Human Research Seminar Series: Informed Consent Process & HIPAA Authorization Requirements

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1 Institutional Review Board Human Research Seminar Series: Informed Consent Process & HIPAA Authorization Requirements Thursday, October 14, 2010 Presented by: Chester Edelmann, MD Chairman Jacqueline Rowan, RN, BSN QA Coordinator

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3 TABLE OF CONTENTS Informed Consent Process & HIPAA Authorization Requirements...1 Informed Consent Guidelines... 26

4 Informed Consent Process & HIPAA Authorization Requirements Page 1 of 29 Einstein Institutional Review Board (IRB) Human Research Seminar Series Informed Consent Process & HIPAA Authorization Requirements Presented by: Chester Edelmann, MD, Chairman Jacqueline Rowan, RN, BSN, QA Coordinator Overview The consent document The consent process Obtaining informed consent Documenting informed consent Special protections HIPAA 1 1 1

5 Informed Consent Process & HIPAA Authorization Requirements Page 2 of 29 Purpose of Informed Consent Respect for Persons (principle of autonomy from the Belmont Report) > Research subjects must be given the opportunity to choose what will or will not happen to them 2 Informed Consent Document: Purpose The Informed Consent Document (ICD) > provides a written summary of all of the information that the participant needs to make a decision to participate > provides a description of what is expected during participation > explains the rights of a participant > serves as a guide for the verbal explanation of the study > documents the subject s agreement to participate in the study > serves as a reference for essential study information 3 3 2

6 Informed Consent Process & HIPAA Authorization Requirements Page 3 of 29 Informed Consent Document: Requirements Introduction, with a clear statement that the project is research Confidentiality of records statement Compensation for injury statement (for greater than minimal risk studies) Whom to contact about the research/problems Purpose of the study Description of the study procedures, including use of randomization and placebo controls 4 Informed Consent Document: Requirements (continued) Duration of the subject s participation Potential risks, discomforts/inconveniences of participation Potential benefits of participation, clearly presented and not overstated For studies of investigational articles, a statement that the purpose of the study includes evaluation of the safety and/or effectiveness of the test article. 5 3

7 Informed Consent Process & HIPAA Authorization Requirements Page 4 of 29 Informed Consent Document: Requirements (continued) Alternatives (other treatments or courses of action) If none, a statement such as, "You may choose not to participate in this study." Voluntariness - Statement that participation is voluntary and that refusal to participate will not result in penalty or loss of benefits, and that the subject may withdraw at anytime 6 Informed Consent Document: Additional Elements If applicable, the following will be included: > Reasons for involuntary termination of participation > Risks with pregnancy (or fetus) and currently unforeseeable risks > Potential costs to participants > Consequences of withdrawal (health/welfare effects) > Significant new findings statement > Number of subjects (if it may impact the decision to participate) > Payments (incentives/expense reimbursements) 7 4

8 Informed Consent Process & HIPAA Authorization Requirements Page 5 of 29 Other Consent Document Requirements Consent Language For Genetic Testing > NY State Civil Rights Law specifies consent language that is required (1) to do genetic testing as part of a research protocol and (2) to use stored specimens for future genetic research. > Einstein IRB Policy Collection and/or Study of Human Specimens, consent guidelines and future use templates are found at: > > > 8 The Process The informed consent process is the foundation of the research study. It establishes a relationship of trust between the participant and the research team and allows for the exchange of essential information to assist the participant in making an autonomous decision about participation during the evolution of a trial. 9 5

9 Informed Consent Process & HIPAA Authorization Requirements Page 6 of 29 The Informed Consent Process Ongoing course of actions to ensure the participant s continuing informed agreement to continue with study participation. The process promotes a dialogue and provides information that evolves with the progression of the study and the needs of the participant. It is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act (OHRP). 10 The Evolving Consent Process Before participation Initial contact (prior to enrollment) During the study > What could happen during the subject s participation that may change a willingness to continue? When does the process end? 11 6

10 Informed Consent Process & HIPAA Authorization Requirements Page 7 of 29 The Evolving Consent Process: Before Participation Advertisements (flyers, media ads, internet ads, press releases) > IRB approval is required > Specific guidelines apply, see: > Advertisement form available at: r/advertisement.dot 12 The Evolving Consent Process: Pre-Consent Contact Initial contact is over the phone, including: > Pre-screening (determination of preliminary eligibility) > Telephone surveys > To provide pre-study information to prospective subjects 13 7

