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Practical Issues and Logistics-Tissue Resources and IRB/HIPAA. William E. Grizzle Department of Pathology University of Alabama at Birmingham [email protected] Practical Issues and Logistics-Tissue Resources and IRB/HIPAA. Tissue Collections-Maximized -Rapid

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practical issues and logistics tissue resources and irb hipaa
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

William E. Grizzle

Department of Pathology

University of Alabama at Birmingham

[email protected]

practical issues and logistics tissue resources and irb hipaa1
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

Tissue Collections-Maximized

-Rapid

-According to Specifications

-Uniform Collections

-Quality Control

-Cost Effective

practical issues and logistics tissue resources and irb hipaa2
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

Tissue Collections

-Fresh -Paraffin Blocks

-Frozen -Paraffin Slides

-Fixed -Frozen Sections

-Tissue Arrays -Whole Blood

-Serum -Saliva

-Plasma -Urine Pellets

-Buffy Coat-Urine Supernatant

practical issues and logistics tissue resources and irb hipaa3
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

>200 Patients per Week

> 500 Specimens per Week

slide5
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

1) Relationship of tissue resource personnel to the patient- the source of the tissues

2) Informed Consent

3) Confidentiality

4) Security of Information

slide6
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

Relationship of tissue resource personnel to the patient.

In general, personnel managing the Tissue Resource and those collecting tissues have no direct relationship with those patients from whom tissues are obtained

slide7
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA
  • Lack of a relationship may cause problems
  • No direct access to patients
  • Identification of patients/tissues of interest
  • Cold contact
  • Efficiency of collection of informed consent and HIPPA authorization
  • Patient’s physician may object to contact
slide8
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

IRB and HIPPA

Patient ‘s Remnant Diagnostic or Therapeutic Tissue and Protected Health Care Information

Identified Tissue and Information

Bank or Tissue Resource

IRB and HIPPA

IRB

Limited Data Set De-identified Anonymized

slide9
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

Too Little

Too Much

Regulations of IRB and HIPPA

Too Little

Research

What are the ethics of not performing research??

slide10
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

INFORMED CONSENT

IF TISSUE IS ANONYMIZED SHOULD INFORMED CONSENT REQUIRED??

slide11
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

Informed Consent-Research Performed Using

clinical protocol

operative model

non-operative diseases-type II diabetes

role of autopsy

Informed Consent-Research Affecting Populations and/or Families

cystic fibrosis

sickle cell anemia

type II diabetes

slide12
Lack of a relationship may cause problems

INFORMED CONSENT

FOR WHAT TISSUES/ACTIONS?

WHEN TO OBTAIN?

WHO WILL OBTAIN CONSENT?

WHERE WILL IT BE OBTAINED?

slide13
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

INFORMED CONSENT

To obtain blood/bodily fluids

To investigate inheritable disease

For recontact

For negative concerns of populations

slide14
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

WHEN TO OBTAIN INFORMED CONSENT

ON ADMISSION

AT CLINIC

IMMEDIATELY PREOPERATIVE

POST OPERATIVE

AFTER DISCHARGE

slide15
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

OBTAINING INFORMED CONSENT ON ADMISSION

GREATEST ACCESS TO PATIENTS

MOST EFFICIENT

# POINTS OF ADMISSION

TRAINING OF PERSONNEL

slide16
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

OBTAINING INFORMED CONSENT ON ADMISSION

CHAOS, INTAKE OF PATIENTS RAPIDLY

PATIENTS VERY BUSY WITH HIGH VOLUME OF INFORMATION

PATIENTS AND FAMILIES UPSET

COSTS SHIFTED TO MEDICAL CENTER

slide17
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

OBTAINING INFORMED CONSENT AT CLINIC

MAY BE CALM TIME

PATIENTS FOCUSED ON DISEASE

SPACE A PROBLEM

TISSUE RESOURCE PERSONNEL ARE GUESTS

TOO MANY CLINICS AT SAME TIME

slide18
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

OBTAINING INFORMED CONSENT IMMEDIATELY PREOPERATIVE

STRESS HIGH

SPACE CONSTRAINT, TISSUE PERSONNEL ARE GUESTS

TIME CONSTRAINT

ONLY OPERATIVE PATIENTS

slide19
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

OBTAINING INFORMED CONSENT POST-OPERATIVE OR WHEN AVAILABLE

MILD SEDATION

PATIENT FOCUSED

TIME PRIOR TO DISCHARGE

PATIENT LOCATION (1 HR/ PATIENT)

CONSENT ONLY PATIENTS ACCESSED

slide20
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

CONFIDENTIALITY

PERSONNEL NEED TO COLLECT PHI ON PATIENTS

SIGN CONFIDENTIALITY AGREEMENT

INFORMATICS SYSTEM

PROVIDE ONLY DE-IDENTIFIED OR LIMITED DATA SET

slide21
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

SECURITY

NEED ACCESS TO PHI

PREVENT UNAUTHORIZED ACCESS TO PHI

AUDIT TRAIL

KEEP DATABASE STRUCTURE SECURE

slide22
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

SECURITY

CONTROL AND MONITOR ALL ACCESS

LIMIT AND MONITOR WRITERS TO DATABASE

LIMIT AND MONITOR THOSE WHO CAN CHANGE STRUCTURE OF DATABASE

slide23
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

SECURITY

ON LINE (INTERNET)

ALWAYS

LIMITED HOURS

NEVER

USE SERVER AS CONTROL

CRYPTOGRAPHIC APPROACH

practical issues and logistics tissue resources and irb hipaa4
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

William E. Grizzle

Department of Pathology

University of Alabama at Birmingham

[email protected]

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