For research eligible for review under one of the Exempt categories, researchers should address how they will establish the voluntary nature of subject's participation (taking care to avoid any potentially coercive procedures; reference the Research Involving Students as Participants (PDF) for some tips) and discuss how they are obtaining subject's consent to participate. The IRB strongly recommends including the basic elements of informed consent required for Expedited or Full Board review studies, but doing so in a manner appropriate to the research. Consent may not be necessary for some research, such as purely observational research or for research using data that were collected earlier for other (nonresearch) purposes. For Exempt research that involves interaction with subjects, there usually should be a process to ask subjects to participate and confirm their agreement. However, signed consent is not required for exempt research, and the consent process and documents can be much simpler than those required for non-exempt research. Verbal or implied consent is usually sufficient for exempt research that involves interaction with subjects.
For example, the consent process for Exempt research when there is some kind of interaction with subjects, such as in most research under Exemption Category 1 (educational practices) and Exemption Category 2 (interviews, surveys, focus groups), the researcher might use a consent script he or she reads aloud or a written document potential participants read that contains the relevant basic elements of consent described and required for Expedited and Full Board review (e.g., stating this is a research study, how long it will take, that subjects can discontinue their participation at any time, that participation is voluntary).
For surveys given in person, a consent script might be used and participants indicate their consent by turning their survey to the researcher rather than by signing a consent form. For online surveys, a researcher might use a written consent form that participants read online, but they indicate their consent by pressing a button, rather than by providing their signature. We recommend the following elements of informed consent be included in consent forms or scripts as applicable:
- Subject rights: State that the activity involves research, participation is voluntary, and that participants may withdraw at any time without any negative consquences for them.
- Purpose of the study: Provide a brief non-technical explanation of the purpose(s) of the research. Explain why the subject is being asked to participate in the study (e.g., "You are being asked to participate in this research study because…").
- Study tasks or procedures: Provide a complete description of procedures (including the order in which they take place). Identify and distinguish procedures that are being performed solely for research purposes from any activities that would otherwise occur. Include information about audio- or videotaping and/or any records that may be accessed (e.g., educational records).
- Duration of subject’s participation: Provide expected duration of the subject’s participation (e.g., time required to complete surveys). Ensure that the proposed time period is realistic for the procedures to be performed.
- Confidentiality: Include a statement describing the extent, if any, to which confidentiality of the data/records will be maintained. Discuss the retention of participants’ data/records following conclusion of the research. Note: Do not interchange the terms “confidential” (i.e., maintained in a way that prevents inadvertent or inappropriate disclosure of participants’ identifiable information) and “anonymous” (i.e., identifiers were not collected or have been permanently removed).
- Contacts and Questions:
- Provide the name and contact information of the Principal Investigator (researcher) for questions, concerns, or complaints about the study. Include area code or international dialing codes for phone numbers.
- Provide Fairfield University contact information by stating “If you have questions about your rights as a research participant, or wish to obtain information, ask questions, or discuss concerns about this study with someone other than the researcher(s), please contact Ms. Susan LaFrance, IRB Administrative Liaison for the Office of Academic Affairs, at (203) 254-4000 x2154 or by email: firstname.lastname@example.org
- Incentives: Explain payments or other incentives (e.g., class credit) to participate, including amount and schedule of payments. Compensation should be pro-rated (e.g., per session) and not contingent upon study completion. Explain the effect of a subject’s decision to withdraw from the research on compensation. If payments are offered, include the following: "By law, payments to subjects are considered taxable income."
- Sponsor: Provide the name of the sponsor funding the research, when applicable.