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.
What’s the difference between research and program evaluation?
Research seeks to prove, evaluation seeks to improve.
Many people, seasoned evaluators included, use the terms research and evaluation interchangeably. Just as there are numerous definitions of evaluation there are many different perspectives about the differences and overlap between the terms. What makes discerning between the two more difficult is that fundamentally they both are about answering questions and they both often use the same methods in the pursuit of those answers. Their differences lie in what types of questions are being asked, what type of knowledge or answers are being generated, and how that knowledge is going to be used. One defining element is that research intends to build generalizable evidence to test theories or explain how something works while evaluation focuses on the systematic assessment of programs and intervention strategies and aims to assess how something is done, its value or worth, and whether or not it had impact or was effective.
What are the 3 types of IRB reviews?
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.
Voluntary Informed Consent
Any IRB will have templates for informed consent forms to be used with adults, informed consent forms to be used with parents of child participants, and assent forms to be signed by child participants. As children have agency over their participation but do not have legal status to sign contracts, their parents or legal guardians must sign informed consent for them. Children under eight generally do not have to sign assent forms unless they want to do so, and children 12 and over are required to sign assent forms.
Utilizing a trauma informed approach to consent and assent is an essential aspect of ethical data collection – especially when working with survivors of family violence. The project must be described in detail and be understandable for the participants. No detail is too small if it will inform the participants about what to expect from the project. A step-by-step list of the requirements of participation should be included. Generally, all informed consent forms for adults should be written at an eighth-grade reading level or lower, and any forms for youth should be written at a fifth-grade reading level at most.
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.
Why get IRB approval?
To protect human subject participants
To be sure that the research proposed poses minimal risk to participants
To be sure that participants’ identities are protected
To protect the integrity of your data if you plan to publish the results of your research
- IRB definitions (Is it Research? And definitions of exempt, expedited and full)
- The Three Types of IRB Review
- HIPAA PHI: Definition of PHI and List of 18 Identifiers
- Institutional Review Board - IRB
- What is the Institutional Review Board (IRB)?
- Elements of Involuntary Informed Consent
- Purpose of the Human Research Protection Office and Institutional Review Board
- Power Through Partnerships: A Community Based Participatory Research Toolkit for DV Researchers
- Building Evidence
- Outcome Evaluations: The Basics