The Human Subjects Institutional Review Board WorkshopPart 2: Preparing Your IRB Protocol

Presented by Alena FilipIRB CoordinatorOffice of ResearchSan Jose State University

What is “The Protocol?”

To ensure compliance IRBs require that allinvestigators submit a standard set of documentsdesigned to communicate all of the essentialinformation about a particular study prior toInitiation of the research. All of the documentsand materials that are submitted to the IRB arewhat 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) audienceKeep in mind the ethical intent of the templateprovided

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 topicInvestigator responsibilities include:• Disclosing dual role and institutional affiliation• Addressing ways to mitigate COF:

Don’t recruit your own clients if feasible alternatives existUse public recruitment strategiesUse third party for recruitmentRefer 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? SubjectsType of subjects:• Age (adults vs. minors)• Vulnerable groups• Inclusion and exclusion criteria • Rationale for employing the type of subjects selected• Estimated number of subjectsRecruitment 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 & ProceduresDesign:• 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 protocolCognitive tests – include description, attach samplesSecondary data – provide info on source and

extraction methods

• How will information be recorded & which devices?

Written notes, audio/video recording, photographs

The Protocol Narrative ConfidentialityRecording 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 confidentialitySecurity and storage:• How and where will data be stored?

Locked cabinet, computer encryption, password protection• Who will have access to the data?

The Protocol NarrativeRisks & 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 NarrativeInformed Consent & Assent ProceduresDescribe how informed consent will be obtained fromparticipants 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 DataAccess to certain types of individually identifying data requiresconsent from the subject (or a parent/guardian if the subject isminor), not just permission from the institution allowing accessto 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 stateFor open case files or direct interaction you must get consent from the legal guardian (judge) not the social worker

Agreement to ParticipateIt’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 DocumentsPurpose:• 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 & TranslationsData instruments• 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 InstitutionsLetters 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.

RespectBeneficence

Justice

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

IRB Protocol SubmissionTwo complete paper copies toAddress: Alena Filip

IRB CoordinatorOffice of ResearchOne Washington SquareSan Jose, CA 95192-0025

Location: Administration Building – Room 223AHours: Mon-Fri 9-12 and 1:30-4

NO EMAIL OR FAX SUBMISSIONSUse assigned tracking number for subsequent communication,

revisions, and resubmissions

STILL HAVE QUESTIONS?Alena.Filip@sjsu.edu408-924-2479

Thank You for Viewing the IRB Workshop!