Risks Associated with Human Subjects

Minimal risk

The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves and those ordinarily encountered in daily life or during the performance of routine physical or psychological evaluations or tests. Minimal risk also includes the issue of confidentiality.

Two dimensions to think about in terms of risk include:

  • Probability: What are the chances that the risk will happen?
  • Magnitude: If the risk does happen, how bad will that be?

Physical, social and psychological risks

Physical 

Research poses a physical risk if subjects may suffer bodily harm as a result of participation in the study.

  • Minor or serious
  • Temporary or permanent: Subjects could suffer permanent physical harm or discomfort as a result of participation.
  • Immediate or delayed: Physical harm or discomfort could be experienced a few days later.

Psychological

Research poses a psychological risk if participation in the study could affect subjects’ perceptions of themselves.

  • Emotional suffering (anxiety or shame): Subjects may be embarrassed about what they find out about themselves.
  • Aberrations in thought or behavior: Subjects may act or think differently.
  • Privacy violation: This is especially the case where subjects are observed without their knowing. Subjects may act differently in private than they do in public.

Social

Research poses a social risk if the subjects could be potentially embarrassed after participating in the study.

  • Insurance discrimination: Could subjects lose their insurance as a result of their participation in the research?
  • Employment discrimination: Could participating be potentially damaging to the subjects’ financial standing, employability or reputation?
  • Classroom discrimination
  • Criminal or civil liability: What if a subject reveals that he/she has committed a crime? Could subjects go to jail or be sued if results are found out from your research?
  • Social stigmatization

When it comes to research some populations are considered “high risk.” They include:

  • Children
  • Handicapped persons
  • Persons with mental incapacity
  • Educationally disadvantaged persons
  • Fetuses
  • Elderly persons
  • Prisoners or other wards of the state
  • Economically disadvantaged persons
  • Students

Situations which may increase the risk in a study:

  • Language
  • Culture
  • Current events or incidents
  • Old age
  • Youth
  • Transient cognitive impairment
  • Chemical use
  • Health status—what if a subject happens to be sick today?
  • Students
  • Employees

Simplify the project

Due to the level of complexity of ethical issues and the level of sophistication that is needed for projects that are greater than Level I risk, the HSIRB recommends that honors-level projects be kept to the less-than-minimal risk or Level I category of review.

The main benefit of keeping a project at a lower level of risk is it’s generally done sooner. Level I research takes less time to review and, often, less time to complete.

Tips to keep a project low-risk

Avoid vulnerable populations

Avoid using certain protected populations in research. Using individuals from these categories will likely move a project up to full-board review status. Because the full board (12 members plus the chair) meets only once per month, there will be a longer delay if the monthly submission deadline has already passed.

Special populations include, but are not limited to:

  • Prisoners or wards of the state
  • Children
  • Pregnant women
  • Cognitively or decisionally impaired
  • Persons with physical handicaps
  • Fetal tissue
  • Elderly persons
Avoid sensitive topics

The second way to keep a project at the Level I status is to avoid sensitive topics. Keep in mind that these will vary by the community be studied. For example, a study on homosexuality may be viewed quite differently in Salt Lake City than in New York City.

Sensitive topics generally include, but are not limited to:

  • Sexual practices
  • Substance use or abuse
  • Illegal behavior

Choose a low-risk project

The HSIRB determines the level or review given to all protocols. It bases this determination on the possible risks to subjects. Usually projects with the following methodologies will be reviewed under the categories below.

Examples of low-risk thesis projects

Often most appropriate for honors theses
  • Anonymous surveys or questionnaires.
  • Collection or study of existing data, documents, or records (if identifiers have been removed).
  • Non-invasive observations of public behavior.
  • Research on regular instructional strategies.
  • Comparison among instructional techniques, curricula or classroom management methods.
  • Taste studies if wholesome foods without additives are consumed.

Examples of thesis projects with potential for higher risk

  • Might need to take steps to manage risk.
  • Collection or study of existing data, documents or records (if identifiers have not been removed).
  • Interviews.
  • Experimental designs which pose low risk to subjects.
  • Oral history.
  • Focus groups.

Examples of high-risk thesis projects

To be undertaken only under the strict supervision of a highly qualified advisor.

  • Research on members of any vulnerable population: children, prisoners, pregnant women.
  • Research that involves more that minimal physical, psychological, social or other risks to the study subjects or participants.