What part of the research explains the benefits that can be gained from the study?

In order to justify the use of participants in a research study, the IRB will look at the potential benefit of the study and weigh it against the risk in the study.  The benefit of a study can be to the participant in the study and/or the general community (which is described in the study’s protocol). 

Therapeutic studies, such as behavioral interventions, are conducted with the intent to study alternative procedures for patient or client care.  For a therapeutic study to be justified the study procedures must offer care that is consistent with other therapeutic options, there are multiple options for treatment none of which are clearly preferred, and the risks are reasonable in relation to the potential benefit to participants.  For example, a psychologist may want to enroll a client in a study that he is conducting to evaluate an alternative approach to anorexia.  The treatment options for anorexia vary and the alternative approach to be studied offers similar potential benefits to other accepted approaches; thus the study can claim to offer therapeutic benefits to a participant.  In a non-clinical setting, an educator may want to enroll students in a study to evaluate the benefit of a new teaching approach to learning the alphabet. The accepted methods for teaching the alphabet vary and the new approach offers similar potential benefits to other accepted approaches; thus the study can claim to offer benefits to a participant.  There are two downsides to therapeutic studies.  If the participant does not benefit from the new approach, sometimes it can cause a reversal in their situation or have a negative impact on their progress.  In the anorexia example, the patient may not recover or could regress in their disease; in the education example, the student may not learn the alphabet or struggle with the learning process.  The researcher should provide options for the participant to receive the normal standard of care if such a result is possible.  The second downside is that often these studies use placebo controls in order to test the validity of the study’s claim.  In those cases, the participant does not receive care or is led to believe they are receiving care but in fact receives no care.  The Board generally requires that you notify participants in the consent form that there will be a control group who will not receive the treatment.  Often the Board will ask that if a participant participates in a control group, the participant will have the option to receive the experimental care if the benefit of the care proves to be valid.  Participants may need to be debriefed after the study to learn that they were part of the control group.  In some cases, lack of treatment may be unethical (for example, failing to treat the anorexic person or failing to teach a child the alphabet) and the Board will require that the control group receive at least the normal standard of care. 

Non-therapeutic studies seek to answer a scientific question without providing any treatment or direct benefit to a participant. In order for a non-therapeutic study to be approved, the risks in the study must be minimized according to sound scientific design and the risks are reasonable in relation to the knowledge gained by the study. Although the participant may not directly benefit from the study, the study may provide valuable information for a community or the general population.  As the level of risk increases in a study, so does the standard of scrutiny that the Board must apply.  For example, a study conducted by an inexperienced researcher with a mediocre design will not receive the same level of scrutiny if it is a minimal risk study versus a study with greater than minimal risk.  The Board does not comment on scientific merit unless the lack of scientific merit is a risk to participants.  This is more often a concern with student researchers; please see the Guide for Student Researchers and Faculty Advisors for more information.         

Please note that the Board does not consider payment to be a benefit.  Payments are used to encourage participation and should not be advertised as a benefit to participating in the study.  Please see Payment for more information.