open access: Future Medicine - Ethical considerations for biobanking: should individual research results be shared with relatives?

Ethical considerations for biobanking: should individual research results be shared with relatives?

The issue of returning individual research results (IRRs) is important and contentious. Indeed, Science magazine calls this, “…the most pressing issue in genetics today” [1]. At stake are several significant concerns, including public trust in, and support for, biomedical research, the wise use of limited research resources and the ethical obligations of the research community.

These concerns become even more complex and challenging with genetic biobank research. In this context, researchers must decide not only whether and how to share IRRs with donors, but also their relatives. After all, many genetic conditions have medical or personal significance for family members, and many ethical arguments for returning IRRs to donors might seem to extend to relatives as well [2].

This editorial briefly defends two important conclusions about these issues:

	▪ The case for sharing IRRs with relatives is no stronger, and almost certainly weaker, than for donors;
	▪ The case for returning IRRs to donors is not particularly convincing.

Taken together, these two claims support a strong presumption against sharing individual research findings with relatives.

Contrasting donors & relatives

The rationale for the first conclusion is straightforward. Outside of perhaps the general public itself, donors are the primary subjects to whom biobanks owe ethical consideration. Donors, not relatives, have explicitly (or, by not opting-out, implicitly) consented to their genetic materials being used by others. Donors’ interests are directly and powerfully affected by what happens in research. Their biological samples and health data reveal considerably more information about them than anyone else with whom they share partial genetic overlaps. Donors stand most fully and extensively to benefit from and/or be harmed by research. Hence, any obligations that biobanks have to donors’ relatives are weaker and narrower than to donors themselves.....cont'd

media: Capital Health Katharine Zinck Lawrence says she viewed files of family and friends out of curiousity. (why the 'Sorry' campaigns don't cut it/patient privacy)

May 2 blog: (privacy-Freedom of Information and Protection of Privacy Act - FIPPA) Ontario Hospital Association - The Facts on FOI and Hospitals' Quality of Care Records

Note: the facts from the perspective of the OHA; references patient safety, communication, data sharing
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The Facts on FOI and Hospitals' Quality of Care Records

"I’m going to use today’s blog to address an issue that has recently generated a great deal of controversy: whether Ontario’s Freedom of Information and Protection of Privacy Act (FIPPA) should be amended to protect a specific, narrow and well-defined class of information created by hospitals for the purposes of quality improvement.

Schedule 15 of Bill 173, Better Tomorrow for Ontario Act (Budget Measures), 2011, proposes to exempt, from the FIPPA, “information provided to, or records prepared by, a hospital committee for the purpose of assessing or evaluating the quality of health care and directly related programs and services provided by the hospital.” Bill 173 is currently being considered by the Standing Committee on Finance and Economic Affairs (SCFEA). This proposed amendment would align Ontario with other jurisdictions in Canada, as well as the United Kingdom and Australia, with respect to the treatment of quality of care information.

Without this kind of protection documented, conversations that health care professionals regularly have about enhancing patient care, as well as documents developed relating to quality, safety, and risk management, may be subject to public disclosure. This would have a chilling effect on the willingness of hospital staff to identify or comment on patient care and quality issues.

To read our submission to the Standing Committee on Finance and Economic Affairs respecting this amendment to FIPPA, click here.

Ontario hospitals unequivocally support openness and transparency; they also support continuous quality improvement. They are keen to strike an appropriate balance between improving care and improving access to information.

The proposed amendment has been criticized by organizations that either do not fully understand its purpose, or are deliberately trying to mislead the public. This has caused confusion about why these protections are necessary, which is incredibly unfortunate.

For me, the fundamental question is, do patients want to be treated in hospitals where issues of quality and safety are examined and discussed by hospital staff on a daily basis, or in ones where they are not? If the answer to the question is “yes, safety and quality matter,” then it is critical to support this amendment. The OHA does, and so do individuals like patient safety expert Dr. Ross Baker from the University or Toronto, as do organizations like the Ontario Medical Association.

We have created a special webpage to explain the truth about the amendment, why it is necessary, and why we support it. You can access it at www.oha.com/thetruth. I encourage you to visit it to learn more."

Tom Closson

(OHA)

worth reading especially the viewpoint: 2 items: editorial (patient consent/genetics) + viewpoint (breaching patient privacy)

Rapid Online Publications

Editorial 

Alerting genetic relatives to a risk of serious inherited disease without a patient’s consent
Graeme K Suthers, Elizabeth A McCusker and Samantha A Wake
   MJA Rapid Online Publication — 24 March 2011
   http://www.mja.com.au/public/issues/194_11_060611/sut11435_fm.html

Viewpoint (blogger's opinion - excellent article)
Doctors breaching patient privacy: Orwell redux
David J Handelsman, Leo A Turner and Ann J Conway
   MJA Rapid Online Publication — 24 March 2011
   http://www.mja.com.au/public/issues/194_11_060611/han10307_fm.html

HHS Proposes Stricter Patient Privacy Rules - HIPPA (U.S.)