The Institutional Review The Institutional Review BoardBoard

An Introduction for SJSU Students An Introduction for SJSU Students and Facultyand Faculty

Prepared by Prepared by

The Office of Graduate Studies & The Office of Graduate Studies & ResearchResearch

What Is the IRB?What Is the IRB?A 10-15 member committee that reviews all research conducted by SJSU students, faculty, and staff that involves the use of human subjects to make sure that the research is being conducted in a manner compliant with SJSU and federal policy.

SJSU Policy: http://www.sjsu.edu/senate/S08-7.htm

Federal Guidelines:http://www.hhs.gov/ohrp/

When Is IRB Review Needed?When Is IRB Review Needed?Two CriteriaTwo Criteria

1. Is it research?A systematic investigation, including research

development,testing and evaluation, designed to contribute to

generalizableknowledge, including the dissemination, presentation, Publication, or use of research findings beyond theboundaries of a specific instructional setting.

Examples: Independent student project, master’s thesis,

activities intended to lead to publication.

When Is IRB Review Needed?When Is IRB Review Needed?Two CriteriaTwo Criteria

2. Does the project involve human subjects?

Yes if: People are asked to participate physically

(physical procedures, manipulation of environment).

People are asked to participate through interaction (communication, interpersonal contact, surveys, interviews, observation).

Researcher seeks access to data that contains identifiable, private information through files, databases, or a third party.

What Is Exemption?What Is Exemption?

Research that involves minimal risk to participants, AND

Does not involve a vulnerable population (minors, prisoners, institutionalized mentally disabled, pregnant women), AND

Falls into one of the following categories…..

Examples of Exempt ResearchExamples of Exempt Research Educational assessment or evaluation

of educational programs.

Anonymous surveys or other data collected anonymously.

Existing data – information that is not publicly available and that contains individually identifying information (pathological specimens and DNA also fall under this category).

Exemption: What’s Required?Exemption: What’s Required? Exempt status is determined by an IRB

representative not the researcher. In order to confer this status, researcher

must submit adequate information about the study to the IRB coordinator.

All of the documents outlined in the checklist that follows are required except documentation of informed consent.

But, Researcher must still provide participants with reasonable information so they may form their own decision to participate.

Exemption: What’s the Exemption: What’s the Difference?Difference?

Does not undergo IRB review. Is evaluated by IRB coordinator and “registered” with the IRB.

Shorter Timeline: 1-2 weeks for notification of registration.

Less restrictive requirements (informed consent).

But: Protocol must still be well prepared. Cannot begin collecting data until you

have been notified of registration.

The IRB ProtocolThe IRB Protocol

To ensure compliance IRBs require thatall researchers submit a standard set of

documentsdesigned to procure all of the essential

informationabout a particular study prior to initiation of theresearch. All of the documents and materials

thatare submitted to the IRB are what constitute theIRB protocol.

The IRB Protocol: Required The IRB Protocol: Required DocumentsDocuments

Training VerificationResearcher or sponsoring professor (if applicant isa student) has completed a mandatory onlineIRB tutorial available at:http://phrp.nihtraining.com/users/login.php

ApplicationRequest to Use Human Subjects Application or

Requestfor Exemption

Sponsoring Professor If researcher is a student, must include a Responsible

FacultyMember Form

The IRB Protocol: Required The IRB Protocol: Required DocumentsDocuments

Protocol Narrative In addition to the IRB Application or

Request forExemption the researcher should attach:

1. Abstract

2. Statement of Purpose

3. A complete description of the methods and procedures of the project that adequately explains the following…

The IRB Protocol: Required The IRB Protocol: Required DocumentsDocuments

Protocol Narrative Continued… Who the subjects are: age and type of subjects

How they will be recruited

What they will be asked to do, step by step, duration

Anticipated Risks (e.g., physical stress, psychological stress)

Anticipated Benefits (e.g., direct, indirect benefits)

Compensation

The IRB Protocol: Required The IRB Protocol: Required DocumentsDocuments

Protocol Narrative Continued…

Materials and/or devices that will be used:

a) How the researcher will recruit and get information from participants (attach tests, surveys, interview and focus group questions, recruitment flyers)

b) How will the information be recorded by the researcher (e.g., written notes, audio/video recording, transcription)

The IRB Protocol: Required The IRB Protocol: Required DocumentsDocuments

Protocol Narrative Continued…

Mechanisms for maintaining confidentiality:

a) What kind of data will be reported? Will identifiers be included? Anonymity vs. confidentiality

b) How will the researcher keep the data that’s collected safe? Who else will have access to the data?

The IRB Protocol: Required The IRB Protocol: Required DocumentsDocumentsProtocol Narrative Continued…

Informed Consent Procedures:Describe 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.

