IRB Proposal Creation Guidelines

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 Colgate 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 Colgate-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 Colgate’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 Colgate (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 Colgate’s IRB at irb_chair@psych.colgate.edu.

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 Colgate-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.