Investigators may have noticed that there seems to be a high degree of variability in Institutional review board (IRB) reviews, both in review type and approval requirements.
Several regulations must be considered when reviewing a study. IRBs are given discretion to interpret and apply the federal regulations governing the protection of human subjects in research. However, the primary gauge an IRB reviewer uses to determine study approval requirements is risk. Some items that factor into a risk assessment might include possible risk to a subject’s health or the risk to a subject if their confidentiality was compromised. The riskier the study, the more rigorous the human subject protections required by the IRB. Levels of risk and review are determined by regulations.
Less Than Minimal Risk
These studies are typically exempt and reviewed via an expedited procedure (45 CFR §46.104, 21 CFR §56.104). Consent is not required for most of these studies BUT IRBs must ensure subjects are treated, and data/specimens are used, ethically. Examples include:
- Education/classroom research.
- Surveys, interviews, educational tests, public observations (that do not involve children)
- Benign behavioral interventions.
- Analysis of previously-collected, identifiable info/specimens.
- Federal research/demonstration projects.
- Taste and food evaluation studies.
- The establishment and/or use of a database or biobank.
Protections an IRB reviewer might look for in a study protocol might include allowing participants to opt out of a survey (a type of consent) or ensuring data are kept secured.
Minimal Risk
These studies are typically reviewed via an expedited procedure (§46.110 and §56.110).
“Minimal risk means that the probability and magnitude of physical or psychological harm does not exceed that which is ordinarily encountered in daily life or in the routine medical, psychological, or educational examinations, tests, or procedures of the general population §46.102(i).” The following types of studies qualify as Minimal Risk:
1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
a. Research on drugs for which an investigational new drug application (21 CFR 312) is not required. Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.
b. Research on medical devices for which (i) an investigational device exemption application (21 CFR 812) is not required; or (ii) the medical device is cleared/approved for marketing and is being used in accordance with its cleared/approved labeling.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
a. from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than 2 times per week; or
b. from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more frequently than 2 times per week.
3. Prospective collection of biological specimens for research purposes by noninvasive means (hair, fingernails).
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing (magnetic resonance imaging, moderate exercise, body composition assessment).
5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7. Research 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.
Greater than minimal risk
In general, this describes any study that does not fall into one of the above categories. These studies require a full board meeting and increased oversight by the IRB.
Taking into account the above regulations, a few examples are described:
- Why do some remote informed consent processes require a second witness, who is independent of the study, and others do not?
- Is the remote consent process taking place so that a legally authorized representative may consent to an experimental procedure on an unconscious subject? Or is a remote consent process happening so that a subject can take part in an online focus group about coupon use? Different consent process may have different requirements, from the use of independent secondary witnesses, to documentation of the process. The IRB must take into account the circumstances surrounding a remote informed consent process request and enforce the regulations accordingly.
- Why can’t a survey of a vulnerable population, like prisoners, qualify for an exemption like other surveys?
- Due to the historical abuse of certain peoples in research, the study of vulnerable populations requires increased oversight. Vulnerable populations might include prisoners, children, and racial or ethnic minorities. Most of these studies must be reviewed by the full board and one of the reviewers must have broad knowledge of the population being studied. Consultants brought in for these IRB reviews might be a pediatrician for the review of a study involving children or neonates, or a former inmate for the review of a study involving prisoners.
Investigators may make an initial assessment of the type of requirements their study might require by reading the regulations. However, the final decision is made by the IRB. Please contact Pearl IRB with any questions you have regarding specific requirements for your study.