INFORMED CONSENT, PARENTAL PERMISSION, AND CHILD ASSENT
Differences Between Consent, Permission and Assent
Consent is a process whereby a research participant 18 years or older voluntarily agrees to
participate as a subject in a research study. Consent also applies to emancipated minors
recruited as subjects in a research study.
Parental permission applies to subjects under the age of 18. Permission is either granted or
denied by parents for subjects 17 years or younger to participate in research (since the
subjects cannot themselves legally consent to being a research participant).
Assent refers to the process whereby an investigator obtains the affirmative agreement of a
minor to participate in a research study. Even if a parent grants permission for his or her child
to be a participant, the child may decline to participate. The desire of the child must be
respected and upheld in all instances related to social-behavioral research.
Informed Consent
Obtaining legally effective informed consent prospectively from each research subject or the
subject's legally authorized representative is a federal mandate. This requirement is not only
applicable to all research activities conducted or supported by the Department of Health and
Human Services (HHS) as stipulated in Title 45 Code of Federal Regulations Part 46 (45 CFR 46),
but also extends to any and all research involving human subjects under the auspices of the
University of Massachusetts Boston.
The requirement to obtain the legally effective informed consent of individuals before
involving them in research is one of the central protections provided for under the regulations.
This requirement is founded on the principle of respect for persons, one of the three ethical
principles governing human subject research described in the Belmont Report. The principle
of respect for persons requires that individuals be treated as autonomous agents and that the
rights and welfare of persons with diminished autonomy be appropriately protected. The
Belmont Report states that an autonomous agent is “an individual capable of deliberation
about personal goals and of acting under the direction of such deliberation.” Respect for
persons requires that prospective research subjects “be given the opportunity to choose what
shall or shall not happen to them” and thus necessitates adequate standards for informed
consent.
The informed consent process involves three key components: (1)



