Reasons for IRBs and Informed Consents
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.
Research Subject Bill of Rights
As a subject involved in an investigational research study, you have the following rights:
- Be informed of the nature and purpose of the experiment.
- Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be used.
- Be given a description of any attendant discomforts and risk reasonably to be expressed from the experiment.
- Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable.
- Be given a disclosure of any appropriate alternative procedures, drugs, or devices that might be advantageous to the subject, and their relative risks and benefits.
- Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise.
- Be given an opportunity to ask any questions concerning the experiment or the procedures involved.
- Be instructed that consent to participate in the medical experiment may be withdrawn at any time. The subject may discontinue participation in the medical experiment without prejudice.
- Be given a copy of a signed and dated written consent form when one is required.
- Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject’s decision.
CISCRP (Center for Information & Study on Clinical Research Participation). CISCRP is an independent nonprofit organization founded for the purpose of educating the public, patients, media, and policy makers in order to promote greater understanding and awareness of clinical research participation and the role it plays in public health.
Clinical Trials – for information on research studies being conducted in your area and to learn more about research studies.