"The process of free and informed consent refers to the dialogue, information sharing and general process through which prospective subjects decide to participate in research involving themselves" (Tri-Council Policy Statement, p. 2.1). These guidelines have been developed to use with Policy 1406 and the Tri-Council Policy Statement (TCPS) to describe specific procedures required by the Bannatyne Campus Research Ethics Boards (REB's) when researchers are obtaining free and informed consent from prospective participants .
University of Manitoba Policy 1406: The Ethics of Research Involving Human Subjects. May 25, 2000.
TRI-COUNCIL POLICY STATEMENT: Ethical Conduct for Research Involving Humans. August 1998.
International Conference on Harmonisation (ICH): Guidelines for Good Clinical Practice. 1998.
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI : Ethical Principals Involving Human Subjects, 2002.3.0 PROCESS TO OBTAIN INFORMED CONSENT
3.2 Special Considerations
1. Illiteracy or Visual Impairment
An impartial witness should be present during the entire face-to-face interview when the participant or the LAR is unable to read the consent document i.e. illiterate or visually impaired. An impartial witness is a person, who is independent of the research team, who cannot be unfairly influenced by people involved in the trial, who attends the informed consent process if the participant or LAR cannot read the consent form and who reads the consent form and any other written material supplied to the participant.
2. Non English Speaking Participants
The Principal Investigator is responsible for ensuring that non-English speaking participants are provided with a consent form/document in the most appropriate language or an appropriate translator is present during the informed consent process.
3. Exception to Written Evidence of Consent
The REB recognizes that written evidence of consent may not always be appropriate if the identification of the participant places them at risk (e.g. research examining illegal drug use). Under circumstances such as these, the REB can allow oral consent with a waiver of the requirement for documentation. This requires an oral consent process that uses a REB approved written script, which contains the basic elements of informed consent. The script must be read to the participant in the presence of a witness. The participant will either verbally agree or not agree to participate in the study. Researchers are not required to secure documentation of these informed consent activities if the participant does not want documentation linking them to the research. The investigator should create a unique identifier for the participant and indicate verbal consent of this individual was obtained.
4. Telephone Consent
When research involves the collection of anonymous data via a survey the researcher is not required to obtain written evidence but must provide participants with appropriate information on the study. The researcher may develop a document that follows the University of Manitoba Bannatyne Campus consent template with the signature section deleted or provide a explanatory letter in lieu of a the consent template, outlining the salient issues (e.g. purpose of the study, amount of time to complete the survey, confidentiality provisions, etc). The cover letter or consent must also indicate that consent is inferred from completing and returning the survey.
6. Records to Be Kept
7. Participant Withdrawal
If a participant withdraws consent, retain the original consent form in the medical chart or Investigators research file and make a note in the medical chart or Investigator's research file that the participant withdrew from the study. Participants must never be required to sign a document indicating his/her desire to withdraw or specifically required to notify the Investigator in writing of their intent to withdraw. The participant's verbal acknowledgement of withdrawal must be honored.4.0 PARTICIPANTS INCAPABLE OF GIVING INFORMED CONSENT In principle, acutely ill or incompetent participants, who are incapable of giving free and informed consent, should not be participants in research. It is recognized however, that important studies would be impossible without using participants who are incapable of giving consent, particularly studies which are designed to benefit those very participants. Special procedures are required to ensure respect for free and informed consent and autonomy of these individuals is considered.
4.2 Incompetent Adults
"Free and informed consent must be voluntarily given, without manipulation, undue influence or coercion" (TCPS, Article 2.2.) The TCPS clearly instructs research ethics boards to pay particular attention to the "elements of trust and dependency, for example with the doctor/patient or professor/student relationships, as these can constitute undue influence on the patient to participate in research projects" (page 2.4).
