Institutional Review Board (IRB) Protocol format:
Using layperson terms, write a protocol (study summary) specifically for IRB review. The protocol should describe the nature of your project, the potential human subjects risks, and the human subjects protection plan. (It is no longer necessary to submit the grant, for comparison, with the IRB application) Please be concise in writing your summary and be sure to fully explain all interactions with human subjects or human subjects data.
-If you are submitting an application to your home institution you may submit the same documents to NBER in lieu of completing the following.
-If the research is a multisite study or if there is more than one PI, please submit the IRB approvals from all locations. Please email the Research Compliance Manager irb@nber.org if your home institution‘s IRB has requested an Authorization Agreement.
Please address all of the following points in your summary and attach any related documents as necessary.
Study Title:
Principal Investigator:
Co-PI: Study staff (be sure to include CITI humans subjects training certificates for all):
A. Rationale: Please succinctly describe the proposed project in a manner that allows the IRB to gain a sense of the project including: the research question, key background literature (supportive and contradictory) with references, and the manner in which the proposed project will improve understanding of the chosen topic.
B. Methodology: This section must describe the procedures and methods planned for carrying out the study, participant recruitment strategies, the consent process, inclusionary and exclusionary criteria, description of data, source of project data, or data collection procedures, and an overview of the manner in which data will be analyzed. Provide all information necessary for the IRB to be clear about all of the contact human participants will have with the project. Please include copies of data use agreements, if applicable. (If using outside nationally-representative panel company (Qualtrics, Survey Monkey, Amerispeak… ) to recruit/consent subjects please include their methods summary)
C. Informed Consent: In this section, please explain the process you plan to use in securing informed consent for study participation. You should select the consent procedure that best meets these goals and is most feasible given your study design. Make sure to attach a copy of your consent document (forms, scripts, etc.) to the application. When appropriate, you may request that the IRB waive one or more components of informed consent. The type of consent you will be collecting MUST be described in the protocol. (Information on Consent) (Consent Checklist)
D. Confidentiality: Please state what, if any, personal identifying information (names, addresses, phone numbers, social security numbers, etc.) will be collected from participants. How are links between personal information and other study data being managed to best ensure participant confidentiality (during data collection and data storage)? Who will have access to the data? Also, discuss how soon identifying information will be destroyed. Please note, if you are not collecting any personal identifying information, your study is anonymous, and should be described as such.
(If using outside nationally-representative panel company to recruit/consent subjects please include their data protection summary)
E. Risk and Benefits: This section describes the potential risks to participants and how the experimental design will minimize those risks and a description of any anticipated benefits, whether to the individual, a particular population, or to the body of science. Compensation is never a benefit.
F. Compensation: How much will the subject receive, in what form (Cash, Venmo, check, Paypal), be sure information in protocol is consistent with information in consent.
G. Procedures for Vulnerable Populations: There are some subgroups of human participants that receive additional safeguards during the IRB review process. If your project specifically seeks recruitment of a vulnerable population, please state what steps you are taking to minimize risk and maximize benefits (directly or indirectly) to this population.
H. Research Outside of the United States: Please describe the culture and customs of the country you will be recruiting subjects from for the research. Describe training for staff in the field and what type of consent will be used. Please note if you will sign a contract with a partner organization for field work.
To be submitted along with the protocol:
-Data Use Agreements
-IRB approvals from other IRBs
-Consent forms
-Scripts of any kind
-Recruitment materials
-Focus group materials