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 a group of people that reviews research studies. The main goal of this review is to protect the rights and well being of the human subjects participating in research studies.

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 the Informed Consent document is printed on the top of each page of the Informed Consent document.

IntegReview Ethical Review Board

IntegReview is an independent IRB whose board members provide IRB services across the nation.

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 Boards currently include: doctors, pharmacists, nurses, toxicologists (studies the harmful effects of chemicals), other specialists, and others who do not have a background in science/medicine.

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.