1. 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

2. 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

3. 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!

4. 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

5. 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

6. 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
...

7. 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)

8. 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

9. 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

10. 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

11. 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?

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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.

19. 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

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

21. Still have questions? 408-924-2479
Thank You for Viewing the IRB Workshop!
Still have questions?