Consent Modules

The Newborn Screening Translational Research Network (NBSTRN) has developed recommendations for model language for informed consent documents for principal investigators conducting research related to newborn screening. Specific requirements regarding consent language and/or use of extant data without express consent varies across IRBs. You will need to contact your local IRB for specific recommendations regarding required language. The model consent language should be considered a working draft or starting point that is modifiable by individual investigators to suit their particular IRB needs. It should be noted that the language and information provided represent general considerations. This should not be viewed as a comprehensive tool, as special situations of the project, the intended use of the data, local IRB requirements and/or state law may govern the actual content of a consent document for a particular research purpose, including participating in a repository.

 

Why keep it simple?

The Informed Consent Form (ICF) should be kept as simple as possible without sacrificing the completeness of its content to insure that the potential study subject makes an informed choice about his/her participation in the research study. It should allow for a meaningful, ethically sound and legally valid exchange of information between the potential subject and the investigator.

The language of the ICF for adult subjects should be written at a 6th- to 8th-grade level or lower in an easy-to-read font, in short sentences and paragraphs, and lay terminology. Information should be accurate and precise. The consent form should be easy to look at, with a clear layout that allows the reader to easily distinguish the different paragraphs.

Subjects are directly addressed as “you”; investigators are referred to as “we,” except in the signature block where subjects are addressed as “I.”

Basic Elements of Informed Consent (From FDA regulation 21 CFR § 50.25  and HHS regulation 45 CFR 46.116)

Required:

  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 and that notes the possibility that the Food and Drug Administration may inspect the records.
  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:
    1. Research questions
    2. Rights questions
    3. Injury questions
  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, as appropriate

  1. 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.
  2. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent.
  3. Any additional costs to the subject that may result from participation in the research.
  4. The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.
  5. 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.
  6. The approximate number of subjects involved in the study.

These requirements are not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed for informed consent.

Notes for Informed Consent Authors

thumbnail of informed consent templateNBSTRN provides a MS Word template to provide structure and guidance to the informed consent process. The document should guide, not serve as your exact informed consent document. Please remember to consult your institution and IRB for specific consent requirements, instructions and templates. Download the General Consent Template.

Under the Privacy Rule or HIPAA, a patient must also authorize the use and disclosure of protected health information for research purposes. Specific requirements regarding inclusion of HIPAA language with the informed consent form or as a stand alone form varies across IRBs.  You will need to contact your local IRB for specific recommendations regarding required language and inclusion in your consent.

General information related to a child’s assent

“Assent” means a child's affirmative, explicit agreement to participate in research (45 CFR 46.402).

A child is a person who has not yet attained the legal adult age, which is 18 years of age in most states. State law determines circumstances under which a child is legally authorized to consent to medical procedures, e.g. the provision of contraceptive services. Certain states recognize the “emancipation of minors,” through which a child may gain certain civil rights, including the right to consent to research participation.

A “guardian,” in the context of obtaining consent for research involving children who is a ward, provides permission, in lieu of a child’s biological or adoptive parents, for the ward to participate in the research (45 CFR 46.402(c)). 

According to 45 CFR 46.408, both the child’s assent and parental/guardian permission are required for the child to participate in research.

  • If the child is capable of providing assent, then provisions should be made for soliciting it. The IRB judges whether the child is capable of providing assent, taking into account his/her age, maturity, and psychological state. The child’s assent can be waived if the IRB deems the child not capable of assent and if the research offers direct benefit to the child’s health only available through the research.
  • Provisions should be made for soliciting parental/guardian permission.
  • The permission of one parent is sufficient for:
  • Research not involving greater than minimal risk (45 CFR 46.404)
  • Research involving greater than minimal risk but with direct benefit to the child (45 CFR 46.405)
  • Unless one parent is deceased, unknown, incompetent, or not available, or only one parent has legal custody of the child, the permission of  both parents is required for:
  • Research involving greater than minimal risk and no direct benefit to the child, but likely to yield knowledge about the child's disorder or condition (45 CFR 46.406)
  • Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the child’s health of welfare (45 CFR 46.407)

If the IRB determines that parental/guardian permission is not a reasonable requirement to protect the child (for example, neglected or abused children), it may waive the consent requirements as long as a mechanism for protecting the child is substituted, and the waiver is not inconsistent with federal, state, or local law.

Permission by parents/guardians shall be documented in the consent form. The child’s assent shall be documented in an assent form, which is a simpler version of the parental/guardian consent form.

If the child is a ward of the state or any other agency, institution, or entity, he/she can be included in research only if such research is:

  • Related to their status as wards; or
  • Conducted in schools, camps, hospitals, institutions, or settings in which the majority of children involved as subjects are not wards.

The IRB requires the appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child. The advocate shall act in the best interests of the child and shall not be associated with the research, the investigator(s), or the guardian organization.

It is commonly recognized that most children age 7 or older can understand basic information provided at their level. In most research studies, children are asked if they agree (assent) to be in a study.

  • Assent section is required for children age 7-14, along with information sheet for children
  • Assent section is required for children age 15-17, along with information sheet for adolescents

The information sheet is a simplified version of the informed consent signed by parents/guardian/LAR and written in language at the child’s level.

To avoid the potential for unintended coercion, it is better that someone other than the researcher him/herself be involved in the assent process.