For these reasons, the University of Manitoba Bannatyne Campus Research Ethics Boards have concluded:
a) When the Principal Investigator is also the treating physician or clinician (nurse, social worker, etc) the informed consent process must be supervised and conducted by an individual, who is not involved in providing medical care to the participant. Similarly, a teacher or supervisor must not obtain consent from their students or employees. The Principal Investigator remains responsible for ensuring the delegate conducting the free and informed consent process is trained and knowledgeable in all aspects of the trial.
b) In special circumstances, (e.g. emergency situations when there may insufficient time to contact the designated delegate), the REB's may consider an alternative to the recommended process of consent when it can be ascertained by the Principal Investigator that there is no individual other than the treating clinician/teacher/supervisor who is adequately trained in all aspects of the trial to conduct the informed consent process. The Investigator must make this request to the Board in his/her initial submission justifying the reasons and describing a process to the Board that ensures the prospective participants clearly understands the research role of their clinician/teacher/supervisor and that refusal to participate would not damage the therapeutic relationship or result in the withholding of health/educational services or affect performance appraisals. When the research is not time sensitive, an alternative approach may involve the treating clinician/teacher/supervisor initially explaining the procedures and risks of the study, followed by the delegate obtaining the actual consent of the individual. The suggested approach is an attempt to avoid the potential for undue coercion or misconception of the intended research component when the treating clinician/teacher/supervisor obtains consent.
6.0 WAIVING OF INFORMED CONSENT
6.1 Minimal Risk Studies
In some cases, the Research Ethics Board will consider waiving the requirement to obtain informed consent for protocols that are clearly below minimal risk when it can be demonstrated that the requirement to obtain consent would constitute an unreasonable barrier to the conduct of the research. Researchers asking for a waiver of consent must justify to the committee:
a) Why such a waiver is necessary for the conduct of the research.
b) That the research presents no risks to the participants.
c) That the participants will not be identifiable from the data collected.
d) That the requirement to obtain consent would constitute an unreasonable barrier.
e) The research does not involve a therapeutic intervention.
6.2 Emergency Health Situations
TCPS, Article 2.8 states, "Subject to all applicable legislative and regulatory requirements, research involving emergency health situations shall be conducted only if it addresses the emergency needs of individuals involved, and then only in accordance with criteria established in advance of such research by the REB. The REB may allow research that involves health emergencies to be carried out without the free and informed consent of the subject or of his or her authorized third party if All of the following apply:
a) A serious threat to the prospective subject requires immediate intervention; and
b) Either no standard efficacious care exists or the research offers a real possibility of direct benefit to the subject in comparison with standard care; and
c) Either the risk of harm is not greater than that involved in standard efficacious care, or it is clearly justified by the direct benefits to the subject; and
d) *The prospective subject is unconscious or lacks capacity to understand risks, method and purpose of the research; and
e) Third party authorization cannot be secured in sufficient time, despite diligent and documented effort to do so; and
f) No relevant prior directive by the subject is know to exist.
* The REB may determine that lack of opportunity due to time factors as a condition for research to be carried out without free and informed consent.
6.3 Waiving of Parental Consent
This waiver will usually only be considered for older adolescents, such as high school students and for protocols clearly below minimal risk. In very limited circumstances, the committee will consider a waiver of parental/guardian consent for above minimal risk studies when participation in the research may be beneficial to the participant and third party knowledge of the subject matter may place the adolescent at risk or intimidation (e.g. studies involving investigations of adolescent beliefs and behaviors regarding sexuality or use of recreational drugs; research addressing domestic violence or child abuse). For studies of this nature, the researcher must be certain that the adolescent understands the nature and consequences of the research. The researcher should still encourage the adolescent to discuss the research with the parent/guardian or a child advocate (i.e.. teacher, guidance counselor, or a person who knows the child well) and ensure adequate resources for counseling are available.
Researchers asking for a waiver of parental consent must justify to the committee:
a) Why such a waiver is necessary for the conduct of the research.
b) That the research presents no risks to the participants or that adequate resources are in place to address the potential risks.
c) That adequate steps have been taken to inform the parents of the research when appropriate
d) That each participant has the capacity to consent, meaning he/she is cognitively mature enough to understand the consent procedure and the potential risks involved.
When preparing assent forms for children it is especially important to convey information that is sensitive to their perspective on the procedures, risks, discomforts, and inconveniences using terms that are developmentally and cognitively appropriate. The form should be as brief as reasonably possible and no longer than 2 pages plus 1 page for the signatures required. The assent form should include all the required elements and sections of the University of Manitoba Bannatyne Campus assent template or justification provided to the REB why the elements have not been included.
Requesting a waiver of consent for secondary use of data/retrospective chart reviews:
Review section 6.0 of the Informed Consent Guidelines and section 3.3 of the CIHR Best Practice for Protecting Privacy in Health Research document to assist you in determining whether a research proposal meets the requirement for a waiver of consent. Your application to the REB must include a detailed rationale for requesting a waiver of consent.