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The informed consent process is designed to honor the right of individuals
to decide whether they wish to become research participants.
Informed consent requires that individuals are provided with information
in a manner comprehensible to them and then given the right to choose
to become enrolled in a study. They may also choose to end their participation
at any time.
Informed consent has two parts. The first is the process, the exchange
of information. The second is the documentation of the process through
the use of an informed consent form. In practice, the form is often used
as the mechanism for the exchange of information, but it is not always
necessary to use a form.
The following discussion of informed consent is divided into two general
areas:
The Process
Documentation of Informed Consent
A checklist of the basic elements
of informed consent maybe useful for assessing your consent process.
The components of the consent process can be defined
as:
- Full Disclosure,
- Adequate Comprehension, and
- Voluntary Choice (as opposed to coerced or unduly
influenced choice)
Note: When research is exempt,
informed consent is required; however,the process is not described in
the federal regulations, as it is for research that requires expedited
or full review. The IRB has prepared Guidelines
for Informed Consent in Exempt Research.
Essential Information (a.k.a. Elements of Consent)
“Really” Full Disclosure
Exculpatory Language
Recruitment as Consent
Waivers of Elements of Consent
Federal regulations for protecting research subject include a list of
the basic required elements of consent.
The following material includes the elements of consent with explanatory
and qualifying notes for items 5 through 11.
- A statement that the study involves research
- An explanation of the research
- The expected duration of the study
- A description of the procedures to be followed
- Identification of any procedures which are experimental
"Experimental procedures" are usually associated with biomedical
research; however, research designed to study behavioral interventions
should be clear that the intervention is the object of study
and the outcome is not known.
- A description of appropriate alternative procedures or courses
of treatment, if any, that might be advantageous to the subject
The intent of this requirement is to give potential subjects the
option to consider alternative approaches, other than that offered
by the researcher, to manage their health and/or disorders. Thus it
is rarely relevant in social and behavioral sciences. Exceptions might
be for behavioral interventions in the treatment of problems such
as Post Traumatic Stress Disorder.
- A description of any foreseeable risks or discomforts
If there is absolutely no risk to subjects, such as when the data
gathered is innocuous, it is not necessary to tell subjects that there
is no anticipated risk. (This assumes that the question of risk has
been thoroughly explored by the investigator and the IRB.)
- A description of benefits to the subject or others which
may result from the study
Much research in social and behavioral sciences research has no direct
benefit to subjects. As a general rule, when there are no benefits
to individual subjects they must be told what the researcher hopes
to learn, how that knowledge will contribute to the field of study,
or may perhaps benefit others, if indeed such cases can be made.
- A statement describing the extent, if any, to which confidentiality
or records identifying the subject will be maintained
Confidentiality procedures should be described in enough detail for
potential subjects to be able to make informed decisions about their
participation.
Descriptions of confidentiality procedures must be truthful about
the extent to which records can be protected. For example, an explanation
must be provided about reporting responsibilities of the researchers
such as when child abuse or suspected child abuse is revealed during
the course of the study.
- An explanation that participation is voluntary and that the
subject may discontinue participation at any time
There may be consequences for withdrawing from a study. For example,
if students in the Psychology Subject Pool withdraw early, they may
or may not receive full credit for their participation, according to
the discretion of the researcher.
Researchers should also think about the ways in which subjects might
worry about consequences or reprisals from some source other than the
researcher. Parents may worry that if they don’t give permission
for their school children to participate in a study, the teacher will
be mad or will think poorly of the family.
It is important to tell prospective subjects that they don’t have
to participate, they may withdraw at any time, and they make skip questions
if they don’t want to answer them.
- An explanation of whom to contact for answers to pertinent
questions about the research and subjects’ rights
This section should include contacts for the researcher and the Chair
of the IRB, although there are circumstance in which provide the contact
for the Chair may be waived, for example, when the subjects are illiterate
or without access to any communications technologies.
- Terms of payment and conditions under which subjects will receive
no or partial payment
:
The following elements will rarely apply to social and behavioral sciences
research.
- For research involving more than minimal risk a description of treatments
available if injury occurs, and if so, what they consist of, and where
further information may be obtained. (In social and behavioral sciences
"injury" refers primarily to psychological distress. "Treatments"
may consist of referrals for counseling and support.)
- Additional costs that may result from participation in the research,
for example, travel expenses
- An explanation of whom to contact in the event of research-related
injury.
- A statement that significant new findings developed during the course
of the research which may relate to the subject's willingness to continue
participation will be provided to the subject.
In addition to considering the above elements, investigators should attempt
to view the matter from the subject's perspective by asking what facts
the subjects might want to know before deciding whether to participate
in the research. Information could be deemed material if it might influence
the decision of any reasonable person.
Informed consent may not contain any exculpatory language: Subjects may
not be asked to waive, or appear to waive, any of their legal rights,
nor may they be asked to release the investigator, sponsor, or institution
(or its agents) from liability for negligence.
