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
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)
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.
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:
Hours:
Administration Building – Room 223A
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?
Alena.Filip@sjsu.edu
408-924-2479
Thank You for Viewing the IRB Workshop!