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Retha Britz Copyright 2013 All rights reserved for this presentation 1 Informed Consent Retha Britz.

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1 Retha Britz Copyright 2013 All rights reserved for this presentation 1 Informed Consent Retha Britz

2 2 A Refresher What is ethics?  How we ought to behave [regardless of legislative requirements] Study of the concepts involved in practical reasoning - “good” vs “bad” & “right” vs “wrong  Reasons for the behaviour  Moral principles Research ethics?  Same in order to protect research pts from being “used as a means to the researcher’s end” i.e. exploitation

3 3 Informed Consent (IC)  For research with/on humans, IC is a ethical cornerstone  Required by all guidance documents and legislation (incl SA Constitution, 1996)  Requirement for and process of obtaining IC differ markedly in guidance documents and legislation contradictory, deficiencies, differences

4 4 What is Informed Consent? “A process by which the subject VOLUNTARILY confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate.” ICH GCP 1.28 p.5

5 5 Definition from an ethical perspective  Process of information sharing and decision making based on mutual respect and participation in the process by both the researcher and the pt (McQuoid-Mason et al., 2011).  The fundamental qualities of dignity and autonomy is central to the question of informed consent in research

6 Act No. 108 of 1996 The Constitution of the Republic of South Africa Section 12(2)(c) “not to be subjected to medical or scientific experiments without their informed consent.” SA Constitution, 1996 underpins right to autonomy… 6

7 7 When should IC be obtained? Before any research related activities  E.g………  Why?

8 8 Ethical and Legal IC Process :  Information sharing/disclosure (IC/assent document) (informed part of informed consent)  Assessment of understanding/comprehension (informed part of informed consent)  Active voluntary decision making (written consent) (consent or refusal of consent part of informed consent)  Subsequent efforts to confirm voluntary participation throughout the [long term] research study

9 9 Function of a REC? Ensure pts are protected by safeguarding their rights and well-being (which includes dignity and safety) to avoid exploitation

10 10 Which moral theories are at stake regarding the function/obligation of the REC? Kantian Deontology: Respect, Dignity Principle-based Ethics : Beneficence and non- maleficence

11 11 Informed Consent Requirements  REC to approve ICF as well as any other documents/information to be provided to participants such as questionnaires, scales, appointment cards, advertisements etc  New information becomes available/Amendments e.g. change in study procedures  Participants should not be coerced or unduly influenced to participate – How can participants be influenced?  Written consent (?but it may be threatening to some pts due to culture?)  Culturally acceptable practices - consider ethnic or social origin Understand pt world-view or value system

12 12 Consultation  Impossible to make voluntary absolute – no person is entirely free from influence  Requirement for voluntary informed consent is substantial autonomy  Pts are allowed to consult  Researchers to ask about pts view and values – never assume  Deferred consent is not allowed e.g…..?  Individual consent can not be bypassed (autonomy)

13 13 Consultation (continue)  Community leader can give permission for research to be conducted in community  Principle of autonomy does not recognise the way in which communities and traditions contribute to self formation in African context  Apply autonomy-based practice in a culturally sensitive manner  BUT universal first-person consent is required

14 14 Content of Informed Consent Documents Some guidance documents and regulations provide guidance for verbal discussion as well as the content of the Informed Consent Document. Enhancement of overall understanding of key information will promote higher ethical standards in research

15 15 Comprehension / Assessment of understanding  Substantial knowledge  No need for full understanding of all aspects of the research (Beauchamp & Childress, 2001)  Understand as a minimum the nature, effect, consequences, risks involved of the act for which consent is being sought, withdrawal

16 16 Language of Consent  Language barriers is common problem (different cultures)  Non-technical, understandable (ICH GCP)  Non-maleficent action if language will enhance understanding  Adapt according to age & education Age to consent?  Wording should be clear - carry the correct meaning intended  Language of choice (SA GCP) (prevents manipulation) vs home language (“blue book”)

17 17 Illiterate participants  Need for first-person consent based on respect for autonomy  Verbal consent by an illiterate prospective participant is ethically correct and legally binding but not prudent when disputes arise  No legislation regarding the manner in which illiterate individuals should agree to a contract  An independent (impartial) witness is essential to attend entire consent discussion and to verify in writing (by signing the consent document) that the prospective pt understood the proposed research and gave verbal consent for participation

18 18 Illiterate participants (continue)  Pt can sign by cross or thumb print  Should the impartial witness be literate or illiterate? (see SA GCP 3.5 and Blue Book)  Who can act as an impartial witness ?

