A sample assent form to be signed by elementary aged children is provided as an appendix to the IRB application. Children younger than elementary aged do not need to sign an assent form but should verbally indicate their willingness to participate if they are old enough to do so. Adolescents require increasingly detailed assent documents such that by the age of 17 an assent document should include all elements of informed consent. The language in the Assent Form or script must be age appropriate and 2) a Long Form OR Short Form With Oral Presentation must be used to gain consent from parents/guardians for their children to participate in research activities.

Researchers sometimes wish to collect data from adolescent parents and their children. In such cases, both adolescent parents and children may be under the age of 18. This raises interesting issues regarding who is legally authorized to provide informed consent for the participation of both adolescent parents and their children. Researchers conducting research with adolescent parents and their children are strongly encouraged to refer to the IRB Standard Operating Procedures, Section 10.1 (Research Involving Children) to familiarize themselves with federal and UNCG requirements regarding research with children.

In some cases, adolescent parents may be emancipated minors and thus legally able to provide consent on the part of themselves and their children. In other cases, adolescent parents’ own parents (children’s grandparents) may serve as legal guardians for both adolescent parents and their children and these grandparents are legally able to provide consent for both adolescent parents and their children. These examples are just two of a number of guardianship arrangements that may apply to the situations of adolescent parents and their children.

Researchers conducting research with adolescent parents and their children should design a single document that contains all elements of informed consent and which refers to aspects of the research project as it applies to both adolescent parents and their children. This form should be signed by grandparents or other legal guardians (except in the case of emancipated minor parents) and adolescent parents (for whom it may serve as an assent form).

The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all participants if it finds either that:

1. The only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breech of confidentiality, or Participants must be asked whether they want documentation linking them with the research, and their wishes must govern. (Example: domestic violence research where the primary risk is discovery by the abuser that the participant is talking to researchers.)

2. The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context. In cases in which the documentation requirement is waived, the IRB requires the investigator to provide in the application materials a written summary of information to be communicated to the participant, including all elements of informed consent and the IRB will consider whether to require the investigator to provide participants with a written statement regarding the research or consent information

(2007 IRB Standard Operating Procedures 9.5 as based on the Common Rule; 45 CFR 46)

The IRB is responsible for the review and approval of the informed consent form.

Researchers should prepare both English language and translated consent forms for proposals that include non-English-speaking participants. An explanation of the translations and evidence of the comparability of the English and non-English consent forms is requested. The IRB may consult with language experts or require a "back-translation"; into English. The translation should provide documentation to verify the accuracy of the translation and back-translation.

If a non-English-speaking participant is enrolled unexpectedly, researchers may rely on an oral translation of the English language consent form, but should take extra care in the informed consent process to ensure that the participant has understood the project. A statement in the research records (and on the English language consent form) should indicate that the
translation took place, identify the translator, and document the translator's belief that the participant understood the study and the consent process. If the participant is a patient, a note about the translation should be made in the patient's research records as well. Researchers should try to provide a written translation of the vital emergency contact information.

Sometimes a participant understands English but does not read or write English. In such cases, an oral presentation of the consent form is acceptable. Again, an impartial witness should document that the participant understands the research and the consent process and consented to participate.

(2007 IRB Standard Operating Procedures 9.9)

Research projects conducted in collaboration with other institutions having their own Institutional Review Boards must receive IRB approval from all involved institutions. Research projects and all associated forms (e.g., consent forms) must conform to requirements of all institutions.

If time permits, it may be easiest for investigators to negotiate IRB reviews consecutively by obtaining approval from one institution, then submitting to the second institution, and so on. If the second institution requires changes to consent forms or other project documents, these changes should then be submitted to the initially reviewing IRB through a modification application. It is critical that all involved institutions receive appropriate documentation regarding all changes made to the project over the course of the multiple IRB reviews.

Each IRB will typically require a copy of the approval of other IRBs prior to issuing approval. UNCG will approve a collaborative project prior to obtaining copies of other IRB approvals so long as copies of the other institutions’ IRB approvals are approved under a modification application prior to the beginning of data collection.

The answer to this question is complex and depends on the type of data being provided. Participants in research have to provide consent for their involvement in a project. Federal regulations define a participant in research as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information” (CFR 46.102(f)).

Of greatest relevance here is the phrase “about whom.” Generally speaking, a teacher who is asked to provide objective information about a student (e.g., grades, test scores, ratings of behavior) would not have to complete a consent form. A teacher who was asked to provide information about his or her relationship with a student would have to sign a consent form.

Investigators are encouraged to consult with their school IRB representatives or the Office of Research Compliance to discuss whether a teacher consent form is required for a specific project. It is critical that the consent form signed by the participant or participant’s legal representative (e.g., parent) explicitly detail the investigator’s intent to obtain information about the student from the teacher.