Chapter 7: Human Participant and Vertebrate Animal Research

7.1 Human Participant Research

In order to conduct research with human subjects, investigators at Duke must do two things:

1. Become certified to conduct research with human subjects.
2. Obtain approval for research protocols.

Both the certification of investigators and the approval of protocols are required of Duke by the federal Office of Human Research Protections and the Food & Drug Administration. Duke University has established and maintains two Institutional Review Boards to review and provide approval of research protocols. Below are the principles and procedures regarding human subjects for those protocols conducted by Duke University researchers outside of Duke University School of Medicine and School of Nursing. For information regarding human subjects in medical research refer to the DUHS IRB policies.

7.1.1 Duke University Principles and Procedures Regarding Research on Human Subjects (Provost Area Management Center)

I. Scope of the Policy

II. Principles

1. Duke University is committed to academic freedom. Research will neither be forbidden nor discouraged because it explores topics that are innovative, unorthodox, sensitive, unusual, or otherwise extraordinary. The university takes responsibility for protecting the right of the faculty to conduct research in the pursuit of knowledge, wherever that search may lead.
2. In the conduct of research, care must be taken to avoid harming the persons being studied. Research procedures should minimize the risk of harm and respect the privacy of subjects. The researcher should not withhold from the subjects information they request about any aspect of the research likely to be significant to the subject or induce subjects to participate by means that might affect the subject’s ability to decide freely about their participation. Researchers who promise confidentiality are responsible for maintaining it and for informing subjects of limits on their capacity to meet that responsibility. Researchers should explain to subjects, prior to their participation, the purposes of the research. Special care is called for when the subjects of the research are especially vulnerable to harm because they cannot understand the risks or because they are not in a position to freely refuse their participation in the research.
3. To resolve any conflict between the above principles, and to assure that research at Duke University follows these principles, the following procedures should be followed.
4. In developing these procedures, the university has considered the ethical codes of all the principal scholarly associations.

III. Procedures

1. The Institutional Review Board for Protection of Human Subjects in Non-Medical Research (IRB) will satisfy the compositional requirements for membership described in federal regulations. The IRB will have sufficient membership to represent the primary disciplines conducting non-medical research with human subjects at Duke, with no fewer than nine members. The Executive Committee of the Academic Council will appoint faculty members. The Provost will appoint non-faculty members. The ordinary term of service is three years.
2. The Office of Research Support will provide administrative and logistical support for the activities of the IRB. Staff of the Office of Research Support will also provide continuing training for the IRB and investigators.
3. The review procedures and criteria set forth in the University’s current Multiple Project Assurance (MPA)* will govern all human subject research conducted under the auspices of the University, outside the Medical Center, regardless of sponsorship.
4. The committee will review submitted research plans and approve, disapprove, or state conditions for the conduct of the research, applying the principles and procedures specified in this resolution and in applicable federal regulations. Other criteria, such as the scientific or social value of the research or the adequacy of the research methods to research goals, are applied elsewhere in the university and are not the charge of the IRB.
5. To assure that extra care is taken in research involving special researcher-subject relationships within the university, several types of research will be submitted to the full committee for review:
   1. Research conducted on employees of the University by their supervisors.
   2. Research conducted by faculty or instructors on students in their classes.
6. Research conducted on subjects whose participation in the Psychology subject pool is a requirement for course credit may not be screened for exemption from review, even if there is no more than minimal risk to the students, but will be subject to "expedited” or “full committee” review, as these terms are used in the Federal Policy for the Protection of Human Subjects.
7. It is the responsibility of faculty members to supervise student research in their courses and departments in accordance with all applicable regulations and to refer students to the IRB when appropriate.
8. These principles and procedures may be amended by vote of the Academic Council.

