Informed Consent w/ Checklist and Templates
Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 16
Effective Date: 10/8/2021
Policy
The College of St. Scholastica (CSS) requires that legally effective informed consent of the subject or of the subject’s parents or guardian before an investigator can involve the person in research. Consent must be documented in writing in accordance with applicable federal regulations unless the IRB finds that the conditions for a waiver of consent (CSS IRB SOP #15 Waiver or Alteration of Consent (Waiver Request Form Reviewer Checklist) or a waiver of documentation of consent (CSS IRB SOP #18 Waiver of Documentation of Informed Consent) are met. Unless an exception applies, an Investigator may not enroll a human subject in a research study until informed consent has been obtained. Informed consent must be legally effective, prospectively obtained and in understandable language. Securing and maintaining consent is an ongoing process that begins with recruitment and continues through the end of the subject’s involvement in the study.
Purpose
The purpose of this standard operating procedure is to describe the required elements of consent and the general requirements for documentation of informed consent. With children, the concept of informed consent shifts from that of a competent adult who grants informed consent to participate in research, to that of parents who grant permission to involve their children in research. This document uses the term informed consent for simplicity; however, it should be recognized that, in the case of children, it is parental permission that is being documented and granted.
Definitions
Informed Consent
A person’s affirmative agreement to participate in a research study after achieving an understanding of what is involved. The informed consent process involves three key features: (1) providing the prospective subject the information needed to make an informed decision (in language understandable to him or her); (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether to participate in the research. Among other requirements, for consent to be legally effective, the potential subject or their legally authorized representative (LAR) must have the necessary decision-making capacity to make a rational and meaningful choice about whether to participate (or continue participating) in a study.
Decision Making Capacity
Decision-making capacity refers to a potential subject’s ability to make a rationale and meaningful decision about whether to participate in a research study. This ability is generally thought to include at least the following four elements:
- Understanding, i.e., the ability to comprehend the disclosed information about the nature and purpose of the study, the procedures involved, the risks and benefits of participating versus not participating, and the voluntary nature of participating;
- Appreciation, i.e., the ability to appreciate the significance of the disclosed information and the potential risks and benefits for one’s own situation and condition;
- Reasoning, i.e., the ability to engage in a reasoning process about the risks and benefits of participating versus alternatives, and
- Choice, i.e., the ability to express a choice about whether to participate.
Decision-making capacity should not be confused with the legal concept of “competence.” While the court may consider information about a person’s decision-making capacity in making a competency determination, the terms are not synonymous. Incompetence is a legal determination made by a court of law. For example, someone who is judged legally incompetent to manage their financial affairs may retain sufficient decision- making capacity to make meaningful decisions about participating in a particular research protocol. As well, persons who have normal cognitive functioning and are considered legally competent may be put into circumstances where their decision-making capacity is temporarily impaired by a physical or mental condition or by alcohol or drugs. Decision-making capacity is protocol-specific and situation-specific. Thus, a subject may have capacity to consent to a low-risk research protocol in usual circumstances, but not have the capacity to consent to a high-risk protocol or when he or she is confused or under duress.
Legally Authorized Representative
A Legally Authorized Representative (LAR) is defined by 45 CFR 46.102(i) and 21 CFR 50.3(l) as “an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.” Who may serve as LAR is determined by state law. Minnesota law does not specifically address informed consent by LARs of incapacitated persons for participation in clinical research. Thus, the applicable guidelines for determining the most appropriate LAR for research are based upon the guidelines that apply in the clinical setting.
Legally Incompetent Adults
For legally incompetent adults unable to make medical decisions, a legal representative (court appointed guardian) or durable power of attorney for health care must provide informed consent for non-emergent medical treatment. The legal guardian must be authorized by the court to make decisions regarding the types of activities, procedures, or treatments called for in the research to serve as LAR. If the patient does not have a guardian or durable power of attorney, consent should be obtained from one of the following, in order of priority:
- spouse,
- parents,
- adult children, or
- adult siblings.