11 Informed Consent Process & HIPAA Authorization Requirements Page 8 of 29 The Evolving Consent Process: During Participation Providing information to keep the participant informed and to assess willingness to continue to participate: > On-study visits (communication, education, studyrelated instructions, abnormal lab results) > Amendments (add or change procedures, new consents) > Adverse events > New findings (risks, newly approved drug for same indication) > Change in subject health status 14 The Evolving Consent Process: End of Participation Normal study completion Subject voluntarily withdraws consent > Effect on patient safety Investigator terminates/withdraws subject from study > Patient safety > Patient doesn t meet all inclusion/exclusion criteria > Patient violates protocol requirements 15 8

12 Informed Consent Process & HIPAA Authorization Requirements Page 9 of 29 The Process of Consent Potential benefits of an effective process: > Increased protocol compliance > Enhanced subject safety > Increased retention rate > Increased reliability of data > Decreased subject-related protocol deviations 16 Who May Obtain Informed Consent from Participants? Those who are qualified to enroll subjects: > Must have completed the CITI educational requirement, which is required by YU/Einstein and Montefiore. AND > Must be knowledgeable about the study and capable of answering any questions that the research participants have. AND > Are considered Key Personnel and are listed in the IRB Research Application (or added as Key Personnel via an amendment). Check your research application. 17 9

13 Informed Consent Process & HIPAA Authorization RequirementsPage 10 of 29 Obtaining Informed Consent Obtain consent prior to initiation of any research procedures. Adequate time must be given for the potential subject to make an informed decision. (The subject decides how much time is adequate.) > Consider allowing the subject to take the consent home for review and discussion prior to signing. The consent form must be read and the information understood. 18 Obtaining Informed Consent (continued) A potential subject may choose to include others (e.g. family members) in the decision making process; The informed consent dialog addresses the subject s questions and concerns; The study team needs to assess the accuracy of information received and verify the subject s understanding; No research intervention, be it as non-invasive as a questionnaire or invasive as a liver biopsy, may be done prior to obtaining consent, unless the consent is waived by the IRB

14 Informed Consent Process & HIPAA Authorization RequirementsPage 11 of 29 The Consent Discussion Consider the subject s: > Maturity > Educational level > Cultural beliefs > Psychological, emotional, and physical limitations > Motivations > Vulnerability - pain, emotional distress Also must consider the type of study (end stage cancer, HIV, drug, device, sensitive info) Ask open-ended questions to assess comprehension 20 Finally The subject must sign and personally date the informed consent document. The person obtaining the consent must sign and personally date the informed consent document. A copy of the consent document must be given to the person signing the consent document. The consent process should be documented. The time of consent should be documented; The original, signed consent form is maintained by the investigator

15 Informed Consent Process & HIPAA Authorization RequirementsPage 12 of 29 Documentation If it wasn t documented, it wasn t done. Documentation should be: > Accurate > Complete > Timely > Legible 22 Einstein IRB Documentation Requirements Federal Law requires written documentation that consent was obtained prior to participation in the study for drug and device studies. Institutional policy extends this requirement to all research that is more than minimal risk or that involves patients: > in significant pain > who have an altered mental status > who may not be capable of giving informed consent > in labor 23 12

16 Informed Consent Process & HIPAA Authorization RequirementsPage 13 of 29 Einstein IRB Documentation Requirements (continued) The documentation should include: > The title of the study > That the inclusion/exclusion criteria for enrollment in the study have been met > That the purpose, procedures, risks, benefits (if any), voluntariness, and alternatives were discussed, understood, and accepted > A statement that the person signing the consent was given a copy of the informed consent form > The date and time that the consent was obtained 24 Documentation Also: > A copy of the consent may be placed in the medical chart (check the institutional policy) > Document atypical circumstances. It is recommended that written documentation of consent always be completed. Template available:

