National Council on Ethics in Human Research                        Conseil national d'éthique en recherche chez l'humain
 
 

S U P P L E M E N T   

Volume 7 Number 2
NCEHR Communiqué CNERH
December 1996

S U P P L E M E N T

FACILITATING ETHICAL RESEARCH:
PROMOTING INFORMED CHOICE

Discussion Document


National Council on Ethics in Human Research
(NCEHR)


774, Promenade Echo Drive
Ottawa, Canada

TEL: (613) 730-6225
FAX: (613) 730-8251

National Council on Ethics in Human Research (NCEHR) / Conseil national d'éthique en recherche chez l'humain (CNÉRH)

The views expressed in this document are for discussion purposes only.
They do not necessarily reflect those of NCEHR.

Copyright © NCEHR 1996. NCEHR authorizes REBs to photocopy the material.
ISSN 1181-8778

Table of Contents

Introduction

Section 1

Consent as an Ethical Imperative: Key Elements of Informed Choice

Section 2.

Competence and Informed Choice

Section 3.

Disclosure and Informed Choice

Section 4.

Voluntariness and Informed Choice

Section 5.

Sample Consent Forms and Checklist

A.

Annotated Research Consent Form : For Competent Adults (including Substitute Decision-Makers)

B.

Research Information Form: For Prospective Research Participants who May be Deemed Competent to Assent or Dissent to Research Participation

C.

Sample Consent Form Checklist

Section 6.

Selected Bibliography on Informed Choice

Back to Home Page


Section 5:

Sample Consent Forms and Checklist

A. Annotated Research Consent Form: For Competent Adults (Including Substitute Decision-Makers)

The requirements for adequate disclosure are summarized below under specific sub-headings. The subheadings in italics should appear in the Research Consent Form to ensure complete information and to further comprehension. To be precise, use of these subheadings helps to:

  1. ensure that relevant information is not inadvertently excluded; and
  2. encourage researchers to present the information in a manner that is more accessible to the average prospective research participant.

Research Consent Form

The form must be properly titled to ensure that the prospective research participant clearly understands that the proposed intervention is for research rather than treatment purposes.

  • Name of the institution
  • Date

The form should be dated on the upper right-hand corner of each page. This should be the date of REB approval of the protocol. The objective is to ensure that any subsequent amended version of the research consent form can be easily identified. For example, it is possible that new information regarding the potential harms and benefits of research might require a revision to the original research consent form. It follows that the date of any revision after the original approval should be placed in the upper right-hand corner.

Title of the Research

The research consent form should include the exact title of the research protocol (i.e., the title under which the research was approved and funded). When the title is particularly cumbersome, a short simplified title may be added.

Researcher(s)

The name(s), degree(s), department (and affiliation, if other than the institution where the research is being conducted), and contact telephone number(s) of all researchers should appear immediately below the title of the research project.

Care must be taken not to mislead or misrepresent facts. For example, if a researcher is a student, this must be explicitly stated and the name(s), degree(s), department (and affiliation, if other than the institution where the research is being conducted), and telephone number(s) of the supervisor must also appear on the form.

A prospective research participant might also be misled if it is not clear that Dr. Smith (M.D.) is a physician, while Dr. Jones (Ph.D.) is not. The difference and its relevant implications must be made clear.

Also, it is imperative that the contact person (usually the principal researcher) be explicitly identified and an invitation offered to the prospective research participant to call with any questions. Time of availability should be clearly indicated (e.g., Monday to Friday, 9:00 to 5:00).

Sponsor(s)

The name of the company(ies) and/or the granting agency(ies) that is (are) sponsoring the research must appear on the form. As well, it is appropriate to indicate if the research is being done at a single site or whether the research is part of a multi-centre trial.

Purpose of the Research

A brief description of the purpose of the research should explain what hypothesis is being tested and what the research is supposed to demonstrate. If there are specific inclusion and exclusion criteria for research participation, these should be noted here.

Description of the Research

A step-by-step description of the research as it will be experienced by the research participant must be provided, and it must clearly explain the expected length of her or his participation in the research. The objective is to provide the prospective research participant with a clear understanding of how she or he will be involved in the research (e.g., completion of a questionnaire, studies in behaviour modification, testing of equipment, testing of a new drug, or surgical intervention). In providing this description it is important to explain:

  1. whether any specific testing is required to determine eligibility for research participation (e.g., HIV testing, psychological testing);
  2. whether the research design involves specific research techniques such as randomization, sequential assignment, blinding, or placebo control;
  3. whether the person's health record will be reviewed;
  4. whether radiation is involved and, if so, the level of radiation to which the participant will be exposed;
  5. whether blood testing is involved and, if so, the amount of blood that will be taken;
  6. whether research participation will result in missed school or work;
  7. whether future use of the research data (e.g., subsequent use of photographs, videos, sound recordings, DNA information, permanent cell lines) is or is not anticipated. If future use of the data/samples is anticipated, this must be explained and the prospective participant must be assured that the data/samples will be maintained in a manner that ensures confidentiality. If future use of the data/ samples is not anticipated, the participant should be told that the data/samples will be destroyed once the research is complete;
  8. rules for stopping the research and/or removing a participant from the research.