Disclosing information to potential research subjects that is needed to make an
informed decision;
Facilitating the understanding of what has been disclosed; and
Promoting the voluntariness of the decision about whether or not to participate in the
research.
The informed consent process is the critical communication link between the prospective
human subject and an investigator, beginning with the initial approach of an investigator to
the potential subject (e.g., through a flyer, brochure, or any advertisement regarding the
research study) and continuing until the completion of the research study. “Investigators” are
individuals who conduct human subjects research projects, including individuals directly
involved in seeking the voluntary informed consent of potential subjects. Investigators can
include physicians, scientists, nurses, administrative staff, teachers, and students, among
others.
The process should be an active one of sharing information between the investigator and the
prospective subject. This exchange of information may occur via numerous means: face-toface contact, mail, telephone, video, or fax, among others.
Prospective subjects should be provided ample opportunity to ask questions and seek
clarification from the investigator prior to rendering a decision about whether or not to
participate as a subject in a research study. Prospective subjects should also be in a position to
freely decide whether to initially enroll in the research, or later, to withdraw or continue
participating in the research. The informed consent process should ensure that all critical
information about a study is completely disclosed, and that prospective subjects or their
legally authorized representatives (LARs) adequately understand the research so that they can
make informed choices.
Procedures used in seeking and obtaining informed consent should be designed to
communicate with the subject in terms that they can understand. Information about a
research project must be presented in such a way that enables each person to voluntarily
decide whether or not to participate as a research subject. Thus, the information must be
conveyed in language understandable to those being asked to participate as subjects in the
research.
For most research, informed consent is documented using a written document that provides
key information regarding the research. OHRP Tips on Informed Consent are contained herein
as Tab 1. The consent document is intended, in part, to provide information for the potential
subject’s current and future reference and to document the interaction between the subject
and the investigator. However, although the signed consent document is required, it alone
does not constitute an adequate consent process. The informed consent process is an ongoing
exchange of information between the investigator and the subject and could include, for
example, use of question and answer sessions, community meetings, and videotape
presentations. In all circumstances, individuals should be provided with an opportunity to have
their questions and concerns addressed on an individual basis.
The consent process and its documentation should be revised when deficiencies in its accuracy
or completeness are noted, when new information about reasonably foreseeable risks and
potential benefits becomes available, or when other additional information becomes known
that will improve the consent process. Such revisions must be reviewed and approved by the
IRB prior to the revised consent document being utilized, except when necessary to eliminate
apparent immediate hazards to subjects.
Basic Required Elements of Informed Consent
The 45 CFR 46 outlines basic elements that all informed consent must provide, whether
presented to prospective participants orally or in writing. A checklist for ensuring all elements
of informed consent are included in the consent process is contained at Tab 2. Templates for
both written and oral informed consent are contained herein as Tabs 3 and 6, respectively. The
mandated basic elements of informed consent include:
1. 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;
2. A description of any reasonably foreseeable risks or discomforts to the subject;
3. A description of any benefits to the subject or to others which may reasonably
be expected from the research;
4. A disclosure of appropriate alternative procedures or courses of treatment, if
any, that might be advantageous to the subject;
5. A statement describing the extent, if any, to which confidentiality of records
identifying the subject will be maintained;
6. For research involving more than minimal risk, an explanation as to whether any
compensation and an explanation as to whether any medical treatments are
available if injury occurs and, if so, what they consist of, or where further
information may be obtained;
7. 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; and
8. 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.
Additional Elements of Informed Consent
Additional elements are described at 45 CFR 46.116(b) and must be provided as part of the
informed consent process whenever determined to be appropriate by the IRB, subjects must
be provided with one or more of the following additional elements of information during the
informed consent process.
1. A statement that the particular treatment or procedure may involve risks to the subject
2.
3.
4.
5.
6.
(or to 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;
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; and
The approximate number of subjects involved in the study.
It is up to the IRB to determine in a particular instance whether some or all of the above
additional elements must be included as part of the informed consent process for a particular
study. The IRB should make this determination based on the nature of the research and its
knowledge of the local research context. If the IRB determines that additional elements are
appropriate to the research study, this additional information should be considered just as
essential as the eight basic elements of informed consent.
An IRB may also require that additional information beyond the basic and additional elements
be given to subjects during the informed consent process, when in the IRB’s judgment the
additional information would meaningfully add to the protection of the rights and welfare of
the subjects.
Circumstances under Which Consent Must be Sought
The consent process is one of the most important aspects of all research studies involving
human subjects. If consent is not obtained properly, then the rights of the individual research
subject is regarded as having been breached.
Consent must be sought under circumstances where the subject or representative is given
enough time to consider whether or not to participate in the study and under conditions that
minimize the possibility of coercion or undue influence. Information provided to the subject
or representative must be written in simple language, so all aspects of the research (e.g.,
purpose, risks, benefits) are clearly articulated in such a manner that an informed decision may
be made.
Capacity to Consent
An assessment of capacity to give consent must be considered for all subjects. While Federal
regulations are silent on the consent procedures specific to subjects with impaired decisionmaking capacity (for example, as a result of trauma, mental retardation, some forms of mental
illness, or dementia, whether temporary, progressive, or permanent). The regulations do
however, require that the IRB ensure that “additional safeguards have been included in the
study to protect the rights and welfare” of all subjects that are “likely to be vulnerable to
coercion or undue influence.” The regulations include “mentally disabled persons” in this
category.
In research involving adult subjects with mental illnesses or cognitive impairments, the IRB and
investigator(s) must be knowledgeable about the condition and any level of impairment that is
likely to be present in the subject population. The IRB must possess “the professional
competence necessary to review specific research activities.” This is achieved either by having
members with the appropriate experience and expertise or inviting consultants with
competence in the special area to assist in the review of issues that require expertise beyond
or in addition to that available on the IRB. Ensuring such expertise on the IRB improves its
ability to make determinations about subject recruitment, enrollment, and informed consent
requirements that best match the needs of the subjects.
In some research, such as longitudinal studies involving progressive disorders or aging
populations, enrolled subjects may be competent to consent on their own behalf at the outset,
yet may experience effects of progressive or intermittent disorders that lead to decisional
impairment during the course of the study. In these situations the IRB and investigators should
consider the need to discuss with the prospective subjects, whether they should designate
someone to serve as a legally authorized representative (LAR) at the outset of the study,
consistent with all applicable laws. Even if a subject has consented on his or her own accord, a
designated representative would be ready to step in as the legally authorized representative if
the subject’s ability to assess his or her own needs and interests becomes compromised during
the study.
Whenever possible, investigators will attempt to obtain informed consent directly from the
subject.
The application reviewed by the IRB must detail a protocol-specific plan for the assessment of
the decision-making capacity of the subject that will be conducted by the investigator for any
subjects who may qualify for LAR consent. Even while there are no standardized measures for
determining capacity to consent, subjects may be assessed on their ability to understand and
express a reasoned choice concerning the:
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Nature of the research and the information relevant to his/her participation;
Consequences of participation for the subject’s own situation, especially concerning
the subject’s health condition; and
Consequences of the alternatives to participation.
Waiver of Informed Consent
Investigators are required to obtain the legally effective informed consent of the subject or
the subject’s legally authorized representative, unless (1) the research is exempt under 45 CFR
46.101(b); (2) the IRB finds and documents that informed consent can be waived (45 CFR
46.116(c) or (d)); or (3) the IRB finds and documents that the research meets the requirements
of the DHHS Secretarial waiver under 45 CFR 46.101(i) that permits a waiver of the general
requirements for obtaining informed consent in a limited class of research in emergency
settings. When informed consent is required, it must be sought prospectively, and
documented to the extent required under HHS regulations at 45 CFR 46.117. [Food and Drug
Administration (FDA) regulations at 21 CFR 50 may also apply if the research involves a clinical
investigation regulated by FDA.]
No investigator may involve a human being as a subject, or use their tissue or data, in a
research activity unless the investigator has obtained the informed consent of the subject or
the subject's legally authorized representative.
There are only two circumstances under which the IRB has authority to waive consent.
The first waiver authority is applicable only to research activities designed to study certain
aspects of public benefit or service programs; the conditions under which this waiver may be
authorized by an IRB are detailed below:
The IRB may waive the requirement for obtaining informed consent or parental permission or
approve a consent or parental permission procedure that leaves out or alters some or all of
the elements of informed consent, provided that the IRB finds and documents that both of
the following two criteria are satisfied:
1. The research or demonstration project is to be conducted by or subject to the
approval of state or local government officials and is designed to study, evaluate, or
otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining
benefits or services under those programs; (iii) possible changes in or alternatives to
those programs or procedures; or (iv) possible changes in methods or levels of
payment for benefits or services under those programs.
[Note that this criterion means that only public benefit or service program research
activities that are under state or local authority meet this criterion; similar research
conducted under federal authority would not qualify here and is treated elsewhere in
the regulations. Research conducted by or subject to the approval of only a private
entity also would not qualify]; and
2. The research could not practicably be carried out without the waiver or alteration.
[This criterion means that the practical circumstances of the research are such that
the research is not feasible if the informed consent of the subjects must be obtained.
For example, a study of identifiable private information about program benefit
recipients using 20-year-old records might meet this criterion, if current contact
information for those recipients is not available].
The second waiver authority described at 45 CFR 46.116(d) stipulates that an IRB may
approve a consent procedure which does not include, or which alters, some or all of the
elements of informed consent, or waive the requirements to obtain informed consent
provided the IRB finds and documents that:
1. The research involves no more than minimal risk to the subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the
subjects;
3. The research could not practicably be carried out without the
waiver or alteration; and
4. Whenever appropriate, the subjects will be provided with
additional information after participation.
Criteria for Waiver of Documentation of Informed Consent
The federal regulations allow for a waiver of the documentation of consent (i.e., a signed
consent form) if one of the following conditions is met:
1. That the only record linking the subject and the research would be the consent
document and the principal risk would be potential harm resulting from a breach of
confidentiality. Each subject will be asked whether the subject wants documentation
linking the subject with the research, and the subject's wishes will govern;
- OR 2. That the research presents no more than minimal risk of harm to subjects and involves
no procedures for which written consent is normally required outside of the research
context.
Investigators may specifically request a waiver of the documentation of the informed consent
requirement by providing information that supports one of the two conditions above.
Nonetheless, the IRB will still require submission of either a consent 'script' (i.e., to verbally
consent a subject, e.g., over the phone) or a consent letter that does not require the subject to
sign, but to, e.g., complete an attached survey. In the latter case, the document is written in
letter format ('Dear Subject'), and rather than requiring the subject's signature to verify
consent, the investigators will sign the letter as in the sample provided at Tab 5.
Determining whether research could not be practicably carried out without a waiver or
alteration of consent should not be made on the basis of whether or not obtaining consent
is difficult for the investigator. The protection of human subjects is always paramount.
Informed consent procedures which provide for other than legally effective and prospectively
obtained consent, fail to constitute informed consent under the HHS regulations for the
protection of human research subjects. Therefore a procedure referred to as "deferred
consent" or "ratification" is not authorized. Similarly, the waiving of informed consent, using
a method other than that requiring the IRB findings and IRB documentation specified in 45
CFR 46.116(c) or (d), is not in compliance with the regulations.
Exculpatory Language and Consent
No informed consent, whether oral or written, may include any exculpatory language
through which the subject is made to waive or appear to waive any of the subject's legal
rights, or releases or appears to release the investigator, the sponsor, the institution, or its
agents from liability for negligence.
Examples of Exculpatory Language

