There is general consensus on the importance of informed consent in research.

Most people
have the expectation that they will be treated with respect and as autonomous individuals.
They also expect that they have the right to make decisions about what will and will not be
done to them and about what personal information they will share with others.

However, researchers also are aware that there are circumstances in which obtaining and
documenting consent in social and behavioral research may be a complex, and often
challenging, process. For instance, potential subjects may be fluent in a language but not
literate. Researchers may need to deceive research subjects in order obtain scientifically
valid data. Asking subjects to sign consent forms linking them to a study about illegal
activities could put them at risk of harm.

The federal regulations provide sufficient flexibility to address some of these concerns,
particularly for research posing no more than minimal risk of harm. For example, the
regulations allow waivers of and alterations in the requirements for the consent and
documentation processes.

Learning Objectives

By the end of this module you should be able to:

 Distinguish between consent as a process and the documentation of consent.

 Recognize the elements of consent.
 Determine when waivers are appropriate.
 Identify methods for ensuring comprehension of consent.

Overview of Informed Consent

Federal regulations require researchers to obtain legally effective informed consent from
the subject or the subject's legally authorized representative (LAR). There are two parts to
informed consent. The first is the process of providing information to prospective subjects.
The second is documentation that the process took place and is a record of the subjects'
agreement to take part in the study. In practice, informed consent forms often are used as a
means to provide information about a study, and, when signed, serve as documentation of
consent. However, in some cases, an oral consent process without documentation may be
approved by an Institutional Review Board (IRB).

The Process
Informed consent is a process that begins with the
recruitment and screening of a subject and continues
throughout the subject's involvement in the research. It
includes:

 Providing specific information about the study to

subjects in a way that is understandable to them.
 Answering questions to ensure that subjects understand the research and their role in it.
 Giving subjects sufficient time to consider their decisions.
 Obtaining the voluntary agreement of subjects to take part in the study. The agreement is
only to enter the study, as subjects may withdraw at any time, decline to answer specific
questions, or complete specific tasks at any time during the research.

Documentation
Documentation of consent provides a record that the consent process took place. It
generally consists of a consent form signed by the subject or the subject's LAR. In practice,
this document often is used as a tool for engaging in the consent process. Informed consent
may be documented by other means, such as audio or video recording, as approved by an
IRB.

Information That Must Be Provided to Subjects

Federal regulations at 45 CFR 46 (Protection of Human Subjects 2009) about informed
consent list specific elements of information that must be provided to subjects. The
elements are divided into two categories. The first includes basic elements to be provided to
subjects. The second lists elements that must be included if appropriate. The two lists are
provided below with comments.

Basic Elements
 A statement that the study involves research, an explanation of the purposes of the
research and the expected duration of the subject's participation, a description of the
procedures to be followed, and identification of any procedures which are experimental.
 A description of any reasonably foreseeable risks or discomforts to the subject.
 A description of any benefits to the subject or to others, which may reasonably be
expected from the research.
If there are no direct benefits, the researchers may tell subjects what they hope to learn,
how that knowledge will contribute to the field of study or how the knowledge might
benefit others if such a case can be made.
 A disclosure of appropriate alternative procedures or courses of treatment, if any, that
might be advantageous to the subject.
This requirement is primarily relevant for biomedical research. However, it might be
applicable to social and behavioral research if behavioral interventions, such as novel
teaching or therapeutic methods, are proposed.
 A statement describing the extent, if any, to which confidentiality of records identifying
the subject will be maintained.
The description must include a full disclosure of any state-mandated reporting
requirements, such as suspicion of child abuse and/or neglect or harm to others, when
warranted by the topic under investigation. State requirements vary, so IRBs and
researchers must be aware of state-specific information.
 For research involving more than minimal risk, an explanation as to whether any
medical treatments are available if injury occurs and, if so, what they consist of, what
compensation will be provided, and where further information may be obtained.
 An explanation of whom to contact for answers to pertinent questions about the research
and research subjects' rights, and whom to contact in the event of a research-related
injury to the subject.
In some field research, there may not be any way for subjects to call or email anyone
about their questions and concerns. Alternative means of communication must be
established, such as a local contact on the research team.
 A statement that participation is voluntary, refusal to participate will involve no penalty
or loss of benefits to which the subject is otherwise entitled, and the subject may
discontinue participation at any time without penalty or loss of benefits to which the
subject is otherwise entitled.
Most researchers in the social and behavioral sciences are not in a position to impose
penalties. However, specific study-related assurances that there will be no negative
consequences associated with choosing not to take part might be appropriate. For
example, parents may need to be assured that if they choose not to participate in a
school-based, school-approved study their children's grades or placement will not be
affected.

