How to Facilitate IRB Protocol Review

Follow directions

• Signatures: For student protocols, students must sign the Protocol Approval form and then obtain two different faculty signatures. These signify that advisor and chair/designated colleague have reviewed and approved of the research as written. Review will not begin without these signatures. For faculty/staff protocols, the researcher must sign and then have the department chair or a designated colleague sign. If the researcher is a department chair, then a designated colleague must sign on the second signature line.
• Template: Follow the protocol template, which prompts the investigator to provide required information. Our web site changes frequently so use it the template on the web site; do not use another researcher’s old protocol as a template. Answer the questions in the outline form provided; this allows faster review of the document.

• Complete protocol: Submit a complete protocol, including all sections and attachments (all consents/assents, recruiting materials, questionnaires, interview questions, permission letters, etc.).
• Background: Provide a scholarly, current review of all pertinent literature and background and explanation of anything needed for the committee to understand your protocol, e.g., if you are using dietary supplements we need to know all about them—studies, risks, benefits, normal dosage; if you are studying Youth Radio, tell us what it is. Be sure your literature review is related to the human subjects portion of your project. Define all terms and acronyms and avoid use of discipline-specific jargon.
• Data analysis: Include methods, not just “the data will be analyzed statistically”. What statistics are you analyzing? Be sure that your data will answer the stated research question.
• Risks: Be inclusive and specific. Realistically acknowledge possible risks.
• Qualifications: Include qualifications to conduct your specific research project, not just “I am a grad student”. Include work or volunteer service with the population you are studying, or on the research topic itself. Be sure you are qualified to take on a risky topic or vulnerable population.
• Proofread: While minor errors can be tolerated in the protocol itself, the documents that go out to the public must be perfect.
  Consistency is crucial. If you say a survey takes 20 minutes in the protocol make sure you say it takes 20 minutes in the consent form. Don't call your research activity a survey on one place and an interview in another. Saying your participants are different ages, in different documents, will trigger a question from us.
• Sample: If you are using a departmental sample protocol to help you with your submission, be sure it is the final, approved version, not an early draft that may have needed extensive work to secure approval.

Attachments

• Consent/assent forms: These need to be complete and concise and written at an appropriate level for the intended audience.
• Interview/survey questions: We need to see the final version, not a draft or a general idea. For on-line surveys, we need to see the print-out for formatting.
• Permission letters: Be sure they cover recruiting and/or conducting research. The letters must be on letterhead and signed by the person in authority.
• Recruiting materials: Include all scripts, flyers, emails, web postings, etc. in their final form

Follow-through

• Receipt of documents: We acknowledge receipt of all documents. If you haven’t heard from us, check.
• Address office’s/committee’s questions: Either incorporate suggested changes or justify why you can't make the changes.
• Timely response: The more quickly you respond to our requests, the faster the process will go.
• Approval: If you have not received an approval email, you probably have not been approved.

When should you submit?

We receive almost half of our yearly total of protocols in October-December (approximately 225-250). We receive only 15-20 protocols in September.

Could this project be modified to be exempt?

Sometimes making a minor change in research design could move a protocol into the “exempt” category, which generally means a faster review than the non-exempt protocols, which have a more stringent review and must be placed on an agenda for committee review.

Does the project need to be as complex as you've written it?

Check with the office for suggestions, especially if you have time constraints and need to finish your thesis or field study within one semester.

Your project may not require IRB review

The following activities may not require IRB review. Please contact the human and animal subjects office to help determine if review is required.

• “Self Improvement” studies (for example, where someone reviews his/her own teaching methods with an eye to becoming a better teacher)
• Key Informant Interviews where the information presented is about the program and not the individual
• Curriculum Development where the curriculum is not being evaluated in the field
• Needs Assessments and Program Evaluation with the sole intent of sharing the results internally with the agency, organization, etc.
• Oral History where the information is merely reported, but not analyzed
• Web Design Evaluations, Product Design Assessments
• De-Identified Secondary/Existing Data
• Classroom projects: If a class project will not be published, it may not need IRB review. If, at a later time, a student wishes to, e.g., use these data in the Student Research Competition or for a thesis, it may be possible to review the project as the use of existing data.