General information related to a child’s assent

“Assent” means a child's affirmative, explicit agreement to participate in research (45 CFR 46.402).

A child is a person who has not yet attained the legal adult age, which is 18 years of age in most states. State law determines circumstances under which a child is legally authorized to consent to medical procedures, e.g. the provision of contraceptive services. Certain states recognize the “emancipation of minors,” through which a child may gain certain civil rights, including the right to consent to research participation.

A “guardian,” in the context of obtaining consent for research involving children who is a ward, provides permission, in lieu of a child’s biological or adoptive parents, for the ward to participate in the research (45 CFR 46.402(c)). 

According to 45 CFR 46.408, both the child’s assent and parental/guardian permission are required for the child to participate in research.

  • If the child is capable of providing assent, then provisions should be made for soliciting it. The IRB judges whether the child is capable of providing assent, taking into account his/her age, maturity, and psychological state. The child’s assent can be waived if the IRB deems the child not capable of assent and if the research offers direct benefit to the child’s health only available through the research.
  • Provisions should be made for soliciting parental/guardian permission.
  • The permission of one parent is sufficient for:
  • Research not involving greater than minimal risk (45 CFR 46.404)
  • Research involving greater than minimal risk but with direct benefit to the child (45 CFR 46.405)
  • Unless one parent is deceased, unknown, incompetent, or not available, or only one parent has legal custody of the child, the permission of  both parents is required for:
  • Research involving greater than minimal risk and no direct benefit to the child, but likely to yield knowledge about the child's disorder or condition (45 CFR 46.406)
  • Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the child’s health of welfare (45 CFR 46.407)

If the IRB determines that parental/guardian permission is not a reasonable requirement to protect the child (for example, neglected or abused children), it may waive the consent requirements as long as a mechanism for protecting the child is substituted, and the waiver is not inconsistent with federal, state, or local law.

Permission by parents/guardians shall be documented in the consent form. The child’s assent shall be documented in an assent form, which is a simpler version of the parental/guardian consent form.

If the child is a ward of the state or any other agency, institution, or entity, he/she can be included in research only if such research is:

  • Related to their status as wards; or
  • Conducted in schools, camps, hospitals, institutions, or settings in which the majority of children involved as subjects are not wards.

The IRB requires the appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child. The advocate shall act in the best interests of the child and shall not be associated with the research, the investigator(s), or the guardian organization.

It is commonly recognized that most children age 7 or older can understand basic information provided at their level. In most research studies, children are asked if they agree (assent) to be in a study.

  • Assent section is required for children age 7-14, along with information sheet for children
  • Assent section is required for children age 15-17, along with information sheet for adolescents

The information sheet is a simplified version of the informed consent signed by parents/guardian/LAR and written in language at the child’s level.

To avoid the potential for unintended coercion, it is better that someone other than the researcher him/herself be involved in the assent process.

Certificate of Confidentiality

Special Populations

Legally Authorized Representative

Waiver of Consent

The information provided here is not sufficient to write a complete informed consent form (ICF). It should be used to complement the general informed consent form template located in the General Consent section. 

What is an Informed Consent Form?

  • The goal of the informed consent process is to provide study participants with sufficient information to make informed choices.
  • The Informed Consent Form (ICF) provides a summary of the research and the individual’s rights as a research participant.
  • The ICF serves as a starting point for the necessary exchange of information between the investigator and potential research participant.
  • The ICF is only one part of the larger process of informed consent.
  • Only approved investigators may explain the research and obtain informed consent.
  • A witness or witness/translator is required when the participant cannot read the consent document, and it was read or translated.

What is the purpose of the consent modules?

To assist a researcher in writing an informed consent form (ICF) thoroughly and efficiently, according to current, ethical, and legal standards.

The template and language samples provided in these interactive modules should not serve as your exact ICF but should be used for guidance. For additional information and specific consent elements that you may wish to include in the ICF, or for legal and regulatory advice, we refer you to your institution and institutional review board (IRB).

How can the consent modules help you?

By providing you with:

  • The basic elements of an informed consent form (ICF) as provided under FDA regulation 21 CFR § 50.25 and HHS regulation 45 CFR 46.116
  • A set of interactive ICF templates including the basic elements along with concrete general examples and language samples
  • Examples and language samples adapted to a variety of specific research topics including:
    • Additional research studies run in parallel with main study, e.g. quality of life study or banking of tissue collected for main study
    • Biorepository
    • Investigational agent/procedure
    • Genetic counseling
    • Genetics/genomics research including information on GINA
    • A HIPAA research authorization form template
  • Concrete examples and information for special considerations regarding:
    • Certificate of Confidentiality
    • Women of childbearing potential and their reproductive risks
    • Legally Authorized Representative
  • Assent templates for:
    • Children aged 7-14
    • Children aged 15-17

If your institution does not provide you with its own ICF template:

  1. Read the Basic Elements section
  2. Start writing your ICF with the General Consent template
  3. Use the HIPAA, Specific Study Types, Special Considerations, and Assent sections as appropriate for additional guidance and specific language samples as you complete your ICF

If your institution provides you with its own ICF template, you can incorporate the sample languages and concrete examples located in all the sections listed above.

Developed by Sally Hiner, Director of Research Integrity and Institutional Review Board Michigan Public Health Institute, and Veronique Weinstein, MCG, CGC in collaboration with the NBSTRN Bioethics and Legal Issues Workgroup

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