Substitute Decision Makers/Delegated Authority to Consent on Behalf of Incapable Party
Substitute decision makers may serve as LAR for research involving clinical procedures or treatments when a court appointed guardian or durable power of attorney for health care are not in place.
Minnesota has two specific limitations on the consent authority of legally authorized representatives. First, under Minn. Stat. § 524.5-313(c)(4)(i), guardians appointed by the court have the power to give consent for necessary medical treatment, “except that no guardian may give consent for psychosurgery, electroshock, sterilization, or experimental treatment of any kind” (emphasis added) without first obtaining a court order. Second, under Minn. Stat. 253B.095, persons under a civil commitment order may not give consent to participate in a psychiatric clinical drug trial unless the court approves the specific drug trial. “Experimental treatment” is not defined.
LARs should be well informed regarding their roles and responsibilities when asked to provide surrogate consent. In addition to the consent information, LARs should be informed that their obligation is to try to determine what the potential subject would do if able to provide consent, or if the potential subject's wishes cannot be determined, what they think is in the person's best interest. Investigators must describe the intended use of LARs in their submission to the IRB. The IRB determines whether the use of LARs is appropriate for a given research study.
Assent
An Individual’s affirmative agreement to participate in research obtained in conjunction with permission of the individual’s parents or legally authorized representative. Failure to object should not be construed as assent.
Clinical Trial
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
Cognitively Impaired
Having a condition that impairs the capacity for judgment and reason. This may include individuals under the influences of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and individuals with severely disabling mental handicaps, all of whom may be compromised in their ability to make decisions in their best interest.
Consenter
The Investigator or a designated member of the research team on the approved protocol who has the appropriate training and knowledge to conduct the informed consent process.
Enroll
To enter into a research study by means of signing an informed consent document.
Funding Source
The source of funding may be through external (e.g., grants, contracts, gifts) or internal (CSS/department) sources. Projects which are internally funded should be acknowledged as funded by The College of St. Scholastica.
Identifiable Biospecimen
A biospecimen for which the identity of the subject is or may readily be ascertained by the Investigator or associated with the biospecimen.
Identifiable Private Information
Private information for which the identity of the subject is or may readily be ascertained by the Investigator or associated with the information. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
Informed Consent Document
A document that certifies a person’s informed consent.
Informed Consent Process
The process of informing a potential subject or a potential subject’s Legally Authorized Representative (LAR) which includes, but is not limited to, explanation of the protocol, review of the consent document, and answering research- related questions.
Minimal Risk
Level of risk in which the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life of a normal healthy person living in a safe environment or during the performance of routine physical or psychological examinations or tests.
Short Form
Written consent document allowing use of an oral consent process.
Witness
A witness is a person who is physically present to observe the consent process and can attest to what actually occurred. Should the subject not speak English, the witness should be fluent in both English and the language of the subject.
Basic Elements of Informed Consent
To be valid, the consent process must provide the following basic elements of information to potential subjects:
- 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 and how they might be minimized;
- A description of any benefits to the subject or to others which may reasonably be expected from the research;
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- A statement describing the extent, if any, to which confidentiality of records identifying the subject must be maintained;
- 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;
- 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;
- 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;
- For FDA-regulated studies, a statement that notes the possibility that the Food and Drug Administration may inspect the records (21 CFR Part 50);
- For “applicable” FDA-regulated clinical trials, the following statement must be included verbatim:
- “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
- One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
- A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
- A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
Additional elements of informed consent to be applied, as applicable:
- A statement that the particular treatment or procedure may involve risks to the subject (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;
- The approximate number of subjects involved in the study.