As well, if the prospective research participants are patients, it is important to explain:

  1. which interventions are part of standard therapy and which interventions are purely research;
  2. whether any therapy that is being received will be altered or discontinued as a result of research participation;
  3. whether research participation will require additional visits to the hospital or lengthen hospital stay;
  4. whether the service/drug/intervention/device will or will not be available to the participant once the research is complete, assuming that the service/drug/ intervention/device was found to be beneficial. (It is expected that, where appropriate, the researcher will attempt to secure agreement from the sponsor to continue to provide the service/drug/intervention/device to research participants beyond the original research time frame, until it is available in a therapeutic context).

Potential Harms

Potential harms and potential benefits of research must be described separately from one another. Moreover, to further the goal of voluntariness, potential harms must be listed prior to potential benefits.

If there are no known or anticipated harms associated with the proposed research, this should be stated explicitly. If there are known potential harms to the research participant, these should be described as accurately as possible. This description should include relevant information about the nature of the potential harm(s) (how serious is the potential harm?), and the probability of occurrence (how likely is it that the potential harm will occur?). As well, information concerning the possibility of reversibility should be included along with a description of any precautions that will be taken to minimize the probability of occurrence. In either case, there should be a statement acknowledging the possibility of unforeseen harms.

Potential Benefits

If there are no potential benefits to the prospective research participant, this must be stated explicitly. If there are potential benefits to the participant, these should be described as accurately as possible. This description should include relevant information about the nature of the potential benefit(s) (how important are these benefits?) and the probability of occurrence (how likely is it that the potential benefits will occur?).

In research projects where there may be anticipated benefits to society or to a specific group within society (e.g., persons with a particular disease/disorder), these potential benefits must be explained in a separate paragraph so as not to confuse potential benefits to others wa particular disease/disorder), these potential benefits must be explained in a separate paragraph so as not to confuse potential benefits to others with potential benefits to the research participant.

Alternatives

If the research does not include patients as research participants, this section may be deleted. If the prospective research participant is not a patient, the alternative to research participation is non-participation and this is explained under the subheading "participation".

If the research does include patients as participants, it is important that the prospective research participant know whether there are any "treatment" alternatives. If there are no such alternatives (i.e., no available therapy), this should be stated. If there are treatment alternatives, the alternatives should be described and this description should include a summary of the nature of the alternative intervention(s), as well as the potential harms and benefits.

Confidentiality

It is important for the prospective research participant to know who will have access to the research data/samples, and how such data/samples will be stored.

Usually, it is possible to assure the prospective research participant that confidentiality will be respected and that no information that discloses the participant's identity will be released or published without the proper consent. It is important to note, however, that certain agencies may legitimately require access to research files to monitor ongoing research. When applicable, this should be explained in the research consent form and the name(s) of the agency(ies) to whom identifying information will be available should be provided (e.g., the research sponsor, Health Protection Branch, the U.S. Food and Drug Administration).

When there are separate plans to use identifying information (e.g., the use of photographs, videos, or sound recordings) for subsequent research or for teaching purposes, this must be disclosed in the research consent form and there should be a separate consent form for the subsequent use of the identifying information. In most cases, this separate consent form should only be presented to the prospective research participant once she or he has had an opportunity to review the identifying information and, on this basis, to decide whether to consent or refuse to allow the data to be used for future research or teaching.

As a separate matter, the research consent form should explain that if the participant is a patient in the institution where the research is being conducted, information regarding her or his participation will be added to her or his health record. At the very least, the signed research consent form will be part of the health record. As well, test results (e.g., HIV test, genetic tests) and other research findings (particularly when these may directly impact on treatment) may be included in the health record. If this is the intention or a likely consequence of the research, it must be disclosed.

Finally, in rare instances it will not be possible to ensure confidentiality (e.g., suspected child abuse, reportable communicable diseases). When this is the case, the prospective research participant should be aware of this limitation.

Reimbursement

When reimbursement is available for lost wages (minimum wage) and out-of-pocket expenses (transportation costs, meals, baby-sitters, etc.), this should be disclosed in the research consent form. As well, it should be explained that a decision to withdraw from the research will not affect any reimbursement costs that may have been incurred prior to withdrawal.

Participation

The prospective research participant must be told very explicitly that she or he has the right to refuse to participate in the proposed research and, moreover, that a decision to participate in the research is not binding. It is important to make it clear that participant withdrawal may be made at any time without negative consequences.

In those rare instances where it will not be possible for the participant to withdraw from the research, this should be explained (e.g., research on somatic cell gene transfer). It is equally important to advise participants that withdrawal of their participation does not necessarily include withdrawal of any data compiled up to that point.

