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Purpose
Jurisdiction
Exceptions
Definitions
Off-Site Research
Affiliated Institutions
Research Conducted by Students,
Trainees Under Another Institution’s
IRB Approval
All Other Off-Site Research
Research Conducted at a Foreign Site

Jurisdiction

A. Purpose

An Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects. This policy defines the jurisdiction of the UT Southwestern Medical Center IRB to review and approve human subjects research.

B. Jurisdiction

UT Southwestern IRB shall review all research involving human subjects, regardless of the source of funding, when one or more of the following criteria apply:

1. The research with human subjects is conducted by or under the direction of any employee, resident, fellow, volunteer faculty, or student of UT Southwestern in connection with his or her institutional responsibilities.

2. The conduct of the research (including recruitment) involves use of institutional resources (property, personnel time, facilities, or funding), including extramural funds (gifts, grants, or contracts) administered by UT Southwestern.

3. The name of UT Southwestern will be used when applying for funds to support the research or in explanations and/or representations to subjects.

4. The investigator plans to use his/her UT Southwestern affiliation in any publication or public presentation resulting from the research.

5. The research is conducted at or sponsored by one or more of the medical institutions with which UT Southwestern has a primary affiliation, namely: Parkland Health & Hospital System, Children's Medical Center, Texas Scottish Rite Hospital for Children, The Retina Foundation of the Southwest, Methodist Richardson Medical Center (cancer-related clinical trials only).

6. The research involves the use of non-public information belonging to UT Southwestern or one of its primary affiliated hospitals to identify or contact human research subjects or prospective subjects.

The Institutional Official also may place a research study under the jurisdiction of the IRB even if not technically human subject research under the definitions provided below. For example, some research involving cadaveric tissue or information about deceased persons may be treated as human research for purposes of this policy.

C. Exceptions (See Off-Site Research Policy)

1. Off-site research at the Dallas Veterans Affairs Medical Center

2. Off-site research by UT Southwestern students and trainees covered under another institution's IRB approval

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D. Definitions

Research means a systematic investigation designed to develop or contribute to generalizable knowledge. Pilot studies and screening tests involving human subjects are considered research. Research does not include (a) instruction, (b) quality assurance activities for evaluating the performance of faculty, staff, and students, or other data collection for institutional use only, (c) student course work or undergraduate theses, unless intended to be made available to the public (e.g., publication, poster session, or presentation) or used by other researchers to develop or contribute to generalizable knowledge.

Human subject means a living person about whom a researcher obtains (a) data through intervention (i.e., venipuncture or cognitive tests) or interaction (i.e., interviews) with the person, or (b) identifiable private information (i.e., medical records). A person may be a human subject when a researcher obtains data about the person from a third party or from the person directly.

Intervention includes both physical procedures by which data is gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

Identifiable in this context implies that the identity of the subject is or may readily be ascertained by the investigator or associated with the information obtained as part of the research. This includes “protected health information” as defined by HIPAA.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record).

Protected Health Information (PHI) includes individually identifiable health information, transmitted, or maintained in any form or medium, including demographic information or other information relating to the past, present, or future physical or mental health or condition of an individual created or maintained by UT Southwestern or a business associate of UT Southwestern. PHI also includes de-identified information that can be re-identified readily via a "link" or "key."

Conducted at or sponsored by means (a) using the institution’s facilities or resources; (b) paid for by or with funds administered by the institution; (c) conducted by an employee in the course of their employment by the institution; (d) using the institution’s students, personnel, or patients (including medical records) as subjects.

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Off-Site Research

A. Purpose

This policy defines the jurisdiction of the UTSW IRB with regard to human subjects research conducted outside of University owned, operated, and leased facilities.

B. Policy

All human subjects research activities performed by or under the direction of UT Southwestern students and personnel in the course and scope of their university duties, or which use University resources, must comply with applicable UT Southwestern policies and procedures, regardless of funding sources and whether performed in UT Southwestern facilities or at off-site locations.

