1. Informed Consent Presented by Marian Serge, RN

2. Goals Informed consent process and form Title 38 CFR 16.116, Common Rule required elements and additional elements elements required by VHA Handbook 1200.05 Documentation of informed consent Waiver of informed consent Waiver of documentation of informed consent 2

3. Informed Consent Process Who can obtain the subject’s consent? Investigator, or Investigator can formally delegate someone else Under what circumstances is consent obtained? Language is understandable Minimize coercion or undue influence No exculpatory language –(may not waive legal rights) Sufficient opportunity for subject to consider participation Adequate time for subject to read before signing Must use VA Form 10-1086 3

4. Informed Consent Form Required Elements Name of the Study Name of the Principal Investigator/LSI The Sponsor of the study Statements Study involves research Purpose of the research Subject’s expected duration in the study Study procedures to be followed Experimental procedures identified 4

5. Informed Consent Form Required Elements Description of foreseeable risks or discomforts This includes risks of physical, social, legal, economic, and/or psychological risks Description of benefits, if any Disclosure of alternatives Confidentiality of records identifying subjects State that FDA, OHRP, ORO, VA Office Inspector General may access records, if appropriate 5

6. Informed Consent Form Required Elements Explanation whether compensation and medical treatments are available if injury occurs (for research involving more than minimal risk) (38 CFR 16) Treatment of VA research related injury (38 CFR 17.85) VA must provide medical treatment for injury for any VA research List contacts for the subject Research questions Research subjects’ rights questions Research-related injury Complaints or concerns At least one contact must be someone other than investigator or study staff 6

7. Informed Consent Form Required Elements Statements Participation is voluntary Refusal to participate will involve no penalty Discontinuing participation will involve no penalty 7

8. Informed Consent Form Additional Elements Used only when relevant for the research study: Unforeseeable risks to subject, embryo, fetus Anticipated circumstances when subjects participation can be terminated Any additional costs to subjects Subjects in VA research are not required to pay for medical services received as a subject in VA research (38 CFR 17.102) Consequences of subject’s withdrawal Significant new findings Number of subjects involved in the study 8

9. VA Requirements of Informed Consent Additional Elements Used only when relevant for the research study: Commercial product development- A statement (if applicable) that the investigator believes the specimens could lead to a commercially valuable product Future use of specimens- Where, who, and how long specimens will be retained Future use of data- Where and who will access Re-contact- Describe if subjects will be re-contacted Payment to subjects- $$ and how payment will be made Disclosure of results- Describe if subjects will receive results 9

10. Informed Consent Documentation Requirements Investigator Responsibility 38 CFR 16.117 Use VA Form 10-1086 (for VA research) most recent version approved by IRB Includes VA investigators working on VA research enrolling subjects at the affiliate hospital or other sites Obtain the signature and date of the subject or subject’s legally authorized representative person who obtained the subject’s consent witness, if relevant File original signed informed consent in subject’s research file and a copy in the medical record, if applicable Give a copy of signed informed consent form to subject 10

11. Informed Consent Documentation Requirements for Hospitalized and Outpatient VA Subjects Handbook 1907.01 6.t.(8) If a health record is necessary, then a copy of the initial enrollment progress note and other applicable progress notes must be placed in the subject’s health record At a minimum the health record must include a) name of the study b) the person obtaining the subject’s consent c) a statement that the subject or the subject’s legally-authorized representative is capable of understanding the consent process d) a statement that the study was explained to the subject e) a statement that the subject was given the opportunity to ask questions, and f) a copy of the signed/dated consent form: VA Form10-1086 Please refer to: VHA Handbook 1200.05, Paragraph 43 11

12. Stamp date or use pre-printed box on each page of informed consent form indicating the date of IRB approval Maintain copies of all informed consent form versions in IRB files Informed Consent Documentation Requirements IRB Responsibilities 12

13. Waiver of Informed Consent Elements 38 CFR 16.116(d) An IRB may approve a consent procedure which does not include some or all the elements or which alters some or all of the elements or may waive the requirement to obtain informed consent provided the IRB finds and documents that: The research involves no more than minimal risk; The waiver or alteration will not adversely affect the rights and welfare of the subjects; The research could not practicably be carried out without the waiver or alteration; AND Whenever appropriate, the subjects will be provided with additional pertinent information after participation 13

14. Waiver of Documentation of Informed Consent 38 CFR 16.117(c) An IRB may waive the requirement for the subject to sign and date a consent form, if it finds either: (a) That the only record linking the subject and the research would be the consent document and the principal risk to the subject would be potential harm resulting from a breach of confidentiality. Each subject must be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; - or - (b) That the research presents 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. In cases in which the documentation requirement is waived, the IRB must document the reason for the waiver and may require the investigator to provide subjects with a written statement regarding the research. 14

15. What have we learned? Informed consent process Elements of informed consent VA requirements Documentation of informed consent Waiver of informed consent Waiver of documentation of informed consent 15

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