Tissue Bank Challenges

Repository and Pathologist View

Elizabeth H. Hammond M.D.

2 Types of Challenges

Repository managers

Pathologists who provide tissue to banks

Repository Manager Challenges

Confidentiality

Tissue Accuracy

Specimen Tracking

Consent Tracking

Specimen Disposition

Which IRB?

Confidentiality

Limited access to identified information

Confidentiality agreements

Security of identified information

Retention of identified information

Tracking of disclosure of information

Tissue Sample Accuracy

Tissue samples and associated identifying information must be used to insure that samples received:

Represent tissue of study patient

Contain tissue of interest to the study

Do not contain artifacts which render tissue unusable for research

Specimen Tracking

Sample identification

Sample storage and retrieval

Tracking of samples to/ from investigators

Tracking of samples back to institutions

Tracking of sample disposal

Consent Tracking

Samples with/without consent

Level of consent

Patients decreased (with documentation)?

Tracking of consent when samples used

Sample reuse beyond study definition

Specimen Disposition

Sample tracking/ retrieval to insure prompt return of samples

Sample disposition when block expended

Sample disposition when study closed

IRB Jurisdiction

Which IRB has ethical oversight for the repository?

Which IRB has ethical oversight when a study using tissue is approved by clinical trial group or other entity?

Repository Approaches

Tracking issues require data bases

Identified information must be secured and dispostion must be controlled by policy

Data base security and access must be carefully controlled

Local IRB coordinated approach to HBM issues must be arranged to insure uniform education about policies

Pathologist Challenges

Patient Care

Patient Consent

Cost

Malpractice Risk

Ownership/credit

Patient Care

Blocks may be needed for future clinical tests (Her2 in breast cancer)

Retrospective review of samples when new risk factors found, new diagnoses considered

Late requests for second opinions

Patient Consent

What documentation should be requested?

How should consent information be recorded?

Institutional policies are highly variable as are the wishes of IRB’s.

Issue of Cost

Pathologists are busier with smaller staffs

Block selection for tissue banking is time consuming (expensive)

Reports, blocks, and slides must be obtained

Report and slides must be reviewed

Block must be selected and shipped

Documentation must be maintained

Issue of Malpractice Risk

Retention of slides or blocks beyond the times mandated by regulatory agencies may be seen as promoting malpractice risk.

Can be used in litigation longer

Can be reviewed and diagnosis challenged

Policy must be specific and documented or patient can challenge removal of tissue from department which may promote litigation

Issue of Ownership

Pathologists view blocks are potential valuable resource for own research.

Issues of ownership vary by state

Ownership becomes bargaining issue

Approaches to Patient Care Issues

Uniform guidelines for tissue retention for patient care are needed that are not state specific and are widely endorsed and enforced by regulatory agencies such as CAP/JCAHO.

Tissue requirements must be mindful of potential patient care needs (retention of unstained slides or availability of rapid return of materials when necessary)

Patient Consent Approaches

Uniform consent form should be provided or education about key elements

Process to assure proper procedures are followed should be available and simple

Documentation guidelines or forms should be created/provided (?web based)

Information should be available to pathologists to enable understanding of process

Approaches to Cost

Mechanisms to provide payment and ease of submission/shipment of materials are needed.

Uniformity of submission requirements would be helpful.

Strategies for case identification are needed which are not disruptive to patient care

Malpractice Risk Approaches

Pathologists should be informed about the value of standardized procedures and documentation in preventing malpractice risk

Policies should be developed for situations of discrepant diagnoses which mitigate against malpractice risk

Approaches to Ownership Issues

National guidelines are needed for determining ownership or establishing priority of granting tissue requests.

Strategies for giving credit to pathologists for participation are needed which they accept.

Access to tissue resources could be enabled for those providing tissue so that individual studies could be done.

Public Education

Public opinion could be marshaled to promote tissue acquisition by publicizing results of studies where cooperation led to important new treatment strategies.

Patient advocacy groups and oncology groups could promote tissue banking using media and individual pathologist contact.

