1. Good Clinical Research Practice Guidelines For Informed Consent Presented by Catherine May Acting Research Practice Development Officer The Office of Research Development - SCGH The following references are the basis for the information included in this presentation – Guidelines for Good Clinical Practice http://www.tga.gov.au/docs/pdf/euguide/ich/ich13595.pdfhttp://www.tga.gov.au/docs/pdf/euguide/ich/ich13595.pdf International Conference of Harmonisation http://www.ich.org/http://www.ich.org/ Declaration of Helsinki http://www.health.gov.au/nhmrc/issues/helsinki.htmhttp://www.health.gov.au/nhmrc/issues/helsinki.htm NHMRC Statement on Ethical Conduct in research involving humans. http://www.nhmrc.gov.au/publications/pdf/e35.pdf http://www.nhmrc.gov.au/publications/pdf/e35.pdf World Health Organisation http://www.who.int/ethics/en/http://www.who.int/ethics/en/

2. Good Clinical Practice Principles  GCP is an International ethical & scientific quality standard for designing, conducting, recording & reporting trials involving humans.  Compliance with the standards assures that the RIGHTS, SAFETY and WELL- BEING of subjects are protected.

3. GCP Informed Consent Introduction: “Informed Consent is the process whereby a person voluntarily confirms their willingness to participate in a research trial after being informed of ALL aspects of the trial relevant to their participation” This is documented by a written, signed & dated Consent Form. Reference: TGA Note for Guidance on GCP Section 1.28 http://www.tga.gov.au/http://www.tga.gov.au/

4. Declaration of Helsinki Basic Principles - Section 9 In any research with human beings, each potential subject must be adequately informed of –  The study aims  The study methods  Anticipated benefits  Potential hazards &  Any discomfort the study may entail

5. Declaration of Helsinki Basic Principles - Section 9 cont.  The participant should be informed that they are at liberty to abstain from participation in the study and that they are free to withdraw their consent to participate at any time.  The physician or delegated person responsible in obtaining consent, should then obtain the subject's freely given informed consent.

6. Human Research Ethics Committee Requirements  Written approval for the trial including the participant information sheet and consent form are obtained prior to commencing recruitment.  Any revision/s to the initial approved documentation must be re-submitted to the HREC for review/approval prior to implementation.

7. Ethical & Legal Requirements 1. Provision of information to participants - Purpose, methods, risks, inconveniences, discomforts, results publication described at a level of comprehension. 2.Participants have the capacity to exercise voluntary choice to participate or withdraw their participation at any stage.

8. Elements of Informed Consent  Informed consent MUST be obtained before ANY trial-related procedures are undertaken e.g. dietary lead-in, medication changes, fasting etc.  Informed consent is an ongoing process throughout the trial.  Revised consent forms are completed as per initial consent procedures (e.g. protocol amendment/s, new findings require EC approval).

9. Elements of Informed Consent cont.  Ample time must be given to the participant to consider participation, ask questions, discuss with others pre consent form completion.  Participation in a trial must be given freely and voluntarily i.e. no elements of coercion, inducement or influence must occur.  The consent process should reflect good communication between researchers and participants.

10. Elements of Informed Consent cont.  Researchers should obtain consent from participants appropriate to their culture & circumstances.  All information should be presented so that potential participants can comprehend and make a decision about what is being asked of them.

11. Elements of Informed Consent cont.  The Investigator must obtain assurance from the participant that ALL queries have been answered to their satisfaction.  The Investigator should feel satisfied that the participant has agreed to participate.  The participant (or legally acceptable representative) must personally sign & date their consent form.

12. Elements of Informed Consent cont.  The person who conducted the informed consent discussion (PI or person assigned this responsibility) must also sign, date the consent form.  The participant must receive a copy of their completed consent form.  A research participant’s informed consent is one of the basic elements for good clinical practice in research. Reference: Informed Consent of Trial Patients – Section 4.8 www.tga.gov.au/docs/pdf/euguide/ich/ich13595.pdf www.tga.gov.au/docs/pdf/euguide/ich/ich13595.pdf

13. Informed Consent – Special Cases It is ethically acceptable to conduct specific types of research without obtaining consent from participants in the following circumstances -  Observational research in public places.  Anonymous surveys.  Use of de-identified data in epidemiological research.  Clinical Audits.  Research or the compilation or analysis of statistics relevant to public health or safety.

14. Informed Consent – Special Cases cont. “In case of legal incompetence to give consent, the Guardianship & Administration Act of WA does not provide a legal authority to a legal guardian to give consent for next of kin to participate in research. Participation in such research is only permitted if determined by medical professionals to be in the best interests of the individual. If that is the case then consent is not required but it is imperative to ensure that next of kin are fully informed of what is happening. In practice this excludes almost all but non-invasive research. Please refer to Section 4,5 and 6 in the national statement for ethical issues.” Further Reading: Karlawish, J.H.T. 2003, 'Research Involving Cognitively Impaired Adults,' NEJM Volume 348:1389-1392 April 3, 2003 Number 14 http://www.nejm.org /http://www.nejm.org / http://www.scgh.health.wa.gov.au/departments/ethics/

15. Consent for Research If EITHER or BOTH Subject/legal Representative Cannot Read The following should be implemented –  An impartial witness must be present throughout the entire informed consent discussion.  The Consent Form is read “IN FULL” & explained to the subject & their legally acceptable representative.

16. Consent for Research If EITHER or BOTH Subject/legal Representative Cannot Read Cont.  The patient/subject/legally acceptable representative can give verbal consent to participate in the trial once all questions have been answered satisfactorily.  If possible, the patient/subject should sign and date their consent form.

17. Consent for Research If EITHER or BOTH Subject/legal Representative Cannot Read Cont. The impartial witness should sign/date the consent form attesting that -  The verbal & written consent information was accurately explained and understood by the subject/patient and/or their legally acceptable representative  That consent was freely given. References: Note for guidance on Good Clinical Practice – Sections 4.8.9 http://www.tga.gov.au/docs/pdf/euguide/ich/ich13595.pdf

18. Module Summary  Bad ethics = bad research.  A research participant’s informed consent is one of the basic elements for good clinical practice in research.

19. Module Summary  When formulating a patient information sheet and consent form, ensure strict adherence to the to the SCGH guiding principles before submitting documents for HREC review and approval.  Ensure that patients/participants are given adequate time to review the patient information sheet.

20. Module Summary  Ensure that patients/participants are given adequate time to ask questions related to their participation in the study.  Prior to the participant signing and dating their consent form, enquire whether or not they have any further questions and do they feel their questions have been answered satisfactorily.

21. Module Summary  The investigator must be satisfied that the participant is making the decision to participate voluntarily.  The investigator must be satisfied that the participant has not been coerced or unduly influenced by circumstances, other people, or incentives offered as part of the trial.

22. Module Summary - Final  REMEMBER Informed consent is an ongoing process throughout the trial.