practical issues and logistics- tissue resources and irb/hipaa william e. grizzle department of...
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Practical Issues and Logistics-Tissue Resources and IRB/HIPAA
William E. GrizzleDepartment of Pathology
University of Alabama at [email protected]
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/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/HIPAA
>200 Patients per Week
> 500 Specimens per Week
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
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
Lack of a relationship may cause problems
1) No direct access to patients
2) Identification of patients/tissues of interest
3) Cold contact
4) Efficiency of collection of informed consent and HIPPA authorization
5) Patient’s physician may object to contact
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA
Identified Tissue and Information
Bank or Tissue Resource
Limited Data Set De-identified Anonymized
Patient ‘s Remnant Diagnostic or Therapeutic Tissue and Protected Health Care Information
IRB and
HIPPA
IRB
IRB and
HIPPA
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA
Regulations of IRB and HIPPA
Too Much
Too Little
Too LittleResearch
What are the ethics of not performing research??
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
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
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
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
WHEN TO OBTAIN INFORMED CONSENT
ON ADMISSION
AT CLINIC
IMMEDIATELY PREOPERATIVE
POST OPERATIVE
AFTER DISCHARGE
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
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
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
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
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
CONFIDENTIALITY
PERSONNEL NEED TO COLLECT PHI ON PATIENTS
SIGN CONFIDENTIALITY AGREEMENT
INFORMATICS SYSTEM
PROVIDE ONLY DE-IDENTIFIED OR LIMITED DATA SET
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
SECURITY
ON LINE (INTERNET)
ALWAYS
LIMITED HOURS
NEVER
USE SERVER AS CONTROL
CRYPTOGRAPHIC APPROACH
Practical Issues and Logistics-Tissue Resources and IRB/HIPAA
William E. GrizzleDepartment of Pathology
University of Alabama at [email protected]