The Patient Perspective on Tissue and Tissue Banking

	Judy Perotti
	May 3, 2004

Advocate or patient…is there a difference?

	Patient
	Usually knows little about their disease
	Focus is on self, family
	Main concern is treatment
	Emotions play significant role in decision making
	Advocate
	Has more in depth knowledge about disease
	Focus is on the healthcare system/research
	Main concern is influencing research and healthcare delivery
	Emotions are channeled into working for larger community

Slide 3

Chain of Trust

	Patient assumption of integrity of process
		All donated tissues are usable for purpose stated
		Collected, stored and used with good controls
		Any abuses degrade the public trust of the entire system
		Regulations developed to safeguard against future abuses may deter research

Patient Education

	Challenges
	Lack of
		information about uses of tissue
		importance of tissue to research
		understanding of the process of tissue collection, storage and quality controls
	Concern about
		Confidentiality/use of identifiers
		Who owns the tissue
	Solutions
	Develop materials for patients, advocates and healthcare professionals
		RAN is developing patient/advocate educational tools on the use of tissue in research

Informed Consent

	Challenges
	Inconsistency of form
		Consent for tissue incorporated in consent for participation in clinical trial
		Consent choices in the middle of the form, often not in context
		Patient  can be unclear about what s/he is consenting to
	Solutions
	Involved constituencies needed to revisit templates
		Consent for use of tissue should be separate unless a requirement for participating in a study
		All consent choices should be at the end of the form
		General statements about the future use of tissue rather than try to predict uses

IRBs

		Challenges
	Low number of community members
	Members are unaware of issues in the use of tissue for research
	Solutions
	Increase the number of patient advocates serving as community members
	Education program to train community/patient advocates
	Mentoring/coaching service for advocates

Rare Diseases

	Challenges
	Smaller pool of patients to pull from
	More demand for tissue
	Longer time to research findings
	Solutions
	Work with advocate organizations
		Identify patients
		Educate patients about research
		Work with the research community

Issues Requiring Attention

	Informed consent
		Consistency
		Language
		Literacy
		Sensitivity to cultural differences in decision making

Issues Requiring Attention

	IRBs
		Informed consents received are inconsistent
		IRBs try to have consistency within their institutions
		Result is inconsistency in what they require for tissue use

Issues Requiring Attention

	Withdrawal of consent or re-call of tissue
		Perception that this can easily be done.   Can it?
		What if all tissue is gone?
		What if tissue has been used in research?
		Can recall tissue but not data

Issues Requiring Attention

	Perceptions of Benefit to Others
		Will the tissue be sold?
		Will the repository or clinician make money from the sale?
		Will someone make money from the development of a new treatment?
		Belief that one persons tissue is critical to the research. No understanding that the value of tissue is in the use of many samples
		In rare cases one individuals tissue may results in a commercial product. How is that case handled?

Issues Requiring Attention

	Names
		Multiple definitions of tissue.
			Patients belief that it is a piece of  the body
			Fluids and other forms of “tissue” are not understood
		Tissue Repository or Bank
			Repository may not be understood by a large majority of the public
			Bank does not have one shared definition.  It creates different images for different people.

Issues Requiring Attention

	Media Understanding
		Public gets their information from the media
		The media has little understanding of medical research in general and even less about research using tissue
		The research community must take responsibility to get out accurate information.

Thank You To

	My two partners
		Mary Lou Smith
		Elda Railey
	Advocates that have shared their concerns and suggested solutions about tissue
	Patients willing to donate tissue - without them we would not need this workshop