Institutional Review Board Review Forms
Proposal Format / Assent / Informed Consent / Forms
Each proposal must include the following:
- A clear and concise statement of the research hypothesis or hypotheses, written in terms that are understandable to non-scientist members of the IRB.
- The purpose of the project
- A full description of all procedures
- A description of the subject population, including the gender and racial/ethnic composition, and criteria for the inclusion or exclusion of any sub-population.
This provision is meant to assure that the benefits and burdens of research are distributed equitably. For many research projects, the “subject population” will be all Wabash students, from which some sample will be recruited for the experiment. Statistics on the raceand ethnicity of the Wabash student body are available from the Institutional Research Office. If the subject population is to be more narrowly defined, investigators should provide a scientific justification for including or excluding any sub-population on campus. Studies of populations outside the University setting will require diversity data from other sources.
- A description of the means by which subjects will be recruited
- A discussion of any and all risks to subjects, how any such risks will be minimized (include copies of all survey instruments , consent forms, assent forms, recruitment flyers, sample recruitment letters and advertisements). Complete details about proposal components for each level of review are provided on the forms for each category of review.
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.
Guidelines for Informed Consent
This page summarizes the guidelines for properly obtaining informed consent from research participants. (see Sample Consent Form).
Components of Informed Consent
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:
- A statement that this is a Wabash College research project
- An explanation of the purposes of the research
- The expected duration of the subject’s participation
- The anticipated number of subjects participating in the study
- A detailed description of the procedures to be followed
- A description of any foreseeable risks or discomforts to the subject
- A description of any benefits to the subject or to others (society, student learning) that may reasonably be expected from the research
- A statement regarding anonymity or confidentiality. If records identifying the subject will be maintained, indicate the extent to which these will be kept confidential.
- If deception is involved (see discussion of deception under "Review Categories" in sidebar), a statement to the effect that “We cannot explain all of the details of the experiment to you at this time, but they will be explained fully at the conclusion of the experiment.”
- An explanation of whom to contact for pertinent questions about the research (generally the PI), and whom to contact about research subjects’ rights and research-related injury (the current Chair of the IRB).
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
- A statement preceding the signature block guaranteeing the legal age of subjects: “ In signing below, I affirm that I am 18 years of age or older.”
- Dated signatures for subject and investigator. The use of witness signatures by the Principal Investigator is optional unless specifically required by the IRB .
- The date of IRB approval of the project (date of e-mail notification) and the expiration date of that approval (generally one year from approval unless otherwise specified in the approval notification message). These items must be added as a footer to the consent form as soon as final IRB approval is received.
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.
Waiver of Signed, Informed Consent
There are some situations where a signed consent form may not be required:
- if the principal risks are those associated with a breach of confidentiality concerning the subject's mere participation in the research (e.g., studies on potentially sensitive topics such as illegal drug use, other illegal conduct, or sexual behavior); AND if the consent document is the only record linking the subject with the research; OR
- if the research presents no more than minimal risk and involves procedures that do not require written consent when they are performed outside of a research setting; OR
- in the case of certain kinds of research (e.g., anthropological or sociological), if the objectives of the research would be compromised by signed consent forms given the nature of the culture under investigation.
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