By agreeing to this use, you should understand that you will give up all claim to
personal benefit from commercial or other use of these substances.

I voluntarily and freely donate any and all blood, urine, and tissue samples to the U.S.
Government and hereby relinquish all right, title, and interest to said items.

By consent to participate in this research, I give up any property rights I may have in
bodily fluids or tissue samples obtained in the course of the research.

I waive any possibility of compensation for injuries that I may receive as a result of
participation in this research.
Examples of Acceptable Language

Tissue obtained from you in this research may be used to establish a cell line that
could be patented and licensed. There are no plans to provide financial compensation
to you should this occur.

By consenting to participate, you authorize the use of your bodily fluids and tissue
samples for the research described above.

This hospital is not able to offer financial compensation nor to absorb the costs of
medical treatment should you be injured as a result of participating in this research.

This hospital makes no commitment to provide free medical care or payment for any
unfavorable outcomes resulting from participation in this research. Medical services
will be offered at the usual rate.
Passive Consent
The term “passive consent” is sometimes used in research with children to describe situations
in which the investigator can assume that a parent is permitting a child to participate. For
example, researchers collecting survey and behavioral data from children at school provide
parents with information regarding the study by mail and ask the parent(s) to return a form if
they do not want their child to participate. Sometimes this practice is referred to as an “opt
out” procedure, which is not consistent with the regulatory requirement for seeking and
obtaining parental permission. This procedure, by its very nature, is contrary to the intent of
informed consent and is not an acceptable method to be utilized by investigators at UMass
Boston.
If the IRB determines that the conditions for waiver of parental permission can be met, then
the IRB could waive the requirement for parental permission under 45 CFR 46.408(c) or 45
CFR 46.116(c) or (d). Even though not required by the regulations, the IRB may require that
parents be given the opportunity to refuse permission even when the IRB has waived the
regulatory requirement to obtain parental permission.
OBTAINING AND DOCUMENTING INFORMED CONSENT OF SUBJECTS WHO DO
NOT SPEAK ENGLISH
An important aspect of the consent process is to provide the information in a language
understandable to the subjects. Accordingly, the IRB recognizes two methods for obtaining
consent from non-English speaking subjects. It is the responsibility of the IRB to determine
which of the procedures is appropriate for documenting informed consent in protocols that it
reviews.
1. For those consent documents that must be translated into a foreign language, an
affidavit of accurate translation must be provided from an appropriate translator
who is unaffiliated with the study. The translated consent form and affidavit
must be submitted and approved by the IRB prior to the use of the consent
document.
-or2. OHRP offers guidance on 'Obtaining and Documenting Informed Consent of
Subjects Who Do Not Speak English', which involves the use of an IRB-approved
English language consent form, an IRB-approved short consent form written in
the non-English language, and a witness fluent in both English and the language
of the subject. The short consent form can only be used for minimal risk
studies.
At the time of consent, the short form document should be signed by the subject (or the
subject's legally authorized representative); the summary (i.e., the English language informed
consent document) should be signed by the person obtaining consent as authorized under the
protocol; and the short form document and the summary should be signed by the witness.
When the person obtaining consent is assisted by a translator, the translator may serve as the
witness.
The IRB must receive all foreign language versions of the short form document as a condition of
approval under the provisions of §46.117(b)(2). Expedited review of these versions is
acceptable if the protocol, the full English language informed consent document, and the
English version of the short form document have already been approved by the convened IRB.
Parental Permission
The "age of majority" in Massachusetts is eighteen. When a person turns eighteen, he or she is
considered to have "full legal capacity." This means that the person can make all legal decisions
for him/herself unless there is some reason other than age that legally prohibits him or her
from making such decisions, such as mental inability. G.L. c. 231 § 85P.
Current regulations tend to avoid the term “consent” when one grants approval for another to
enroll in research. Parents or legal guardians, therefore, grant “permission” for children to
participate in research. The “permission” form is in essence a consent document and should
follow all applicable requirements for informed consent as outlined in this Handbook.
The document should be written to the parent(s) who will give permission for the child to
participate as a research subject. Whenever possible, the permission of both parents should be
obtained; however, current Federal regulations do not require permission from both parents in
all research situations. In general, the risk to the child and the prospect of direct benefit for
the child as a research subject determine whether single parent/guardian permission may be
permitted. If the research involves no greater than minimal risk, permission of one parent is
sufficient.
Both parents/guardians must give their permission for a minor's participation in research if the
research exposes the minor subject to greater than minimal risk and there is no prospect of a
direct benefit to the individuals. The only exception to this policy is if one parent is deceased,
unknown, incompetent or not reasonably available or if only one parent has legal responsibility
for the care and custody of the child.
The permission of one parent/guardian will be acceptable only if a) the research is a minimal
risk study or b) the research exposes the minor to greater than minimal risk, but the research
presents the prospect of a direct benefit to the minor subject. In both such cases, the consent
procedures must be approved by the IRB.
Only after parental permission has been obtained, can the agreement or assent of the child be
obtained. While the parents/guardians must provide legal permission for the child to
participate in research, the child must always assent to his/her own participation; assent being
an active affirmation of a desire to participate. Children who are able to read and write will
participate in the consent process by using an assent form written in language especially for the
child. As with parental consent, the assent procedures must be approved by the IRB.
Under certain limited conditions it may be possible for the minor subject to consent on her/his
own behalf, without the need for parental permission. In such cases the IRB must grant a
waiver of parental permission in advance of subject enrollment. The following are the only
conditions under which a waiver of parental permission will be acceptable:

