ࡱ>  Qbjbj 4}c}cI<, , sssss8sT_~|L^^^^^^^$ta*d_s"~~""_ss._(&&&"^ss^&"^&&qQWU+# S.^V_<_7S d#rdPWUWUPdsU8 \& & t*!\\\__[%l\\\_""""d\\\\\\\\\, 9: Saint Louis University Institutional Review Board GUIDANCE FOR OBTAINING INFORMED CONSENT FROM RESEARCH VOLUNTEERS PURPOSE The purpose of this guidance is to assist investigators in determining who can obtain informed consent, who may give consent for research activities including those that are emergent and those that involve minors, and appropriate documentation of the consent process. It is very important that the PI and research team keep in mind that informed consent is a process, not just a form. The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. The fundamental mechanism by which investigators ensure respect for persons involves providing a thoughtful consent for the voluntary act of participating in a research study. Please see the SLU IRB model informed consent for additional information. The process of obtaining informed consent must comply with the regulations of the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA). WHO MAY OBTAIN INFORMED CONSENT With input from investigators, IRBs have the final authority for ensuring the adequacy of the information contained in the informed consent document. This section is to assist investigators in determining who is responsible for obtaining consent from participants in which research activities require consent. Responsibility According to DHHS  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html" \l "46.116" 45 CFR 46.116, the investigator must obtain the legally effective informed consent of the subject or the subjects legally authorized representative. However, we recognize that it is not always possible for an investigator to personally obtain informed consent in a university setting. Residents, nurses, and other qualified individuals play an integral role in conducting the research, in the care of patients, and in determining eligibility for participation in the research project. Although the principal investigator (PI) is always legally responsible for the informed consent process and for establishing the necessary content of the informed consent discussion, it is often reasonable for designated, qualified individuals to obtain informed consent. Issues influencing who may obtain consent for subject participation in research activities The PI is responsible for stating in the IRB application who will obtain initial and ongoing consent. This is signified by checking the Obtains Consent box in the duties pick list in the personnel information section. When assigning responsibility for obtaining consent to research team members, the PI should consider carefully the qualifications of the team members, including their understanding of protocol procedures and risks. The IRB determines whether the proposed consent procedure, outlined in the eIRB application, is appropriate. Issues that could potentially influence who may obtain consent for subject participation in research activities include: the risk level of the research as determined by the IRB, the competence of the subject population, and the vulnerability of the subject population (e.g., pregnant populations, prisoners, children, cognitively impaired persons). In greater-than-minimal risk or high risk research, an investigator who is well versed in the research, including both physicians and other team members (i.e. nurse or research coordinator, physician assistant,), may explain the research and obtain both oral and written consent. If a non-physician obtains informed consent, a physician (either the PI or a qualified physician co-investigator) must be available (i.e. physically present or contacted to arrange a face to face consultation) if the participant has a specific question/issue to discuss before the subject signs the consent form. The IRB may, in certain high-risk research, require that a physician be responsible for obtaining written consent. Circumstances when the IRB requires the PI/physician designee to obtain consent In some instances, the IRB will require that the PI obtain consent him/herself. Usually this occurs in greater than minimal risk research that involves relatively high risk. Often a well-instructed and qualified clinical research coordinator is well-equipped to provide much of the study information to the participant. This is permissible, even if the IRB requests that the PI (or a physician designee) obtain consent, provided that the PI (or physician designee) personally talk with the participant regarding the protocol (particularly regarding risks of the study and/or side effects of the investigational therapy) and give the participant an opportunity to ask questions of the physician. If the IRB has mandated that a PI obtain consent, and you wish to appeal this mandate, please provide the following justification: Why the designee is qualified to obtain consent (you must provide evidence of a designees knowledge of all aspects of the study); Why the PI is unable to consent all the participants him/herself; How the participant will be given the option to speak with the PI before making his/her decision to participate in the research. WITNESS SIGNATURE: Who should sign the witness line The witness signature should be signed by an individual who witnesses the research participant sign and date the consent form document. ICH guidance for Good Clinical Practice defines the impartial witness as a person, who is independent from the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subjects legally acceptable representative cannot read, and who reads the consent form and any other written information supplied to the subject. The ICH guidance for impartial witness is as follows: ( HYPERLINK "http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf" ICH