ALL research at RIT must include an informed consent process. All subjects must receive the required information before participating in a research activity.
The information provided to potential subjects will be evaluated in light of the risks and benefits of the proposed research procedures.
- Review is from the subject's perspective: what facts would a prospective subjects want to know before deciding whether or not to participate in the research?
- Does the information inform prospective subjects as clearly as possible? Are there any coercive (intimidating) aspects which might impede free choice? In cases where there is reason for special concern about pressure (e.g., when students or employees are asked to participate in research conducted by their professors or supervisors), the researcher may be required to provide some form of monitoring (such as the presence of an impartial observer).
- Obtaining informed consent is an educational process; researchers should do everything they can to enhance the prospective subject's understanding of the information presented.
Review of the Informed Consent Process considers:
- the characteristics of the subject population,
- the type of information that will be given to the subjects, and
- the circumstances under which the consent process will take place (e.g., method, timing, place, and personnel involved).
After considering all of these items, the HSRO may suggest changes in the wording of the consent documents or in the timing or location of an investigator's contact with potential subjects. These requests are made to provide subjects with as much relevant information as possible to ensure they take part as informed and voluntary participants.
Federal regulations on informed consent specify the information that must be disclosed to prospective subjects Basic Elements of a Consent Form. The IRB will review the consent document(s) in relation to these regulations.