IV. Procedures for Proposals Requiring Review

1. The IRB will meet twice a month from September through April and at least once per month during the remaining months. The schedule of meeting dates and submission deadlines will be posted on the human subjects’ web site, maintained by the Office of Research Support. Ad hoc meetings may be held at the discretion of the chair.
2. Procedures for the submission of materials for review, and additional administrative guidelines, are provided on the human subjects web site.
3. Basic review, as described in Duke’s MPA*, will ask the following questions:
   1. Have the risks to subjects been minimized?
   2. Are the risks reasonable in relation to anticipated benefits?
   3. Is the selection of subjects equitable?
   4. Are adequate procedures in place to ensure privacy and confidentiality?
   5. Has informed consent been sought and appropriately documented?
   6. Are safeguards in place to protect vulnerable populations?
   7. If the research is federally funded, is the protocol consistent with the grant application?
4. IRB actions will be promptly communicated to investigators in writing.
5. Copies of all protocol materials will be maintained at the Office of Research Support.

*The Multiple Project Assurance was replaced by a Federal-wide Assurance in March of 2001. The assurance process has been streamlined and the resulting documents given a new name.

7.2 Animal Care and Use

Duke University, through the Institutional Animal Care and Use Committee (IACUC) and the Office of Animal Welfare Assurance (OAWA), utilizes oversight and service capacities to help ensure all animal care and use is carried out in observance of federal and state regulations, accreditation requirements, funder requirements, and local policies. All members of the research enterprise are responsible for maintaining an environment that ensures appropriate care for animals and supports the integrity of research results and experimental methods.

This includes oversight for contracted services and collaborations external to Duke, where Duke personnel is conducting or supporting animal activities at a non-Duke performance site; animal activities involving wildlife, fieldwork or owned pets; and animal activities or in-vitro research involving controlled substances. For further information regarding seeking appropriate oversight, review and approval, consult myRESEARCHpath.

I. Roles and Responsibilities

Institutional Animal Care and Use Committee: A committee of scientists, nonscientists, veterinarians, and community members with the following responsibilities:

• Overseeing and routinely evaluating the Duke Animal Care and Use Program. This is done, in part, by approving and monitoring the care, treatment, housing, and use of animals under the Duke Animal Care and Use Program.
• Certifying compliance with regulatory and oversight standards (e.g., the Animal Welfare Act/Regulations, the PHS Policy, the Guide for the Care and Use of Laboratory Animals, AAALAC International, etc.).

Office of Animal Welfare Assurance: The Duke University office designated to provide administrative support for the Duke IACUC. OAWA has the following responsibilities:

• Assisting the IACUC in fulfilling its institutional, regulatory, and oversight responsibilities.
• Assisting in grant congruency reviews and controlled substance use in research.
• Providing customer service to all participants of the Duke Animal Care and Use Program.

Research Personnel:

The following are expectations for any member of the Duke Animal Care and Use Program, defined as any individual who uses live vertebrate animals or cephalopods in research, teaching, testing, or experimentation. Individuals must adhere to regulatory, external oversight, and internal oversight requirements; and maintain an environment that enables the appropriate care for animals and supports high quality research This includes, but is not limited to:

• Adhering to all aspects of approved IACUC protocols by performing only those animal activities described and approved in an IACUC protocol.
• Incorporating any new animal activities or other changes to a protocol through the IACUC protocol amendment process. Modifications and new activities cannot be initiated before receiving final IACUC approval. Furthermore, scientific exceptions, exemptions, and/or deviations to animal welfare standards, like metered fluid provision, must only be performed as described and approved in the current IACUC protocol. These must be based on scientific necessity and should only be performed for the shortest duration necessary.
• Performing animal activities for which they have the requisite training and qualifications to perform and are included in an approved IACUC protocol.
• Reporting any animal welfare concern to an appropriate University official. For the purposes of this policy, an animal welfare concern may be associated with any animal related activity that does not look or seem right (e.g., housing conditions, husbandry, handling methods, experimental procedures, or illness). A complete list of reporting methods and contact information can be found on the Duke Animal Care and Use Program Reporting Concerns page on myRESEARCHpath.
• Engaging the Duke clinical veterinarians immediately when a potential animal concern or unforeseen event occurs to help ensure appropriate and timely care of the animals, if needed. This includes following any Duke clinical veterinarian recommendation for care or treatment of an animal.
• Reviewing and adhering to further requirements related to the care and use of laboratory animals such as specific funding, award, or grant requirements; institutional policies and SOPs; and/or department or unit level polices and SOPs.