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The Human Subjects Institutional Review Board Workshop. Presented by Alena Filip IRB Coordinator Office of Graduate Studies & Research San Jose State University. Part 2: Preparing Your IRB Protocol. What is “The P rotocol?”. To ensure compliance IRBs require that all

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the human subjects institutional review board workshop

The Human Subjects Institutional Review Board Workshop

Presented by AlenaFilip

IRB Coordinator

Office of Graduate Studies & Research

San Jose State University

Part 2: Preparing Your IRB Protocol

what is the p rotocol
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
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:
  • Training for students – Optional unless part of a classroom assignment or if federally funded.
  • No Retroactive Approval!
document 1 the irb application
Document #1:The IRB Application


  • 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
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


the protocol narrative who s involved personnel
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
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
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
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
The Protocol Narrative What’s Involved – Methods & Procedures


  • 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
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
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 narrative informed consent assent procedures
The Protocol NarrativeInformed 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
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), notjust 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 stateFor open case files or direct interaction you must get consent from the legal guardian (judge) notthe social worker
agreement to participate it s a process not a form
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 documents
Document # 3: Consent Documents


  • 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


  • 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
Document # 4: Data Instruments & Translations

Data 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)


  • Provide translations of the consent documents, data instruments, and any other materials to be distributed toparticipants
  • Include Verification of Translation Accuracy Form
  • Make provisions for having an interpreter available in applicable situations
document 5 permission from participating institutions
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

irb protocol submission
IRB Protocol Submission

Two complete paper copies to

Address: AlenaFilip

IRB/Thesis Coordinator

Office of Graduate Studies & Research

One Washington Square

San Jose, CA 95192-0025

Location: Administration Building – Room 223

Hours: Mon-Fri 9-12 and 1:30-4


Use assigned tracking number for subsequent communication, revisions, and resubmissions

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