Document Sample
					1st Annual Ontario Translational Research Network Forum
                     October 3, 2008

     Ethical, Legal & Policy Issues in
         Biospecimen Research:
     Ethical and Privacy Perspective

                Ronald J. Heslegrave, Ph.D.
               Chair, Research Ethics Board
   University Health Network, Mount Sinai Hospital and
          Ontario Cancer Research Ethics Board
What are the rights of this biospecimen donor and
             surrounding scientists?
 Laws, Regulations and Guidelines
Relevant to Biospecimen Repositories

  ICH Good Clinical Practice (GCP)
  Department of Health and Human Services (DHHS)
  and FDA laws and requirements (US)
  Tri-Council Policy on Privacy and Confidentiality
  (Canadian National Code)
  PIPEDA (Canadian Federal Privacy Legislation)
  Personal Health Information Protection Act
  (PHIPA - Ontario Privacy Legislation)
        Of Most Relevance

Tri-Council Policy on Privacy and
Confidentiality (Canadian National Code)

PHIPA (Ontario Privacy Legislation)
    T R I -C O U N C I L P O L I C Y
           S T A T E M E N T:
  Ethical Conduct for Research Involving
Medical Research Council of Canada
Natural Sciences and Engineering Research Council of Canada
Social Sciences and Humanities Research Council of Canada
T R I -C O U N C I L P O L I C Y
Ethical Conduct for
Research Involving

                         Section 3
                Privacy and Confidentiality

Medical Research Council of Canada
Natural Sciences and Engineering Research Council of Canada
Social Sciences and Humanities Research Council of Canada
          Human Dignity
Dignity and autonomy of human subjects is
the ethical basis of respect for the privacy of
research subjects

Privacy is perceived to be an essential
means of protecting and promoting human
              Human Tissue
“The use of human tissue for the purpose of
  research has proven to be of immense
  importance to the advancement of

“The ethical considerations raised by research
  involving human tissue centre on the moral
  status of human tissue…”
             Human Tissue
“It is fundamental that researchers… respect
  individual and community notions of human

“It is generally held that human tissue
  deserves some degree of respect for reasons
  of the dignity of the person from whom
  tissue was obtained”

“The use of tissue for research depends on an
  individual’s altruism in donating the tissue”
T R I -C O U N C I L P O L I C Y
Ethical Conduct for
Research Involving

                           Section 10
                          Human Tissue

Medical Research Council of Canada
Natural Sciences and Engineering Research Council of Canada
Social Sciences and Humanities Research Council of Canada
              TCPS – Article 10.1
Research proposing the collection and use of human
 tissues requires ethics review by an REB. The
 researcher shall demonstrate the following to the REB:
(a) That the collection and use of human tissues for
  research purposes shall be undertaken with the free
  and informed consent of competent donors;
(b) In the case of incompetent donors, free and informed
  consent shall be by an authorized third party;
(c) In the case of deceased donors, free and informed
  consent shall be expressed in a prior directive or
  through the exercise of free and informed consent by
  an authorized third party.
                 TCPS – Article 10.2
For the purpose of obtaining free and informed consent,
  researchers who seek to collect human tissue for research shall
  provide potential donors parties with information about:
(a) The purpose of the research
(b) The type, amount and location of tissue to be taken
(c) The safety and invasiveness of acquisition and the duration of
(d) The potential uses for the tissue including any commercial
(e) The safeguards to protect the individual’s privacy and
(f) Identifying information attached to the tissue and its
(g) How the use of the tissue could affect privacy
     ACT, 2004 (PHIPA)
Provincial privacy legislation for the health care sector only -
Ministry of Health & Long-Term Care and Information
Privacy Commissioner of Ontario
2 Acts:
 – Personal Information Protection Act, 2004
 – Quality of Care Information Protection Act, 2004
Received first reading Dec 17th
Hearings in Toronto week of January 26th
Hearings in Sault Ste Marie, Kingston and London week of
February 2nd
Second reading April 8, 2004
Third reading May 17, 2004
Came into force as of November 1, 2004
Research: means a systematic investigation
designed to develop or establish principles,
facts or generalizable knowledge, or any
combination of them, and includes the
development, testing and evaluation of
Researcher: means a person who conducts
Personal Health Care Information is identifying if it:
 – pertains to the physical or mental health of the
   individual or that individual’s family information
   that relates to one’s health care
 – relates to payments for health care
 – relates to a plan of service, or health number
 – identifies a substitute decision maker of the
 – is in a record where any of the above is contained
 Personal Health Care Information is identifying when
the information relates to the donation by the
individual of any body part or bodily substance of the
individual or is derived from the testing or
examination of any body part or bodily substance
 Biobank specimens are most useful when clinical
information characterizes the specimen and this is
regarded as PHI
Identifying Information:
 – information that identifies an individual or for
   which it is reasonably forseeable in the
   circumstances that it could be utilized, either
   alone or with other information, to identify an
Tri-Council Policy discusses Identifiable,
Traceable, Anonymous and Anonymized Data
Who Authorizes Access to Specimens
 and PHI for Research Purposes?

