Exceptions, Alterations, or Waivers
Written informed consent is not always appropriate in some educational, social and behavioral science research, e.g., some ethnographic, field, or qualitative research studies.
The Swarthmore IRB may provide a waiver, an exemption or otherwise approve alterations of documented informed consent if the investigator justifies that:
- The research involves no more than minimal risk; and
- The waiver or modification will not adversely affect the rights and welfare of the subjects; and
- The research could not be practicably carried out without the waiver or modification; and
- Whenever appropriate, the subjects will be provided with additional, pertinent information after participation.
Please note the bolded “ands” in the 4 conditions above. All four of these conditions must be met in order for any exceptions, waivers, or alterations to be approved.
When applying for exceptions, waivers or alterations, the investigator must explicitly address each of the conditions above and propose alternative measures for obtaining and documenting informed consent. Deception research must always include a request for a waiver of consent and documentation since the research could not be practicably carried out without a waiver.
Waiver of Documented Informed Consent
The IRB may also waive the requirement to obtain a signed consent form if it finds either:
1) That the only record linking the subject to the research would be the consent form and the most serious risk would be breach of confidentiality; or
2) That the research involves no more than minimal risk and involves no procedures for which written consent is normally required outside of the research context.
For research studies of minimal risk involving the use of questionnaires, the required elements of informed consent may be included in an introductory letter or information attached to the instrument which includes a statement that completion and return of the questionnaire (hard copy or electronically) will constitute consent to participate in the study.
