All research subjects (or their Legally Authorized Representatives (LAR) if they are unable to consent for themselves) must be able to understand enough about a research study and the elements of consent in order to be able to make an informed decision regarding participation. This means the consent and study materials must be presented in a language the potential participant or LAR can understand. Implementation will require either a written translation or oral presentation by a person who is fluent in both English and the other language. The requirements for consent and the translation of documents will depend on whether or not it is known in advance that non-English speakers will be eligible for the study.
Informed Consent for Children and Parents
Federal law defines "children" as 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.
Under Pennsylvania law, persons under the age of eighteen (18) generally meet this definition of "children" with the exceptions noted below. As a result, permission of the child's parent(s) or guardian(s) must generally be obtained prior to the participation of that child in research.
The following exceptions to the general rule apply where a person under the age of 18 does not meet the federal definition of "child" and may provide legally effective consent to participate in research if either:
- The research involves the provision of medical care or treatment AND if the person:
- has graduated from high school, or
- is married, or
- is or has been pregnant.
- The person is an emancipated minor.
If the emancipated minor provides consent for him or herself, the court order must be copied and included in the research records with the consent document.
The general requirement is that explicit parental consent be obtained in writing for each participant. However, parental consent may be waived by the IRB if it is not a reasonable requirement to protect the subjects (e.g. neglected or abused children). Investigators requesting the waiver must propose an alternative mechanism for protecting the children who will be participating in the study.
If the research involves minimal risk, the permission of one parent is sufficient.
If the research involves GREATER than minimal risk, consent of both parents must be obtained unless one parent is deceased, incompetent, not reasonably available, or when parent has legal responsibility for the care and custody of the child.
A template for parental consent can be found on the Guides and Templates page of the IRB website.
Assent means a child's affirmative agreement to participate in research. In all instances where children are capable of providing assent, the investigator shall develop a separate assent form written at a developmental level appropriate to the child's age, maturity, and experience. As a guideline, children age seven and older are considered capable of assenting. A template for child assent forms for use by children and minors is available on the Guides and Templates page.
Any research proposal involving children must include the following:
- How assent will be obtained (what the investigator will say to the child and whether or not the child's parent(s) or guardian(s) will be present.
- How the child's verbal assent will be documented. The child must either sign a brief assent form and/or verbally indicate a willingness to participate (typically this is the mode of assent for children younger the age of 9 years).
- Signed assent forms are required for children age 9 years or older; optional for children younger than 9 years.
If research is being conducted in schools or other education settings, investigators should inform teachers and administrators of the following:
- Written parent consent is required for children to be given the option to participate.
- Administrators and teachers may invite but should not instruct children to participate.
- Children are allowed to decline participation with no repercussions.
Exceptions, Alterations, or Waivers
Written informed consent is not always appropriate in some educational and social and behavioral research e.g. some ethnographic, field, or qualitative research studies.
The Swarthmore IRB may provide a waiver, an exemption, or otherwise approve alterations of documented informed consent if the investigator justifies that:
- The research involves no more than minimal risk; and
- The waiver or modification will not adversely affect the rights and welfare of the subjects; and
- The research could not be practicably carried out without the waiver or modification; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Please note the bolded "ands" in the four conditions above. All four of these conditions must be met in order for any exceptions, waivers, or alterations to be approved.
When applying for exceptions, waivers, or alterations, the investigator must explicitly address each of the conditions above and propose alternative measures for obtaining and documenting informed consent. Deception research must include a request for a waiver of consent and documentation since the research could not be practicably be carried out without the waiver.
Waiver of Documented Informed Consent
The IRB may also waive the requirement to obtain a signed informed consent form if it finds either:
- That the only record linking the subject to the research would be the consent form and the most serious risk would be a breach of confidentiality; or
- That the research involves no more than minimal risk and involves no procedures for which written consent is normally required outside of the research context.
Documenting Informed Consent
Most subjects make their decision regarding whether to participate in research during the initial contact with the investigator(s). The investigator(s) should avoid the potential for any misunderstandings and provide the subjects with sufficient time to reflect on the nature of their proposed participation.
When written informed consent is appropriate, an informed consent form should be presented to potential research subjects and a member of the research should ensure the subject reads and understands the information presented in the form. Federal regulations require that all consent form statements describe the nature of the research and the request for human subjects' participation in language that is understandable to each potential subject. Consent forms should avoid technical jargon or terminology that is not defined. The forms should also adjust for educational backgrounds, mental abilities, and the ages of the intended subjects. Consent forms should be easily identified in bold text as "Consent to Participate in Research" at the top of the first page. The title should be descriptive and not overly technical.
Informed consent shall be documented by having the subject (or legally authorized representative) sign the informed consent form and receive a copy. The investigator or member of the research team must also sign the consent form.
Sample consent forms are available on the Guides and Templates page of the IRB website.
Required Elements of Informed Consent
This Information MUST be provided to potential research subjects.
The consent templates on our Guides and Templates page include these required elements. The researcher must adequately address each per the research study design. If the required elements are not adequately stated in the consent document, the IRB will be unable to grant approval for the research. Once approved, only the versions that were included in the approved protocol should be used. Any changes to approved consent documents require IRB approval.
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 subjects.
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 minimal risk, an explanation as to whether any medical treatments or compensation 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 subject's rights, and whom to contact in the event of a research-related injury to the subject.
8) A statement that participation is voluntary and refusal to participate will not involve penalty or loss of benefits to which the subject is otherwise entitled, that the subject may discontinue participation at any time without penalty or loss of benefits to which he/she is otherwise entitled, and that the subject will receive a copy of the signed informed consent.