          In Ontario,
   Research Ethics Boards
   as defined under PHIPA
       The Research Plan
A research plan
checklist and sample
research application is
provided on pg. 221 of
the OHA Toolkit
      Research Ethics Board
The research ethics board must consider everything relevant
when deciding to approve a plan for conducting research
without consent, including:
Whether the research goals could be achieved without using
personal health information
Whether there is a public interest in carrying out the research
Whether adequate safeguards will be in place to protect
privacy and preserve the information’s confidentiality, and
Whether it would be impractical to require the researcher to
get the affected individuals’ consent.
  Research Plan must include:
An explanation as to why the research cannot
reasonably be accomplished without the personal
health information and, if it is to be linked to other
information, an explanation as to why this linkage is
An explanation as to why consent to the disclosure
of the personal health information is not being
sought from the individuals to whom the
information relates
  Research Plan must include:
A description of the reasonably foreseeable harms
and benefits that may arise from the use of the
personal health information and how researchers
intend to address those harms
A description of all persons who will have access
to the information, why their access is necessary,
their roles in relation to the research and their
related qualifications
  Research Plan must include:
The safeguards that the researcher will impose to protect the
confidentiality and security of the personal health
information, including an estimate of how long the
information will be retained in an identifiable form and why
Information as to how and when the personal health
information will be disposed of or returned to the health
information custodian
The funding source of the research
Whether the researcher has applied for the approval of
another REB and, if so the response to or status of the
  Research Plan must include:

Whether the researcher’s interest in the disclosure of
the personal health information or the performance
of the research would likely result in an actual or
perceived conflict of interest with other duties of the
     Who Interprets PHIPA?
 Privacy Commissioner Dr. Ann Cavoukian stated
that she and her office interprets PHIPA

 It could be argued that REBs interpret PHIPA for
research purposes and such interpretations will vary
by REB

 Should there be a central body making research
REBs Balance Competing Interests
                Balance individual rights
                against societal needs
                Balance unknown risks against
                potential benefit
                Balance competing legislation
                Balance competing interests
                from researchers
                Balance industry interests and
                the need for improved therapies
                Balance the need for explicit
                Consent against a waiver of
   Ethical Issues with Biobanks-
    Free and Informed Consent
The notion of informed consent for the use of
banked biological material for research has been
considered problematic
Consent may either be general or obtained for
specific projects or research areas
In the former case, it can be questioned whether
such “blanket consent” for unspecified research
satisfies the requirements of informed consent. A
person who consents to all future research uses of
tissue may not have thought of controversial
research that they may have objected to
        Ethical Issues with Biobanks –
   Misuse and Unauthorized Dissemination of
             Genetic Information
Use of genetic information in insurance decisions and preemployment

Genetic sequencing could be used as a routine test in healthcare and
full genetic information may become part of many health records:
    More difficult to prevent insurers from using genetic information
    It may become impossible to guarantee the anonymity of unlinked
    tissue specimens
    Medical records will become useful for forensic identification
       Ethical Issues with Biobanks –
Who Owns the Sample? At least 4 positions
   Sample is unowned
   Owned by Humanity
   Owned by the person from whom it was taken
   Owned by the researcher or company who transformed it
   into a useful commodity
Issue remains contentious but there is an emerging view that
originally it is unowned but when someone invests time and
skill in developing a commodity from such material, that
person/company has property rights to the developed
In recent years with the Privacy Laws, there has been an
avoidance of the discussion of ownership of the original sample
Summary of Ontario Translational Research
          Network Repository
 Limited PHI is collected with the specimen
 Due to multi-site involvement in OTRN, OTRN applied to
 OCREB for REB approval for the process underlying the
 collection of PHI and specimens
 OCREB granted approval and the use of a more general
 Informed Consent Form
 Project specific requests will be approved by the
 investigator’s local REB
 Perhaps a central REB should be considered for multi-site
 collaborative projects