17 Informed Consent Process & HIPAA Authorization RequirementsPage 14 of 29 Reconsenting Subjects must be informed of any change in the protocol including important new information and new risks, and given the option to withdraw from the protocol. > Subjects currently enrolled in the study are not routinely required to sign the revised informed consent document. Such a decision is made by the IRB on a case-by-case basis. > Unless otherwise specified, they can be informed by phone, letter, or in person, with documentation in the research record. 26 Non-Reading Participants A person who speaks and understands English, but does not read and write, can be enrolled in a study by making their mark on the consent document (when consistent with applicable law) Documentation that the ICD has been read and explained is required Thorough documentation of the consent activities is strongly recommended 27 14

18 Informed Consent Process & HIPAA Authorization RequirementsPage 15 of 29 Non-English Speaking Participants A fully translated document for populations commonly seen at this institution (Spanish) > The consent process should be conducted in the language of the participant. An interpreter (not family member) fluent in English and the subject s language > Consent translation services are available through Bronx CREED s Scientific Director and Research Core Director, Joel Zonszein, MD, at (718) , or For a subject who speaks an unanticipated language, see the Short Form Consent Process slide. 28 Justification for Population Exclusion Scientific justification is needed for excluding non- English speaking subjects. > Insufficient funds to hire a translator is not an appropriate justification. > Lack of validation of the measures in the other languages is an appropriate scientific justification

19 Informed Consent Process & HIPAA Authorization RequirementsPage 16 of 29 Short Form Consent Process The oral translation of informed consent information is permitted when a non-english speaking subject is unexpectedly encountered (does not apply to Spanish speaking subjects). A short-form that is written in a language understandable by the subject is used, and A written summary (the complete English consent) of what is presented orally is used A witness to the oral presentation, who is fluent in both English and the language of the subject, is required. The witness cannot be a friend or family member of the subject. 30 Short Form Consent Process (continued) The subject must be given copies of the short form document and the summary At the time of consent: > the short form document must be signed by the subject > the summary (i.e. the English consent) must be signed by the person obtaining consent; and > the short form document and the summary must be signed by the witness

20 Informed Consent Process & HIPAA Authorization RequirementsPage 17 of 29 Vulnerable Populations Vulnerable populations may consist of individuals who lack the capacity for self-determination: > Temporarily > Permanently > Related to maturity > Susceptibility to undue influence or coercion 32 Classes of the Population Requiring Special Protection Minors Patients in significant pain Patients who have an altered mental status (e.g. patients who are under the influence of sedatives or narcotics, etc.) Patients who may not be capable of giving informed consent (e.g. patients with mental retardation, dementia, acute psychiatric disorders) Women in labor Fetuses Prisoners Students, employees 33 17

21 Informed Consent Process & HIPAA Authorization RequirementsPage 18 of 29 Consent Forms for Research Involving Minors Ages 0-6 > Parental Permission Form Ages 7-12 (capable of assenting) > Parental Permission Form > Child Assent Form Ages > Combined Parental Permission and Young Adult Assent Form Templates are available in PATS. 34 Signature Requirements for Research Involving Minors Generally the signature (permission) of one parent and signature (assent) of the child (aged 7-17) is required. The signature of both parents* is required for greater than minimal risk research with no prospect of direct benefit. > *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

22 Informed Consent Process & HIPAA Authorization RequirementsPage 19 of 29 Parental Permission: Is it Always Required? Parental permission may be waived in protocols designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects. E.g.: > Where disclosure about the research to the parent may bring harm to the minor. > When the research involves procedures that NYS law permits on minors in the clinical setting without parental permission, e.g., abortion, STD treatment, etc. > NOTE: General counsel s review is required. 36 Reconsenting - Minors When minors participate in a study over a period of time, they should be given the opportunity to (re)assent: > When they turn 7 and 13, and > Upon turning 18, individuals must consent to continuing in the research

23 Informed Consent Process & HIPAA Authorization RequirementsPage 20 of 29 Informed Consent Tips The consent conversation is private and should be performed in a location that ensures confidentiality; Only use consent forms that have been approved by the IRB and include the stamped dates of approval. Use the most recently approved consent form (print from PATS); Do not date the informed consent form for the subject; Maintain current and previously signed informed consent documents Document atypical circumstances Before the participant leaves the office, be sure the consent is complete and accurate (dates, initials, choices, etc.) 38 ICD Stamp Samples APPROVED IRB 2/14/10 through 2/13/11 VALID (Manual) Institutional Review Board PENDING Protocol #: INVALID (PATS - not yet approved) Institutional Review Board APPROVED 4/2/2010 through 1/7/2011 Protocol #: VALID (PATS) Institutional Review Board EXPIRED! Date of Approval: 12/17/2007 Protocol #: INVALID (PATS - expired) 39 20

