The Policy for the Protection of Human Subjects (Title 45, Part 46) and its various subparts were introduced in 1981 by the Department of Health and Human Services. Subpart A explains the basic foundations of institutional review boards (IRBs), and the remaining subparts B, C, and D provide protection to vulnerable populations, including pregnant women, fetuses, and neonates; prisoners; and children, respectively. When conducting a research study, the IRB will consider these subparts when determining the type of approval needed.1

THE INSTITUTIONAL REVIEW BOARD

The IRB is a committee composed of at least 5 members from various disciplines and at least 1 community member. The board must be diverse in terms of sex and racial and cultural backgrounds. The IRB acts as the advocate for human subjects involved in research studies; thus, the goal of the IRB is protection of research subjects. This board has the authority to require changes in study procedures, approve or disapprove research, and terminate studies if the researcher is not complying with federal statutes.1

IRB APPROVAL

When reviewing human subjects research, the IRB ensures equitable subject selection, assures adequate informed consent in nontechnical language, minimizes risks, and maintains privacy and confidentiality. Therefore, IRB approval is needed for any type of human subjects research including human individuals, human tissues, human body fluids, and certain human cell lines. Based on possible risks to the subjects, the study may need to be reviewed by the full board at least annually or reviewed more frequently throughout the year.1

TYPES OF REVIEWS

Research studies may be reviewed at 1 of 3 different levels: exempt, expedited, or full board. Studies that demonstrate minimal risk are usually reviewed as an exempt or expedited review. Exempt studies do not require ongoing IRB review unless changes are made that may no longer make the study qualify for exemption. Exempt studies must fall into 1 of the following federal categories:

* Research conducted in established or commonly accepted educational settings, involving normal educational practices;

* Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior;

* Research in which there are identifiable subjects in special circumstances;

* Research involving the collection or study of existing data, documents, records, or pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded in such a manner that subjects cannot be identified;

* Research and demonstration projects that are conducted by or subject to the approval of department or agency heads for the public benefit; and

* Taste and food quality evaluation.1

Expedited reviews are also applied when the research is believed to contain no more than minimal risk. The IRB chairperson may conduct this review or delegate it to one of the board members, but each person needs to keep in mind that the review covers issues that would otherwise come before a full board. The federal regulations contain expedited categories as listed below:

* Clinical studies of drugs and medical devices when research on the drugs does not require a new drug application or an investigational medical device exemption application is not required;

* Collection of blood samples by fingerstick, heel stick, ear stick, or venipuncture from healthy, nonpregnant individuals who weigh more than 110 lb or from other adults and children considering the age, weight, and health of the subjects;

* Prospective collection of biological specimens for research purposes by noninvasive means;

* Collection of data through noninvasive procedures;

* Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis);

* Collection of voice, video, digital, or image recordings made for research purposes; and

* Research on individual or group characteristics or behavior.1

A full board review is conducted on research studies that involve more than minimal risk at a regularly convened meeting in which a majority of board members is present. A list of studies requiring full board review follows:

* Studies using vulnerable populations;

* Studies taking place internationally;

* Studies where information may be disclosed that could require mandatory legal reporting (child abuse and drug use);

* Studies involving deception that raises the risk of the subjects; and

* Studies that fall under the jurisdiction of the Food and Drug Administration.1

IMPLICATIONS FOR NURSING

Nursing research is conducted primarily on human subjects and potentially vulnerable populations and is therefore subject to IRB review. Each type of review serves to protect the subjects, the primary goal of the IRB.

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