- Additional Elements (must be included when appropriate) [§46.116(c)]
- A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
- b. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions;
- For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
Subject Withdrawal or Termination
A subject enrolled in a research study may decide to withdraw from the research, or an investigator may decide to terminate a subject’s participation in research regardless of whether the subject wishes to continue participating. Investigators must plan for the possibility that subjects will withdraw from research and include a discussion of what withdrawal will mean and how it will be handled in their research plans and consent documents. When seeking informed consent from subjects, the following information regarding data retention and use must be included:
- For FDA-regulated clinical trials, when a subject withdraws from a study, the data collected on the subject to the point of withdrawal remain part of the study database and may not be removed. This should be disclosed in the consent.
- For research not subject to FDA regulations, the investigator should inform subjects whether the investigator or study sponsor intends to either: (1) retain and analyze already collected data relating to the subject up to the time of subject withdrawal; or (2) honor a research subject’s request that the investigator or study sponsor will destroy the subject’s data or that the investigator or study sponsor will exclude the subject’s data from any analysis.
When a subject’s withdrawal request is limited to discontinuation of the primary interventional component of a research study, research activities involving other types of participation for which the subject previously gave consent may continue. Investigators should ask a subject who is withdrawing whether the subject wishes to participate in continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the subject would distinguish between study-related interventions and procedures and continued follow-up in person, by phone, or via records review.
If a subject withdraws from the interventional portion of the study, but agrees to continued follow-up as described in the previous paragraph, the investigator must obtain the subject’s informed consent for this limited participation in the study (assuming such a situation was not described in the original consent document). IRB approval of consent documents for these purposes would be required.
If a subject withdraws from the interventional portion of a study and does not consent to continued follow-up, the investigator must not access or gather private information about the subject for purposes related to the study. However, an investigator may review study data related to the subject collected prior to the subject’s withdrawal from the study, and may consult public records, such as those establishing survival status.
Oral Consent
When subjects are unable to read a written consent form (such as blind or illiterate subjects), the IRB may approve an oral consent process, provided the subject (1) retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained orally and (2) is able to indicate approval or disapproval to study entry.
For minimal risk research, documentation of consent may be waived according to the criteria in CSS IRB SOP #18 Waiver of Documentation of Informed Consent. The IRB may waive the requirement for the investigator to obtain a signed consent form following the criteria in CSS SOP #15 Waiver or Alteration of Consent (Waiver Request Form Reviewer Checklist).
For greater than minimal risk research, the consent form must be read to the subjects and the subjects must be given an opportunity to ask questions. An audiotape approved by the IRB may also be used. If capable of doing so, the subject signs, or marks an X to signify consent. If that is not possible, the subject will provide oral consent. The person obtaining consent and a witness will sign the written study consent form with a statement that documents that an oral process was used and, if necessary, that the subject gave oral consent. The consent process will also be documented in the subject’s research record. Signed copies of the consent form are given to the subject and, whenever possible, these documents should be provided to the subject on audio or videotape.
Documentation of Informed Consent
Informed consent must be documented by the use of a written consent form approved by the IRB.
- Informed consent is documented by the use of a written consent form approved by the IRB and signed (including in an electronic format) and dated by the subject or the subject's LAR at the time of consent.
- For research conducted in accordance with facilities subject to Joint Commission requirements, the name of the person who obtained consent and the date they did so is documented on the written consent form.
- A written copy of the signed and dated consent form must be given to the person signing the form. The investigator should retain the signed original in the research records.
The consent form may be either of the following:
- A written consent document that embodies the basic and required additional elements of informed consent. The investigator shall give either the subject or the subject’s LAR adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject or the subject’s legally authorized representative; or
- A short form written consent document stating that the elements of informed consent have been presented orally to the subject or the subject's LAR and that the key required information was presented first to the subject, before other information, if any, was provided. When this method is used:
- The oral presentation and the short form written document should be in a language understandable to the subject; and
- There must be a witness to the oral presentation; and
- The IRB must approve a written summary of what is to be said to the subject (the approved full consent document may serve as this summary); and
- The short form document is signed by the subject;
- The witness must sign both the short form and a copy of the summary; and
- The person obtaining consent must sign a copy of the summary; and
- A copy of the summary must be given to the subject or representative, in addition to a copy of the short form.