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

The research involves a treatment for which a minor's consent is permissible
under law (i.e., outpatient mental health care, pregnancy, treatment for
venereal disease or treatment for alcohol or drug dependence).
The subject is legally emancipated.
The IRB may determine that a research protocol is designed for conditions or for
a subject population for which permission is not a reasonable requirement to
protect the subjects. For example, an important area of inquiry is why and how
certain teenagers come to live on the streets. An anthropologist wishing to
interview teenagers who are runaways or who have severed ties with their
families could not do so if parental permission were required. The IRB may waive
the parental permission requirements provided that an appropriate mechanism
is in place to protect the children.
Parental permission is not a reasonable requirement because it poses additional
risk or may be at odds with the interests of the minor subject (i.e., research
concerning neglected or abused children, reproductive health issues, etc). In
such cases the research protocol will propose an alternative to parental
permission appropriate to the nature and purpose of the research, the risk and
anticipated benefit to the minor subjects, as well as one's age, maturity, status
and condition.
Child Assent
A child's ability to volunteer to participate in research begins when one or both parents (or
legal guardians) provide permission. If the parent or legal guardian does not actively sign a
permission document, affirming their permission for the child to participate, then the child
cannot participate.
Information should be provided to the parent or legal guardian in the same format as a consent
document. Permission must be sought before the researcher contacts the child. After parental
(or guardian) permission is documented, next it is the child's turn to decide if he or she would
like to participate. This process is called assent. “Assent” is defined by the regulations as "a
child’s affirmative agreement to participate in research. Mere failure to object should not,
absent affirmative agreement, be construed as assent." In other words, the child must actively
show his or her willingness to participate in the research through the assent process.
The ability to provide assent varies with age, maturity, and the psychological state of the
population or child to be studied. When judging whether children are capable of assent, the
Institutional Review Board (IRB) is charged with taking into account the nature and all
circumstances of the proposed research activity, along with the ages, maturity, and
psychological states of the children involved. The IRB has the discretion to judge children’s
capacity to assent for all of the children to be involved in a proposed research activity, or on an
individual basis.
Most consent forms contain scientific information that is already difficult to transform for a
non-scientific audience of adults (e.g., the parental consent form; written at the 8th grade level
for a college educated sample and the 6th grade level for a community sample). However,
when the participants are children the task of writing assent becomes much more difficult. The
basic elements of informed consent must be transformed into a language that every
prospective child participant can understand. The more complex the procedures and the
younger the child, the more difficult an investigator's task becomes.
For children whose age and maturity level limits their ability to fully comprehend the nature of
the research activity but who are still capable of being consulted about participation in
research, it may be appropriate to focus on conveying an accurate picture of what the actual
experience of participation in research is likely to be (for example, what the experience will be,
how long it will take, whether it might involve any pain or discomfort). The assent procedure
should reflect a reasonable effort to enable the child to understand, to the degree they are
capable, what their participation in research would involve. If the researcher is collecting data
from children who possess a wide range of cognitive abilities, assent forms will need to be
drafted that are appropriate for every level of cognitive abilities.
In determining whether participants are capable of assenting, the IRB shall take into account
the age, maturity, and psychological state of the participant involved. This judgment may be
made for all participants to be involved in research under a particular protocol, or for each
participant, as the IRB deems appropriate. If the IRB determines that the capability of some or
all of the participants is so limited that they cannot reasonably be consulted or that the
intervention or procedure involved in the research holds out a prospect of direct benefit that is
important to the health or well‑ being of the participant and is available only in the context of
the research, the assent of the participant is not a necessary condition for proceeding with the
research. Even where the IRB determines that the participants are capable of assenting, the IRB
may still waive the assent requirement under circumstances in which consent may be waived.
In all cases in which assent is sought from a minor subject, the assent discussion will include the
following:

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



A simplified description of the purpose of the research, including the risks and
benefits
A description of the procedures and interventions to which the minor subject
will be exposed
An explanation of any procedures that may hurt and for how long
A statement explaining to the minor child that s/he has the right to decide
whether or not to participate in the research study
An explanation of the research alternatives
A question and answer period in which the minor subject will be encouraged to
ask questions about her/his participation in the study.
So as to encourage the minor subject to ask questions, and to ensure that he or she
understands the nature and purpose of the research, the principal investigator or person
obtaining assent will ask the minor subjects open-ended questions as appropriate to their age
and comprehension level. Such questions may include the following:




Just so that I'm sure that you understand what is expected of you, would you
please tell me in your own words what you will be doing in this study?
Would you please tell me the purpose of the study in your own words?
What is the possible benefit to you of being in the study? What are the possible
risks?
What more would you like to know about the study?
Documenting assent is required for nearly every study conducted at UMass Boston. The act of
"signing" a consent form is important for ensuring respect for persons. In obtaining the assent
of minors the following guidance is provided:


Adolescents can usually sign a consent form just as an adult would. Most healthy
children with no cognitive impairments can provide a signature, in cursive, by about
third or fourth grade. Children K-3 can usually print their name. Pre-school aged children
or those who cannot yet write their name can "color a picture in the box" on the assent
form to show that they would like to participate.
When children are not able to affirm assent in writing (e.g., children with severe
cognitive impairments, infants) researchers rely on behavioral cues that might indicate
agreement to participate or withdraw. Particularly when child assent involves behavioral
indices, the precise behaviors for "assent" and "withdrawal" must be explained fully in
the protocol so that each IRB member, regardless of their scientific background or
discipline, can reach a uniform understanding (operational definition) for "child assent."
During the assent process, children are to be reminded that they do not have to be in the
research, even if their parents want them to participate. When parents are present, researchers
should take great care in controlling the research context, from the assent process through the
execution of the research protocol, to ensure that parents or guardians do not employ undue
influence or coercion to force the child to participate or to keep the child in the study once
procedures have begun. The child is to remain in complete control over whether or not he/she
agrees to participate or continues to participate.
Researchers are to be sensitive to nonverbal indications the child wants to take a break or quit,
as many children are eager to please and/or have not yet learned how to be assertive. Children
will tend to defer to the requests of an authority figure and it is the researcher's responsibility
to take cues from the child; when appropriate, the researcher is to ask the child, "Do you want
to keep doing this? Remember, it is really okay if you want to quit."
Child assent is to be handled on a case-by-case basis. Researchers cannot copy and paste
content from one assent form to another, because each research context is truly unique and
most studies involving child participants use multiple assent forms. However, looking at well
written assent forms can be helpful to gain a better sense of what is required (refer to Tab 2).
Child assent is required, except in the following three circumstances described at 45 CFR
46.408(a):
1. The capability of some or all of the children is so limited that they cannot reasonably be
consulted;
2. The intervention or procedure involved in the research holds out the prospect of direct
benefit to the health or well-being of the children and is available only in the context of
the research;
3. The research meets the same conditions as those for waiver or alteration of informed
consent in research involving adults, as specified in the regulations at either 45 CFR
46.116(c) or 45 CFR 46.116(d).
OHRP Tips on Informed Consent

Informed consent is a process, not just a form. Information must be presented to enable
persons to voluntarily decide whether or not to participate as a research subject. It is a
fundamental mechanism to ensure respect for persons through provision of thoughtful
consent for a voluntary act. The procedures used in obtaining informed consent should
be designed to educate the subject population in terms that they can understand.
Therefore, informed consent language and its documentation (especially explanation of
the study's purpose, duration, experimental procedures, alternatives, risks, and
benefits) must be written in "lay language", (i.e. understandable to the people being
asked to participate). The written presentation of information is used to document the
basis for consent and for the subjects' future reference. The consent document should
be revised when deficiencies are noted or when additional information will improve the
consent process.

Use of the first person (e.g., "I understand that ...") can be interpreted as suggestive,
may be relied upon as a substitute for sufficient factual information, and can constitute
coercive influence over a subject. Use of scientific jargon and legalese is not
appropriate. Think of the document primarily as a teaching tool not as a legal
instrument.

Describe the overall experience that will be encountered. Explain the research activity,
how it is experimental (e.g., a new drug, extra tests, separate research records, or
nonstandard means of management, such as flipping a coin for random assignment or
other design issues). Inform the human subjects of the reasonably foreseeable harms,
discomforts, inconvenience and risks that are associated with the research activity. If
additional risks are identified during the course of the research, the consent process and
documentation will require revisions to inform subjects as they are re-contacted or
newly contacted.

Describe the benefits that subjects may reasonably expect to encounter. There may be
none other than a sense of helping the public at large. If payment is given to defray the
incurred expense for participation, it must not be coercive in amount or method of
distribution.

Describe any alternatives to participating in the research project. For example, in drug
studies the medication(s) may be available through their family doctor or clinic without
the need to volunteer for the research activity.

The regulations insist that the subjects be told the extent to which their personally
identifiable private information will be held in confidence. For example, some studies
require disclosure of information to other parties. Some studies inherently are in need
of a Certificate of Confidentiality which protects the investigator from involuntary
release (e.g. subpoena) of the names or other identifying characteristics of research
subjects. The IRB will determine the level of adequate requirements for confidentiality
in light of its mandate to ensure minimization of risk and determination that the residual
risks warrant involvement of subjects.

If research-related injury (i.e. physical, psychological, social, financial, or otherwise) is
possible in research that is more than minimal risk (see 45 CFR 46.102[g]), an
explanation must be given of whatever voluntary compensation and treatment will be
provided. Note that the regulations do not limit injury to "physical injury". This is a
common misinterpretation.