GCP 4.8.9). If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion. After the written informed consent form and any other written information to be provided to subjects, is read and explained to the subject or the subject's legally acceptable representative, and after the subject or the subject's legally acceptable representative has orally consented to the subject's participation in the trial and, if capable of doing so, has signed and personally dated the informed consent form, the witness should sign and personally date the consent form. By signing the consent form, the witness attests that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject's legally acceptable representative, and that informed consent was freely given by the subject or the subject's legally acceptable representative. The witness should not be the person to discuss or obtain consent. The only time a witness signature is required by FDA ( HYPERLINK "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.27" 21 CFR 50.27) or HHS (HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html" \l "46.117"45 CFR 46.117) regulations is with the use of a Short Form consent document. The IRB adheres to DHHS and FDA regulations. However, in some cases, the IRB, the Sponsor or Researcher may request the use of a witness signature. The use of signature line is permitted as long as it is used as defined above. WHO MAY CONSENT When determining who may consent for a person to participate in a research study, the PI must follow the general provisions and contracts set forth by Missouri state law. (Missouri statute HYPERLINK "http://www.moga.mo.gov/statutes/C400-499/4310000061.HTM"431.061, HYPERLINK "http://www.moga.mo.gov/statutes/C400-499/4310000064.HTM"431.064, and HYPERLINK "http://www.moga.mo.gov/statutes/C400-499/4310000065.HTM"431.065) Missouri Statute HYPERLINK "http://www.moga.mo.gov/statutes/C400-499/4310000061.HTM"431.061 (Note: this statute refers to consent to medical treatment). In addition to such other persons as may be so authorized and empowered, any one of the following persons if otherwise competent to contract, is authorized and empowered to consent either orally or otherwise, to any surgical, medical, or other treatment or procedures not prohibited by law: Any adult eighteen years of age or older for himself; Any parent for his minor child in his legal custody Any minor which has been lawfully married and any minor parent or legal custodian of a child for himself, his child and any child in his legal custody; Any minor for himself in case of: Pregnancy, but excluding abortions Venereal disease Drug or substance abuse including those referred to in chapter 195, RSMo; Any adult standing in loco parentis, whether serving formally or not, for his minor charge in case of emergency as defined in section 431.063; Any guardian of the person for his ward; During the absence of a parent so authorized and empowered, any adult for his minor brother or sister; During the absence of a parent so authorized and empowered, any grandparent for his minor grandchild; Absence as used in 7 and 8 above shall mean absent at the time when further delay occasioned by an attempt to obtain consent may jeopardize the life, health or limb of the person affected, or may result in disfigurement or impairment of faculties. Missouri Statute HYPERLINK "http://www.moga.mo.gov/statutes/C400-499/4310000064.HTM"431.064 When an adult person, because of a medical condition, is treated at a teaching hospital and such person is incapable of giving informed consent for an experimental treatment, test or drug, then such treatment, test or drug may proceed upon obtaining consent of a legal guardian, attorney in fact, or a family member in the following order of priority: Spouse unless the patient has no spouse, or is separated, or the spouse is physically or mentally incapable of giving consent, or the spouse's whereabouts is unknown or the spouse is overseas; Adult child; Parent; Brother or sister; Relative by blood or marriage. Nothing in this section shall authorize such legal guardian, attorney in fact, or family member to consent to treatment in contravention to such incapacitated person's expressed permission regarding such treatment. In a life-threatening emergency, consent of such an incapacitated person to any research program or experimental procedure shall not be required when the institutional review board responsible for the review, approval, and continuing review of the research activity has approved both the research activity and a waiver of informed consent and has both found and documented that the requirements for an exception from informed consent requirements for emergency research, as provided under Part 50 of Title 21 or Part 46 of Title 45 of the Code of Federal Regulations, as amended, have been satisfied. Missouri Statute HYPERLINK "http://www.moga.mo.gov/statutes/C400-499/4310000065.HTM"431.065 Minor spouse or parent may give consent, when, any minor who has been lawfully married and any minor parent or legal custodian of a child, if otherwise competent to contract, shall be considered an adult for the purpose of entering into a contract for surgical, medical, or other treatment or procedures for himself, his spouse, his child and any child in his legal custody. SPECIAL CONSIDERATIONS FOR CONSENTING MINORS Consenting minors once 18 years of age or emancipated: When a minor participant reaches the age of legality (18 years in the state of Missouri) or becomes emancipated, the consent provided by the minors parent(s) is no longer valid for continued participation. Therefore, the participants consent must be obtained if the participant is to continue to participate in the study. There are several options available for obtaining