ࡱ>  Yhbjbj  9_I d8d#K,,^(> JJJJJJJ$OMPbJ"JJK K K XJK JK K >EXJIp[k|F(JJ0#KFcPdcPPJIcPJIDK JJK #KcP *:  Institutional Review Board (IRB) GUIDELINES FOR RESEARCH INVOLVING MINORS 1. Introduction Federal regulations require additional protections for minors involved in research. Requirements include limits on exemption from IRB review, use of parental permission and child assent, and conditions for IRB approval of proposed research depending on the level of risk to participants. The purpose of these guidelines is to assist researchers conducting research with minors with compliance by outlining the special considerations for research involving minors. 2. Definitions Subpart D refers to regulations that apply to research involving minors as subjects. Subpart D is found in both 45 CFR 46 (DHHS) and 21 CFR 50 (FDA). Minor (also child) is a person who has 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. For purposes of this policy, individuals under 18 years of age are considered Minors in Missouri and Illinois unless they meet the definition of Emancipated Minors, with the following exceptions: In Missouri, a Minor may consent to medical treatment if married or in the case of pregnancy (excluding abortion), sexually transmitted infections, or substance abuse. In Illinois, a Minor may consent to medical treatment if married, a parent, or a victim of sexual assault. Emancipated Minors, for purposes of this policy, refer to the following persons who, because of their unique circumstances, have the legal rights of Adults, including the right to consent to treatments or procedures involved in research: In Missouri: A person under the age of eighteen years of age is an Emancipated Minor if any of the following conditions are satisfied: he/she enters into a valid marriage, whether or not the marriage is subsequently dissolved; he/she has served or is currently serving with the armed forces or National Guard of the United States; or he/she receives a judgment of emancipation pursuant to sections 2 to 4 of the Missouri  HYPERLINK "http://www.house.mo.gov/content.aspx?info=/bills99/biltxt99/intro99/HB0309I.htm" Emancipation of Minors Act. In Illinois: A person 16 years of age or over and under the age of 18 years who has demonstrated the ability and capacity to manage his/her own affairs and to live wholly or partially independent of his/her parents or guardian and was granted emancipation by the court according to the  HYPERLINK "http://www.ilga.gov/legislation/ilcs/ilcs3.asp?ActID=2094&ChapterID=59" Illinois Emancipation of Minors Act. Ward refers to a child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State, or local law. A court may take responsibility for the legal protection of the child and will generally stand in loco parentis to the child. Generally, this entails assuming all lawful authority to make medical and legal decisions on the childs behalf. Parent refers to a child's biological or adoptive parent. Legally Authorized Representative is an individual, judicial, or other body authorized under applicable law to consent on behalf of a prospective subject to the subjects participation in the procedure(s) involved in the research. The State of Missouri has enacted legislation that outlines how research participants unable to consent for themselves may be enrolled in research studies. For more information on the use of a Legally Authorized Representative, see Guidelines for Use of Legally Authorized Representatives. Guardian refers to an individual who is authorized under applicable state or local law to consent on behalf of a minor to general medical care. Parents are generally the first in line to be guardians for their minor children. Assent is an agreement to participate in research expressed by an individual (e.g., a child) who cannot provide legally effective informed consent to participate on his/her own behalf. Note: Failure to object does not constitute assent. Permission is the agreement of parent(s) or guardian to the participation of their child or ward in research. Minimal Risk is when 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 or during the performance of routine physical or psychological examinations or tests. [45 CFR 46.102 (I)]. 3. Permissible Categories of Research with Minors Research with minors involves special considerations for researchers and IRBs. IRBs must consider the degree of risk and discomfort involved in the research in relation to the direct benefits it offers to the minor in order to determine whether the study is approvable under federal regulations. This standard of review is conducted consistently, regardless of full board or expedited review. The IRB can only approve research involving minors that falls into one of the following categories: Does not involve greater than minimal risk. Involves greater than minimal risk but presents the prospect of direct benefit to the individual participants. The risk is justified by the anticipated benefit to the child. Comparison of the risk to the anticipated benefit is at least as favorable as that presented by available alternative approaches. Involves greater than minimal risk and no prospect of direct benefit to the individual participants, but is likely to yield generalizable knowledge about the participant's disorder or condition. The risk presents no more than a minor increase over minimal risk. The research involves experiences that are reasonably equivalent to those in the childs actual (or expected) medical, dental, psychological, social, or educational situations. The research is likely to yield generalizable knowledge about the childs disorder or condition that is of critical importance for the understanding or improvement of the disorder/condition. The research is not otherwise approvable, but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. The IRB must refer research subject to DHHS or FDA regulations to the Secretary of DHHS and the Commissioner of the FDA and research can ONLY be approved by the IRB if the Secretary of DHHS and/or the Commissioner of the FDA review and approve the research as applicable. Note: The exemption in DHHS regulations for research involving survey or interview procedures or observation of public behavior (Category 2) does not apply to research with children, except for research involving observations of public behavior when the investigator does not participate in the activities being observed. Other Exempt categories may involve minors. 