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