INSTITUTIONAL REVIEW BOARD (IRB) - Promising Futures

Any project that meets the definition of research and that involves human subjects would require submission of an IRB application prior to any data collection. To meet the definition of research, a project’s purpose would be to contribute to generalizable knowledge, would be designed in advance, and be systematic. Conducting research with human subjects requires the submission of an IRB application whereas conducting program evaluation may not. In general, any data collected to be used internally for the purposes of quality improvement or program evaluation are not subject to IRB. In many cases, this remains true even if this de-identified data is being shared with a federal funding agency because of a grant. 

There are three major levels of human subjects’ research review: Exempt, Expedited, and Full.  

Exempt: Studies that receive an exemption determination from IRB are exempt from the specific regulations and requirements in Title 45, Part 46 of the Code of Federal Regulations. Please note, however, that they are still considered human subject research. 

Many projects in the social sciences, social work, mental health, and public health will meet the criteria for exempt or expedited IRB review. Even exempt projects must get a basic IRB review, however, are the only type of IRB designation not required to be updated and reviewed annually. Exempt status may be given for educational research, “benign behavioral interventions” with confidentiality of participants, and secondary data analysis of archival data. 

Expedited: In order to meet expedited criteria, human subjects must have no more than minimal risk and must not be part of any “vulnerable” populations such as: children, prisoners, economically disadvantaged adults, and those with diminished capacity or developmental delays.  

Full Review: Full IRB review would be required when working with “vulnerable” populations or when research is found to pose greater than minimal risk to human subjects. If any of the above populations are part of the project, then a Full IRB review will be required. Additionally, such activities that pose more than minimal risk might cause physical harm or emotional distress, discuss sensitive topics, gather information about illegal activity, or could harm a participant’s social, legal, or financial standing if they might be identified.  

Additionally, any Protected Health Information (PHI) collected by a health care or mental health organization would be subject to HIPAA regulations. These PHI include 18 indicators that might make a person identifiable if their information became known, such as name, address, date of birth, social security number, medical record numbers, and insurance numbers. When working with survivors of family violence it is also important to adhere to federal regulations concerning protecting confidentiality.  

Informed consent forms must stress the voluntary nature of the project being discussed. Coercive language should not be used, and participants should be reminded that they will receive the same services from your organization whether or not they participate in the research part of the project. Participants must also be reminded that they can quit at any time and still receive the services they need. Voluntariness lasts for the duration of the research.  

Informed consent forms should also outline the risks and benefits of participation. Most social science, mental health, and social work projects will not have specific benefits for the participants. The benefits might be that the results of the research will help to improve treatment for future participants. Be sure to list all the risks of a particular project including that the sensitive nature of the questions asked might trigger or make participants sad or upset. 

Finally, informed consent forms will let participants know who to contact if they have a problem or issue with how the process was handled.