4. Obtaining Informed Consent in Research Involving Minors Research involving minors requires permission (informed consent) from parents/guardians unless a waiver is granted by the IRB. Investigators must follow IRB policies and determinations for obtaining and documenting informed consent, including exclusively using the IRB-approved consent materials in the course of the research. The parent or legal guardian must be provided with a description of the research (e.g. the consent document), and HIPAA Authorization. The information should be presented in language understandable to the parent or legal guardian in an environment free from coercion or undue influence. Sufficient time should be provided to the parent or legal guardian to make a decision whether or not to allow the minor to take part. Based on regulatory requirements, IRBs must determine whether the permission of both parents/guardians is required or if the permission of one parent/guardian is sufficient as described below. Investigators will be notified when both parents are required. For research that involves minimal risk or more than minimal risk with the prospect of direct benefit to the minor, the IRB typically determines the permission of one parent/guardian is sufficient, though consent from both parents can be required as described in the scenario below. For research that involves more than minimal risk without the prospect of direct benefit to the minor, the permission of both parents is required 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. In Loco Parentis According to Missouri Statute 431.061.1(5) adults standing in loco parentis can give consent for medical treatment (not research) of a minor in their charge only in an emergency. Studies involving minors being conducted in an educational setting require permission from the legal guardians of the minors as well as the educational institution unless the IRB grants a waiver. Whenever parental permission is required, signatures must be obtained from parents or legal guardians. In loco parentis signatures are not acceptable. 5. Obtaining Assent for Research Involving Minors Federal regulations also stipulate that adequate provisions be made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent when taking into account the ages, maturity, and psychological state of the children involved [45 CFR 46.408]. In general, investigators should obtain the assent of children to participate in research whenever children are capable of providing it. The IRB is responsible for determining when the assent of some or all children is required in proposed research, as described below. In determining whether proposed participants are capable of providing assent, investigators and IRBs will take into account the ages, maturity, condition, and psychological/emotional states of the minors involved. The IRBs determination of the minors capacity to assent may apply to some or all of the children to be involved in a proposed research activity. Assent processes should include the key elements of informed consent and be provided in language appropriate for minors, based on the nature of the study and the expected capacity of the potential participant(s). 91Ů Model Assent Templates available on the IRB Website should be used to prepare assent forms. Comparable, alternative formats may be accepted. Minors should be provided with essential information and asked whether or not they wish to participate in the research, particularly if the research does not involve direct benefit. For research activities involving older children or adolescents whose capacity to understand is similar to that of adults, the assent process will include information similar to what would be provided for informed consent by adults or for parental permission. For children whose age and/or maturity level limits their ability to fully understand the research but who are still capable of being consulted about participating, it may be appropriate to focus only on providing an accurate description of the experience itself (e.g., what will happen, how long it will take, whether it might involve any pain or discomfort, etc.). Assent should be obtained except in the following circumstances: The minors are not capable of providing assent based on age, maturity, or psychological state; The capability of some or all of the minors is so limited that they cannot reasonably be consulted; The intervention or procedure involved in the research holds out a prospect of direct benefit to the health or well-being of the minors and is available only in the context of the research; The criteria for waiver (or alteration) of informed consent or parental/guardian permission applies, as described below. Currently, the IRB does not require the assent of minors under the age of 7. 