Part 4 – Informed Consent Procedures

Presentation of Informed Consent

Informed Consent forms are usually reviewed and discussed with participants by research staff to answer any questions. In the event that a legally authorized representative (LAR) is enrolling an individual on their behalf, such as the parent of a minor, a guardian of a decision-impaired adult or a prisoner, they will assume the role of authorizing the research.

There must be special attention given to not infringing on the voluntary consent of the participants. There should be ample time to review the information and make a consideration, no undue influence from research incentives, and an environment that does not pressure participants into agreeing (such as close proximity to parents or peers who are agreeing to the same research). Further, a subject must never be asked to or even appear to waive any legal rights, or release a researcher or institution from liability.

Finally, informed consent must be written in a format that is comprehensible for its readers and signatories. This includes being in the proper language for all prospective participants, and also at the correct reading level for the participants. This increases the value of the explanatory power of the research staff discussing the informed consent with the participants.

 

Modifications of the Informed Consent Process

In some situations it might be necessary to modify the informed consent process to make sure results are scientifically valid. For exempt research, an IRB may, at their discretion, allow oral consent procedures or shortened procedures if necessary.

If the principal risk of participation is being associated with the study (for example, for studies on criminal behavior or on domestic abuse),  the documentation of informed consent may be waived (however, the informed consent process must still be conducted in some manner and written information on the study offered). They may also find another means of affirming and documenting consent if the culture of the study participants does not include signing forms.

Parts of the informed consent or study procedures may be omitted if necessary to achieve scientifically valid results. This includes circumstances where the subject may behave differently if they knew the real aim of the study (necessitating deception) or that they may behave differently if they knew they were being observed (non-disclosure (not informing them they are part of a study)). In order for parts or all of an informed consent to be waived for these reasons, these five criteria must be met:

  1. There is no more than minimal risk to the subject
  2. There research would be skewed or invalid if the alterations/waivers are not made (such as disclosing the purpose of the research swaying how a participant will respond to questions)
  3. Identifiable private information is only used if necessary for the study
  4. The waiver/alteration does not adversely affect the participant or their rights (for instance, tricking them into participating in research they would not normally have condoned)
  5. Participants will be provided with at the conclusion of the study with all the pertinent information excluded in the initial consent process (this is called a debriefing). This is not required where it would cause more harm than good, such as if the participant was selected for an undesirable or unflattering characteristic

It is up to the IRB to decide whether these waivers/alterations are appropriate.