When the short form procedure is used with subjects who do not speak or read English, or have Limited English Proficiency (LEP), or are unable to fully comprehend the written consent form, the oral presentation and the short form written document should be in a language understandable to the subject. The IRB-approved English language informed consent document may serve as the summary.
The witness should be fluent in both English and the language of the subject. The witness to the consent process may be a member of the study team (in addition to the person obtaining consent). For research subject to FDA regulation, FDA expects that the subject will be provided with a fully translated consent document as soon as possible.
Vulnerable Subjects in Research
When participants in research conducted under the auspices of the CSS IRB are likely to be vulnerable to coercion or undue influence or have diminished decision-making capacity, the research must include additional safeguards to protect the rights and welfare of these participants. When vulnerable populations are included in research, regulations require that additional safeguards are put in place to protect the rights and welfare of these subjects. [45 CFR 46.111(b)/21 CFR 56.111(b)]
Adults with Impaired Decision-Making Capacity
Adults with impaired, fluctuating, or diminishing decision-making capacity are particularly vulnerable. Researchers and IRBs must carefully consider whether inclusion of such subjects in a research study is appropriate; and when it is, must consider how best to ensure that these subjects are adequately protected. The IRB must ensure that all the regulatory requirements for the protection of vulnerable subjects are met and that appropriate additional protections for vulnerable subjects are in place.
Research involving adult subjects without the ability to provide consent or with impaired decision-making capacity should only be conducted when the aims of the research cannot reasonably be achieved without their participation. Investigators must disclose to the IRB both plans and justification for including individuals with impaired, fluctuating, or diminishing capacity in a given study. If persons with questionable, impaired, or fluctuating capacity will be included, investigators must specify procedures for assessing capacity prior to providing informed consent and, if appropriate, for re-evaluating capacity during study participation.
If a prospective subject’s capacity to consent is expected to diminish, the investigator may be required to request designation of a future LAR at the time of the initial consent process and written documentation of the subject’s wishes regarding the study. When the study includes subjects likely to regain capacity to consent, the investigator should include future provisions to inform them of their participation and seek consent for ongoing participation, if applicable. For research involving subjects who may have fluctuating or declining decision-making capacity, the IRB may require periodic re-evaluation of capacity and/or periodic re-consent.
Plans for evaluation of capacity should be tailored to the subject population and the risks and nature of the research. In some instances, assessment by the investigator may be appropriate. However, an independent, qualified assessor other than the investigator should evaluate subjects’ capacity when the risks of the research are more than a minor increase over minimal or the investigator is in a position of authority over a prospective subject. In all cases, the person(s) evaluating capacity must be qualified to do so and use appropriate, validated tools and methods. Assessments of capacity should be documented in the research record, and when appropriate, in the medical record.
Under some circumstances, individuals with decisional impairment may be able to make voluntary and informed decisions to consent or refuse participation in research. In these cases, investigators use an array of methods to optimize the prospective subjects’ ability to comprehend study procedures, risks, and benefits such as presenting the information multiple times or on multiple occasions and use of audiovisual presentations (e.g., audio or video recordings) and an oral consent following oral consent procedures. In addition, investigators use a variety of methods to evaluate prospective subjects’ comprehension before proceeding to obtain informed consent such as second opinions, use of independent consent observers, interpreter for hearing-impaired subjects, allowing a waiting period before enrollment, or involvement of a trusted family member or friend in the disclosure and decision making process. Audio or videotapes, computer video presentations, or written materials used to promote understanding must be provided to the IRB for review. Third party consent monitors may be used during the recruitment and consenting process or waiting periods may be required to allow more time for the subject to consider the information that has been presented.
