Each proposal must include the following:
NOTE: When departments or Principal Investigators repeatedly use standardized protocols for recruiting subjects, they can save time by submitting in advance for IRB review/approval a generic recruitment protocol. Once accepted by the IRB, the protocol can be simply referenced in an investigator’s IRB application—as long as the same protocol is to be implemented exactly as written.
This page summarizes the guidelines for properly obtaining informed consent from research participants. (see Sample Consent Form).
Participants must have sufficient information to make an informed decision to participate in the research study. If participants cannot give informed consent, it must be obtained from their legal representatives. For example, when participants are minors (under 18) or when they are mentally incapacitated, the consent of legal representatives is required.
Consent documents must be clearly written and understandable to participants. The consent form should include language that is non-technical. Scientific, technical, or medical terms should be plainly defined.
The required components of an informed consent document include the following:
Protected Classes of Research Participants
Federal regulations provide higher standards of protection for individuals belonging to certain classes of research subjects, such as prisoners, the seriously ill, mentally or cognitively compromised adults, and minors (children under the age of 18). In the case of prisoners, there is concern that the coercive environment of a prison may compromise the inmate’s voluntary participation. With other protected classes, the issue is the ability of the subjects to provide adequate, informed consent, either because of physical/cognitive limitations or because of age. Of the classes of protected participants, children are the most commonly studied at Wabash and are therefore the only protected class discussed in detail below. For information on research with other protected groups, you may consult the Federal regulations or a member of the IRB.
Excluding exempt research (e.g., naturalistic observation), all research with children requires signed consent forms from the parents or legal guardians. In addition, the child, if of sufficient age to be verbal, must give her/his own assent, or agreement to participate (see Sample Assent Form). Such assent must follow an explanation--at a level appropriate to the individual’s age, maturity, experience, and condition--of the procedures to be used, their meaning to the child in terms of discomfort and inconvenience, and the general purpose of the research. Children should be asked if they wish to participate in the research or not. Mere failure to object on the part of the child should not, in the absence of affirmative agreement, be construed as assent. In the proposal, the investigator should indicate: 1) how assent will be obtained (what the investigator will say to the child and whether or not the child's parent(s) or guardian(s) will be present); and 2) how assent will be documented. The child may either sign a very brief assent form or verbally indicate a willingness to participate. Whether assent is to be obtained verbally or in writing, a copy of the assent form must be submitted to the IRB with the proposal (see: sample Assent Form).
If the research is to be conducted in an institutional setting, the IRB also requires permission from an appropriate institutional official. Within a school system, the permission of a school superintendent or principal will be sufficient for research conducted in a public assembly or similar venue; research in a classroom, however, requires the additional permission of the classroom teacher.
There are some situations where a signed consent form may not be required:
If the PI believes a research project meets the above guidelines, s/he must petition the IRB for a waiver of informed consent as part of the proposal review package. The specific justification for each waiver of informed consent will be documented in the IRB minutes.
NOTE: A waiver of signed consent does not reduce in any way the responsibility of the PI to convey (orally or in writing) all of the elements of informed consent disclosure that are normally found in a signed form.
|Research Review Declaration||(doc)||(PDF)|
|Application for Exempt Status||(doc)||(PDF)|
|Application for Expedited Review||(doc)||(PDF)|
|Application for Full IRB Review||(doc)||(PDF)|
|Sample Assent Form||(doc)||(PDF)|
|Sample Consent Form||(doc)||(PDF)|
Questions? Contact the Wabash IRB Chair John Lamborn, Director of Lilly Library, Telephone: 765-361-6081, Email: firstname.lastname@example.org