6. Participant Dissent Regardless of the ability to provide assent, when dissent is demonstrated, minors should not be forced or coerced to participate in research. The study must include clear and appropriate procedures for respecting dissent. A minor's dissent, which should normally be respected, may be allowed to be overruled by the child's parents/guardians if approved by the IRB. This could occur if the intervention or procedure involved in the research holds out a prospect of direct benefit to the health or well-being of the minors and is available only in the context of the research. Such scenarios should be described in the Assent Section of the IRB application and will be considered by the Board. When research involves the provision of experimental therapies for life-threatening diseases such as cancer, however, researchers should be sensitive to the fact that parents may wish to go to extremes, even when the likelihood of success is marginal and the probability of extreme discomfort is high. Should the child not wish to undertake such experimental therapy, and if, for example, the child is a mature adolescent and death is imminent, the child's wishes should be respected. 7. Documentation of Parental Informed Consent Parental permission must be documented unless a waiver of documentation was obtained. Attention should be paid to providing the necessary amount of signature lines to document all required signatures. Research subject to parental permission from both parents can refer to the 91Ů IRB  HYPERLINK "http://www.slu.edu/Documents/research/IRB/Checklist_Consent_46.406_50.53.docx" Checklist: Obtaining Consent in 45 CFR 46.406/21 CFR 50.53 Research. 8. Documentation of Informed Assent When a childs assent is required, investigators and IRBs must determine the appropriate method, if any, of documenting assent. A minors assent signature is not required by the 91Ů IRB; however, the minors agreement to participate should be documented in the research record. Parents are asked to provide an additional signature on the consent document that attests to the assent of their child. 9. Waiver or Alteration of Parental Permission In some circumstances, the IRB can waive or alter the requirements for obtaining parental permission; however, waivers are not granted for FDA regulated research with the exception of research meeting Emergency Use or IVD exception provisions. The IRB will consider requests for waiver of parental permission on a protocol-by-protocol basis. The IRB can waive or alter the requirements for informed consent for non-exempt research that meets all of the following criteria: The research involves no more than minimal risk to subjects; The waiver or alteration will not adversely affect the rights and welfare of subjects; The research could not practicably be carried out without the waiver or alteration; Whenever appropriate, subjects will be provided with additional pertinent information after participation; and The research is not FDA-regulated, other than an in vitro diagnostic device study (see section In Vitro Diagnostic Devices, below). The IRB can also waive or alter the requirements for parental permission for non-exempt research (including greater than minimal risk research) 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 (e.g., neglected or abused children) when the following additional criteria are also met: An appropriate mechanism is in place to protect the children; and The waiver is not inconsistent with federal, state, or local law. When determining an appropriate mechanism for protecting child participants (e.g., appointment of an advocate or assent monitor), investigators and IRBs will consider the nature of the research (including any potential risks and anticipated benefits) and the minors ages, maturity, condition, and psychological/emotional states. 10. Pregnancy Testing in Minors When pregnancy testing is done for research purposes (e.g., to determine eligibility), parents are told the test results. Therefore, the 91Ů IRB requires that both the study protocol and the document used to obtain informed consent/assent for research state clearly that results of a positive pregnancy test for a minor will be reported to the parents of the minor. 11. Children Who Reach the Legal Age of Consent While Enrolled in a Study Informed consent is an ongoing process. When a minor who was enrolled in research with parental permission reaches the legal age of consent or becomes emancipated, the subjects participation is no longer regulated by the requirements regarding parental permission. Legally effective informed consent must be obtained (unless waived) from the now-adult participant for any continued interactions, interventions, or other activities that meet the definition of research involving human subjects, including analysis of individually identifiable data or specimens. The researcher and the IRB need to ensure that adequate provisions are made for soliciting the consent of minors who turn 18 years of age or become emancipated during study participation. If the minor participated in a study in which the only remaining procedures are data analysis, or inclusion of data/specimens in a registry, consent may not be required and justification for a waiver of consent should be provided in the IRB Application. Consent may be obtained using a full consent or an addendum created specifically for minors who reach adulthood. If the study was approved with a waiver of written consent (e.g., verbal or implied consent process), it is likely that method of consent is also appropriate for minors who reach adulthood. The protocol should describe whether the consent materials (e.g., recruitment statement) used for adults will be used for minors who reach adulthood and how that process will be conducted. Once obtained, the verbal/implied consent of the minor should be noted in the research records. 