Informed Consent Guidelines

"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 .

2.0 RELEVANT POLICIES

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

3.1 Process

• Informed consent must be obtained from the participant or if the participant is not able to give consent, from the participant's legally acceptable representative (LAR) (e.g. parent, guardian or designated other) prior to involvement in any research related activity. Written evidence of informed consent should be obtained and must be in the case of biomedical clinical trials. If an alternative to written evidence is proposed the researcher must justify to the REB why written evidence will not be obtained.
• When the attending clinician has knowledge of the research, such knowledge should be shared with the patient in an objective way. The clinician should ascertain whether or not the patient is agreeable to be spoken to by research personnel and may identify only those patients who are interested. Under no circumstances should the clinician actively recruit the patient for a research project.
• Someone trained and knowledgeable in all aspects of the study and informed consent procedures must observe the informed consent process and be available to answer questions.
• The informed consent process begins when a member of the research team has the first contact with the participant or the LAR and continues through the course of the study. The initial contact should involve a face-to-face interview where the investigator/delegate gives information in simple, non-technical language that suits the individual's level of understanding and provides adequate opportunities for the participant to ask questions and contemplate participation. After the verbal exchange, the participant should be presented with a consent document and given sufficient time to read the form before agreeing to participate.
• Prior to obtaining consent, whether it is written or verbal, the researcher/delegate must ensure the prospective participants or the LAR adequately understands the purpose of the research study, the nature and extent of his or her participation, and the risks involved. If the risk is high or the issues are complex it may be necessary to administer a series of oral or written questions to confirm comprehension.
• To obtain written evidence of consent, have the participant or LAR initial each page of the consent form and sign the final page where indicated. The person obtaining consent must sign the form as well. In special circumstances a witness or translator are required to sign the consent form if involved in the informed consent process. Each signatory is to date his or her own signature.

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

• In some minimal risk studies (e.g. questionnaires, surveys) it may be appropriate to obtain informed consent by a witnessed telephone call or initial telephone consent followed by a mail returned consent form.
• Telephone consent that is witnessed by an individual independent of the research team may be acceptable for research in emergency health issues. This consent procedure may be used only when the LAR has not arrived with the potential study participant and is not expected at the hospital within the limited time frame that the research must commence. Where feasible, the LAR should be faxed a copy of the consent and given time to read the consent form or the consent form must be read/explained to them over the phone. The time, relationship and telephone number of the individual who provides consent must be recorded. At the next available opportunity however, a signed consent form should be obtained. The REB office must be notified within 5 days if telephone consent has been obtained as described above.

5.  Surveys

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

• The participant or the LAR is to be provided with a signed copy of the consent (photocopy is acceptable) following the consent process. The signed original must be retained by the Investigator according to the particular institutional policy in either the medical chart or research file. Research genetic consent forms should not be placed in the medical chart of the participant. The consent form must not be forwarded to the study sponsor as it contains identifying information.
• If verbal consent was obtained from the participant, a copy of the informed consent should be left with the participant. This copy should include a note on the signature page that verbal consent was obtained on a specified date.
• Each research unit should develop a policy describing the step-by-step process for obtaining consent and present this to the REB for review. A note must be made in the medical chart or participant's research record describing the procedures/process used to seek free and informed consent. If an REB approved consent policy was followed, a note indicating the policy was followed would be sufficient.

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.

4.1 Children

• The consent of the parent or guardian is required for all ages up to 18. The REB may determine that a research protocol is designed for a condition or participant population for which parental or guardian permission is not a reasonable requirement to protect the participant and may waive such requirement (see section for waiver of parental consent).
• Up to 6 years of age, in addition to parental/guardian consent, the child should be provided with appropriate information on the study procedures directly affecting them.
• From the age of 7, the child's willingness to participate in research must be assessed after he /she has been involved in a process that describes the purpose and procedures of the study using terms and concepts that are developmentally and cognitively appropriate. Prior to the discussion, the Investigator/delegate should consult with the parent/guardian to determine whether they want to present the information or if the Investigator/delegate is to present the information. At some point prior to enrolling the child in the research, the investigator/delegate must either observe the parent /guardian discussion or assess the child's understanding and when appropriate provide additional information to ensure the child is adequately informed.
• An age appropriate assent form (see assent form requirements in section 7.0 and assent template) must be developed which can be incorporated into the assent process for children 7-13 years of age. After consultation with the parent/guardian for permission to present the form and an assessment of the child's cognitive skills, the child should be encouraged to read the form or have it read to him/her. If the parent/guardian does not want their child to read the form, the form can be used as a reference during the consent process.
• From approximately the age of 14, children who are able to read should be encouraged to read the informed consent form or an age appropriate assent form after the discussion.
• The child should sign an assent or consent form if they agree to participate. If the child does not want to sign the form but displays their willingness to participate, the process of the discussion must be documented.
• The child's objection to participating in research should be binding unless the intervention holds out a prospect of direct benefit that is important to the health or well being of that child and is available only in the context of research. It would be desirable in these types of studies if the Investigator/delegate first consult the parent/guardian as to what information will be presented and whether the child's objection to the research would be supported by the parent/guardian. Any objection must be closely evaluated prior to entering the child into the research and the details of the issues documented precisely. The REB must be notified in writing within one working day of the justification to the inclusion of a child who has objected. The REB recommends that the decision of cognitively mature children over the age 13 is respected and not solely decided by the parent /guardian.
• No financial or other inducement should be offered to parents, guardians or children to persuade them to enter their child into a research project: any reasonable expenses incurred, however, should be reimbursed (e.g. transportation costs).
• The Investigator/delegate must document the assent process and are encouraged to develop a policy for the unit, which describes the step-by step processes used to obtain assent/consent. This policy must be submitted to the REB for initial review and approval.

4.2 Incompetent Adults

• Consent of all cases involving research on incompetent adults, excluding some emergency research, must be obtained from the legally acceptable representative, prior to the research project being initiated.
• As with children the incompetent adult must be involved in a similar consent/assent process to the extent reasonably possible and presented with information in concepts/terms they can understand. Their willingness to participate must be assessed and respected when reasonably possible.

5.0  WHO CAN OBTAIN CONSENT?

"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.

• The Investigator must provide justification for this waiver in the initial application to the board.
• At the time of enrolment, the Investigator should also consult a patient representative/advocate, if available, to assess the circumstances . When consent of the participant or the LAR is not obtained, the investigator and a physician not involved in the investigations must justify in writing the above conditions and summarize the efforts made to contact the legally authorized representative within 5 working days . This report will initially be reviewed by the Chair of the Board and presented to committee members at the next full board meeting.

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.

7.0 REQUIRED ELEMENTS OF INFORMED CONSENT

8.0 ASSENT FORM REQUIREMENTS

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.