If you’re completely new to the IRB process, this page should help demystify the IRB process and guide you in submitting your first protocol.
Usually, the first question new researchers ask is whether their project must be reviewed by the IRB. Merely including people in your project does not necessarily mean the study involves “human subjects” as the federal regulations define a “human subject.” If there is any ambiguity as to whether your project should be reviewed by the IRB, your first step should be to submit a Determination through Kuali to our office. In the Determination through Kuali, you provide our office a synopsis of your planned study, and with that information, our office will make a formal determination as to whether you should submit a protocol to the IRB or whether your project is not “human subjects research” as defined by the federal regulations.
If you submitted a Determination form and received a memorandum from our office stating that you must submit a protocol to the IRB, please review the following:
- Ensure that you’ve completed CITI training. All personnel listed on the protocol (including any Faculty Sponsor) must have current CITI training on file. While you can submit a protocol to the IRB without personnel having completed CITI training, the IRB will be unable to approve any protocol listing personnel lacking current CITI training.
- You can find the link to the Kuali login page here, use your NetID credentials to log in. Select "Switch Apps" on the lower left margin, then select the tile called "Protocols." Clicking on "Protocols" will take you to your Dashboard and you'll see an option to create a protocol by clicking the "+New Protocol" button.
- Download our Kuali User Guide, it will guide you in how to do simple actions such as accessing the IRB Kuali module, submitting a new protocol, submitting a Revision, submitting a Renewal, etc.
- When filling out the protocol, be thorough but concise. In general, we expect that protocols will focus on the human subject aspect and not literature reviews, archival work, or background research.
- If you’re a student researcher (undergraduate, graduate, and postdoctoral candidate) you will need a Faculty Sponsor (this person can be any faculty member who works for UMass who is willing to sponsor your research). The Faculty Sponsor should be listed under “Faculty Sponsor Name” and under “Study Personnel – People section” on the Kuali form. The Faculty Sponsor should provide a statement with language such as the following: “I am acting as the faculty sponsor for the research protocol (Protocol number) submitted by (Student name) titled, (Protocol Title). I accept responsibility for the research described. I further attest that I am fully aware of all the procedures to be followed, will monitor the research, and will notify the IRB of any significant problems or changes.” If the Faculty Sponsor is an/a: Adjunct, Visiting Scholar, Lecturer, Emeritus Faculty, Post-Doc, or Professional Staff (non-student) the Faculty Sponsor will need to get a Letter of Support from their Department Chair/Head of their Department. The letter/email from the Department Chair/Head in support of this research should be uploaded under the Faculty Sponsor’s name in the People section.
- Focus on recruitment — how will individuals come to know about your study? Will you post flyers in a certain area? Will you post social media notices? Will you speak before a group gathering? Describe the recruitment process in the protocol and be sure to provide copies of all recruitment documents (provide a copy of the flyer, social media post, and/or oral script, etc.). If there are any potential power differentials (i.e., are you recruiting your own students) be sure to address that in the recruitment section and describe actions you will take to minimize or eliminate potential undue influence or possible coercion.
- Please be sure to visit our Forms and Templates page, we especially recommend using our Informed Consent templates. The webpage provides several consent templates and hopefully one of them will closely align with your study. The Informed Consent document is arguably the most important part of the protocol. In the Informed Consent, you will disclose to participants any potential risks and benefits as well as clearly outline what the participant is committing to (What’s the time commitment? What actions will they be expected to do? Will they receive compensation? etc.). Take care to ensure that the Informed Consent is as transparent as possible. The participant should know what they are getting themselves into and most importantly that they can end their participation at any point.
- If you are providing compensation to participants, make sure that providing compensation is not contingent on you (the researcher) receiving usable data. Also, the IRB strongly encourages that compensation be pro-rated. That is, if your study is an hour long but the participant decides to end their participation halfway through, we expect that the participant will receive partial compensation.
- Be sure to provide copies of any materials that give the IRB a better sense of what participants will see. Are you administering a survey? Please include a copy of that survey. Are you conducting an interview? Please provide a copy of that interview guide, etc.
- If any aspect of these instructions is unclear or there are any questions about how to answer any of the protocol questions, feel free to contact our office to set up a consultation with an IRB Analyst.
- After submitting the protocol to the IRB, if you have not received initial comments after 5 business days, please check in with our office at firstname.lastname@example.org for a status update. In most, cases researchers should expect some communication from our office within that timeframe.
 Human subject means a living individual about whom an investigator conducting research:
1.(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.