Institutional Review Board

Institutional Review Board

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Risk/Benefit Assessment Checklist

Federal regulations, based on the ethical principle of beneficence, require that risks associated with research are reasonable in relation to the anticipated benefits. Subjects must be informed about the potential risks of a study.

Risk/Benefit Assessment Checklist

To use the checklist for assessing risk, begin with the federal regulatory definition of minimal
risk. Once you have completed the checklist, refer to the type of IRB review your research will
require.

When assessing risk, bear in mind there are five major types of risk:

  1. physical risk (for example, pain, bruising and infection associated with venipuncture,
    muscle soreness and pain as a consequence of exercise testing, heart attack induced
    by maximal exercise tests)
  2. psychological risk (for example, stress associated with experiments and testing, feelings
    of guilt or discomfort because of sensitive survey topics)
  3. social risk (for example, invasion of privacy, loss of community standing)
  4. legal risk (for example, criminal prosecution or revocation of parole)
  5. economic risk (for example, loss of employment, loss of potential monetary gain)

     

Risk/Benefit Assessment Checklist

Definition of minimal risk: Minimal risk means that 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 (45 CFR 46.102 (h) (i)).

 Risk Categories

 Check the appropriate risk category of your research:

  1. ___ The research involves no more than minimal risk to subjects.
     
  2. ___ The research involves minimal risk to subjects.
     
  3. ___ The research involves more than minimal risk to subjects. 

            a. ___The risk(s) represents a minor increase over minimal risk, or
            b. ___The risk(s) represents more than a minor increase over minimal risk, or
            c. ___The risk(s) represents a major increase over minimal risk.


Definition of benefit: A research benefit is considered to be something of a health-related,
psychosocial, or other value to an individual research subject, or something that will
contribute to the acquisition of generalizable knowledge. Money or other compensation
for participating in research is not considered to be a benefit. A great deal of research in
the social and behavioral sciences offers little potential for direct benefits to the subjects
themselves. Rather, the benefits often encompass the importance of the knowledge to be
gained, and/or to the contributions the research makes to science or society.

 Benefits Categories

 Check the appropriate benefits category (ies) of your research:

 

  1.     ___ The research provides no prospect of direct benefit to individual subjects, but likely
                will yield generalizable knowledge about subject’s disorder or condition. 
  2.     ___ The research provides no prospect of direct benefits to individual subjects, but
                likely will yield generalizable knowledge to further society’s understanding of the
                disorder or condition under study.
  3.     ___ The research provides the prospect of direct benefits to individual subjects.
  4.     ___ The research provides no prospect of direct benefits to individual subjects, to science,
                or to society.


If you checked numbers 1 or 2 under Risks Categories, and numbers 1, 2, or 3, in the
Benefits Categories, your protocol will generally be reviewed as Exempt unless the
research involves one of the categories of vulnerable subjects; refer to children,
prisoners, mentally disabled persons, economically or educationally disadvantaged
persons, pregnant women, fetuses and neonates.

If you checked number 3.a or 3.b under Risks Categories, and numbers 1, 2, or 3, in the
Benefits Categories, your protocol will be reviewed as Expedited or require a full-board review.

If you checked number 3.c under Risks Categories, and/or number 4, in the Benefits
Categories, your protocol will not receive IRB approval, and you will be unable to conduct
your research.