins consenting research participants, etc.).
C. Approval considerations
1. Approval of research for foreign institutions or sites “engaged” in research is only permitted if the foreign institution or site holds an Assurance with OHRP.
2. The CPHS will consider local research context when reviewing international studies to assure protections are in place that are appropriate to the setting in which the research will be conducted. The CPHS may require an expert consultant to address issues of local research context if the CPHS does not have a committee member with the expertise or knowledge required to adequately evaluate the research in light of local context. The local PI or co-PI must provide the expertise necessary to understand the local context.
3. The informed consent documents must be in a language understandable to the proposed participants.
D. Monitoring of Approved International Research
1. The CPHS is responsible for the ongoing review of international research conducted under its authority.
a) The PI is responsible for providing to the CPHS, for review, appropriate documentation of data and safety measures throughout the course of the study, including unexpected adverse events and unanticipated problems to participants or others.
b) The CPHS must demonstrate that it has obtained necessary information about the local research context through written material or discussions with either committee members knowledgeable of the local context or appropriate expert consultants. The level of local knowledge required is based on the degree of risk presented by the research. Extra considerations may include the following to enhance human research protections:
(1) The relevance of the research to the area’s health needs;
(2) The influence of local officials/health care providers on the population;
(3) The nature of the procedures conducted
(4) The literacy rate of the area;
(5) The local legal rights of the population;
(6) How complaints will be reported and to whom;
(7) The economic prosperity of the area
(8) The possibility of including officials from the area in the monitoring of the research; and
c) The CPHS will review the consent process taking into consideration the following additional issues:
(1) Disclosure of scientific and medical facts to individuals who may be unfamiliar with and distrustful of the concepts;
(2) Variation in cultural and societal norms;
(3) Differences in the role of women in society;
(4) Differences in the role of family and community in the consent process;
(5) Multiple local languages; and
(6) Literacy level.
d) The CPHS must assure that adequate provisions are outlined for data and safety monitoring keeping in mind that some foreign ethics committees may not require continuing review of approved research.
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Applicable Regulations and Guidelines 21CFR
50 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr50_04.html
) 21CFR
50 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr56_04.html
) 38CFR
16 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/38cfr16_04.html
) 45CFR
46 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html
) ICH
E6 ( http://www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB
) |
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Updated 5/2007, Report
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