Previously, TC Institutional Review Board [IRB] explored the Exempt Review categories outlined by the Department of Health and Human Services [] alongside case examples of research that met [or did not meet] the Exempt criteria. TC IRB will now review how research studies may apply to the Expedited level of review. Federal regulations permit the IRB to review and approve proposed research through an Expedited Review 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 4 - Collection of data through non-invasive procedures.
Category 4 indicates that data collected through non-invasive procedures [not involving general anesthesia or sedation] may be considered under this category, if the procedures are “routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications. Examples include:
- Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subjects privacy;
- Weighing or testing sensory acuity;
- Magnetic resonance imaging;
- Electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
- Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.”
Below are a few scenarios that we will review to see if they meet the requirements for Expedited Category 4.
Example A: A researcher plans to measure the average number of steps per day that triathletes take compared to adults who exercise moderately. Participants must be adults competent to consent and in good physical health in order to participate. The researcher gives each of her participants a pedometer that can be worn around the wrist or ankle at their discretion. The pedometer that she chooses is commonly used in clinical practice and has been vetted by the United States Food and Drug Administration [FDA]. Each participant will wear the pedometer every day for one week, taking it off when they sleep, bathe, or shower.
- Is it Expedited Category 4? Yes, this study would meet the requirements for Expedited Category 4, as the pedometer is both “non-invasive” and has been approved by the FDA. The IRB would evaluate the common use of the device in clinical practice settings to determine if it is suitable for the proposed purpose and function described in the research study. Additionally, the researcher would need to provide each participant with an information sheet describing how to use the pedometer, an example of how it is similar to other common items [e.g., worn like a wristwatch], inclusion or exclusion criteria [e.g., individuals with a pacemaker], any risks that could occur from wear [e.g., skin irritation], and what to do in an adverse situation [e.g., cease wearing the device immediately and contact the team’s physician].
Example B: A researcher wants to examine the efficacy of a therapeutic movement intervention for elementary school-aged children with anxiety or low self-esteem. The movement intervention includes 10 minutes of stretching and breathing exercises, and it can be conducted by trained therapists. The researcher plans to recruit therapists and mental health clinicians who work with youth. Clinicians who decide to participate will be trained and then asked to implement the breathing intervention in their typical practice. Both parents and youth will be informed that this is an experimental research study and they will be asked to give permission/assent to participate. The program will take about 10 minutes once a week, and will last for 6 weeks.
- Is it Expedited Category 4? Although the research study includes mild exercise, the intervention likely does not meet the requirements for Expedited Category 4, as it involves the inclusion of youth as the research population. Additionally, a study about youth suffering from mental health disorders may need to be reviewed at a higher review category, depending on the type of data collected [e.g., mental health disorder diagnosis, medical history] and how it is presented. Depending on how the intervention is implemented, it might be classified as a program evaluation or a full board study. According to the federal regulations, youth are a protected population and thus research involving youth may be subject to additional protections. In a case like this, the IRB administrator would need to review the full scope of the study to make the final determination of the appropriate review category.
Example C: A researcher is interested in examining the parts of the brain that are associated with affection and social relationships in high-functioning individuals with Autism Spectrum Disorder [ASD]. The researcher will show participants pictures and videos of their loved ones while using fMRI to map their brain patterns. The researcher plans to recruit adult patients diagnosed with ASD and a control sample of neurotypical adults. The researcher will not require a formal diagnosis of ASD in order to be eligible for the study, only self-report.
- Is it Expedited Category 4? It depends! The federal regulations require additional protections for individuals with “impaired decision-making capacity or impaired consent capacity,” which includes some, but not all, individuals living with ASD. However, the interpretation of which individuals with ASD have the capacity to consent will fall on the IRB to decide, as ASD has an incredibly wide range of symptoms and impairment. In cases like these, the IRB will work closely with the researcher to determine whether their population of interest has the capacity for informed consent and decision-making and what safeguards to implement to protect the participant. If this study were only conducted with the control group of typically developing adults, then it would likely meet the requirements for Category 4.
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.