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Waivers of Written Informed Consent

There are two categories where the Institutional Review Board (IRB) may waive all or part of the normal consent requirements:

1. The IRB may waive part or all of the normal consent requirements if:

a) the research involves no more than minimal risk to the subjects;
b) the waiver or alteration of normal consent procedures will not affect adversely the rights and welfare of the subjects;
c) the research could not be carried out effectively without the waiver or alteration; and
d) whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Category (d) of waiver includes those cases in which the researcher desires to withhold from the subject some information about the project that, if known by the subject, would bias the results of the study.

Ordinarily, the researcher would plan a debriefing session (oral debriefing template) after completion of the subject's participation in order to provide the subject with the missing information, and give the subject the option of including his/her data in the study or having it destroyed. 

In no case should a researcher seek to withhold information about the research or the subject's role in the research solely to reduce the chance that the subject will refuse to participate.

2. The IRB may waive the requirement for written consent if it finds that:

a) the only record linking the subject and the research would be the consent document and the principal risk would be the potential harm resulting from breach of confidentiality; or
b) the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.

This type of waiver applies especially to anonymous interviews (including face-to-face and telephone interviews) where the researcher's sole knowledge of the identity of the subject would come from the consent document.

Implied Consent Waiver

Implied consent is the tacit indication that a person has knowingly agreed to participate in research by performing a research activity or task. By completing the research task (e.g., completion of a questionnaire, interview, survey, etc.), the participant has provided consent to participate in the research.

Implied consent is actually a type of waiver of documentation of informed consent. Before granting such a waiver, the IRB may require the researcher to provide the participants with a written summary or an information sheet about the research, including (1) purpose of research; (2) time involved; (3) assessment of minimal risk; (4) statement regarding benefit to participants; (5) contact for questions about the research; and (6) contact for questions about rights as a research participant.

Consent for Internet-Based Research

For internet-based surveys, it is sometimes appropriate to use implied informed consent.  Participants would still need to be presented with the consent information, but would be informed that their consent is implied by submitting the completed survey.

If for study design purposes, the researcher needs to keep track of who participated or if the IRB determines that some sort of documented consent is required, instead of "signed" informed consent, the researcher may email the consent form to participants who may then type their name and the date into the spaces provided on the consent form, and return it to the researcher via email.  This process may be appropriate for data collected via email, chat rooms, online interviews, etc.  Alternatively some internet-based survey vendors and/or software packages provide a means to record whether a respondent has consented to participate before beginning a survey (e.g., a date/time stamp feature).

Waiver of Parental Consent

All research participants under the age of 18 must provide written parental (or guardian) consent (DOC) in order to participate in college-sponsored research projects.

A waiver of consent for parental permission could be requested for children 17 years old or younger depending upon the type of research being conducted (i.e., the research study is conducted on campus, is a survey or questionnaire, and is determined to be a minimal risk.) The waiver must be requested and justified in the IRB application for each of the following OHRP requirements:

Research in general: an IRB may waive or alter the requirement of informed consent under 45 CFR 46.116(d), provided that the IRB finds and documents that all of the following four conditions are met:

  1. the research involves no more than minimal risk to the subjects;
  2. the waiver or alteration will not adversely affect the rights and welfare of the subjects;
  3. the research could not practicably be carried out without the waiver or alteration;
  4. whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Researcher's Responsibility

Waiver of written consent procedures does not imply waiver of the researcher's responsibility to obtain consent from the subject.

In all cases, the researcher must provide the subject with a statement describing the research that includes all relevant elements of informed consent. The IRB requires that when the use of written informed consent is waived, a cover letter be given to the subjects outlining the purpose and procedures of the project and containing a statement such as "Completion and return of the survey [questionnaire, interview, etc.] indicates consent to participate in the study."