Which Activities Are Affected?

Today, most federal and private granting institutions require certain activities that may constitute research and are subject to federal law. For instance, programs that do not have any expertise in research and evaluation, such as those that provide direct services, may wonder if the activities in which they are participating constitute research.

Two common types of activities that programs may conduct and that may be considered research are needs assessments and program evaluations:

• Needs assessment. A systematic effort to gather information from various sources that will help identify the needs of victims and the resources that are available to help them. For more information on conducting a needs assessment, please refer to the Guide to Conducting a Needs Assessment included in this series.
• Program evaluation. The systematic process of obtaining credible information to be used to assess and improve a program. Additional information on program evaluation can be found in the Guide to Performance Measurement and Program Evaluation included in this series.

Conducting a needs assessment or program evaluation is not always research, but may at times be considered research and may be subject to federal laws protecting human subjects. To determine whether your project activities constitute research, consult with an expert in program evaluation or review Title 48 of the CFR, “Federal Acquisition Regulations System.”

If you determine that your activities constitute research and involve human subjects who need to be protected, then you most likely will need to go through the Institutional Review Board (IRB) process. The remainder of this guide acquaints you with the general workings of the IRB and the forms that are commonly used to ensure that subjects’ privacy and confidentiality are protected.