PoPulationand Public HealtH etHics
PoPulationand Public HealtH etHics
PoPulationand Public HealtH etHics
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ulk of health-care needs, health-care research is also a communal<br />
enterprise, ecouraging people’s participation.<br />
» The nature of the emergency situation: In clinical settings, law<br />
and ethics generally allow for intervention without consent in true<br />
emergency situations. In research settings, the existence of an emergency<br />
situation needs to be taken into consideration, but ReBs are<br />
still expected to demonstrate continuing commitment to the core<br />
principles of ethics review. Any exceptions and infringements of the<br />
ethics principles and procedures have to be demonstrably justified<br />
by those urging the exception or infringement. It is also important<br />
1 (Chapter 6D)<br />
that these exceptions should not be unduly broad.<br />
» Secondary use of data and human biological samples: Secondary<br />
use refers to the use of data or materials originally collected<br />
for another purpose. Secondary use of anonymous information or<br />
anonymous tissue samples does not require review by an ReB or<br />
consent of those who provided data or biological samples. However,<br />
the researcher in our case is requesting access to data and samples<br />
that will have personal identifiers attached. Such access normally<br />
requires the consent of each research participant. An ReB may authorize<br />
the release of the identifiable information and biological<br />
samples if the researcher requests it and if the researcher can prove<br />
1 (Chapter 5,<br />
that certain conditions for protection of paticipants are met.<br />
article 5.5 and Chapter 12, article 12.3)<br />
» Likely harm or risks to the welfare of participants: Concern<br />
for the welfare of participants is one of the core principles that must<br />
guide ReBs in all decisions. 1 (Chapter 1B) In this case, the access to data<br />
and samples by another researcher is unlikely to result in any new<br />
harm or risk of harm to the physical, mental or spiritual health or<br />
to the social and economic standing of participants. In fact, these<br />
participants, as well as the rest of the population, may benefit from<br />
successful control of the infectious disease outbreak, if the new research<br />
project is allowed to go ahead rapidly.<br />
» The perspective of research participants: ReBs, when deciding<br />
on access to previously collected data and samples, are expected<br />
1 (Chapter 1B)<br />
to be mindful of the perspective of research participants.<br />
One participant, Jonathan Bleau, enrolled in the biobank because<br />
To Share or Not to Share?<br />
37
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