The regulations prohibit waiving or appearing to waive any legal rights of subjects.
Therefore, for example, consent language must be carefully selected that deals with
what the institution is voluntarily willing to do under circumstances, such as providing
for compensation beyond the provision of immediate or therapeutic intervention in
response to a research-related injury. In short, subjects should not be given the
impression that they have agreed to and are without recourse to seek satisfaction
beyond the institution's voluntarily chosen limits.

The regulations provide for the identification of contact persons who would be
knowledgeable to answer questions of subjects about the research, rights as a
research subject, and research-related injuries. These three areas must be explicitly
stated and addressed in the consent process and documentation. Furthermore, a
single person is not likely to be appropriate to answer questions in all areas. This is
because of potential conflicts of interest or the appearance of such. Questions about the
research are frequently best answered by the investigator(s). However, questions about
the rights of research subjects or research-related injuries (where applicable) may best
be referred to those not on the research team. These questions could be addressed to
the IRB, an ombudsman, an ethics committee, or other informed administrative body.
Therefore, each consent document can be expected to have at least two names with
local telephone numbers for contacts to answer questions in these specified areas.

The statement regarding voluntary participation and the right to withdraw at any time
can be taken almost verbatim from the regulations, see 45 CFR 46.116[a][8]. It is
important not to overlook the need to point out that no penalty or loss of benefits will
occur as a result of not participating, or withdrawing at any time. It is equally important
to alert potential subjects to any foreseeable consequences to them should they
unilaterally withdraw while dependent on some intervention to maintain normal
function.

