"Informed Consent Document Checklist"
IRB Reviewer Checklist Informed Consent Document Document contains an understandable description of: All basic required elements as listed on the “Informed Consent” Guidance Poster (HRPP Program Guide Section 1.6 Appendix A) and IRB Members website and 45 CFR 46.109, 45 CFR 46.112, 21 CFR 50.25 21 CFR 56.109(b). 1. Explanation of research purpose/reason for selection. Yes No 2. Adequate description of all procedures/activities. Yes No 3. An explanation of the expected duration of the subject’s Yes No participation. 4. Description of reasonably foreseeable risks/discomforts. Yes No 5. Description of anticipated benefits to subjects or others. Yes No 6. Description of all alternative courses of treatment. Yes No 7. Description of all costs of participation and any additional Yes No costs to subjects resulting from research participation. 8 Information on subject compensation, amount, and payment Yes No schedule. 9. Identification of all experimental procedures/test articles. Yes No 10. For tests articles (regulated by the FDA), a statement that “the Yes No NA purpose of the study includes evaluation of both the safety and the effectiveness of the test article”. 11. Clearly separates research component from any concurrent Yes No NA medical treatment. 12. A statement that subject will be notified of significant new Yes No NA findings during the course of the study. Additional elements of disclosure, when appropriate: 13. A statement that the particular treatment or procedure might Yes No NA involve risks to the participant, which are currently unforeseeable. 14. A statement that if the participant is or becomes pregnant, the Yes No NA particular treatment or procedure might involve risks to the embryo or fetus, which are currently unforeseeable. 15. Anticipated circumstances under which the participant’s Yes No NA participation might be terminated by the investigator without regard to the participant’s consent. 16. The consequences of a participant’s decision to withdraw Yes No NA from the research. 17. Procedures for the orderly termination of participation by the Yes No NA participant. 18. The approximate number of participants involved in the Yes No NA study. Vulnerable population requirements: 19. Does the study involve cognitively impaired participants? If yes, Yes No complete the Addendum for obtaining Informed Consent from Cognitively Impaired Subjects. IRB Reviewer Checklist – Informed Consent Document Page 1 of 4 As of: February 2, 2009 20. Does the study involve children? If yes, complete the Addendum for Yes No obtaining Assent from Children. Standard Paragraphs included stating: 21. A statement describing the extent, if any, to which confidentiality of Yes No records identifying the participant will be maintained 22. An explanation of whom to contact for answers to pertinent questions Yes No about the research. 23. An explanation of whom to contact for answers to pertinent questions Yes No about the research participants rights. 24. An explanation of whom to contact in the event of a research-related Yes No injury to the participant. 25. Contact information for the research team for questions, comments, Yes No concerns or complaints. 26. Contact information for someone independent of the research team for Yes No problems, concerns, questions, information or input. 27. A statement that participation is voluntary. Yes No 28. A statement that refusal to participate will involve no penalty or loss of Yes No benefits to which the participant is otherwise entitled. 29. A statement that the participant may discontinue participation at any Yes No time without penalty or loss of benefits to which the participant is otherwise entitled. Additional Standard Paragraphs included for VA research stating: 30. A statement that in the event of a research-related injury the Yes No NA VA will provide necessary medical treatment to a participant injured by participation. 31. A statement that a veteran-participant does not have to pay Yes No NA for care received as a participant in a VA research project except in accordance with federal law and that certain veterans have to pay co-payments for medical care and services provided by VA. For FDA-Regulated Research 32. A statement that notes the possibility that the Food and Drug Yes No NA Administration may inspect the records. For Research involving more than minimal risk 33. An explanation of whether any compensation is available if Yes No NA injury occurs. 33. If compensation is available, what it consists of, or where Yes No NA further information may be obtained. 34. An explanation as to whether any medical treatments are Yes No NA available if injury occurs. 35. If medical treatments are available if injury occurs, what it Yes No NA consists of, or where further information may be obtained. IRB Reviewer Checklist – Informed Consent Document Page 2 of 4 As of: February 2, 2009 Addendum Obtaining Informed Consent from Cognitively Impaired Subjects Answer all questions. Any question for which “Insufficient Information to Evaluate” is checked requires clarification by PI in order to answer Yes or No. The Informed Consent Addresses the Following Points 1. The investigator obtains the legally effective consent of the participant or the participant’s Yes No Insufficient legally authorized representative. information to evaluate 2. The circumstances of the consent process provide the prospective participant or the legally Yes No Insufficient authorized representative sufficient opportunity to information to consider whether to participate. evaluate 3. The circumstances of the consent process minimize the possibility of coercion or undue Yes No Insufficient influence. information to evaluate 4. The individuals communicating information to the participant or the legally authorized representative Yes No Insufficient during the consent process provide that information to information in language understandable to the evaluate participant or the representative. 5. The information to be communicated to the participant or the representative during the consent Yes No Insufficient process does not include exculpatory language information to through which the participant or the legally evaluate authorized representative is made to waive or appear to waive any of the participant’s legal rights. 6. The information to be communicated to the participant or the legally authorized representative Yes No Insufficient during the consent process does not include information to exculpatory language through which the evaluate participant or the legally authorized representative releases or appears to release the investigator, the sponsor, the organizations, or its agents from liability for negligence. IRB Reviewer Checklist – Informed Consent Document Page 3 of 4 As of: February 2, 2009 Addendum Obtaining Assent from Children Answer all questions. Any question for which “Insufficient Information to Evaluate” is checked requires clarification by PI in order to answer Yes or No. 1. The assent is a requirement of All Some or None of the Children Insufficient information to evaluate 2. When assent is not a requirement of some Insufficient children, there is sufficient detail to determine Yes No information to which children are not required to assent. evaluate 3. When assent is not a requirement of some or all children, there is sufficient detail to determine: o These children are not capable of providing assent based on the age, maturity, or Yes No Insufficient psychological state. information to evaluate o The capability of these children is so limited that they cannot reasonably be consulted. Yes No Insufficient information to evaluate o The intervention or procedure involved in the research holds out a prospect of direct benefit Yes No Insufficient that is important to the health or well being of information to the children and is available only in the context evaluate of the research. o The assent can be waived using the criteria for waiver of the consent process. Yes No Insufficient information to evaluate 4. When assent is required, there is sufficient detail to determine if the assent would be documented. Yes No Insufficient information to evaluate IRB Reviewer Checklist – Informed Consent Document Page 4 of 4 As of: February 2, 2009