The UT Southwestern IRB may approve/register human subjects research that is proposed to occur at or in collaboration with off-site locations when appropriate documentation demonstrating the support and collaboration of the off-site location(s) and compliance with federal requirements is provided.

The documentation necessary for UT Southwestern approval/registration of off-site human subjects research is dependent upon several factors, including but not limited to UT Southwestern's relationship with the site, the source of funding for the research, and the degree of responsibility UT Southwestern personnel will assume.

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Affiliated Institutions

Proposed research that is to occur solely at the Dallas Veterans Administration Medical Center (VAMC) need not undergo dual review by both IRBs. When UT Southwestern personnel wish to participate in research studies approved by the VAMC IRB for performance exclusively at the VAMC, UT Southwestern will not routinely require additional approval from the UT Southwestern IRB. However, if the human subjects or will undergo research procedures at both sites, the IRB approval of both institutions will be required. It will be the responsibility of UT Southwestern personnel to inform the UT Southwestern IRB of any VAMC IRB approvals prior to initiating involvement in a VAMC study. See submission instructions. UT Southwestern reserves the right to limit, suspend, or terminate the involvement of UT Southwestern personnel in studies approved by the VAMC IRB.

Research Conducted by Students and Trainees Under Another Institution’s IRB Approval

When a UT Southwestern student/trainee wishes to participate in the conduct of human research entirely at another institution with an OHRP Federal-Wide Assurance, the UT Southwestern IRB need not perform a dual review of the protocol provided that all of the following conditions are met:

1. The student or trainee will be listed on an IRB-approved protocol at the study site.

2. UT Southwestern is not the recipient of funding for conduct of the study.

3. The research is conducted entirely at the other site.

If any of the aforementioned conditions is not met, the research proposal must be submitted to the UT Southwestern IRB for review and approval.

It will be the responsibility of UT Southwestern student/trainee to inform the UT Southwestern IRB of any off-site IRB approvals prior to initiating involvement in an off-site study. See submission instructions. When UT Southwestern students and trainees wish to participate in research studies approved by the off-site entity’s IRB for performance exclusively at the off-site entity, UT Southwestern will not routinely require additional approval from the UT Southwestern IRB. However, if the human subjects will be recruited from or will undergo research procedures at both sites, the IRB approval of both institutions will be required. UT Southwestern reserves the right to limit, suspend, or terminate the involvement of UT Southwestern personnel in studies approved by an off-site IRB.

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All Other Off-Site Research

Proposed research that is to occur at a non-UT Southwestern affiliated institution requires UT Southwestern IRB approval prior to initiation of any off-site human subjects research activity performed by, or under the direction of, UT Southwestern personnel.

"Evidence of IRB approval and a copy of the consent form (if applicable) from the off-site location is required. If the institution has no IRB, permission from the off-site location's equivalent entity may be accepted. If the off-site institution has no equivalent entity, a letter of permission or collaboration from an authorized institutional official may be accepted. In rare instances, the off-site institution may be permitted to use UT Southwestern’s IRB as its IRB of record.

"Proposed research that is to occur at a non-affiliated institution and at UT Southwestern requires UT Southwestern IRB approval in addition to approval from the off-site location prior to initiation of any human subjects research activity.

"Proposed research that is to occur at a site without an OHRP Federal-Wide Assurance requires that the director of the facility (clinic, hospital, institution, school, etc.) provide a Letter of Compliance. Such letters must be on the facility’s letterhead and contain the assurance statement that the agency will 'abide and comply with the UT Southwestern IRB requirements for the protection of human research subjects.'"

Research Conducted at a Foreign Site

When research is to be conducted at a foreign site, the UT Southwestern IRB must approve the protocol and will pay close attention to the investigator’s understanding and awareness of possible cultural vulnerabilities within the population to be studied. In addition, the UT Southwestern IRB will scrutinize the protocol according to the ethical principles articulated in the Belmont Report and The Common Rule (45CFR Part 46). Approval from an IRB at the foreign site, and possibly from the government of the sovereign nation within which the site operates, may also be required.

Last updated: 07/14/2010

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