Pathologist Cooperation

Participation of all types of pathologists in creating solutions will promote cooperation.

Involvement of pathology organizations as resources for information and guideline development will foster support.

Communication about the impact of tissue banking on future cancer care will promote cooperation.


	Confidentiality
	Tissue Accuracy
	Specimen Tracking
	Consent Tracking
	Specimen Disposition
	Which IRB?


	Limited access to identified information
	Confidentiality agreements
	Security of identified information
	Retention of identified information
	Tracking of disclosure of information


	Tissue samples and associated identifying information must be used to insure that samples received:
		Represent tissue of study patient
		Contain tissue of interest to the study
		Do not contain artifacts which render tissue unusable for research


	Sample identification
	Sample storage and retrieval
	Tracking of samples to/ from investigators
	Tracking of samples back to institutions
	Tracking of sample disposal


	Samples with/without consent
	Level of consent
	Patients decreased (with documentation)?
	Tracking of consent when samples used
	Sample reuse beyond study definition


	Sample tracking/ retrieval to insure prompt return of samples
	Sample disposition when block expended
	Sample disposition when study closed


	Which IRB has ethical oversight for the repository?
	Which IRB has ethical oversight when a study using tissue is approved by clinical trial group or other entity?


	Tracking issues require data bases
	Identified information must be secured and dispostion must be controlled by policy
	Data base security and access must be carefully controlled
	Local IRB coordinated approach to HBM issues must be arranged to insure uniform education about policies


	Patient Care
	Patient Consent
	Cost
	Malpractice Risk
	Ownership/credit


	Blocks may be needed for future clinical tests (Her2 in breast cancer)
	Retrospective review of samples when new risk factors found, new diagnoses considered
	Late requests for second opinions


	What documentation should be requested?
	How should consent information be recorded?
	Institutional policies are highly variable as are the wishes of IRB’s.


	Pathologists are busier with smaller staffs
	Block selection for tissue banking is time consuming (expensive)
		Reports, blocks, and slides must be obtained
		Report and slides must be reviewed
		Block must be selected and shipped
		Documentation must be maintained


	Retention of slides or blocks beyond the times mandated by regulatory agencies may be seen as promoting malpractice risk.
		Can be used in litigation longer
		Can be reviewed and diagnosis challenged
		Policy must be specific and documented or patient can challenge removal of tissue from department which may promote litigation


	Pathologists view blocks are potential valuable resource for own research.
	Issues of ownership vary by state
	Ownership becomes bargaining issue


	Uniform guidelines for tissue retention for patient care are needed that are not state specific and are widely endorsed and enforced by regulatory agencies such as CAP/JCAHO.
	Tissue requirements must be mindful of potential patient care needs (retention of unstained slides or availability of rapid return of materials when necessary)



	Uniform consent form should be provided or education about key elements
	Process to assure proper procedures are followed should be available and simple
	Documentation guidelines or forms should be created/provided (?web based)
	Information should be available to pathologists to enable understanding of process


	Mechanisms to provide payment and ease of submission/shipment of materials are needed.
	Uniformity of submission requirements would be helpful.
	Strategies for case identification are needed which are not disruptive to patient care


	Pathologists should be informed about the value of standardized procedures and documentation in preventing malpractice risk
	Policies should be developed for situations of discrepant diagnoses which mitigate against malpractice risk


	National guidelines are needed for determining ownership or establishing priority of granting tissue requests.
	Strategies for giving credit to pathologists for participation are needed which they accept.
	Access to tissue resources could be enabled for those providing tissue so that individual studies could be done.


	Public opinion could be marshaled to promote tissue acquisition by publicizing results of studies where cooperation led to important new treatment strategies.
	Patient advocacy groups and oncology groups could promote tissue banking using media and individual pathologist contact.


	Participation of all types of pathologists in creating solutions will promote cooperation.
	Involvement of pathology organizations as resources for information and guideline development will foster support.
	Communication about the impact of tissue banking on future cancer care will promote cooperation.