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Past Interpretations of the TCPS

Subject Data Withdrawal in Emergency Health Research Situations
Keywords Emergency interventions, informed consent, exceptions to consent requirement, rights over subject data
TCPS Articles 2.1, 2.2, 2.4, 2.8, ethics framework
Date December 2007

PDF Data_Withdrawal_in_Emergency_Research_Health_Situations_december_2007.pdf

1. Thank you for your request for interpretation of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS).1 Your question concerns rights over data that have been gathered as part of research in emergency health situations, where a subject cannot give prospective free and informed consent to the research. When the subject regains capacity or an authorized third party can be located do they have the right to insist that the data already collected from those subjects be withdrawn from the study? Does the commentary to TCPS Article 2.1(c) apply, in which it indicates that a researcher can refuse to withdraw the previously collected data, on the grounds that the “elimination of the subject's data will compromise the validity of the research design, and hence diminish the ethical value of participation by other subjects”2? Your questions have been referred to the Interagency Advisory Panel on Research Ethics (PRE) for advice.3

2. In general, using a participant or subject-centred perspective4, a participant should always have the right to withdraw his/her data.

3. In the case of research involving an emergency health situation, the TCPS does not outline any circumstances under which a researcher may override the desires of the research subject to withdraw and eliminate data associated with_the subject’s participation in the study. Rather, the TCPS indicates that_“[b]ecause their incapacity to exercise free and informed consent makes them vulnerable, prospective subjects for emergency research are owed special ethical obligations and protections commensurate with the harms involved.”5 The right to withdraw one's data is thus particularly important in the context of research done in an emergency health setting, because the normal consent process is not possible.

4. The exception set out in Article 2.1(c) does not apply to research in an emergency health situation and it is not appropriate to apply the commentary elucidating Article 2.1 to Article 2.8. While Articles 2.1(c) and 2.8 both describe alterations to the normal process of free and informed consent, they are distinct from one another in both spirit and letter, and the conditions set out in each must be respected. Article 2.8 provides for a very limited exception to the normal process of free and informed consent to allow research in emergency health situations, where it would not be possible to obtain free and informed consent due to a temporary lack of competence, and immediate free and informed consent from an authorized third party is unlikely. It is not considered a waiver of consent. Once an authorized third party is found, or when the subject regains capacity, free and informed consent must be sought promptly for continuing participation.

5. On the other hand, an alteration or waiver of the normal free and informed consent process under 2.1(c) may be applied if:

  1. The research involves no more than minimal risk to the subjects;
  2. The waiver or alteration is unlikely to adversely affect the rights and welfare of the subjects;
  3. The research could not practicably be carried out without the waiver or alteration;
  4. Whenever possible and appropriate, the subjects will be provided with additional pertinent information after participation; and
  5. The waived or altered consent does not involve a therapeutic intervention.6

6. The commentary to Article 2.1(c) states:

In studies in which a waiver of informed consent has been allowed, it may still be practicable for subjects to exercise their consent at the conclusion of the study, following debriefing. In cases where a subject expresses concerns about a study, the researcher may give the subject the option of removing his or her data from the project. This approach should be used only when the elimination of the subject's data will not compromise the validity of the research design, and hence diminish the ethical value of participation by other subjects.7

7. The provisions in Article 2.8 are not considered a waiver of consent but rather an alteration of the normal process with criteria approved by the REB in advance. This commentary therefore, does not apply to research in an emergency health situation.

8. The commentary refers to particular cases of research in which subjects have been deceived about the nature of the research and thus it is not unreasonable to think that they may be upset at the debriefing depending on the true question of the research.

9. As stated above, the TCPS espouses a subject-centred perspective in which subjects “will not be treated simply as objects”8 but rather as collaborators in the research enterprise. It also emphasizes voluntariness in participating in research. The commentary following Article 2.2, states that “[c]onsent must be freely given and may be withdrawn at any time.”9 In addition, Article 2.4 states that “at the commencement of the process of free and informed consent, researchers or their qualified designated representatives shall provide prospective subjects with the following:

[…] (d) An assurance that prospective subjects are free not to participate, have the right to withdraw any time without prejudice to pre-existing entitlements, and will be given continuing and meaningful opportunities for deciding whether or not to continue to participate.10

10. Thus, the wishes of the research subject should outweigh the researchers’ concerns related to loss of data, in cases where the researcher and subject’s wishes are not in accord.

11. As the circumstances in 2.1(c) set out an exceptional circumstance in which the integrity of the research takes precedence over the wishes of the research subjects, it must be read as narrowly as possible.

We hope you will find this information helpful to your human research ethics deliberations.

Sincerely,


Secretariat on Research Ethics
On behalf the Interagency Advisory Panel on Research Ethics
pre.ethics.gc.ca


  1. Official version of the TCPS on PRE’s website at: http://pre.ethics.gc.ca/eng/archives/tcps-eptc/.
  2. TCPS, Article 2.1, p. 2.3.
  3. PRE provides advice on such interpretation questions to assist the research ethics community in applying the TCPS to the ethical issues it faces. While responses to TCPS interpretation questions may address ethical dimensions of legal issues in research ethics, PRE does not provide legal advice. Nor does it act as an appeal body on REB or institutional decisions.
  4. Please see TCPS Context of an Ethics Framework, Subsection D. “A Subject-Centred Perspective,” p. i.7.
  5. TCPS, Article 2.8, p. 2.12.
  6. TCPS, Article 2.1(c). p. 2.1
  7. TCPS, p. 2.3
  8. TCPS, p. i.7
  9. TCPS, p. 2.4.
  10. TCPS, p. 2.5 and 2.6