Note: For HCDE, researchers cannot determine that their research is exempt. That decision is made by the IRB committee.

If your evaluation doesn't use identifiable private information, your project most likely will not need IRB approval.

Research utilizing the following types of data (and only these types) is typically exempt from IRB review:

1. Data, documents, and records that are publicly available. Examples of public data include AFCARS or NCANDS data or public court records.

2. Data that is recorded by the investigator in a way that the subjects cannot be identified, either directly or through identifiers linked to the subjects (HHS, 2004). An anonymous survey, where respondents do not provide their name or any other piece of identifying information, cannot be linked back to respondents (as long as there is no coding key).

IRBs review any proposed research protocol involving human subjects, including medical research and all behavioral or social research studies, which includes evaluation research.

A human subject is defined 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.

Human subjects can include clients, program participants, members of an organization, constituencies, or the general public. IRBs also make sure provisions are in place to protect vulnerable populations such as children, prisoners, pregnant women, and the cognitively impaired.

Specifically, IRBs ensure that research investigators satisfy the following requirements:

(1) Risks to subjects are minimized.

(2) Risks to subjects are reasonable in relation to any anticipated benefits to subjects and the importance of the knowledge the study is expected to produce.

(3) Selection of subjects is equitable, in regards to the problems of research involving vulnerable populations.

(4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representative.

(5) Informed consent will be appropriately documented.

(6) When appropriate, the research plan makes adequate provisions to monitor the data collected in order 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 (Protection of Human Subjects, 2005).

An Institutional Review Board (IRB) is a committee set up by an organization to review, approve, and regulate research conducted by its members, on its premises, or under its sponsorship (Babie, 2001). The National Research Act, passed by Congress in 1974, directed all institutions receiving federal support for research and evaluation studies—including universities, public schools, hospitals, and nonprofit organizations—to establish IRBs.

The primary responsibility of an IRB is to ensure that the risks faced by human participants in research are minimal. If an IRB determines a research project to pose more than minimal risk, the IRB may ask the researcher to revise the study design. In some cases, the IRB may refuse to approve a study if the research is deemed harmful to participants, careless, or unethical (Protection of Human Subjects, 2005).

An IRB consists of at least five members with varying backgrounds in respect to race, gender, cultural background, and profession. IRB members must have expertise in the areas of research they review, and at least one member of the IRB must be a representative of the greater community, rather than the affiliated institution (Protection of Human Subjects, 2005).