12. Children Who Reach the Age of Assent While Enrolled in a Study The researcher and the IRB should consider whether assent of children who are participating in longitudinal research is appropriate. When appropriate, the researcher and the IRB need to determine whether adequate provisions should be made for soliciting the assent of children who reach 7 years of age during study participation. When appropriate, the researcher should determine whether additional assent should be obtained from continuing subjects who turn 15 years of age. 13. Payment for Study Participation Minors may receive small gifts of appreciation for participation. Studies may compensate adolescent minors for travel or time lost from work. Parents or legal guardians may also be compensated for travel or time lost from work. The protocol should be clear who will receive study payments, and payments should be made in accordance with the 91Ů Policy on Participant Payments within Research and/or Sponsored Activities. 14. Research Involving Wards of State If investigators are planning to enroll children who are wards of the state, the IRB must be informed as additional requirements apply. Children who are wards may be included in research involving greater than minimal risk without the prospect of direct benefit but likely to yield generalizable knowledge about the childs disorder or condition if the research is either: Related to their status as wards, or Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as participants are not wards. In such cases, an advocate must be appointed for each child who is a ward to protect the child, to the extent possible, from exploitation, coercion, or undue influence. The following requirements apply to individuals serving as advocates: The advocate will serve in addition to any other individual acting on behalf of the child as a guardian or in loco parentis. An individual may serve as an advocate for more than one child. The advocate must be an individual who has the background/experience and agrees to act in the best interests of the child throughout the childs participation in the research. This includes: Helping to ensure that the child understands what will be required of him/her during the research, and if capable, that the child provides assent to participate; and Acting in the best interest of the child by evaluating the ongoing effect(s) of the research on the child. The advocate must not be associated in any way (except in the role as an advocate or IRB member) with the research, investigator(s), or guardian organization. If the investigator did not originally intend to involve children who are wards of the state in a study, but decides to do so after the study has been approved, he/she must alert the IRB before enrolling the child into the research study. The IRB requires the investigator to submit an amendment outlining his/her intent to involve a child who is a ward of state. Investigators should never enroll wards of state without prior IRB approval. Minors in custody of the Missouri Department of Social Services (Wards of the State): A child in the custody of the Childrens Division is considered a minor until age 21 (Missouri State Statute 453.015(1)). Often times, the wards Family Support Team, which includes the childs parents, parent attorneys if applicable, foster parents, juvenile officer, Childrens Division staff, Guardian ad Litem appointed for the child, service providers, and other natural supports, must be included and aware of a specific childs participation in a study. The juvenile court with jurisdiction of the child may be involved as well. After discussion and collaboration, a member of the childs Family Support Team is likely to be the one authorized to provide consent. Additionally, any research that will involve wards must be approved by the Childrens Division, in addition to the 91Ů IRB, prior to enrolling any wards. An Application to Conduct Research must be submitted to the Research Committee of the Missouri Department of Social Services, Children's Division prior to enrolling wards of the state. To submit: a. Complete the application available at:  HYPERLINK "http://dss.mo.gov/cd/info/forms/pdf/886-4454s.pdf" http://dss.mo.gov/cd/info/forms/pdf/886-4454s.pdf b. Include with your application to the Childrens Division: i. 91Ů IRB approval letter ii. A copy of your IRB approved and stamped Informed Consent Document iii. Childrens Division cover letter c. Send the application via e-mail to  HYPERLINK "mailto:CD.ResearchCommittee@dss.mo.gov" CD.ResearchCommittee@dss.mo.gov Obtain concept approval to enroll Wards of State from the Missouri Childrens Division Research Committee and CD local office approval for each individual Ward of the State to be enrolled in the research study. Carefully review any conditions of approval provided the Childrens Division. Submit an Amendment if there are updates needed to the 91Ů IRB Application, consent forms or protocol materials to make them consistent with CD requirements. Minors in custody of the Illinois Department of Children and Family Services: A child in the custody of the Illinois DCFS is considered a minor until age 18. All research involving any child in the custody of Illinois DCFS must be approved by the DCFS IRB, as well as the 91Ů IRB, prior to enrolling any wards. Consent must be obtained from all parents who retain guardianship of the child. When children are under the guardianship of the state, consent must be obtained from the guardianship administrator. For children over 12 years of age, written assent must also be obtained (Illinois DCFS). Additionally, the DCFS review board will not approve any research involving experimental drugs (DCFS Procedures 432.7). Carefully review any conditions of approval provided the Illinois DCFS. Submit an Amendment if there are updates needed to the 91Ů IRB Application, consent forms or protocol materials to make them consistent with DCFS requirements. 15. References 21 CFR Parts 50.3, 50.20, 50.25, 50.51-.55, 56.109, 56.111 45 CFR Parts 46.111, 46.116, 46.402-408 FDA Information Sheet: A Guide to Informed Consent FDA Frequently Asked Questions: Informed Consent Process and Informed Consent Document Content OHRP Informed Consent Frequently Asked Questions AAHRPP, Inc. 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