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FAQ (Frequently Asked Questions)

Who serves on the IRB?

IRB members are appointed by the the Provost for one-year terms, and may be reappointed for successive periods. In accordance with applicable federal regulations, the Board must have a minimum of five members, including at least one individual who would be considered a non-scientist. Members are selected from faculty, staff, students, and community members. Considerable effort is expended to recruit individuals from all three University campuses who have expertise in different areas. This diversity helps to ensure that protocols are evaluated fairly by knowledgeable individuals. If necessary, non-voting consultants may be enlisted to review specific protocols for which there is no IRB member with sufficient knowledge of the research method or scientific discipline to conduct a substantive review.

Upon what federal regulations is IRB policy based?

The primary regulation that pertains to human subjects research Title 45 of the Code of Federal Regulations, Part 46 (45 CFR 46). This statute defines relevant terms and describes all aspects of human subject protection, including the composition of review boards, criteria for protocol review, guidelines for informed consent, requirements for record-keeping, special protections for vulnerable populations, types of review, and procedures for dealing with non-compliance. It is based on the ethical principles identified in the Belmont Report. As written, 45 CFR 46 applies only to federally funded research, however, UT Dallas maintains an agreement with the federal Department of Health and Human Services (DHHS) that extends the protections of 45 CFR 46 to all research conducted by University personnel, regardless of the source of funding, or lack thereof. This agreement is the Multiple Project Assurance (MPA) and is required before the institution may receive federal research funds.

If a protocol includes the use of FDA-regulated drugs, devices, or biologics, then Title 21 of the Code of Federal Regulations (21 CFR) is applicable. The terms described in 21 CFR and 45 CFR 46 are similar in many ways, but there are important differences that investigators should be aware of (comparison of regulations: http://www.fda.gov/oc/ohrt/irbs/appendixe.html).

What is the Belmont Report and how has it influenced federal regulations regarding the protection of human subjects?

On July 12,1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (I) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (II) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (III) appropriate guidelines for the selection of human subjects for participation in such research and (IV) the nature and definition of informed consent in various research settings.

The Belmont Report attempts to summarize the basic ethical principles (respect for persons, beneficence, and justice) identified by the Commission in the course of its deliberations. Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for administrative action by the Secretary of the Department of Health and Human Services (formerly the Department of Health, Education, and Welfare). Rather, the Commission recommended that the Belmont Report be adopted in its entirety, as a statement of the Department's policy.

How do the ethical principles identified in the Belmont Report relate to human subjects protection?

Respect for persons: Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy. In most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information (informed consent). Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated (e.g., assent of the subject, permission from a parent/guardian).

Beneficence: Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. The obligations of beneficence affect both individual investigators and society at large, because they extend both to particular research projects and to the entire enterprise of research. In the case of particular projects, investigators and members of their institutions are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from the research investigation. In the case of scientific research in general, members of the larger society are obliged to recognize the longer term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures.

Justice: Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly.

Questions of justice have long been associated with social practices such as punishment, taxation and political representation. Until recently these questions have not generally been associated with scientific research. However, they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients. Against this historical background, it can be seen how conceptions of justice are relevant to research involving human subjects. For example, the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.

What are the criteria for IRB review of a protocol?

When reviewing a protocol, the IRB must make the following determinations:

(1) Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons.

(4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116.

(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.

(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

When is IRB review required?

IRB review is required whenever an investigator who is affiliated with the institution conducts research with human subjects.

Research is defined in 45 CFR 46 as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge". Student projects are considered to be research whether or not there is intent to disseminate study results, if all other conditions are met.

A human subject is defined in 45 CFR 46 as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information". Individuals who provide information for research that is not about themselves are not considered to be human subjects in this context. While researchers should take steps to ensure that these individuals are not placed at risk, it is not necessary for the IRB to approve their participation.

Once the board reviews my study,when can I start enrolling subjects?

If the board has asked for revisions, you will receive a letter outlining the revisions that are needed. When the revisions have been completed, reviewed, and approved by the IRB, they will sign your application for approval. Once you have received the signed application, you may begin enrolling subjects.

What is informed consent?

Informed consent is one of the primary ethical requirements underpinning research with human subjects; it reflects the basic principle of respect for persons. It is too often forgotten that informed consent is an ongoing process, not a piece of paper or a discrete moment in time. Informed consent assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. The prospective subject should be presented with the information, and then given an opportunity to ask questions and have them answered, prior to signing the consent document.