What is a consent form?

The Informed Consent document contains the required information as found in and required by the United States regulations regarding the protection of human subjects (Code of Federal Regulations, Title 21, Part 50-Protection of Human Subjects). As required by this regulation, the informed consent must be reviewed and approved by an Institutional Review Board (IRB).

What is an Institutional Review Board (IRB)?

An Institutional Review Board (IRB) is any board, committee or other group, which reviews, approves, and provides continuing review of biomedical research involving human subjects. The primary purpose of such review is to guarantee the protection of the rights and welfare of the human subjects.

IRBs were established as the result of unfair treatment of human subjects. Prior to this, other committees existed as a requirement of the United States Public Health Service (USPHS) policy established in 1965. IRBs are regulated by the Food and Drug Administration and the Office for Human Research Protections (OHRP). The FDA and OHRP regulations require IRB review and approval of the study design (Protocol), Informed Consent form, and any recruiting materials prior to the enrollment of study subjects.

What does an IRB mean to me?

The purpose of the IRB is to inform and protect human subjects through the information provided in the informed consent document. Therefore, the IRB is acting as a supporter for the research subject. This means that the IRB, during its review of the informed consent document, has the right and responsibility to ensure that the research subject is fully informed of the procedures involved in the study as well as the risks and other treatments that are available if participation in the study is refused.

How can I tell that an IRB has reviewed and approved this study?

The date that IntegReview approved the study design as well as the information in this Informed Consent document is printed on the top of each page of this Informed Consent form.

IntegReview, the IRB for this study

IntegReview is an independent IRB whose board members are individuals who work in the Austin, Texas community. IntegReview provides services nation-wide to research professionals.

FDA regulations require that the committee have at least five members with varying backgrounds to provide complete and adequate review of research activities.

To fulfill these requirements the IntegReview Board currently includes physicians, pharmacists, Ph.Ds., a toxicologist (someone who studies the harmful effects of chemicals), a psychologist, an oral surgeon, and lay members (non-scientific).

The telephone number of the Chair is available in every informed consent document in the contacts section. You may contact the Chair with concerns regarding your rights as a subject.