24 Informed Consent Process & HIPAA Authorization RequirementsPage 21 of 29 Oral Consent (Waiver of Documentation of Consent) Requests for Oral Consent must be submitted to the IRB (via application or amendment) prior to use. Two waivers exist. Waiver #1 > No more than minimal risk of harm to subjects and > Involves no procedures for which written consent is normally required outside of the research context 40 Oral Consent (Waiver of Documentation of Consent) Waiver #2: > For studies in which: The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. > Each subject is to be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern

25 Informed Consent Process & HIPAA Authorization RequirementsPage 22 of 29 Waiver of Informed Consent Requirements: > No more than minimal risk. > Will not adversely affect the rights and welfare of the subjects. > Could not practicably be carried out without the waiver. > Whenever appropriate, the subjects will be provided with additional pertinent information after participation. Similar criteria apply to HIPAA as well. Requests for a waiver of informed consent must be approved by the IRB. 42 Health Insurance Portability And Accountability Act (HIPAA) The Act establishes the conditions under which Protected Health Information (identifiable health information) may be used or disclosed by covered entities for research purposes. > Einstein, Montefiore, and NBHN (JMC/NCB) are all covered entities

26 Informed Consent Process & HIPAA Authorization RequirementsPage 23 of 29 Core Elements Of HIPAA Authorization The Authorization Form templates on the Einstein IRB website and in PATS contain all of the required elements. Modification or use of another model requires review by legal counsel prior to use. The research participant must be given a signed copy of the HIPAA authorization form. Combined models (consent and HIPAA Authorization) require approval by the HIPAA Security Officer. 44 Alteration or Waiver of Research Participants Authorization A request for a waiver or alteration of HIPAA Authorization can be submitted to the Einstein IRB for review and approval The criteria are listed in the Waiver/Alteration Form in PATS

27 Informed Consent Process & HIPAA Authorization RequirementsPage 24 of 29 Exemptions from HIPAA Authorization Use of PHI preparatory to research, e.g., review of data to determine the feasibility of a study. Research on protected health information of decedents. Use of a limited data set Check with the IRB before using or disclosing subject data. 46 Questions? Any future questions, please contact the Einstein IRB East Campus: > Jackie Rowan, QA Coordinator > > West Campus: > Kathleen O'Connor, QM Analyst > x228 > 47 24

28 Informed Consent Process & HIPAA Authorization RequirementsPage 25 of 29 Einstein IRB Contact Information East Campus IRB (CCI) > Einstein IRB Belfer Building, Room Morris Park Avenue Bronx, NY Phone: Fax: Website: > Including: Policies and Procedures, Submission Guidelines, and Educational Materials West Campus IRB (MMC IRB) > 3308 Rochambeau Ave Bronx, NY Tel: Phone: Fax: Website: search/irb/ 48 25

