Compliance

Human Subjects Institutional Review Board (HSIRB)

Undergraduates - Keeping Your Project Low Risk



Hints for Identifying Risk


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/Psychological Risks

Physical Risk. Where the research subject may actually suffer bodily harm.

  • Minor or Serious
  • Temporary or Permanent: Subjects could suffer permanent physical risks as a result of participation.
  • Immediate or Delayed: Physical risks could even happen a few days later.

Psychological Risks.

Participation in the study could affect the subject's perception of themselves.

  • Emotional suffering (anxiety or shame): The subject may be embarrassed about what they find out about themselves.
  • Aberrations in thought or behavior: They 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 Risk.

Could the subject be potentially embarrassed after participating in your research?

  • Insurance Discrimination: Could they lose their insurance as a result of their participation in your research?
  • Employment Discrimination: Participation could be potentially damaging to the subjects' financial standing, employability or reputation.
  • Classroom Discrimination
  • Criminal or Civil Liability: What if your subject reveals that they have committed a crime? Could they 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"

  • 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 your subject happens to be sick today.
  • Students
  • Employees

How to Simplify Your 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 your project at a lower level of risk is the amount of time it takes to complete your project. Level I research often takes less time to complete, which means that it will take less time to complete your project and you can graduate and move on with your life. You also save time in waiting for your project to be reviewed.

Here are some tips to keep your project at low risk:

    1. Avoid Vulnerable Populations

      You will want to avoid using certain protected populations in your research. Using individuals from these categories will likely move your project up to Full Board Review Status. Remember the Full Board (12 members plus the Chair) meets once a month, which means a longer delay if you miss the first Wednesday of the month deadline.

      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 (We realize this one is highly unlikely, since you probably wouldn't have access to this)
      • Elderly Persons
      • Avoid Sensitive Topics.

        The second way to keep your project at the Level I Status is to avoid sensitive topics. (Keep in mind that these will vary by the community you are studying) 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/Abuse
        • Illegal Behavior

Choosing 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 Higher 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

Questions? Contact Research Compliance at (269) 387-8293.

 
Office of the Vice President for Research
Western Michigan University
210 W Walwood Hall
Kalamazoo, MI 49008-5456 USA
(269) 387-8298 | (269) 387-8276 Fax