19 Consent for special cases specific to clinical research 19

20 20 Surrogate Consent When is surrogate consent required?  Legally incompetent  Mentally incompetent  Emergency care research Who can act as a surrogate?

21 21 Legally incompetent pts  Age for consenting to CR participation in SA is…?  In case of prospective pt does not have legal capacity parent/guardian/caregiver to exercise a decision  NHA No 61 (2003) section 8(2)(b) and SA Children’s Act No 38 (2005) requires that the prospective pt is informed of research to the extend s/he understands  Deontological Ethics & Principle of Autonom:y pt still understands to a degree and right to choose

22 22 Legally incompetent pts (continue)  Consent vs assent?  Consent - mental & legal capacity to give permission  Assent – not full decision-making capacity; based on less than full understanding

23 23 Criteria to determine competency to assent  Comprehension (to a degree)  Exercise a choice  Communicate the choice

24 24 Assent for minors  Assent form or verbal assent?  From age 7 (literature)  Reasoning ability from age 14  Depends on complexity of research  Dissent should be respected

25 25 Mentally incapacitated participants  Ethically the intent is more NB than outcome  Attempt to respect pts’ autonomy is ethically correct  May however not fulfil criteria for competency  Not able to assent but not declining treatment surrogate decides on beneficence  Mental impairment can change e.g….?

26 26 Emergency care research  Extra vulnerable  Consent refer to an individual’s choice  First-person consent (ethically & legally required)  Presumed surrogate consent – substituted (not proxy consent)  Presumed incl pts’ choices, wishes & values  Paternalistic idea of beneficence changed over last century

27 27 Emergency care research (continue)  Deferred or subsequent consent is NOT retroactive authorisation for research initiation! (also not universalisable)  Beneficence competes here with autonomy  Deontology & Principle-based Ethics: Intrinsic worth therefore dignity & autonomy should be respected  SA Constitution, 1996 underpins autonomy

28 28 Surrogate in case of emergency care (NHA section 7(1)(b)) Specific order:  Spouse/Partner  Parent  Grandparent  Adult child  Brother or sister of the person Highly unlikely that a court order will be issued for research to continue without written informed consent as discussed e.g. research to continue only if REC has approved the research (as required by Declaration of Helsinki 2008) Challenging but researchers should consider this in the planning of the research protocol

29 29 Bibliography  BEAUCHAMP, T.L. & CHILDRESS, J.F. 2001. Principles of biomedical ethics. 5th ed. Oxford: University Press. 454 p.  GILLON, R. 2003. Ethics needs principles – four can encompass the rest – and respect for autonomy should be “first among equals”. Journal of biomedical ethics, 29(5):307-311, Oct.  GILLON, R. 1994. Principles of biomedical ethics. British medical journal, 309(6948):184- 185, 16 Jul.  HEUBEL, F. & BILLER-ANDORNO, N. 2005. The contribution of Kantian moral theory to contemporary medical ethics: a critical analysis. Medicine, health care and philosophy, 8:5- 15.  MOODLEY, K. 2011. Respect for patient autonomy. (In Moodley, K., ed. Medical ethics, law and human rights. Pretoria:Van Schaik publishers. p. 41-56.)  RACHELS, J. & RACHELS, S. 2010. The elements of moral philosophy. 6th ed. New York: McGraw-Hill p. 122-172.  VAN NIEKERK, A.A. 2011. Ethics theories and the principlist approach in bioethics. (In Moodley, K., ed. Medical Ethics, law and human rights: a South African perspective. Hatfield, Pretoria.: Van Schaik Publishers. p.19-39.)

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