29 Albert Einstein College of Medicine: Page 1 of 4 10/14/2009 7:07:00 PM Informed Consent Process & HIPAA Authorization RequirementsPage 26 of 29 INFORMED CONSENT GUIDELINES Informed Consent Process Guidelines and Templates Policy and Procedure ETHICAL PRINCIPLES OF INFORMED CONSENT The principle of respect for persons requires that people be given the opportunity to choose what will or will not happen to them. Freely given informed consent must be obtained from every decisionally capable, potential adult subject before any research procedures begin, unless the CCI has waived some or all of the consent requirements. This policy provides guidance for conducting a proper informed consent process and ensuring adequate documentation in the research record, in compliance with institutional policy, Department of Health and Human Services (HHS) regulations for the Protection of Human Research Subjects (45 CFR 46) and FDA regulations (21 CFR 50 & 56). Informed consent is not just a form or a signature, but a process of information exchange that takes place between the prospective subject and the investigator before, during, and sometimes after the study, which includes: 1. Subject recruitment materials; 2. Verbal instructions; 3. Written materials; 4. Question and answer sessions; 5. Agreement documented by signature. I. WHO MAY ENROLL SUBJECTS The Principal Investigator is required to submit to the IRB or CCI for each protocol the names of the individuals authorized to obtain informed consent from the subjects in the study. All of these individuals must be knowledgeable about the study and must have completed the training program required by AECOM and MMC. The PI must obtain the CCI/IRB's approval prior to adding additional individuals to the authorized list. The PI remains responsible fore ensuring that adequate informed consent is obtained from each subject enrolled in the study protocol. The prospective participants or their representatives must be given sufficient information to make an informed decision whether or not they want to participate and have the opportunity to have their questions answered. Consent must be informative, interactive, understandable, voluntary, and free of coercion or undue influence. II. DOCUMENTATION REQUIREMENTS FDA regulations (312.62(b) state "The case history of each individual shall document that informed consent was obtained prior to participation in the study" for studies utilizing either an experimental drug or device or an approved drug in an unapproved fashion. Institutional policy extends this requirement to all research that is more than minimal risk or that involves patients 1. in significant pain, 2. who have an altered mental status, 3. who may not be capable of giving informed consent, 4. in labor. A. Minimal Risk Research

30 Albert Einstein College of Medicine: Page 2 of 4 10/14/2009 7:07:00 PM Informed Consent Process & HIPAA Authorization RequirementsPage 27 of 29 For behavioral studies, observational studies, and clinical studies, the presence of the properly executed informed consent document in the study file is adequate. B. All Other Research The following should be documented in the research file by the person designated to conduct the consent process: 1. The title of the study 2. That the inclusion/exclusion criteria for enrollment in the study have been met 3. That the purpose, procedures, risks, benefits (if any), voluntariness, and alternatives were discussed, understood, and accepted. 4. That the participant was given a copy of the informed consent. 5. The date and time that the consent was obtained. III. THE CONSENT PROCESS The consent process contains four main components: 1. Information: "The reasonable person" standard should be used. This means that enough information is given to enable the person to decide whether or not to participate in the research. The person should clearly understand the range of risk, the potential benefits, if any, and the voluntary nature of participating in the study. Although each research study involving human subjects has unique elements, federal regulations and institutional policy require that all consent documents contain the following information elements: 1. Introduction (with clear statement that this is research). 2. Confidentiality of records statement (the mechanism for maintenance of confidentiality and who will have access to the research records and medical records). 3. Compensation for injury statement (for greater than minimal risk studies). 4. Whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury. 5. Purpose of study. 6. Description of study procedures (identifying any that are experimental), including use of randomization and placebo controls, if applicable. 7. For studies of investigational articles, a statement that the purpose of the study includes evaluation of the safety and/or effectiveness of the test article. 8. Duration of the subject's participation. 9. Potential risks, discomforts, and inconveniences of participation, especially for tests that carry significant risk of morbidity/mortality. 10. Potential benefits of participation, clearly presented and not overstated. 11. Alternatives (medical treatment or other courses of action, if any). If none, a statement suc as, "You may choose not to participate in this study." 12. Statement that participation is voluntary, refusal to participate will involve no penalty or los of benefits to which the subject is otherwise entitled, and that the subject may withdraw from the study at any time without penalty or loss of benefits to which the subject is otherwise entitled. If applicable, the following information should be included in the consent form: 1. Reasons for involuntary termination of participation. 2. A statement that the particular treatment or procedure may involve risks to the subject (or to the fetus, if the subject is or may become pregnant) that are currently unforeseeable. 3. Potential costs to participants. 4. Consequences of withdrawal (adverse health/welfare effects. 5. A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject. 6. Number of subjects (if it may have an impact on the decision to participate). 7. Payments (incentives and/or expense reimbursements)

