Institutional Review Board Protecting Human Research Subjects

Presentation Outline n Structure n Tips for Teachers n Background: Ethical Problems in Research n Purpose n Rules n Process n Examples n Q & A

Structure n IRBs required by Federal Law n ALL Human Subjects Research MUST be approved by Gallaudet’s IRB n IRB responsible to Fed. Govt., not Gallaudet n IRB can be audited by Government n IRB must contain professionals and community members

Structure n Gallaudet’s IRB is responsible for reviewing ALL research involving Gallaudet students, faculty, staff and teachers. We are also responsible for research involving recruitment of alumni through records held in the Alumni Office.

Structure (Gallaudet’s IRB) n The Gallaudet Institutional Review Board currently has 17 members, representing various components of the Gallaudet campus n The Gallaudet IRB office is in Kendall Hall room 101A n The chair of the IRB is Dr. Carolyn Corbett n The Institutional Review Board coordinator is Ms. Carlene Thumann-Prezioso who is located in Fowler Hall, Room 214

Tips for Teachers n Your own human subjects research needs to be submitted to the IRB n Student human subjects research in your class needs to be submitted to the IRB (grad/undergrad, theses, dissert.) n Other researchers cannot use your students as subjects unless approved by the Gally IRB (surveys, etc.)

Tips for Teachers (Cont’d) n Build enough time into class projects for IRB approval n In most cases, the IRB requires some changes in projects n The IRB chair or a member is available to lecture to your class on issues and procedures n The IRB chair & staff are available for consultations

Background: Ethical Problems n Nuremberg Trial (1946) n Milgram Study (1963) n Tuskegee Study (1933, 1972) n Belmont Report (1974): –Respect for persons –Beneficence –Justice

Purpose n Carry out Objectives of Belmont Report Through Guaranteeing: –Informed Consent –Voluntary Participation –Risk/Benefit Analysis –Minimization of Risk –Justice in the subject selection

“Rules” n Risks (Psychological, Social, Economic, Physical) must be minimized n Risks must be offset by benefits n Subjects must be informed and voluntarily consent n Special populations must be protected

“Rules”: Protected Groups n Children younger than 18 years n Prisoners n Pregnant women n Mentally ill n Individuals with mental retardation

“Rules”: Classes of Research n Exempt--Examples: –Anonymous Surveys –Observation of Public behavior NO Videotaping –Use of Public Records –ONLY the IRB Decides if the Research is Exempt

Classes of Research n Expedited: All Other Human Subjects Research that presents at least a minimal risk of harm (as determined by the IRB); –if minimal risk is involved can be “expedited”. n Full Board Review: More than minimal harm or protected populations involved

Processes n Fill out form (Found under Gallaudet Research Institute on the Gallaudet website) n Write Up Research Proposal, including: –Informed Consent Form –Video Consent/Release (if applicable) –Interview/Survey Questions (if applicable) –Cover letter (if applicable) –Brief Literature Review

Processes (continued) n Timelines: –1 week if the IRB decides it does not need any modifications and is exempt –1-2 weeks if the IRB decides it does not need any modification and is expedited –If the IRB suggests modifications the timeline varies –For Full Board Review, from 2 weeks to 2 months depending on modifications

Processes (continued) n When the project is finished, the researcher must notify the IRB n Projects that continue past 1 year must get a renewal n Any modifications require approval n Any adverse results must be immediately reported to IRB

Common Examples n Anonymous Surveys versus Confidential Surveys n Questions that pose risks n Videotaping n Use of classmates or students (adults) n Compensation for Subjects n Deception

There Has Never Been A Research Project At Gallaudet University That Has Not Been Done Due To Lack Of IRB Approval!

Questions??? Thank you for your attention.