Additional Elements
Depending upon the nature of the research and the risks
involved, there may be additional required elements,
including:

 A statement that the particular treatment or

procedure may involve risks to the subject (or the
embryo or fetus, if the subject is or may become
pregnant), which are currently unforeseeable.
 Anticipated circumstances under which the subject's
participation may be terminated by the investigator without regard to the subject's
consent.
 Any additional costs to the subject that may result from participation in the research.
 The consequences of a subject's decision to withdraw from the research and procedures
for orderly termination of participation by the subject.
Subjects need to know, for example, how their compensation will be affected if they
choose not to complete an interview. Discussion of what happens to data already
collected if they withdraw midway through the study also may be addressed in this
section.
 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.
This requirement applies primarily to biomedical research involving new treatments and
procedures, but also may apply to research on experimental behavioral interventions.
 The approximate number of subjects involved in the study.

Incentives
Incentives are payments or gifts offered to subjects as reimbursement for their participation.
These must be described during the consent process as well as the conditions under which
subjects will receive partial or no payment.

Recruitment
Recruitment is part of the consent process because it begins the process of providing
information about the study. All recruitment strategies such as fliers, email messages,
newspaper advertisements, phone scripts, and so on must be reviewed and approved by an
IRB before they are used.

Exculpatory Language
Subjects may not be asked to waive or even appear to waive any of their legal rights. They
may not be asked to release a researcher, sponsor, or institution from liability for
negligence. Institutions may provide information about how liabilities will be covered.

Ensuring Comprehension of Consent Information

Researchers are required to provide information in a manner understandable to the subjects.
This requires preparing material in the subjects' language at the appropriate reading level.
When a study is complex and/or the reading or educational level of the prospective study
population is low, the role of dialog and explanation becomes an even more crucial part of
the consent process.

Ensuring Free Choice

The principle of respect for persons requires that participation in research be truly
voluntary, free from coercion or undue influence. Even when a study is innocuous, subjects
must be informed that they do not have to take part, and they may choose to stop
participating at any time.

Setting and Time

Researchers should consider ways in which the setting
of the consent process might include elements of undue
influence. Potential subjects might not feel entirely free
to choose whether to take part in a research study if
they are:

 Adolescents whose parents are in the room

 Adolescents in a group of other adolescents being
recruited for the same study
 Parents who receive a letter from the school principal asking them for permission to
enroll their children in a study
 Athletes recruited by their coach
 Employees asked to take part by their employer
Subjects must be given adequate time to consider whether they wish to take part in a study.
This is particularly true if the study procedures involve more than minimal risk or will
require subjects to disclose sensitive information.

Compensation or incentives to participate may not be so high that they override other
considerations for potential subjects. Determining whether incentives are unduly influential
depends on the research context and the financial and emotional resources of the subjects.

Safeguards for Vulnerable Subjects during Consent

Federal regulations state that IRBs must ensure that appropriate safeguards are in place to
protect the rights and welfare of subjects likely to be vulnerable to coercion or undue
influence. Potentially vulnerable subjects include children, prisoners, pregnant women,
mentally disabled persons, or economically or educationally disadvantaged persons.
Additional safeguards for three of these groups are provided in subparts of the federal
regulations for protecting research subjects: Subpart B for research on pregnant women,
human fetuses, and neonates; Subpart C for prisoners; and Subpart D for children.
Discussions of the additional protections for prisoners and children can be found in CITI
Program modules "Research with Prisoners – SBE" and "Research with Children - SBE."

Safeguards employed for vulnerable subjects include, among many other strategies,
assessing the decision-making capacity of potential subjects, requiring parental permission
from both parents rather than just one parent for some studies with children, and ensuring
that incentives are not coercive.

Informed Consent in Exempt Research

If an institution determines that a study meets the criteria for exempt research, the detailed
regulatory requirements for informed consent in 45 CFR 46.116 do not apply. However,
research that is exempt from federal regulations is still research with human subjects and
the ethical principles as outlined in the Belmont Report still apply. Each institution or IRB
decides how to handle informed consent in research that is eligible for exemption from the
regulations.