When a prospective subject is deemed to lack capacity to consent to participate in research, investigators may obtain informed consent from the individuals’ surrogate or LAR (See above). Under these circumstances, the prospective subject should still be informed about the trial in a manner compatible with the subjects’ likely understanding and if possible, be asked to assent to participate. Subjects who express resistance or dissent (by word, gesture, or action) to either participation or use of surrogate consent, should be excluded from the study. Some subjects may initially assent but later resist participation. Under no circumstances may an investigator or caregiver override a subject’s dissent or resistance. When assent is possible for some or all subjects, the investigator should provide the IRB with an assent plan that describes when and how assent will be obtained, provisions that will be taken to promote understanding and voluntariness; how assent will be documented; and a copy of the assent form. If the investigator intends to use audio or video recordings to document assent, provisions to ensure the security of the recordings should be described to the IRB.
When inclusion of persons with impaired decision-making capacity is not anticipated and a plan for inclusion of such subjects has not been reviewed and approved by the IRB, but a research subject becomes unable to provide consent or impaired in decision- making capacity after enrollment, the investigator is responsible for notifying the IRB. The investigator should consider whether continuing participation is appropriate and, if so, present a plan for surrogate consent from a LAR and, if appropriate, a plan to periodically evaluate capacity and re-obtain consent if possible.
Research Involving Prisoners
The CSS IRB does not currently review research involving prisoners. If this were to change, procedures consistent with the requirements of Subpart C of 45 CFR 46 will be developed. If a subject were to become incarcerated while participating in a study that has not been approved for inclusion of prisoners, the IRB must be notified immediately so that the IRB can determine whether the subject may continue in the research, whether additional safeguards are needed, and to make the determinations required by the regulations.
Research Involving Children
Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
According to Minnesota law, minors are persons under the age of eighteen. However, under Minnesota law, minors may provide consent for their own medical treatment for “Confidential Minor Services.” While no formal system exists in Minnesota for a judge to legally emancipate a minor, a minor living separately from parents or guardians, and managing his/her own financial affairs, may seek any medical treatment without the consent of a parent or guardian. This exception applies to a minor regardless of whether the minor’s parents have consented to the minor living apart, or regardless of the extent or source of the minor’s income. Minnesota law also allows minors who have been married or have given birth to seek treatment without the consent of parent or guardian for their own medical, mental, dental, or other health services or for services for the minor’s child.
Minnesota statute §144.343 addresses requirements for parental notification before a minor may undergo an abortion.
Because Minnesota law does not specifically address when minors may provide consent for research, the CSS IRB applies the above standards to research involving medical care or treatment. When research does not involve medical care or treatment, the CSS IRB defines children as persons who are under the age of eighteen and, unless specified otherwise, allows “emancipated” minors and minors who have been married or given birth to provide consent for their own participation, or their child’s participation, in research not involving medical treatment. NOTE: For research conducted in jurisdictions other than Minnesota, the research must comply with the laws regarding the legal age of consent in the relevant jurisdictions. Legal counsel should be consulted as needed with regard to the laws in other jurisdictions.
Confidential Medical Services are those services for which a minor can give consent and the consent of a parent or other person is not required, including care related to pregnancy (including birth control), STDs, drug or alcohol dependency, hepatitis B vaccination, and admission of a 16 or 17-year-old for treatment of a mental illness.
A guardianship is a legal relationship created when a person is assigned by the court to take care or make decisions for an individual of any age. In many cases, a legal guardian has the authority to make healthcare decisions for the protected person (ward). Minnesota Law provides that a court appointed guardian for an incapacitated person cannot give the necessary consent to enable the ward to partake in experimental treatment of any kind unless the procedure is first approved by order of the court Minnesota Statute 524.5-313 and 524.5-207. Minnesota Statute 524.5-313 also provides that a court appointed guardian for an incapacitated person cannot consent to any medical care which violates “known, conscientious, religious, or moral belief of the ward.”