consent. If the study has an adult consent form, the participant may sign the most recent adult consent form. If the study has only a minor consent form, the participant may sign the most recent version for him/herself on the participant line. If the study has only a minor consent form, the participant may sign the most recent version for him/herself on the parent line and note the relationship to the participant as self. Additionally, the participants birthday (or reason for emancipation) should be noted to indicate that the individual is legally capable of providing consent. If the participant is no longer actively participating, but consent/authorization is needed for continued access to the individuals medical record for follow-up, verbal consent may be obtained. The consent script should be submitted to the SLU IRB for approval, and the verbal consent should be documented in the research record. 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  HYPERLINK "http://www.moga.mo.gov/statutes/C400-499/4530000015.HTM" 453.015(1)). Foster parents may not consent to experimental treatment or research, only the case manager can provide such consent. Additionally, any research that will involve wards must be approved by the Childrens Division, in addition to the SLU IRB, prior to enrolling any wards ( HYPERLINK "http://dss.mo.gov/cd/info/memos/2008/cd0815.pdf" Missouri Childrens Division). 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 SLU 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 ( HYPERLINK "http://www.state.il.us/dcfs/library/com_communications_IRB.shtml" Illinois DCFS). Additionally, the DCFS review board will not approve any research involving experimental drugs ( HYPERLINK "http://www.state.il.us/dcfs/docs/ocfp/procedure/Procedures_432.pdf" DCFS Procedures 432.7). In Loco Parentis According to Missouri Statute  HYPERLINK "http://www.moga.mo.gov/statutes/C400-499/4310000061.HTM" 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 being conducted in an educational setting, using minors, need to obtain permission from the legal guardians of the minors as well as the educational institution unless the IRB grants a waiver of guardian consent. Whenever parental permission is required (independent of whether the study is behavioral or biomedical in nature), signatures must be obtained from parents or legal guardians. In loco parentis signatures are not acceptable. OBTAINING INFORMED CONSENT IN NON-EMERGENCY, URGENT SITUATIONS This guideline applies to protocols that are not based on emergency situations, but which require an accelerated consent process or consent gathered from a third party (for example, cardiac catheterization and stent installation). If the protocol is based on an emergency situation, please see the SLU IRB HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/guidelines_emergency_use.doc"Guidance for emergency use of test articles (investigational drugs, biologics, or devices) for requirements for informed consent in emergency situation. When consent must be obtained in urgent situations, special precautions must be taken to ensure the truest possible informed consent. In addition to obtaining informed consent from the subject, the SLU IRB recommends obtaining consent from a legal representative (when available) according to HYPERLINK "http://www.moga.mo.gov/statutes/C400-499/4310000064.HTM"Missouri statute 431.064 (see provisions above). In addition, the subject should be re-visited after the research procedure to verify the subjects consent and understanding of his or her participation in the study. DOCUMENTATION OF INFORMED CONSENT A copy of the signed consent form should be provided to the participant once the study has been discussed and consent has been obtained. The SLU IRB expects the original signed consent form to be kept in a secure location to protect each participants confidentiality. DEFINITIONS Minimal Risk: Research is deemed minimal risk 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. [ HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html" \l "46.102" 45 CFR 46.102 (I)] Greater than minimal risk: Research is deemed greater than minimal risk when the probability and potential magnitude of harm to subjects in the conduct of the proposed research are greater than those ordinarily encountered in daily life or during performance of routine physical or psychological examinations or tests. Minor: any person under eighteen years of age or any person in the custody of the Missouri division of family services who has not attained the age of twenty-one. Adult: any person eighteen years of age or older. REFERENCES  HYPERLINK "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50" FDA Code of Federal Regulations (21 CFR 50)  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html" OHRP Code of Federal Regulations (45 CFR 46)  HYPERLINK "http://www.state.il.us/dcfs/index.shtml" Illinois Department of Children and Family Services  HYPERLINK "http://dss.mo.gov/cd/" Missouri Department of Social Services Childrens Division  HYPERLINK "http://www.moga.mo.gov/STATUTES/STATUTES.HTM" Missouri Statutes  HYPERLINK "http://www.usm.edu/irb/forms/Tips%20on%20Informed%20Consent%20do.pdf" University of Southern Mississippi Tips on Informed Consent  HYPERLINK "http://hrpohome.wustl.edu/study_team/guidelines/consentguidance.rtf" Washington University Consent Guidance for Subject Participation of Research Activities     07/01/07 SMR (Rev 1/2019)  PAGE 7 5uvw~    # : U i    E P žŐŐŐŐ|r|e[[hOJQJ^Jh3XhZTOJQJ^JhzOJQJ^Jh3XOJQJ^Jh2OOJQJ^Jh0&?OJQJ^JhZTh0&?OJQJ^JhYOJQJ^JhYhYOJQJ^J hYhYhZThZTOJQJ^Jh1OJQJ^JhZTh)'OJQJ^JhdhZThhi@ hLhi@"345vw  ^gdZT $^a$gdZT & FgdZT $^a$gdi@ $h^ha$gd)' 7$8$H$^gde) $ & Fa$gdZT $h^ha$gdZTgdi@P Q S W X ? 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