Recruitment is part of the consent process because it begins the disclosure
process. Thus all recruitment materials such as fliers, email messages,
newspaper ads, phone calls, and so on, must be approved by the IRB before
they are implemented.
If investigators plan to post flyers at Duke University Medical Center
they must receive permission to do so.
The IRB may waive, or alter, some or all of the elements of consent if
it ensures that all the following criteria are met:
- The research involves no more than minimal risk.
- The research could not practicably be carried out without the waiver
or alteration.
- The waiver or alteration will not adversely affect the rights and
welfare of the subjects.
- Whenever appropriate, the participants will be debriefed after participating
in the research.
The option to waive or alter the consent process is a useful tool for
social and behavioral scientists. It allows the use of deception, for
example. The criteria may also permit waivers of the entire consent process,
such as when it is not a reasonable requirement that parental permission
be secured for some kinds of research with older adolescents.
Language Issues
Format
Ideally, obtaining consent is a process in which the researcher has the
opportunity to explain the research, ask potential subjects if they have
questions, and ask questions of the subject to be sure they understand
what is being asked of them. This process is documented by the use of
a consent form.
However, much social and behavioral science research is conducted through
mailed surveys or initiated with written communications, such as letters
sent home with parents. In these instances, reading level and the structure
of the document become very important.
- The IRB must ensure that information will be presented to prospective
subjects in language they can understand.
- One of the most common problems with consent forms is that they are
written at a grade level much higher than that of the prospective subjects
and include jargon rarely understood by people outside the researcher's
discipline.
- It is not possible to prescribe a grade level for consent forms.
We know that the average American reads at the eighth grade level,
but many read at a lower level.
- Common sense is important. The IRB will not approve consent forms
written at a twelfth grade level for distribution in a low-resource
neighborhood.
- The best way to ensure comprehension is to pilot consent forms
and find out what works and doesn't work.
- If English is not the subject population’s primary language,
the explanations and the forms should be translated into the subjects’
primary language. The IRB may require an independent confirmation of
the translation.
- The IRB may ask members of the prospective subject population: for
exmple,, children, to review consent forms and indicate which parts
they do not understand.
- Consent forms should be written in the second person. “If you
agree to be in this study, you will be asked to complete three questionnaires."
- Instructions for signing a consent form should be extremely clear,
particularly if the consent is layered, that is there is more than one
decision the subject must make. For example a subject may agree to be
interviewed, but not agree to be videotaped.
If the material is complex and/or the IRB anticipates that subjects may
have difficulty understanding the material, the IRB may suggest that researchers
use techniques such as bold-faced titles within the document. One technique
is to include enough information in the headings that a subject could get
the basic structure of the study if they just read the headings. For example,
“You will be asked to complete three questionnaires” as a heading
followed by more information about when and where and how long.
Even is a study is innocuous, subjects must be informed that they do
not have to participate, they do not have to answer if they so chose,
and they may withdraw at any time.
Duke Policy has identified categories of researcher subject relationship
in which the possibility of coercion exists. They are when the potential
subjects are students or employees of the researcher. This relationship
is discouraged and will only be permitted under limited circumstances.
The setting and timing of the interaction may be as important as the
content of the consent document. For example, undocumented aliens confronting
a researcher holding a clipboard at their front door might not feel free
to decline. Athletes recruited under the watchful eye of their coach might
not either.
Subjects must be given adequate time to consider whether or not they
wish to participate in a study.
Compensation must be appropriate for a study and not coercive. Determining
whether or not proposed compensation is coercive will require a knowledge
of the local research context.
Exempt research is research with
human subjects. It is research that carries no risk and is thus exempt
from the provisions of 45 CFR 46. Those provisions include specific requirement
for elements of informed consent.
However, the ethical principles in the Belmont
Report covers all research with human subjects. Therefore, exempt
research must include a consent process. The principle of respect for
persons requires that subjects be fully informed in a manner comprehensible
to them, and that it be made clear that they do not have to participate
and that they may withdraw at anytime.
Procedures for Documenting Consent
Waivers of the Requirement for Documenting Consent
There are two distinct procedures for documenting consent.
- The subject or the subject’s legal representative signs a form
containing all the required elements of consent and any other elements
necessary to provide complete disclosure. The person who signed the
consent form must be given a copy as a reference and reminder of the
information conveyed.
- The consent is done orally and is documented by an impartial witness.
The witness confirms that the process took place and confirms the content
of the process. Subjects who consent to participate are given short
written summaries of the information presented to them. Although they
may not be able to read themselves, they may have a family member or
friend who may be able to do so. (This becomes moot if the subject population
has no written language.)
Documentation of the consent process is not always required. It may be waived
under the following two conditions:
- The principal risks are those associated with a breach of confidentiality
concerning the subject's participation in the research (for example.,
studies on sensitive topics such as drug abuse or sexual deviance);
and the consent document is the only record linking the subject with
the research.
- The research involves procedures for which consent is not normally
required outside the research environment, for example, phone surveys.
In cases where the requirement for documentation is waived, the IRB may
require the investigator to present a written statement regarding the
research to each subject.
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