repositories: ethical & regulatory issues. plan of analysis definitions & distinctions ...
TRANSCRIPT
TERRENCE F . ACKERMAN, PH.D.CHAIRMAN, UTHSC INSTITUTIONAL REVIEW
BOARDPROFESSOR OF BIOETHICSDEPARTMENT OF MEDICINE
REPOSITORIES: ETHICAL & REGULATORY ISSUES
PLAN OF ANALYSIS
DEFINITIONS & DISTINCTIONS
CREATION OF REPOSITORIES & IRB APPROVAL
THE INTAKE PROCESS & INFORMED CONSENT
INVESTIGATOR USE OF REPOSITORY MATERIALS
DEFINITIONS & DISTINCTIONS
DEFINITION OF“RESEARCH REPOSITORY”
A RESEARCH REPOSITORY IS AN ENTITY CREATED TO PROCURE, PROCESS, STORE AND DISTRIBUTE SPECIMENS AND/OR DATA FOR
USE IN MULTIPLE RESEARCH PROJECTS
ACTIVITIES THAT ARE NOT RESEARCH REPOSITORIES:
--COLLECTION OF SPECIMENS/DATA FOR USE IN A SINGLE STUDY
--LONG-TERM STORAGE OF SPECIMENS/DATA FOR A SPECIFIC STUDY
--COLLECTION OF SPECIMENS/DATA FOR NON-RESEARCH PURPOSES
A TOPOGRAPHY OF SPECIMEN/DATA COLLECTIONS
REGISTRIES, DATABASES, & DATABANKS INVOLVE DATA COLLECTION ONLY
BIOREPOSITORIES, TISSUE BANKS, BIOBANKS ARE ENTITIES THAT INCLUDE THE STORAGE OF
SPECIMENS
SUCH COLLECTIONS MAY FUNCTION NOT AT ALL, PARTLY OR EXCLUSIVELY AS RESEARCH
REPOSITORIES
PREVIOUSLY GENERATED NONRESEARCH COLLECTIONS MAY BE INTEGRATED OR MERGED
INTO RESEARCH REPOSITORIES
CREATION OF RESEARCH REPOSITORIES & IRB
APPROVAL
THE FOCUS & LIMITS OF IRB PURVIEW
PRE-EXISTING MULTI-USE COLLECTIONS OF SPECIMENS/DATA NOT DESIGNED FOR
RESEARCH PURPOSES DO NOT REQUIRE IRB APPROVAL, ALTHOUGH SPECIFIC STUDIES
USING THOSE MATERIALS DO
COLLECTIONS DESIGNED SPECIFICALLY FOR RESEARCH PURPOSES DO REQUIRE IRB APPROVAL AS RESEARCH REPOSITORIES
MULTI-USE COLLECTIONS DESIGNED IN PART FOR RESEARCH PURPOSES REQUIRE
IRB APPROVAL AS RESEARH REPOSITORIES
BASIC IRB REQUIREMENTS
CREATION OF A REPOSITORY IS CONSIDERED “RESEARCH” UNDER THE
FEDERAL REGULATIONS
AS SUCH, IT REQUIRES A PROTOCOL THAT CAN BE EVALUATED ACCORDING TO THE BASIC CRITERIA FOR IRB APPROVAL
THIS PROTOCOL MUST INCLUDE THE INFORMED CONSENT OF SUBJECTS,
UNLESS THE LATTER CAN BE WAIVED OR ALTERED
KEY COMPONENTS OF IRB REVIEW
PURPOSE OF THE REPOSITORY
PROVISIONS FOR SUBJECT CONSENT
PROTOCOL FOR PROCESSING, MAINTAINING & DISTRIBUTING MATERIALS, ESPECIALLY USE OF
IDENTIFIERS
INVESTIGATOR ACCESS TO REPOSITORY MATERIALS
SOME OPTIMAL DESIGN FEATURES FROM A REGULATORY PERSPECTIVE
BROAD STATEMENT OF PURPOSE & USE CIRCUMVENTS QUESTIONS REGARDING
ADEQUACY OF PRIOR CONSENT OF SUBJECTS
DE-IDENTIFICATION OF MATERIALS REDUCES INFORMATIONAL RISKS & SIMPLIFIES THE IRB PROCESS FOR
INVESTIGATORS UTILIZING THE REPOSITORY
CREATIVE CONSENT MECHANISMS MAY INCREASE INTAKE WHILE ADEQUATELY
PROTECTING SUBJECT RIGHTS
THE INTAKE PROCESS & INFORMED CONSENT
ALTERNATIVE MODELS OF CONSENT
TIERED CONSENT
BLANKET CONSENT
BLANKET CONSENT + PERIODIC RECONTACT
TIERED CONSENT EXAMPLE
MY TISSUE MAY BE USED IN CANCER RESEARCH
