Informed Consent Requirements and Documentation Policy and Procedure

AC-AER-002
Informed Consent Requirements and Documentation Policy and Procedure
DepartmentApplied Educational Research
Creation DateJanuary 4, 2011
Approval DateJanuary 4, 2011
Effective DateJanuary 4, 2011

Organizational Scope

This policy pertains to all staff, faculty, students or external persons intending to participate in or carry out research at and/or in collaboration with the Michener Institute.

Purpose

The purpose of this policy is to describe the requirements for obtaining and documenting informed consent.

Definitions

Legally Acceptable Representative: an individual or entity authorized by law to consent, on behalf of a prospective participant, to participation in a research study.

ICF: Informed Consent Form

RHPA: Regulated Health Professions Act, 1991.

Policy

The process of free and Informed Consent is a cornerstone of ethical research involving human participants.  It starts before the initial participant contact and continues through the entirety of the study involving the dissemination, information exchange and process in which participants choose to take part in a research project.  At all times during the informed consent process, the three core principles of the TCPS 2: Respect for Persons, Concern for Welfare and Justice, will be maintained.  Unless otherwise indicated, it is presumed that individuals have the capacity and right to make a free and informed decision regarding their participation in any potential study.

The Research Ethics Board (REB) reviews consent documents and procedures to ensure compliance with current scientific, regulatory and ethical standards.  Unless the REB has granted a waiver, investigators are responsible for obtaining informed consent from potential research participants or their legally acceptable representatives before conducting any research-related procedures.

Responsibility:

This policy applies to the Chair,  investigator(s), members of the REB and research office.

The investigator will provide the REB with detailed consent documents; outline the consent process and recruitment methods.

The investigator and sponsor (if applicable) will ensure that all the required elements are clearly included in the consent form.  (Requirements for informed consent documentation can be found on the website or by contacting the research office).

The investigator will provide translated consent documentation if required.

The REB will determine the applicability of exemptions and waivers to informed consent.

2.0 Procedures

2.1         General requirements for Informed Consent

2.1.1      The process of informed consent will comply with the requirements defined by the TCPS 2 and the ICH-GCP Good Clinical Practice: Consolidated Guidelines;

2.1.2      If applicable (i.e. US studies), the process of informed consent will comply with any other requirements deemed necessary.  (see Policy: US Based or Funded research with specific  focus on: 45 CFR 46.116 and 21 CFR 50.25)

2.2         Required elements for of informed consent documents

2.2.1      The research office will appropriately distribute consent documentation to reviewers for review;

2.2.2      REB member(s) will review consent documentation utilizing the Michener Consent Form Checklist and Template in order to assure that all requirements have been met;

2.2.3      The REB will approve or request changed to the ICF documents and the research office will document these required changes (see Policy: REB Documentation);

2.2.4      The REB Chair or designate will approve the required changes to the ICF documentation requested as a result of review.

2.3         Translation:

2.3.1      The process of informed consent should occur in a language that is understandable to the potential participant or legally acceptable representative;

2.3.2      When a potential study participant does not speak and/or understand English one of the two following methods may be used for obtaining informed consent:

  • Written translation of the ICF documents: The REB approved English version of the ICF is translated to the potential subject’s native language;
  • Oral consent of the ICF documents: A translator fluent in English and the potential participants native language will translate the REB approved English version of the ICF.  The translator should be impartial and if the study involves clinical interventions the translator should be a member of the RHPA;
    • Translated material must be submitted to the REB via delegated review for approval prior to use if English documents have been previously approved. An attestation certificate of the translator is required;

2.3.4      The translator will sign and date the ICF indicating that the information was accurately translated and understood by the potential participant.

  • Re-Consenting Participants

2.4.1      In situation where new information comes to light that may affect a participant’s willingness to continue to participate in an ongoing research project, the investigator will inform research participants of the new information;

  • In situations where there is a significant change to the protocol or an increase in risk to the participant, the investigator will obtain consent from the participant to continue participation in the study. This consent will be documented preferably via an REB approved amended ICF.
  • Recruitment Materials
    • The REB will review recruitment materials as part of the study review process. Recruitment materials (advertisements, letters, notices, emails) will be free from coercive or influential tone and be consistent with the study protocol;
    • Information on recruitment materials will be limited to only the information a potential participant needs to make an informed decision. Information that should be readily available to the potential participant includes:
  • Full Study Title
  • Michener Logo
  • The name of the investigator(s)
  • Contact information of investigator/person knowledgeable in research ethics
  • Purpose of the study
  • Summary of what will be done and participant’s responsibilities
  • Number of participants needed
  • Duration of study and duration each participant will be involved
  • Where the study will take place
  • Payments/costs of participating
  • Participant’s rights
  • Documentation of Informed Consent
    • Unless otherwise approved, evidence of free and informed consent will be documented in writing by the investigator via an REB approved ICF;
    • The ICF will be version dated and will be signed and dated by the participant and/or their legally acceptable representative, and by the person obtaining consent;
    • A copy of the signed, dated ICF will be given to the participant;
    • The investigator will be responsible for maintaining the signed, dated ICF in a secure environment and may be asked to produce them if required by the REB.
  • Waivers or Alterations of Informed Consent
    • In certain circumstances the REB may grant a waiver of consent or allow some of the processes of informed consent to be altered. These instances usually occur when:
  • The research involves no more than minimal risk to participants;
  • The lack of the participant’s consent is unlikely to adversely affect the rights or welfare of the participant;
  • The research could not practicably be carried out without a waiver or alteration of consent;
  • The research does not involve a therapeutic intervention or other clinical or diagnostic intervention;
  • The benefits to the public of conducting the research outweigh public interest of protecting the privacy of individuals;
  • The study specifics meet all the required regulatory elements for waivers.
    • If appropriate and possible, the participant will be provided with information regarding their involvement after the fact;
    • The REB will document justifications for waivers or alterations in their minutes (see Policy: REB Documentation).

3.0 References

  1. Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans, Medical research Council of Canada 2010. Chapter 3

http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/

  1. ICH Harmonized Tripartite Guideline. Good Clinical Practice: Consolidated Guideline (E6)1996. Section 4.8.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php

  1. Government of Ontario. The Regulated Health Professions Act (RHPA) 1991.

http://www.e-laws.gov.on.ca/html/statutes/english/elaws_statutes_91r18_e.htm

Associated Documentation

Policy:  US Based or Funded Research

Policy:  REB Documentation