Prepared by The Office of Graduate Studies & Research The Institutional Review Board An Introduction for SJSU Students and Faculty Prepared by The Office of Graduate Studies & Research

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? Two Criteria Is it research? A systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge, including the dissemination, presentation, Publication, or use of research findings beyond the boundaries of a specific instructional setting. Examples: Independent student project, master’s thesis, activities intended to lead to publication.

When Is IRB Review Needed? Two Criteria 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? 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 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? 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 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 Protocol To ensure compliance IRBs require that all researchers submit a standard set of documents designed to procure 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.

The IRB Protocol: Required Documents Training Verification Researcher or sponsoring professor (if applicant is a student) has completed a mandatory online IRB tutorial available at: http://phrp.nihtraining.com/users/login.php Application Request to Use Human Subjects Application or Request for Exemption Sponsoring Professor If researcher is a student, must include a Responsible Faculty Member Form

The IRB Protocol: Required Documents Protocol Narrative In addition to the IRB Application or Request for Exemption the researcher should attach: Abstract Statement of Purpose A complete description of the methods and procedures of the project that adequately explains the following…

The IRB Protocol: Required Documents 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 Documents 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 Documents 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 Documents Protocol Narrative Continued… Informed Consent 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.

The IRB Protocol: Required Documents 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 to contact if they have any questions. Consent forms containing all the elements of informed consent should be submitted (and distributed) on SJSU letterhead. This is a legal document that protects your participants, yourself, and SJSU. Refer to the IRB website and follow the sample consent forms provided for adults or minors.

Consent Form Elements Name of Researcher(s), Title (Student/Faculty) Affiliation Explain the purpose of research (You have been asked to participate in a research study investigating…). Describe procedures, duration, location, materials, devices (You will be asked to…). Describe risks or discomforts. Include provisions for addressing risks. Describe benefits. Describe compensation/incentive, if any.

Consent Form Elements Describe the extent, if any, to which confidentiality will be maintained and how, including procedures for storing data. Provide contact information: Questions about research (You). Complaints about research (Dept Chair). Questions about participant rights (Dr. Pamela Stacks, 408-924-2427). 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 Documents Data Instruments Attach to the application all tests, data instruments, and other materials to be distributed to participants (e.g., surveys, questionnaires, interview questions, recruitment material). Translations If applicable, provide translations of both the consent forms and all data instruments to be distributed to participants AND provide a Verification of Translation Form signed by someone other than yourself who is adept in the language (The Verification of Translation Form is available on the IRB website). Resource: Department of Foreign Languages. Permissions from Participating Institutions If applicable, obtain permission from outside institutions or agencies that either serve as a source of subjects, a source of records and information, or on whose facilities your project will be conducted.

The IRB Protocol: Required Documents Permissions 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 their letterhead and must include: the title of the study (indicating knowledge of it), the inclusive dates for which the permission is granted, and the title and type written name of the individual with the authority to grant such permission, in addition to their signature.

IRB Procedures and Timelines Three types of review: Exempt (IRB coordinator) Expedited (single reviewer) Full Review (entire IRB) Researcher submits 2 copies of complete IRB protocol to the IRB Coordinator. Any subsequent documents or revisions that are submitted must contain the researcher’s name and/or protocol number (2 copies of each).

IRB 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 Timelines Returned to IRB Coordinator (1-5 days) Exempt Fully Approved Provisionally Approved Declined/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 Information Addendums 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 Information Alena Filip IRB/Thesis Coordinator Graduate Studies and Research (408) 924-2479 Alena.Filip@sjsu.edu http://www.sjsu.edu/gradstudies

Your Questions And…. THANK YOU FOR ATENDING THE IRB WORKSHOP!