The Human Subjects Institutional Review Board Workshop Part 2: Preparing Your IRB Protocol Presented by Alena Filip IRB Coordinator Office of Research San Jose State University

What is “The Protocol?” To ensure compliance IRBs require that all investigators submit a standard set of documents designed to communicate all of the essential information about a particular study prior to Initiation of the research. All of the documents and materials that are submitted to the IRB are what constitute the IRB protocol. IRB checklist – one page summary of required documents

Preliminary Steps Sponsoring professor – If you are a student, your protocol must be read and signed by a faculty member who has completed human subjects research training: https://www.citiprogram.org/Default.asp? Training for students – Optional unless part of a classroom assignment or if federally funded. No Retroactive Approval!

Document #1: The IRB Application Includes: Request to Use Human Subjects in Research Start date must be reasonable Faculty signature must be present if applicant is a student Exclusion Screening Tool Exemption Screening Tool

Document #2: The Protocol Narrative Outlines the design, methods, and procedures of your research. Basic expectations for the narrative: Well-conceptualized Specific Well-written Proof-read For a general (non-specialist) audience Keep in mind the ethical intent of the template provided

The Protocol Narrative Who’s Involved ? Personnel List investigator(s) and other personnel Qualifications List participating institutions Source of subjects, source of records, use of facilities Part A – name all participating institutions attach letters of support Part B – disclose your specific affiliation, if any (e.g., employee/intern, owner, other financial interest) Part C – address any potential conflict of interest ...

The Protocol Narrative Conflict of Interest (COF) COF, whether real or perceived, occurs when: Investigator has a dual role as a service provider Subjects rely on investigator for non-research related services Subjects are recruited out of convenience and accessibility rather than relevance to the research topic Investigator responsibilities include: Disclosing dual role and institutional affiliation Addressing ways to mitigate COF: Don’t recruit your own clients if feasible alternatives exist Use public recruitment strategies Use third party for recruitment Refer to discipline specific handbooks (social work & education)

The Protocol Narrative Abstract Provide a brief description of the research objectives: what is being studied, background, importance of the research, the hypotheses or questions to be addressed, a summary of the methods and design, and the goals of the proposed project If research involves experimental procedures build a rationale based on previous studies and be sure to cite the literature See Sample Abstracts

The Protocol Narrative Who’s Involved? Subjects Type of subjects: Age (adults vs. minors) Vulnerable groups Inclusion and exclusion criteria Rationale for employing the type of subjects selected Estimated number of subjects Recruitment plan: How will the research be advertised? Who will solicit participation and how? Recruitment materials (e.g., flyers, scripts, signup sheets) Strategies for minimizing coercion and stigmatization Strategies for protecting privacy

The Protocol Narrative What’s Involved – Methods & Procedures Design: What subjects will be asked to do, step by step, duration Where, when, and by whom the research will be conducted Materials and devices: How will information be obtained? Data instruments – list and attach to protocol Cognitive tests – include description, attach samples Secondary data – provide info on source and extraction methods How will information be recorded & which devices? Written notes, audio/video recording, photographs

The Protocol Narrative Confidentiality Recording and reporting: What kind of data will be recorded? Anonymity vs. Confidentiality vs. Privacy – know the difference! What kind of data will be reported? Will identifiers be included? If not, describe mechanisms for maintaining confidentiality Pseudonyms, coding, aggregate data Describe limits to confidentiality Security and storage: How and where will data be stored? Locked cabinet, computer encryption, password protection Who will have access to the data?

The Protocol Narrative Risks & Benefits…& Compensation Examples of potential risks: physical stress, psychological stress, anxiety, embarrassment, stigmatization, loss of privacy Examples of risk reduction: availability of trained medical professional, reference to counseling or other support services, sound data management plan Examples of potential direct benefits: health, social, educational Indirect benefits: contribution to society and scholarship Compensation Small / reasonable incentive for time and effort

The Protocol Narrative Informed Consent & Assent Procedures Describe how informed consent will be obtained from participants and how assent will be obtained from minors. Exemption requests: consent form or cover letter recommended but not required Standard application: consent form or cover letter required, but written consent may be waived under certain circumstances if requested Research involving minors: consent form is always required; written consent must be obtained from parents. Assent can be obtained verbally or in writing

Consent & Secondary Data Access to certain types of individually identifying data requires consent from the subject (or a parent/guardian if the subject is minor), not just permission from the institution allowing access to the data: Patient records (HIPAA – Health Insurance Portability and Accountability Act) In most cases you must get permission from the patient to access individually identifying medical records, including accessing records for recruitment Student records (FERPA – Family Educational Rights and Privacy Act) Foster youth and minors in the custody of the state For open case files or direct interaction you must get consent from the legal guardian (judge) not the social worker

Agreement to Participate It’s a Process, Not a Form Basic expectations for establishing agreement with participants: Process is tailored to the subject population (consent vs. assent) Process must demonstrate sensitivity to age, maturity, developmental ability, literacy and comprehension level, primary language, cognitive capacity, and psychological state of subject population Process is continuous Process includes debriefing when study involves deception

Document # 3: Consent Documents Purpose: Explain what the research entails Explain risks vs. benefits Explain measures for protecting confidentiality Inform participants of their rights (e.g., participation is voluntary) Inform participants about who to contact if they have any questions Expectations: Well-written in laymen’s language No exculpatory language Clean, clutter-free formatting that is easy to read Departmental letterhead when applicable Translations when applicable

Document # 4: Data Instruments & Translations Use valid, well-established, and appropriate instruments Attach all tests, data instruments, and other materials to be distributed to participants (e.g., surveys, questionnaires, interview or focus group questions) Translations Provide translations of the consent documents, data instruments, and any other materials to be distributed to participants Include Verification of Translation Accuracy Form Make provisions for having an interpreter available in applicable situations

Document # 5: Permission from Participating Institutions Letters of support or permission may be sought from: Schools, hospitals, government agencies, community organizations, etc. Other IRBs Minimum requirements for permission letters: Title of study and name(s) of investigator(s) Dates for which permission is granted Title and name of the person granting permission and his/her signature On the institution’s letterhead when applicable or complete contact info for institution.

Respect Beneficence Justice Recap of the ethical principles and documents that should be included in the protocol package and demonstrated in the research design Respect Beneficence Justice

IRB Protocol Submission Two complete paper copies to Address: Alena Filip IRB Coordinator Office of Research One Washington Square San Jose, CA 95192-0025 Location: Administration Building – Room 223A Hours: Mon-Fri 9-12 and 1:30-4 NO EMAIL OR FAX SUBMISSIONS Use assigned tracking number for subsequent communication, revisions, and resubmissions

Still have questions? 408-924-2479 Alena.Filip@sjsu.edu 408-924-2479 Thank You for Viewing the IRB Workshop! Still have questions?