The IRB Protocol: Required The IRB Protocol: Required DocumentsDocuments

Consent Forms

The purpose of consent forms is to inform the participants of the

research, to inform participants of their rights (e.g., participation is

voluntary), and to provide them with information on who tocontact if they have any questions. Consent forms

containing all theelements of informed consent should be submitted (anddistributed) on SJSU letterhead. This is a legal document

thatprotects your participants, yourself, and SJSU. Refer to the

IRBwebsite and follow the sample consent forms provided for

adultsor minors.

Consent Form ElementsConsent Form ElementsName of Researcher(s), Title (Student/Faculty)Affiliation1) Explain the purpose of research (You have been

asked to participate in a research study investigating…).

2) Describe procedures, duration, location, materials, devices (You will be asked to…).

3) Describe risks or discomforts. Include provisions for addressing risks.

4) Describe benefits.

5) Describe compensation/incentive, if any.

Consent Form ElementsConsent Form Elements6) Describe the extent, if any, to which confidentiality

will be maintained and how, including procedures for storing data.

7) Provide contact information: Questions about research (You). Complaints about research (Dept Chair). Questions about participant rights (Dr. Pamela Stacks, 408-924-2427).

8) Provide information about participants rights: Consent is voluntary. You have the right not to answer any questions you do not wish to answer. You can withdraw at any time with no negative effect on your relationship with SJSU or any participating agencies. No services of any kind will be lost or jeopardized by choosing not to participate.

Participants receive a copy for their records, signed and dated

by the researcher. Researcher receives signed copy if written

consent was not waived by IRB.

The IRB Protocol: Required The IRB Protocol: Required DocumentsDocuments

Data InstrumentsAttach to the application all tests, data instruments, and othermaterials to be distributed to participants (e.g., surveys,questionnaires, interview questions, recruitment material).

TranslationsIf applicable, provide translations of both the consent forms and all datainstruments to be distributed to participants AND provide a Verificationof Translation Form signed by someone other than yourself who is adeptin the language (The Verification of Translation Form is available on theIRB website).

Resource: Department of Foreign Languages.

Permissions from Participating InstitutionsIf applicable, obtain permission from outside institutions or agencies that

eitherserve as a source of subjects, a source of records and information, or on

whosefacilities your project will be conducted.

The IRB Protocol: Required The IRB Protocol: Required DocumentsDocumentsPermissions from Participating Institutions

Continued…

Participating Institutions may include:

• Schools, hospitals, government agencies, community organizations.

• Other institutions may have their own IRBs; if so, you must make your project known to them and go through the proper channels to get permission.

Permission from participating institutions must be on theirletterhead and must include: the title of the study

(indicatingknowledge of it), the inclusive dates for which the

permissionis granted, and the title and type written name of theindividual with the authority to grant such permission, inaddition to their signature.

IRB Procedures and TimelinesIRB Procedures and Timelines Three types of review:

• Exempt (IRB coordinator)• Expedited (single reviewer)• Full Review (entire IRB)

Researcher submits 2 copies of complete IRBprotocol to the IRB Coordinator. Any

subsequentdocuments or revisions that are submitted

mustcontain the researcher’s name and/or protocolnumber (2 copies of each).

IRB Procedures and TimelinesIRB Procedures and Timelines

Submitted to Graduate Studies

Pre-screening (1-7 days)

Revisions if needed (varies)

Forwarded to IRB Reviewer (7-20 days)

IRB Procedures and TimelinesIRB Procedures and TimelinesReturned to IRB Coordinator (1-5 days)

ExemptFully Approved

Provisionally ApprovedDeclined/Need Re-submit

Request for a Full IRB Review

Forwarded to Associate Vice President of Graduate Studies for final approval (1-5

days)Allow at least 1-2 month(s) before data

collection.

Additional InformationAdditional InformationAddendums and Extensions Once a research protocol has received

final IRB approval, researchers may submit any changes to their project to the IRB coordinator. Approval is granted for one year.

Researchers must apply for an extension to continue with data collection beyond the one year approval period.

The Extension Request Form is on the second page of the Request to Use Human Subjects in Research Cover Sheet.

Contact InformationContact Information

Alena FilipAlena Filip

IRB/Thesis CoordinatorIRB/Thesis Coordinator

Graduate Studies and ResearchGraduate Studies and Research

(408) 924-2479(408) 924-2479

Alena.Filip@sjsu.eduAlena.Filip@sjsu.edu

http://www.sjsu.edu/gradstudieshttp://www.sjsu.edu/gradstudies

Your QuestionsYour Questions

And….

THANK YOU FOR ATENDINGTHE IRB WORKSHOP!