Requirements for Nonexempt Research on Children
- Requirements for Assent by Children: Adequate provisions must be made for soliciting the assent of children, when in the judgment of the IRB, the children are capable of providing assent. Assent means a child's affirmative agreement to participate in research. Mere failure to object should not absent affirmative agreement, or be construed as assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, 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 under circumstances, in which consent may be waived.
- Requirements for Parental Permission
- Adequate provisions should be made for soliciting the permission of each child's parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted involving minimal risk or greater than minimal risk, but with direct benefit to the subjects. Research with greater than minimal risk that does not provide a direct benefit to the subject requires permission to be obtained from both parents, 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.
- If the IRB determines that a research protocol is designed for conditions, or for a subject population, for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further 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, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.
Activities Directed Toward Pregnant Women as Subjects
- No research can be conducted on pregnant woman unless (a) the purpose of the activity is to meet the health needs of the mother, and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or (b) the risk to the fetus is minimal.
- An activity permitted under paragraph (A.) of this section may be conducted only if the mother and father are legally competent and have given their informed consent, after having been fully informed regarding possible impact on the fetus, except that the father's informed consent need not be secured if: (1) the purpose of the activity is to meet the health needs of the mother, (2) his identity or whereabouts cannot reasonably be ascertained, (3) he is not reasonably available, or (4) the pregnancy resulted from rape. (45 CFR 46.207)
Activities Directed Toward Prisoners as Subjects
- Contact the IRB (firstname.lastname@example.org) prior to proposing, considering, or in any way becoming involved in research involving prisoners as human subjects.
- Any activities directed toward prisoners as subjects will follow 45 CFR 46 Subpart C
Research Involving Use of Translators
- Consent Form Procedure
- The translator must translate the entire IRB-approved English version of the consent form to the subject in a language understandable to him/her, and the subject must be given a copy of the written translation of the consent document to read;
- The entire consent process must be witnessed by an individual who is fluent in both English and the language understandable to the subject. The translator may serve as the witness;
- The IRB-approved English version of the consent form must be signed by the investigator who’s authorized by the IRB to obtain consent, and signed by the witness to the consent process (may be the translator). The form must also be signed by the subject and the witness to the consent process (again, this may be the translator);
- The subject must be given copies of both the IRB-approved English version of the consent form and the translated version of the consent form. The originals of both forms should be placed in the subject’s research record.
- Verification of Translation Accuracy
- The translated documents (any translated documents that relate to this study) should be verified for accuracy
- This may be accomplished by completing a form that includes:
- Name of the Investigator
- Title of the Project
- Name of Verifying Individual
- The language being verified (Spanish, French, etc.)
- Contact information for the verifying individual
- A signatory line (signature and date) for the verifying individual that states: "I, the undersigned, verify that all translated materials related to the above named study reflect the intent and spirit of the English text."
- The verifying individual may be someone from the Department of Foreign Languages or someone who has a bachelor’s degree in the language being verified. It does not have to be a certified translator.