IRB Proposal Creation Guidelines

Guidelines detailing obligatory and optional documentation to be included in proposals submitted to 51�Թ��’s Institutional Review Board, as well as example proposals.

Overview

All proposals submitted for either expedited or full review must contain four primary sections:

Purpose of investigation and procedures
Anticipated risk and potential benefits to participants
Steps taken to protect the participants
Manner of obtaining participants

Details regarding what should be included in each of the four sections are shared below.

Additional documents may also be required in an appendix, depending on the nature of the proposal.

In general, this section should briefly outline what the researcher plans on doing and why. This section should begin with a brief background literature review (complete with citations) centered on the research question at hand.

The background portion of this section should be followed by a full description of what the anticipated participants will be asked to do during the course of the study. For example, if in-depth interviews will be employed, the researcher must address where the interviews will take place, along with whether or not the interviews will be recorded.

Any non-standardized material used in a given study (e.g., questionnaires, interview protocols, vignettes, etc.) should be included with the proposal in an appendix, and referenced in this section.

The IRB is composed of 51�Թ�� faculty and staff from a broad range of backgrounds. Thus, your proposal should be written for a general audience, and not rely on terminology specific to any particular field of study. If the purpose and/or procedures are unclear, your proposal will be returned with a request for clarification.

Risks

This section must address all reasonable risks. These include physical, emotional, legal, and potential threats to one’s reputation.

If the researcher has deemed that the risks within their study are no greater than risks associated with everyday living, then the researcher should discuss why that is the case.

Benefits

Typically, there are no benefits to participants in 51�Թ��-sponsored research. Benefits are typically present only in medical research in which participation provides tangible benefits (e.g., experimental medical procedures) that would otherwise be unavailable. Promotion of science, personal insight, participation credit, and payment are not considered benefits in this context.

This section should contain a full account for how the researcher plans on maintaining participant confidentiality or anonymity.

Specificity of Terms

Please be sure to use the terms confidential and anonymous carefully, and according to the following definitions:

Confidential: This means that only certain authorized people will have access to the data and that appropriate measures will be taken to ensure that a given participant’s data will never be available and identifiable to others. This might entail discussion of how the data will be stored, ways in which personally identifiable information will be removed from the original surveys, notes, and computer files, and whether names will be replaced with code numbers. If names will be replaced with code numbers, please detail how the list of numbers and names will be stored. If data are recorded in audio or video format, then the researcher must specify what will happen to those recordings once the study is complete.
Anonymous: There is a high threshold for being able to claim that data will be anonymous. In order for data to be truly anonymous, there must be no viable mechanism by which the identity of the respondent could be connected to the data. Thus, even if investigators with a warrant sought the identity of the respondents, they would be unable to make the connection between names and data. Interview data is almost never anonymous, since the interviewer is likely to recall who said what. Lab-based data might be anonymous, but only if all identifiable information is removed and the order of completion is randomized. Anonymity would be violated if data were stored by order of completion, and the order of completion was recorded on the original sign-up sheet.

Please note that either confidential or anonymous are acceptable forms of protecting the privacy of potential participants, therefore, if anonymity cannot be guaranteed, promising confidentiality will suffice.

It is important that the researcher specifically explains to the IRB just how confidentiality or anonymity will be maintained in this section. Any study involving surveys, in-depth interviews, or experimental manipulation (broadly construed) that do not explicitly state how either confidentiality or anonymity will be maintained will be returned to the researcher for clarification.

If you have any questions about maintaining either confidentiality or anonymity, please seek advice from your faculty supervisor, or the chair of 51�Թ��’s IRB at irb_chair@psych.colgate.edu.

This section should also clearly state how participants will be reminded that their participation will be completely voluntary.

Finally, should your study require a debriefing statement, the debriefing statement should be included in the appendix, and referenced in this section.

This section should briefly outline how the experimenter plans on acquiring participants.

If participants will be recruited from 51�Թ�� (e.g., PSYC 150), this section should describe how they will be approached. If data collection is to involve actual class time, the researcher should note that the faculty have specific preferences for how they would like to be approached about the use of class time for data collection.