Don't forget to ensure provision for appropriate additional requirements which concern
consent. The IRB may impose additional requirements that are not specifically listed in
the regulations to ensure that adequate information is presented in accordance with
institutional policy and local law.
Signed Informed Consent Document
Checklist & Sample
Using the Sample following this checklist as a guide, write a consent document which accurately reflects
your project. Indicate in the narrative where you are addressing each element by inserting a number in
parenthesis (see example) or check that the element is not applicable (NA) to this research. Include this
checklist with your consent form. ALSO INCLUDE a duplicate copy of the consent form without the
numbers which will be stamped for use with your participants.
Required Elements
1
A statement that the study involves research.
2
An explanation of the purpose(s) of the research
3
An explanation of the expected duration of the subject’s participation.
4
A description of the procedures to be followed.
5
A description of any reasonably foreseeable risks or discomforts to the subject.
6
7
8
9
10
11
A description of any benefits to the subject or to others which may reasonably be expected
from the research.
The disclosure of appropriate alternative procedures or courses of treatments, if any, that
may be advantageous to the subject.
A statement describing the extent, if any, to which confidentiality of records identifying the
subject will be maintained.
The alternative procedure(s) or course(s) of treatment that may be available to the subject,
and their important potential benefits and risks.
For research involving more than minimal risk, an explanation as to whether any
compensation is available if injury occurs, an explanation as to whether any medical
treatments are available if injury occurs, and if so, of what they consist, OR where further
information may be obtained.
An explanation of whom to contact for answers to pertinent questions about the research
subjects’ rights (should include someone other than the investigator).
12
An explanation of whom to contact in the event of a research-related injury to the subject.
13
A statement that participation is voluntary and that the subject may withdraw at any time.
14
15
16
Other
A statement that refusal to participate will involve no penalty or loss of benefits to which
the subject is otherwise entitled; a statement that the subject may discontinue participation
at any time without penalty or loss of benefits to which the subject is otherwise entitled.
A statement that the particular treatment or procedure may involve risks to the subject (or
embryo, or fetus, or nursing infant if the subject is or may become pregnant) which are
currently foreseeable.
Anticipated circumstances under which a subject’s participation may be terminated by the
investigator without regard to the subject’s consent.
17
Any additional costs to the subject that may result from participation in the research.
18
The anticipated prorated payment, if any, to the subject for participating in the trial.
19
A description of the procedures for orderly termination of participation by the subject.
NA
-SAMPLE CONSENT LETTER (ON DEPARTMENT LETTERHEAD)-
University of Massachusetts Boston
Consent to Participate in Research
You are invited to participate in a research study about Teaching Fellows, an education program
for first year teachers at the University of Massachusetts Boston (1). This study, to be
conducted by name, title, department, [under the supervision of name, title, department] is
designed to answer three questions related to the Teaching Fellows Program. The questions
are: 1) to what degree has UMass Boston been able to attract and retain academically strong
candidates into teaching; 2) to what degree have we at the University developed strong teacher
leaders; and 3) to what degree has the Teaching Fellows Program contributed to the
improvement of our quality of teacher education?(2)
Participation in this study would require about 2 1/2 hours (3). I will send you a set of questions
that should take you approximately one hour to complete. We will meet together for about one
more hour during which time I will ask you to clarify some of your written answers. You may
also ask questions of me at this time. I may have to call you on the phone with a follow up
question (4). When the study is in its final draft I will ask you to read it to make corrections
and/or additions.
Your participation is completely voluntary (13). You make likewise discontinue participation in
the study at any time (14) just by informing me (19). I know of no risk or discomfort associated
with this research (5). Indeed, you would be making a contribution to the profession and to the
knowledge base about teaching by your participation (6). I will keep your information strictly
confidential; as a matter of fact, I ask you to select a pseudonym, a name, by which I will refer
to you in this study in order to protect your real identity. The notes I take and the surveys will
be kept in a locked file cabinet located in the Education Department at the University, and I will
dispose of them by shredding when the study and retention period is complete (8).
Should you have any questions concerning the purpose, procedures, and outcomes of this
project please contact me at 617-xxx-xxxx or e-mail (xxxxxx.xxxxxx@umb.edu) [or my faculty
advisor at ]. You may also contact Kristen Kenny, IRB Administrator, in the Office of Research
& Sponsored Programs (617-287-5374) if you have questions or concerns about this research
(11). You will be given a copy of this form to keep.
________________________________
Printed Name of Participant
UMass Boston
IRB Approval:
_________________________________
Signature of Participant
____________
Date
_________________________________
____________
Signature of Person Obtaining Consent
Date
UNIVERSITY OF MASSACHUSETTS BOSTON
Informed Consent Agreement to Participate in Research
The following information describes the research study in which you are being asked to participate.
Please read the information carefully and feel free to ask any questions that you may have regarding the
research. Afterwards, you will be asked to sign if you agree to participate.
A. INVESTIGATOR(S): (Principal Investigator's name) of the (department/unit name), will conduct this
research project. (If applicable, include same information for co-investigators, including students.
Note if any co-investigators are associated with another institution and provide same descriptive
information.)
B. PURPOSE: The purpose of this research is to (describe the purpose of the study in lay language/terms
that will be understandable to the research subject/parent/guardian).
C. EXPECTED DURATION: The length of time you are expected to participate in the study is (estimate
total duration of the subject's participation, either as a one-time activity or as a repeated activity over a
period of time).
D. PROCEDURES: The research will be conducted using the following procedures: (Describe the step-bystep activities in which the subject will be involved. If any interventions with the subject are
"experimental" [i.e., not yet scientifically validated with respect to safety and efficacy], identify them as
such in this section.)
E. POSSIBLE DISCOMFORTS AND/OR RISKS: We know of no significant risks or discomforts associated
with this study outside of those that may be encountered in everyday life.
or
This investigation is felt to present minimal risk to the participant. Past experience indicates that
the most common and foreseeable consequences of participation in this activity will be...
or
This investigation is felt to present more than minimal risk to the participant. Past experience
indicates that the participant is likely to experience...
F. POSSIBLE BENEFITS: Benefits that you may experience through participation in this study include...
(describe potential benefits to the individual research subject)
or
Although it is not anticipated that you will benefit directly through your involvement in this study,
the project is expected to benefit the (define the larger population) by (describe potential benefits to
the larger population).
UMass Boston
IRB Approval:
G. ALTERNATIVE PROCEDURES: Not applicable.
or
Describe any alternative procedures or courses of treatment that might be advantageous to the
subject.
H. CONFIDENTIALITY: Describe the extent to which confidentiality of research records identifying the
subject will be maintained. As appropriate, discuss privacy concerns during collection of the data,
identifiers that will be recorded which may link the subject to the data, persons who will have access to
the data, measures that will be followed to ensure security of the data, how data will be reported, and
ultimate disposition of records.
I.
COSTS AND COMPENSATION: There are no costs or compensation associated with your
participation in this study.
or
Describe any costs and/or compensation to the subject for participation in the research project.
(Compensation may include cash payment to the subject, free services that the subject would not
otherwise receive extra credit in academic courses, etc.).
If the study places the participant at some risk of injury, even if minimal, include the following
statement: The University of Massachusetts Boston will not provide compensation or medical
(and/or psychological) treatment of any kind to you for an injury which occurs as a direct result of
your participation in this study. If the study presents more than minimal risk, the following optional
statement may be added: You will be required to show proof of third party (health insurance)
coverage prior to being enrolled in this study.
J.
VOLUNTARINESS: Your participation is completely voluntary. Refusal to participate in this study will
not result in any penalty or loss of benefits to which you might otherwise be entitled. You [your
child] may likewise discontinue participation in the study at any time without penalty or loss of
benefits.
K. CONTACT INFORMATION: (Principal Investigator's name) (617-xxx-xxxx) will gladly answer any
questions you may have concerning the purpose, procedures, and outcome of this project. You may
