A risk is a potential harm (injury) associated with the research that a reasonable person would be likely to consider possible or significant in deciding whether to participate in the research. The concept of risk includes, but is not limited to, discomfort, distress, burden, embarrassment, loss of privacy/confidentiality, or inconvenience an individual subject may experience because of the research procedures.
Underlying the consideration of risk, is the implicit ethical guideline that all researchers have a duty not to harm their subjects and must minimize potential risk to the greatest extent possible. This duty may include pausing or stopping the study, reassessing the situation, checking-in with the study subjects if it is reasonable to continue, and/or consulting with another researcher, site official, Institutional Review Board (IRB) administrator, or study advisor on next steps.
Risk can refer to:
- The chances that specific individuals are willing to undertake for some desired goal; or
- The conditions that make a situation harmful to a subject.
The five common types of risks are:
- Physical risk (e.g., pain, bruising, and infection associated with venipuncture, muscle soreness and pain because of exercise testing, heart attack induced by maximal exercise test);
- Psychological risk (e.g., stress associated with psychological testing, stimulation of painful memories, feelings of guilt or discomfort precipitated by a sensitive survey);
- Social risk (e.g., invasion of privacy, loss of community standing);
- Legal risk (e.g., criminal prosecution or revocation of parole); and
- Economic risk (e.g., loss of employment, loss of potential monetary gain).
The IRB will review both immediate and delayed risks of any procedure involving human subjects. In addition, the estimated probability, severity, average duration, and reversibility of any potential harm will be considered according to available empirical data.
Vulnerable populations may be at greater risk than others and the IRB will take into consideration the potential risk characterization of the study subjects.
- Victims of (child) abuse or assault, for example, may be at increased risk in sociological or psychological studies.
- Children, the elderly, prisoners, physically or mentally challenged individuals, and ethnic or racial minorities may incur an increased level of risk in certain kinds of research projects.
- Individuals with undocumented, immigrant, or undisclosed (citizen) status may have added concerns about privacy and confidentiality.
- Groups with nuanced vulnerabilities or individuals with compromised ability to consent (e.g., emergency situations) may require patience and care to best understand their current situation and if it has short-or-long term impacts.
- Individuals who are economically, socially, or educationally disadvantaged may volunteer for studies that offer compensation, despite the risks.
Risk is classified as:
- Less than minimal risk: Most “less than minimal risk” procedures are interventions that usually (but not always) have no known associated risk. Examples of “less than minimal” risk studies include:
- Procedures that include collection of urine, collection of sweat, weighing, pulse measurement, blood pressure measurement, voice recordings, skinfold body composition measurements, and any standard psychological testing with no stress.
- Human interaction may occur regardless of the study because it is considered typical engagement (e.g., students, as part of a typical day, attend an afterschool program).
- Minimal risk: Federal regulations (45 CFR 46.102(i)) define minimal risk as, “The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” The term “minimal risk” is used as a base or standard by which the risk associated with research is judged. Examples of “minimal” risk studies include:
- Study poses no more risk than expected in daily life (e.g., physical exam, routine psychological assessment).
- Procedures that include electrocardiography, collection of blood by venipuncture from healthy adults who are not pregnant, moderate exercise testing, administration of standard psychological tests with only a minor level of associated stress, and magnetic resonance imaging.
- Non-interventional studies (e.g., observational studies of behavior or nutrition).
- Survey/Questionnaire studies include topics of a non-sensitive nature.
- Research involving the collection or meta-analysis of existing data, documents, records, pathological specimens, or diagnostic specimens to understand basic bio-behavioral processes.
- Greater than minimal: All “greater than minimal,” risk studies are reviewed at the convened full board meeting. The IRB Full Board votes to approve the greater than minimal study (1) “as is,” (2) “approve with changes,” or (3) table until next convened meetings as there are too many significant risks (or risks are not adequately mitigated), the study is not scientifically justified or clear. Examples of “greater than minimal” risk studies include:
- Any disclosure of illegal activities, sexual attitudes, genetics, religious beliefs, mental health that could place participants at risk of criminal or civil liability, be damaging to the participants financial standing, employability, insurability, reputation, or be stigmatizing.
- Procedures that include radiology exams (x-ray, CT scan), maximal exercise testing, and stressful psychological testing, including asking sensitive or personal questions on a survey.
- Depression and mental health disorders
- Sexual (and other physical) abuse
- Violent crimes or other criminal behavior
- Opinions about employer, that could put the employee at risk of job loss or job stress
- Coercion (e.g. student/teacher)
- Deception or incomplete disclosure
- Population involves persons with cognitive disabilities or inability to provide consent
- Pregnant women, specifically in instances where the study involves physical activities
- Medically invasive
Since risk is such a relative concept, the IRB classification system does not distinguish between “no known risk” and “less than minimal risk” research except for the purpose of risk disclosure on the consent form.
The IRB will carefully review the risk classification of the research which determines the type of IRB review and consent form format.
Under certain circumstances, application of the minimal risk classification will be based upon a consideration of the risks inherent in each subject’s life, thereby resulting in a relative standard of minimal risk. Thus, for example, the standard of minimal risk may be different when applied to a person with cancer or an individual with an intellectual disability versus a healthy person.