Finally, this section should include an offer to share the research findings with the participant upon completion of the research.

Publication

The investigator must:

  1. undertake to alert the participant to publication of results; and
  2. tell the participant that such publication will not reveal the identity of the participant.

Consent

This section should provide a brief (one paragraph) summary of the research stating that the potential harms, benefits, and alternatives have been explained. There should be a statement to the effect that the prospective research participant:

  1. has read and understood the relevant information;
  2. understands that she or he may ask questions in the future;
  3. indicates free consent to research participation by signing the research consent form.

When consent is provided by a substitute decision-maker, there should be a record of the prospective research participant's assent to research participation, provided the prospective participant is capable of assent (e.g., this is possible for older children but not for comatose patients). The research participant's assent should be indicated on the form by the researcher who obtained the consent from the substitute decision-maker, not by having the participant sign the form.

The participant's (or substitute decision-maker's) signature should be followed by a signed statement from the researcher who obtained the consent. This statement should indicate that she or he explained the research to the prospective participant or substitute decision-maker and, that to the best of her or his knowledge, the prospective participant or substitute decision-maker understood the proposed research and freely consented to research participation.

Warning

The research consent form should not include any reference to a waiver by the participant of any of the participant's legal rights. The participant should not be asked to release the researcher, the sponsor, or the institution where the research is being conducted, from liability or negligence.

Suggested Wording

Potential Harms

"There are no known harms associated with your participation in this research. However, there may be harms that we don't yet know about."

Potential Benefits

"There are no known benefits to you associated with your participation in this research."
"You will not benefit directly from participation in this research."

Confidentiality

"Confidentiality will be respected. No information that discloses your identity will be released or published without your specific consent to the disclosure."

"Confidentiality will be respected. No information that discloses your identity will be released or published without your specific consent to the disclosure. However, it is important to note that the original signed research consent (and the data which will follow), will be included in your health record."

"Confidentiality will be respected. No information that discloses your identity will be released or published without your specific consent to the disclosure. However, it is important to note that the original signed research consent (and the data which will follow), will be included in your health record. As well, research records identifying you may be inspected by representatives of (at this point name the sponsoring company, the Health Protection Branch, and the U.S. Food and Drug Administration, etc.) for the purpose of monitoring the research."

But

"If we find information we are required by law to disclose (e.g., child abuse, inability to hold a valid driver's licence, etc.), we cannot guarantee confidentiality."

Participation

"Participation in research must be voluntary. If you choose not to participate, you and your family will continue to have access to quality care. If you choose to participate and later decide to change your mind, you can say no and stop the research at any time. Again, you and your family will continue to have access to quality care."

B. Research Information Form: For Prospective Research Participants who May be Deemed Competent to Assent or Dissent to Research Participation

This form can be used along with the Research Consent Form but not without it.

The following format should be used:

  • Title of the Research
  • Researcher
  • Why are we doing this research?
  • What will happen during the research?
  • Are there good things and bad things about the research?
  • Who will know about what I did in the research?
  • Can I decide if I want to be in the research?

The substance of the content listed under these headings should be the same as for the analogous headings outlined for the Annotated Research Consent Form. The information form is meant to be understood by a child seven years of age. Wording should be kept very simple. Sentences should use the active voice at all times. Restrictive clauses should be avoided.

C. Sample Consent Form Checklist

This checklist is designed to assist researchers in drafting, and REB members in reviewing, research consent forms. The checklist enumerates elements that should be included in the research consent form. Carefully review the draft consent form and check each element that is present.

The consent form clearly identifies:

the researcher(s), and if the researcher(s) is/are a student(s), the supervisor(s) (the person who is available to answer pertinent questions should be clearly identified);
the sponsor(s) of the research.

The consent form clearly explains:

that the proposed intervention is for research
(drug, device, procedure, etc., used for research purposes);
the purpose of the proposed research
(why the research is being done);
the nature of the proposed research
(what the research involves; this should include details re: the use of a placebo: the nature of the randomization; the need to discontinue standard therapy);
the likely duration of participation
(how long the research and each intervention will take):
the potential harms and inconveniences associated with the research
(the nature of the harms and inconveniences and the likelihood of their occurrence);
the potential benefits associated with the research
(the nature of the benefits to the participant or to others, and the likelihood of their occurrence);
the alternative(s) to research participation
(e.g., available standard medical therapy);
the measures taken to ensure confidentiality
(who will have access to the data? how will it be stored?);
the details regarding reimbursement;
that participation in research is voluntary
(the right to refuse and the right to withdraw without prejudice).

The consent form does not include:

any statement releasing the researcher(s), sponsor(s), institution(s), or agent(s) from liability for negligence.

The consent form is written:

in the prospective participant's (or her or his substitute decision-maker's) preferred language;
in lay terms (ordinary language); at an appropriate level (taking into consideration the nature of the participant (e.g., child or adult);
with simple explanations of clinical terms.