also contact the UMass Boston Institutional Review Board (IRB) through the Office of Research &
Sponsored Programs (617-287-5374) to convey any questions or concerns you may have about the
rights of study participants. (The IRB is a college committee concerned with the protection of
human research participants.)
UMass Boston
IRB Approval:
I have read and understand the information in this consent form and agree to participate in this study.
Although the investigator will make every effort to maintain confidentiality, I understand that research
records must be made available to the University's Institutional Review Board and federal regulatory
agencies for compliance auditing purposes, should they be requested. I will receive a copy of this form
after it has been read and signed. By signing this form I am indicating that I am at least 18 years of age
or older.
I would like to receive a copy of the results of this study:
_____ Yes
_____ No
Mailing Address: ___________________________________________________________
______________________________________________
_________________________________________
Printed Name of Participant
Signature of Participant
Date
__________________________________________________
Signature of Person Obtaining Consent
Date
UMass Boston
IRB Approval:
UNIVERSITY OF MASSACHUSETTS BOSTON
Parental Permission for Participation of Child as a Research Subject
The following information describes the research study in which your child is being asked to participate.
Please read the information carefully and feel free to ask any questions that you may have regarding the
research. Afterwards, you will be asked to sign if you agree to allow your child/ward to participate.
A. INVESTIGATOR(S): (Principal Investigator's name) of the (department/unit name), will conduct this
research project. (If applicable, include same information for co-investigators, including students.
Note if any co-investigators are associated with another institution and provide same descriptive
information.)
B. PURPOSE: The purpose of this research is to (describe the purpose of the study in lay language/terms
that will be understandable to the parent/guardian).
C. EXPECTED DURATION: The length of time you are expected to participate in the study is (estimate
total duration of the subject's participation, either as a one-time activity or as a repeated activity over a
period of time).
D. PROCEDURES: The research will be conducted using the following procedures: (Describe the step-bystep activities in which the subject will be involved. If any interventions with the subject are
"experimental" [i.e., not yet scientifically validated with respect to safety and efficacy], identify them as
such in this section.)
E. POSSIBLE DISCOMFORTS AND/OR RISKS: We know of no significant risks or discomforts associated
with this study outside of those that may be encountered in everyday life.
or
This investigation is felt to present minimal risk to the participant. Past experience indicates that
the most common and foreseeable consequences of participation in this activity will be...
or
This investigation is felt to present more than minimal risk to the participant. Past experience
indicates that the participant is likely to experience...
F. POSSIBLE BENEFITS: Benefits that you may experience through participation in this study include...
(describe potential benefits to the individual research subject)
or
Although it is not anticipated that you will benefit directly through your involvement in this study,
the project is expected to benefit the (define the larger population) by (describe potential benefits to
the larger population).
UMass Boston
IRB Approval:
G. ALTERNATIVE PROCEDURES: Not applicable.
or
Describe any alternative procedures or courses of treatment that might be advantageous to the
subject.
I.
CONFIDENTIALITY: Describe the extent to which confidentiality of research records identifying the
subject will be maintained. As appropriate, discuss privacy concerns during collection of the data,
identifiers that will be recorded which may link the subject to the data, persons who will have access to
the data, measures that will be followed to ensure security of the data, how data will be reported, and
ultimate disposition of records.
I.
COSTS AND COMPENSATION: There are no costs or compensation associated with your
child’s/ward’s participation in this study.
or
Describe any costs and/or compensation to the subject for participation in the research project.
(Compensation may include cash payment to the subject, free services that the subject would not
otherwise receive extra credit in academic courses, etc.).
If the study places the participant at some risk of injury, even if minimal, include the following
statement: The University of Massachusetts Boston will not provide compensation or medical
(and/or psychological) treatment of any kind to you for an injury which occurs as a direct result of
your child’s/ward’s participation in this study. If the study presents more than minimal risk, the
following optional statement may be added: You will be required to show proof of third party (health
insurance) coverage prior to your child being enrolled in this study.
J.
VOLUNTARINESS: Your child’s/ward’s participation is completely voluntary. Refusal to give
permission for your child to participate in this study will not result in any penalty or loss of benefits
to which you or your child/ward might otherwise be entitled. Although you may give permission for
your child to participate, your child may decline to participate and the child’s decision will be
respected. Your child/ward may likewise discontinue participation in the study at any time without
penalty or loss of benefits.
J.
CONTACT INFORMATION: (Principal Investigator's name) (617-xxx-xxxx) will gladly answer any
questions you may have concerning the purpose, procedures, and outcome of this project. You may
also contact the UMass Boston Institutional Review Board (IRB) through the Office of Research &
Sponsored Programs (617-287-5374) to convey any questions or concerns you may have about the
rights of study participants. (The IRB is a college committee concerned with the protection of
human research participants.)
UMass Boston
IRB Approval:
I have read and understand the information in this consent form and agree to allow my child/ward to
participate in this study. Although the investigator will make every effort to maintain confidentiality, I
understand that research records must be made available to the University's Institutional Review Board
and federal regulatory agencies for compliance auditing purposes, should they be requested. I will
receive a copy of this form after it has been read and signed. By signing this form I am indicating that I
am at least 18 years of age or older.
I would like to receive a copy of the results of this study:
_____ Yes
_____ No
Mailing Address: ___________________________________________________________
___________________________________
Printed Name of Participant
__________________________________
Signature of Person Obtaining Consent
______________________________
Signature of Participant
________________
Date
UMass Boston
IRB Approval:
_____________
Date
MODEL CHILD ASSENT SCRIPT FOR PARTICIPATION IN A RESEARCH STUDY
Tile of the Research
*The Child Assent Script may be provided in written form or verbally to the child(ren). Although
regulations are deliberately flexible with respect to the age and method of seeking the assent of children
to participate as research subjects, it is a commonly accepted practice and endorsed by the American
Academy of Pediatrics that assent, in most cases, should be obtained from any child with an intellectual
age of 7 years or more. Whether provided verbally or in writing, it should be provided in terms and at a
level that is developmentally appropriate for the age of the child(ren). In the event an investigator is
working with a significantly diverse age group, the script should be written or explained in terms
understandable to the youngest participants. If provided verbally, an assent script must still be included
as part of the application.
Why am I here?
• We are asking you to take part in a research study because we are trying to learn more about [briefly
explain what you are studying in terms appropriate to the age of the child(ren)]
Why am I doing this study?
• Include a brief explanation why the study is being conducted
Why do we need you?
• Include a brief explanation why the participant is being selected to participate in the research
What will happen to you?
• Include a brief explanation of what will take place from their point of view
• If appropriate, include a sentence about whether or not the procedure will involve any risks
& what they are, whether any procedures will be painful and/or the level of discomfort anticipated
How long will it take?
• Estimate how long the procedure will take
Did your parents say it was OK?
• Include a statement that indicates the study was explained to the parents and that the child’s parent
or guardian has already given permission for him/her to participate (if applicable)
• Include a statement that makes it clear to the child(ren) that even though their parent(s) have given
permission, they still do not have to participate if they so choose
Who will be helped by the research?
• Include a brief description of the anticipated benefits of the research, both to the participant (if
appropriate) or to the other children, or to society in general
• If appropriate, include a sentence(s) that indicates if the child can expect any direct benefit at the end
of participation
Do you have to be in the Study? Will you get in trouble if you are not in it?
• Include a statement that participation is voluntary, that they do not have to be in the study, and that
they may stop at any time. Make certain they are told and understand that they can say “yes” now and
change their minds at any time.
• Ensure that it is understood that they will not get in any trouble if they do not participate.
Do you have any questions?
• Make certain the child(ren) does (do) not have any questions that have not been answered before
getting their assent
__________________________________
Printed name of minor
__________________________________
Signature of minor (if appropriate)
____________________
Date