If you have any questions regarding data collection during class time, please contact the chair of 51�Թ��’s IRB at irb_chair@psych.colgate.edu.

Certificate of Informed Consent

Any researcher who intends to work with human participants should seek legally effective informed consent from each prospective participant, or the participant’s legally authorized representative. Under federal regulations, this is a mandate, not an optional matter, because informed consent is one of the primary ethical requirements underpinning research with human subjects, reflecting the principle of respect for persons. It is therefore critical that a certificate of informed consent accompany the proposal as a part of the appendix.

It is important that researchers retain a copy for their records and provide a copy to every participant for their records. It is therefore necessary to provide a place for both the experimenter and the potential participant to sign the Certificate of Informed Consent. If this form represents the only record of a participant’s identity, then the IRB may, at its discretion, waive some or all of the sections listed on the template provided.

The Certificate of Informed Consent should be written in clear, simple language at the 5th grade level. It should be written in the second person (e.g., “you,” “your”) and not the first person (e.g., “I”). In accordance with federal regulations, the CIC should address specific concerns, outlined as follows:

A brief paragraph clearly and succinctly explaining what the participant will do and/or experience during the research project. It is permissible to omit certain details if necessary for methodological purposes (e.g., the hypothesis of the study). However, information that might reasonably make a potential participant choose to opt out of a study may not be withheld. This section must also include the expected duration of participation in this study.

All reasonable risks must be revealed to participants. These include physical, emotional, legal, and potential threats to one’s reputation. In many cases, it will be sufficient to say that the risks involved with participation are no greater than the risk of everyday living. There are typically no benefits to participants in 51�Թ��-sponsored research. Benefits are typically present only in medical research in which participation provides tangible benefits (e.g., experimental medical procedures) that would otherwise be unavailable. Promotion of science, personal insight, participation credit, and payment are not considered benefits in this context.

This should be a brief statement regarding how a potential participant’s confidentiality or anonymity will be maintained. Specifically, the potential participant must be informed as to how the data will be stored, and if necessary (e.g., audio or video recordings) ultimately destroyed. Please be sure to use the terms confidential and anonymous carefully (see "Steps taken to protect participants" above for further explanation).

Update 10/7/24: If you plan to publicly post de-identified data (or any other type of data) in an open science forum that is publicly available, then this section of the consent form also needs to specify where you plan to post those data and in what format they will be posted.

This typically refers to participation credit, direct payment, or participation in a raffle of some sort. Raffles should reveal the expected odds of winning and the value of the prize. If a study is completely voluntary (i.e., no compensation), then this portion should simply state that there is no compensation.

Here the potential participant is reminded that their participation is voluntary, and has the right to withdraw at any time, and still be provided with the specific form of compensation described above. Also, participants should be informed that they have the right to have any data collected up to the point of withdrawal discarded, and told how the data will be destroyed.

Full contact information — including names, phone numbers, and email addresses — should be provided for the principal investigator, the faculty supervisor (if applicable), and the Chair of the IRB. If the project is student research, then the student conducting the study should be listed as the principal investigator.

Participant Debriefing Form

A debriefing form is typically read aloud to the participant once he or she has completed the study. The form itself should explain to the participant the full aim of the study he or she has just completed.

If the proposed study involves some degree of deception, or manipulation of behavior that could lead to moderate (or greater) levels of physical and/or psychological distress, a debriefing form (signed by both the participant and the experimenter) must accompany the proposal as a part of the appendix. If a proposed study does not contain either of the above, a debriefing form is not required, but may be included at the researcher’s discretion (but does not need to be signed by the participant).

Information for Researchers Planning Audio or Video Recordings

Some research may include audio or video recordings taken of participants. If this applies to your research then please note the following:

The informed consent needs to inform participants that there will be such recordings.
After the study is complete, participants must be given an audio/video release form to be signed by participants indicating whether or not they provide permission for the recordings to be used by a) researchers working on the study and/or b) future participants, depending on the intentions of the researchers. Samples of such audio/video release forms appear below.

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