Federal regulations permit the Institutional Review Board (IRB) to review and approve proposed research through an Expedited review process if...
- The research constitutes a minor change in a previously approved research project during an approved period; or
- The research is not greater than minimal risk and falls into one of the categories listed under the New Common Rule (45 CFR 46.110 or 21 CFR 56.110).
Expedited review may not be used if the risks related to the invasion of privacy and breach of confidentiality are greater than minimal. Additionally, research that meets the requirements for Exempt review would not be considered under Expedited review categories. For help determining your review category, please download our guide: Does my human subjects research fall under the expedited review category?
Researchers new to the IRB may be unfamiliar with the different activities within each Expedited review category. This post will provide examples of research that typically falls under Expedited Review type, Category 7 - Group Characteristics & Behaviors.
Category 7 indicates that protocols may be categorized as Expedited if the research is “on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.”
Below are a few scenarios that we will review to see if they meet the requirements for Expedited Category 7.
Example A: A private tutoring center instructor is approached by a researcher who would like to test a new way of teaching grammar with elementary school students. The instructor agrees to split his students into two groups: one group of students will receive the new method of teaching grammar, and the other group will receive the standard method. Both methods of instruction are considered typical and not deemed to give an unjust advantage to one group of students over another. The researcher will not have any contact with students. The next day, the groups will switch so that all students receive both methods of instruction conducted by the instructor. The researcher will receive ungraded assessments from both groups in order to compare instruction methods; these assignments will not impact the students grades or access to tutoring resources. The researcher’s access to the data will depend on the parent permission and assent forms. The instructor will not be involved in any of the data analysis.
- Is it Expedited Category 7? Yes, the research method described above is considered a randomized controlled trial (RCT). Although the research involves typical educational practices and the researcher will not make contact with the students (requirements for Exempt Category 1), the introduction of a new method is researcher-designed and that disqualifies the research from being Exempt. In order to ensure fairness in education RCTs, students should receive both methods of instruction as it is not guaranteed that the new instructional method will be effective. The research should also not take away from typical learning or access to resources that the student might otherwise receive. As the research will be with youth under the age of 18, the researcher will need to obtain both parental permission and youth assent. Research with youth may be subject to additional protections and safeguards, as defined by the Office of Human Research Protections (OHRP). Additionally, the researcher should seek a site permission letter signed by the tutoring center’s administrator, once the research has been IRB approved.
Example B: A researcher plans to conduct an online survey using Qualtrics on LGBTQ+ individuals’ beliefs regarding specific laws targeted at trans individuals. Only adults over 18 years of age are eligible to participate in the study. The researcher plans to provide a $10 gift card compensation to participants who successfully complete the survey and meet all attention checks. Interested participants can enter their email address at the end of a study into a separate, password protected database that is not linked to their survey responses. No other identifiers will be collected.
- Is it Expedited Category 7? So long as the survey questions do not ask about sensitive information (e.g., illegal behaviors, medical records) and the only identifiers collected are the emails, this study would be categorized not as Expedited, but as Exempt. The study activities meet the criteria for Exempt Category 2, which states that recorded information from the survey procedures “cannot readily identify the subject (directly or through identifiers linked to the subjects).” Because participant emails will be recorded separately from the data, there is no way for the recorded information to be linked back to the subjects.
Example C: A researcher plans to interview professional athletes about their thought patterns, daily habits, and sleep schedules before and after a game. She would like to video record the interviews and use them as part of the data analysis and in her published materials. She may also refer to the athletes by name (with their consent) and use their direct quotes in the published findings. The researcher plans to attend three games that are open to the public and take notes about the athlete’s performance. Any other athletes or individuals at the game will not be observed for research purposes.
- Is it Expedited Category 7? Yes, this research meets the criteria for Expedited Category 7 as the research activities are not greater than minimal risk. However, the athlete may be identified in the published materials (with their consent) and due to the nature of their profession and fame, the researcher may be unable to guarantee confidentiality. The researcher should disclose to the athlete that she cannot guarantee their anonymity due to the nature of the research, even if the athlete does not consent to their name or direct quotes being used, they may be found out by process of elimination when the findings are published. An IRB may also require that the researcher obtain permission to conduct the study from the athlete’s coach or team administrator and clarify if there are any potential conflicts of interest or copyright issues associated with a professional athlete's participation in research.
Research activities may fall into one or more review categories depending on a variety of factors, including the study population, researcher expertise, coinciding events, etc. Researchers can access the Expedited review categories on TC IRB’s website or from the Department of Health and Human Services (HHS). TC IRB administrators will always review research on a case-by-case basis.