31 Albert Einstein College of Medicine: Page 3 of 4 10/14/2009 7:07:00 PM Informed Consent Process & HIPAA Authorization RequirementsPage 28 of Comprehension: The manner and context in which the information is conveyed is as important a the information itself. The individual's ability to understand is based upon that person's level of intelligence, rationality, maturity, and language. The presentation of the information must be adapted to each person's capabilities. 3. Voluntariness: Subjects must be told that they have the right to decline participation and to withdraw from the study at any time after it has begun. 4. Signatures: Signatures should be dated. IV. NON ENGLISH-SPEAKING RESEARCH PARTICIPANTS 1. The informed consent document must be "in language understandable to the subject" 45 CFR and 117, and 21 CFR Subjects who do not speak English should be presented with a fully translated consent document written in a language that is understandable to them. The translation can be obtained through a translation service of your choice. (E.g. Inlingua Language Centers, ) An 'Affidavit of Accuracy' is required. Alternatively, the translation can be prepared "in house". This requires that one individual translate the document into the appropriate language and another individual convert the translated document back into English. The two English documents can then be compared side by side for accuracy and completeness. For the "in house" translation, submit to the CCI/IRB the translated and back translated consents together with the names and qualifications of the individuals involved in the process. 2. If a non-english speaking subject is unexpectedly encountered, the investigator must rely on oral translation. The oral presentation of informed consent information is permitted, in conjunction with a short form written consent document in the language understandable to the subject (stating tha the elements of consent have been presented orally) and a written summary of what is presented orally. A witness to the oral presentation, who is fluent in both English and the language of the subject, is required. This cannot be a friend or family member. The subject must be given copies o the short form document and the summary. At the time of consent, (I) the short form document should be signed by the subject (or the subject's legally authorized representative); (ii) the summary (i.e. the English language informed consent document) should be signed by the person obtaining consent; and (iii) the short form document and the summary should be signed by the witness. a. The IRB/CCI must receive all foreign language versions of the short form document as a condition of approval under the provisions of (b)(2). Expedited review of these versions is acceptable if the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened IRB/CCI. 3. It is the responsibility of the IRB/CCI to determine which of the procedures at (b) is appropriate for documenting informed consent in protocols that it reviews. V. ILLITERATE ENGLISH-SPEAKING PARTICIPANTS AND THOSE WITH PHYSICAL DISABILITIES "A person who can understand and comprehend spoken English, but is physically unable to talk or write, can be entered into a study if they are competent and able to indicate approval or disapproval by other means. If (1) the person retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally and (2) is able to indicate approval or disapproval to study entry, they may be entered into the study. The consent form should document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study. An impartial third party should witness the entire consent process and sign the consent document. A video tape recording of the consen interview is recommended." (FDA Information Sheet, 9/98) VI. VII. INCLUSION OF MINORS See CCI/IRB policy for Enrollment of Minors in Research WAIVER OF INFORMED CONSENT ALTERNATIVE CONSENT MECHANISM WAIVER OF DOCUMENTATION O INFORMED CONSENT A waiver of informed consent, alternative consent mechanism, or waiver of the documentation of

32 Albert Einstein College of Medicine: Page 4 of 4 10/14/2009 7:07:00 PM Informed Consent Process & HIPAA Authorization RequirementsPage 29 of 29 informed consent is permitted under the regulations. A CONSENT WAIVER FORM is included in the CCI Research Application. All waivers require CCI review and approval. VIII. INFORMED CONSENT TEMPLATES 1. The Individual Informed Consent Document (consent form). This template is required for: 1. Adults (aged 18 years and over), capable of understanding. 2. Family members or legal guardians for instances in which the subject lacks the capacity to consent. 3. The template applies to both 'minimal risk' research and 'more than minimal risk' research. 4. For Non English-Speaking populations and those who are unable to read English, the investigator is required to use this form and the Short Form Consent Document. 2. The Simplified Informed Consent Document This template is required for potential subjects with an altered mental status, or who may not be capable of understanding the Individual Informed Consent Document (consent form). Depending on the nature of the study, an Informed Consent Document signed by a family member may also be required. 3. Consent Forms for Research Involving Minors Depending on the age of the subjects, the following consent documents must be used: 1. Ages 0-12 years old: Parental Consent Template. 2. Ages 7-12 years old, capable of assenting: a. Parental Consent Template and b. Child Assent Template 3. For adolescents ages years old: Parental and Young Adult Template Informed Consent Guidelines Revised: 2/01 Revised: 1/28/03 CCI/IRB Joint Policy - approved 1/28/03 Revised 3/10/03 Administrative revision, 3/4/08

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