MY TISSUE MAY BE USED TO LEARN ABOUT OTHER HEALTH PROBLEMS
MY TISSUE MAY BE ASSOCIATED WITH MY MEDICAL RECORD
INFORMATION THAT IDENTIFIES ME MAY BE DISTRIBUTED TO INVESTIGATORS
I AM WILLING TO BE RECONTACTED FOR FUTURE STUDIES
KEY ELEMENTS OF CONSENT INFORMATION
PURPOSES SERVED BY THE REPOSITORY WHAT MATERIALS WILL BE USED
WHO WILL HAVE ACCESS TO MATERIALS WHETHER IDENTIFIERS WILL BE
RETAINED TYPES OF ANALYSIS
PROVISIONS FOR CONFIDENTIALITY NOTIFICATION OF RESULTS
POSSIBILITY OF RECONTACT OWNERSHIP & PROFITS
ALTERING CONSENT FOR LARGE SCALE REPOSITORIES
CONSENT INTERVIEW & FULL CONSENT FORM MAY BE
IMPRACTICAL FOR LARGE REPOSITORIES
A BRIEF CONSENT STATEMENT MAY BE A PERMISSIBLE ALTERNATIVE
OPT OUT RATHER THAN OPT IN ARRANGEMENTS ARE ALSO POSSIBLE
REGULATORY CONDITIONS FOR WAIVING OR ALTERING CONSENT
45 CFR 46.116(d)
THE RESEARCH INVOLVES NO MORE THAN MINIMAL RISK
THE ALTERATION WILL NOT ADVERSELY AFFECT THE RIGHTS & WELFARE OF SUBJECTS
THE RESEARCH COULD NOT PRACTICABLY BE CARRIED OUT WITHOUT THE ALTERATION
SUBJECTS WILL BE PROVIDED WITH ADDITIONAL PERTINENT INFORMATION AFTER
PARTICIPATION
INVESTIGATOR USE OF REPOSITORY MATERIALS
IRB REQUIREMENTS FOR INVESTIGATOR USE
IRB APPROVAL FOR THE USE OF MATERIALS IS SEPARATE FROM IRB
APPROVAL FOR THE REPOSITORY ITSELF
APPROVAL REQUIRES ASSURANCE THAT MATERIALS ARE BEING USED IN ACCORD WITH IRB-APPROVED CONDITIONS FOR
CREATION OF THE REPOSITORY
MOST USES OF REPOSITORY MATERIAL WILL QUALIFY FOR EXEMPT REVIEW
LEVEL OF IRB REVIEW
IF THE MATERIALS DO NOT CONTAIN PERSONAL IDENTIFIERS, THE RESEARCH DOES NOT
INVOLVE “HUMAN SUBJECTS” UNDER THE REGULATIONS
IF THE RESEARCH INVOLVES PRE-EXISTING IDENTIFIABLE MATERIALS, BUT IDENTIFIERS
WILL NOT BE RECORDED, IT IS STILL APPROVABLE AS EXEMPT
USE OF REPOSITORY SPECIMENS WILL REQUIRE AN EXPEDITED APPLICATION ONLY IF ALL
MATERIALS ARE NOT PRE-EXISTING AND/OR IDENTIFIERS WILL BE RETAINED & RECORDED
ALTERNATIVE FORMS OF APPROVAL FOR USE OF REPOSITORY MATERIALS
SINGLE STUDY APPROVAL
MASTER PROTOCOL FOR THE CONDUCT OF MULTIPLE,
SIMILAR ANALYSES
BLANKET EXEMPTION
CONDITIONS FOR BLANKET EXEMPTIONS
USE OF SPECIMENS/DATA INVOLVES “HUMAN SUBJECTS” ONLY IF THE IDENTITY
OF INDIVIDUALS CAN BE “READILY ASCERTAINED” BY INVESTIGATORS
(45 CFR 46.102(f))
REPOSITORIES THAT RELEASE ONLY NON-IDENTIFIABLE MATERIALS TO
INVESTIGATORS DO NOT INVOLVE “HUMAN SUBJECTS”
USE OF MATERIALS FROM SUCH A REPOSITORY QUALIFIES FOR A BLANKET
EXEMPTION
SUMMARY DESIGN OF A DATA/SPECIMEN COLLECTION
FOR RESEARCH USE REQUIRES IRB APPROVAL AS A RESEARCH REPOSITORY
ALTERATIONS OF CONSENT ARE PERMISSIBLE FOR LARGE SCALE REPOSITORY PROJECTS
USE OF REPOSITORY MATERIALS REQUIRES IRB APPROVAL SEPARATE FROM THAT FOR THE
REPOSITORY ITSELF
USE OF NON-IDENTIFIABLE MATERIALS ALLOWS THE SIMPLEST LEVEL OF IRB REVIEW & MAY QUALIFY FOR A BLANKET EXEMPTION