Parental Permission and Assent
Parental Permission
The IRB must determine that adequate provisions have been made for soliciting the permission of each child’s parent or guardian. Parents or guardians must be provided with the basic elements of consent and any additional elements the IRB deems necessary. The IRB’s determination of whether permission must be obtained from one or both parents will be documented in the reviewer’s notes when a study receives expedited review, and in meeting minutes when reviewed by the convened committee.
Permission from both parents is required for research to be conducted unless:
- One parent is deceased, unknown, incompetent, or not reasonably available; or
- When only one parent has legal responsibility for the care and custody of the child. Permission from both parents is also required for research involving care or treatment to a child in connection with an abortion.
For research not covered by the FDA regulation, the IRB may waive the requirement for obtaining permission from a parent or legal guardian if:
- The research meets the provisions for waiver in Section 45 CFR § 46.116; or
- If the IRB determines that the research is designed to study conditions in children or a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children) provided that an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and that the waiver is not inconsistent with Federal, State, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol/research plan, the risk and anticipated benefit to the research subjects, and the child’s age, maturity, status, and condition.
Parental permission may not be waived for research covered by the FDA regulations.
Assent from Children
The IRB is responsible for determining that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. This judgment may be made for all children to be involved in the study, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children 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 children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement when consent may be waived in accordance with the applicable regulations. It is important to note that the FDA regulations do permit the IRB to waive the assent requirement if it finds and documents that:
- The clinical investigation involves no more than minimal risk to the subjects;
- The waiver will not adversely affect the rights and welfare of the subjects;
- The clinical investigation could not practicably be carried out without the waiver; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Because “assent” means a child’s affirmative agreement to participate in research, the child must actively show his or her willingness to participate in the research, rather than just complying with directions to participate and not resisting in any way. The IRB should consider the nature of the proposed research activity and the ages, maturity, and psychological state of the children involved when reviewing the proposed assent procedure and the form and content of the information conveyed to the prospective subjects. For research activities involving adolescents whose capacity to understand resembles that of adults, the assent procedure should likewise include information similar to what would be provided for informed consent by adults or for parental permission. 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.
Parents and children will not always agree on whether the child should participate in research. Where the IRB has indicated that the assent of the child is required for him or her to be enrolled in the study, dissent from the child overrides permission from a parent. Similarly, a child typically cannot decide to be in research over the objections of a parent. There are individual exceptions to these guidelines but in general, children should not be forced to be research subjects, even when permission has been given by their parents.
Documentation of Assent
When the IRB determines that assent is required, it also is responsible for determining whether and how assent must be documented. When the research targets the very young child or children unable or with limited capacity to read or write, an oral presentation accompanied perhaps by some pictures with documentation of assent by the person obtaining assent in a research note is likely more appropriate than providing the child a form to sign. In this case, the investigator should provide the IRB with a proposed script and any materials that they intend to use in explaining the research.
When the research targets children who are likely able to read and write, investigators should propose a process and form that is age appropriate and study specific, taking into account the typical child's experience and level of understanding, and composing a document that treats the child respectfully and conveys the essential information about the study. The assent form should:
- Tell why the research is being conducted;
- Describe what will happen and for how long or how often;
- Say it's up to the child to participate and that it's okay to say no;
- Explain if it will hurt and if so for how long and how often;
- Say what the child's other choices are;
- Describe any good things that might happen;
- Say whether there is any compensation for participating; and
- Ask for questions.
Whenever possible, the document should be limited to one page. Illustrations might be helpful, and larger type and other age appropriate improvements are encouraged when they have the potential to enhance comprehension. Studies involving older children or adolescents should include more information and may use more complex language.
Children Who Are Wards
Children who are wards of the State or any other agency, institution, or entity can be included in research approved, only if such research is:
- Related to their status as wards; or
- Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.
If the research meets the condition(s) above, an advocate must be appointed for each child who is a ward (one individual may serve as advocate for more than one child), in addition to any other individual acting on behalf of the child as legal guardian or in loco parentis ( Latin for "in the place of a parent" refers to the legal responsibility of a person or organization to take on some of the functions and responsibilities of a parent).