Waivers of the Elements of Consent

Federal regulations allow IRBs to authorize researchers to modify the consent process by
omitting one or more elements of information or to provide no information at all. The
waiver or alteration of any or all of the elements of consent can be authorized only if these
four criteria are met:

1. The research involves no more than minimal risk to the subjects.

o "Minimal risk" means "the probability and magnitude of harm or discomfort anticipated
in the research are not greater in and of themselves than those ordinarily encountered in
the daily life or during the performance of routine physical or psychological
examinations or tests" (Protection of Human Subjects 2009).
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects.
o In the absence of specific legal rights, this criterion is often difficult to apply because the
federal regulations do not define "rights and welfare." Also, the parties involved in the
research process (researchers, IRBs, and the community of subjects) may not always
agree on how to define subjects' rights and welfare. When a waiver is required because
the research involves deception, this requirement usually is interpreted to mean that
subjects are not "tricked" into participating in a study that they would find objectionable.
3. The research could not practicably be carried out without the waiver or alteration.
o Impracticable does not mean time consuming, expensive, or inconvenient. It means that
securing consent is not feasible, regardless of cost and time.
 Impracticable may mean that without a waiver it would not be possible to answer the
research question. Disclosing the purpose of the research may influence how subjects
respond.
4. Whenever appropriate, the subjects will be provided with additional pertinent
information after participation.
o This process often is referred to as debriefing. The debriefing process is an opportunity
to provide subjects with information not disclosed during the initial consent process. It
also provides an opportunity for subjects to withdraw and not have their identifiable data
included in the research.

Note: Debriefing is not required in situations in which debriefing would cause more harm
than good, for example, if subject selection was based on an undesirable or unflattering
characteristic.

Uses of Waivers
Deception: Outright deception can sometimes be justified as essential for investigating a
particular phenomenon. For example, subjects may be told that a study is about perception
of visual phenomenon, when in fact it is about susceptibility to peer pressure from the
researcher's confederates.

Complete Non-Disclosure: If people know that they are being observed, they may alter
their behavior in such a way that obtaining meaningful results is not possible. Covert
observation requires a waiver of all of the elements of consent if the research takes place in
a setting in which subjects could reasonably expect that their behavior was not being
observed and recorded.

Waivers of Parental Permission and Child Assent

An IRB may waive the requirement to secure parental permission for children to take part
in research, in accordance with the same criteria for waiving consent.

The regulations do not include a list of elements that must be included in a child assent
process. It is up to an IRB to determine whether child assent is required, what elements
must be included in the assent process, and whether the assent must be documented.

Documentation of Informed Consent

When documentation of informed consent is required, there are two methods available:

1. The subject or the subject's legally authorized representative signs a form containing all
the required elements of consent and any additional information necessary to provide
complete disclosure. The person who signed the consent form is given a copy as a
reference and reminder of the information conveyed.
2. The consent is done orally in language understandable to the subject and is documented
by an impartial witness. This process uses two documents: (1) a short- form written
consent document stating that the required elements of consent have been presented
orally to the subject or the subject's legally authorized representative, and (2) a written,
IRB-approved summary of what will be said to the subject or the subject's
representative. The subject signs the short form. The witness signs both forms. The
person actually obtaining consent signs the summary. Copies of the short form and the
summary are given to the subject.

Note: Illiterate English-speaking subjects can "make their mark" on the informed consent
document, as long as it is consistent with applicable state or local laws.

Waivers of Documentation
Documentation of the consent process is not always required. Note, however, that waivers
of documentation are not waivers of the consent process itself. For waivers of consent, see
the criteria noted above.

Documentation may be waived under two circumstances:

1. The principal risks are those associated with a breach of confidentiality concerning the
subject's participation in the research, and the consent document is the only record
linking the subject with the research. For example:
o Research about women who have left abusive partners.
o Research on the black market capitalist economy in Cuba in which illicit vendors will be
interviewed in a safe space.
o When the requirement for documentation is waived, the IRB may require the researcher
to offer the subjects information about the study in writing.
2. Study participation presents minimal risk of harm to the subject and the research
involves no procedures requiring consent outside the context of participation in a
research study, for example, a telephone survey.

Summary
Informed consent includes both the process of sharing information and documenting that
the process took place. To ensure that potential subjects can truly make informed decisions
about whether to take part in research, issues of comprehension, language, and culture need
to be considered in addition to the elements of information provided in the regulations. The
regulations provide criteria for waiving any or all of the elements of information and the
documentation of consent.
Reference
 Protection of Human Subjects, 45 CFR § 46 (2009).

Original Release: January 2004

Last Updated: November 2014