The College of St. Scholastica (CSS) requires that legally effective informed consent of the subject or of the subject’s parents or guardian before an investigator can involve the person in research. Consent must be documented in writing in accordance with applicable federal regulations unless the IRB finds that the conditions for a waiver of consent (CSS IRB SOP #15 Waiver or Alteration of Consent (Waiver Request Form Reviewer Checklist) or a waiver of documentation of consent (CSS IRB SOP #18
Common Rule regulations (45 CFR 46.116) allow the IRB to waive the requirement for obtaining informed consent or parental permission or to approve a consent procedure that leaves out or alters some or all of the elements of informed consent otherwise required under the regulations. The purpose of this Standard Operating Procedure (SOP) is to provide guidance on obtaining and approving requests for a waiver of informed consent at The College of St. Scholastica (CSS).
The default in the US regulations is that the consent document is signed by the research participant. However, the regulations also contain flexibility to approve a waiver of the documentation of consent, in essence, while there is a consent process and information is communicated to the potential subject, the person does not have to sign a consent document. Note that a waiver of documentation of consent is different than a waiver or alteration of consent.
The purpose of this SOP is to describe the special regulatory requirements that the researcher and the IRB must take into consideration when a proposed research study involves children, a vulnerable population, to provide additional protection for children involved in research.
The CSS IRB will assure that additional protections are implemented, as necessary, to protect vulnerable research subjects (such as those with impaired decision-making capacity, neurological, developmental or psychiatric disorders; educational disadvantages; medical, social, or economic conditions; or other circumstances that might restrict the individual’s capacity to provide inform). The extent of additional protection afforded should depend upon the risk of harm and the likelihood of benefit.
It is the policy of this institution that when students are used as research participants, the researchers should carefully review and understand the concepts of coercion and undue influence.