Who Approves Affected Activities?

If you determine that your research activities involve human subjects who need to be protected, you may have to seek approval of these activities from a reviewing board known as an Institutional Review Board (IRB). An IRB is an administrative body established pursuant to federal regulations to review research activities involving human subjects. An IRB consists of at least five members with diverse backgrounds, expertise, and experience. It has the authority to approve, require modifications to, or disapprove research activities involving human subjects that fall within its jurisdiction.

The role of an IRB is to ensure that—

• Risks to subjects are minimized.
• Risks to subjects are reasonable in relation to anticipated benefits and the importance of knowledge.
• There is proper informed consent and documentation of informed consent.
• The research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects.
• When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
• Additional safeguards have been included in the study to protect the rights and welfare of any subjects likely to be vulnerable to coercion or undue influence.

This section reviews—

• How To Find an IRB
• IRB Application
• IRB Review
• Possible Outcomes of an IRB Review

How To Find an IRB

IRBs may be found within public entities such as hospitals and universities or may be run by private companies within your community. If you decide to hire a local evaluator to assist with your project, the evaluator may be affiliated with a local IRB. You may also find a list of registered IRBs (http://ohrp.cit.nih.gov/search) online. Some IRBs offer their services at no charge, but others charge for their time at varying rates. You should build the cost of an IRB review into your evaluation budget.

IRB Application

In general, you will submit an application that includes sufficient information regarding the research study to an appropriate IRB for review. Each IRB has its own tailored application form, and you are advised to contact the relevant IRB about the review process and the forms you will need to complete.

For example, an IRB application may include the following types of forms:

• Request for IRB Action Form. By submitting this form, you are formally requesting a date for the research review. It is your responsibility to request a review date that allows sufficient time for review and approval before you conduct research involving human subjects. Check with your IRB for its submission deadlines.
• Protocol Review Form. This form provides the IRB with relevant information such as the objectives of the research study, procedures for obtaining consent, procedures for maintaining confidentiality, and the potential risk to human subjects. Make sure you submit supporting documentation with the form, including consent forms; relevant sections from grant applications or contract proposals; letters, advertisements, and other materials used to recruit potential subjects; information packets about the research that are distributed to its subjects; and full protocols, questionnaires, and other data collection forms.

The forms included in appendix B (PDF 101 KB) are samples only. Obtain the forms and supporting documentation that you will need to include in your application from your IRB.

IRB Review

Upon initial review of your research project, the IRB may make one of the following determinations about how the review process will be handled:

• Exemption From IRB Review. Your project activities meet the criteria for exempt research as established in the regulations. Examples of exempt research are outlined in appendix A (PDF 92.1 KB). (See 28 CFR 46.101(b).)
• Expedited IRB Review. Your research activities present no more than minimal risk to the human subjects involved and meet the criteria for an expedited IRB review as established in the regulations. Information about the procedures for expedited IRB review is outlined in appendix A (PDF 92.1 KB). (See 28 CFR 46.110.)
• Full IRB Review. Your research activities involve minimal risk or greater than a minimal risk to the human subjects involved and your project must receive a full IRB review. Generally, when research activities are subject to a full IRB review, members of the IRB read the IRB application and the research protocols prior to the IRB meeting. At the meeting, a quorum of the IRB members must be present for review and approval of the research project and the protocols to take place.

Research activities, such as conducting a needs assessment or program evaluation, may require a full IRB review if they involve interviewing or surveying victims who are vulnerable to potential risks in connection with their participation in these evaluations, or if the research involves sensitive questions that participants are likely to find stressful or confusing. A full IRB review can take several months before approval is granted, so plan your evaluation timeline accordingly.

Possible Outcomes of an IRB Review

After the IRB reviews the research activities, it can render one of three decisions:

• Approve the research involving human subjects without revisions.
• Conditionally approve the research involving human subjects pending revisions.
• Disapprove the research involving human subjects.

If your study is approved, you will receive documentation that IRB approval has been given. Keep the original documentation on file, as well as copies of the original, in case funders or other interested parties request it.