Practical issues and logistics tissue resources and irb hipaa
This presentation is the property of its rightful owner.
Sponsored Links
1 / 24

Practical Issues and Logistics-Tissue Resources and IRB/HIPAA PowerPoint PPT Presentation


  • 65 Views
  • Uploaded on
  • Presentation posted in: General

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

Download Presentation

Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


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


Practical issues and logistics tissue resources and irb hipaa

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


Practical issues and logistics tissue resources and irb hipaa

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


Practical issues and logistics tissue resources and irb hipaa

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


Practical issues and logistics tissue resources and irb hipaa

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


Practical issues and logistics tissue resources and irb hipaa

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??


Practical issues and logistics tissue resources and irb hipaa

Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

INFORMED CONSENT

IF TISSUE IS ANONYMIZED SHOULD INFORMED CONSENT REQUIRED??


Practical issues and logistics tissue resources and irb hipaa

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


Practical issues and logistics tissue resources and irb hipaa

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?


Practical issues and logistics tissue resources and irb hipaa

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


Practical issues and logistics tissue resources and irb hipaa

Practical Issues and Logistics-Tissue Resources and IRB/HIPAA

WHEN TO OBTAIN INFORMED CONSENT

ON ADMISSION

AT CLINIC

IMMEDIATELY PREOPERATIVE

POST OPERATIVE

AFTER DISCHARGE


Practical issues and logistics tissue resources and irb hipaa

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


Practical issues and logistics tissue resources and irb hipaa

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


Practical issues and logistics tissue resources and irb hipaa

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


Practical issues and logistics tissue resources and irb hipaa

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


Practical issues and logistics tissue resources and irb hipaa

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


Practical issues and logistics tissue resources and irb hipaa

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


Practical issues and logistics tissue resources and irb hipaa

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


Practical issues and logistics tissue resources and irb hipaa

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


Practical issues and logistics tissue resources and irb hipaa

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]


  • Login