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Informed Consent Statement Checklist

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					Informed Consent Statement Checklist Investigators must specify precisely what will be told to, or read by, the subject when the informed consent is obtained. This checklist, along with the informed consent template should be used in developing an informed consent statement. The information that appears in italics should be included as it pertains to the research study. The National Cancer Institute (NCI) model consent should be used for studies funded or supported by the NCI. It is available at NCI Informed Consent Template. Additionally, if the study is being conducted at the VA and/or utilizing VA funding or VA subjects, VA Form 10-1086 must be used Refer to: http://medicine.iupui.edu/ctp/pdf/VA%20forms/B.1.VA%20Research%20Consent%20Form%20(VA%20Form%20101086)%200504.rtf for additional information. Following these sample formats will help to ensure that the informed consent statement meets the necessary criteria for approval. The following items are required elements of an informed consent statement that must be included in any informed consent used for human subjects research. Be sure to use the most current version of the informed consent template whenever you develop your informed consent statement (ICS). Checking off an item as it is written into the informed consent statement will assist you in assuring that each element has been addressed in the document. 1. Use proper headers and footers. Use the heading "IUPUI and Clarian Informed Consent Statement" Include the exact title of the project (as it appears on the DRA Page, Summary Safeguard Statement and protocol). Number the pages of the consent form. A version date may also be included. 2. Use wording understandable to the subject population (8th grade language). Explain technical and medical terminology. 3. Include a statement that the study involves research and explain the: a. purpose of the research and the expected duration of subjects’ participation; b. procedures (identify any experimental and standard procedures); c. any foreseeable risks, side effects, and discomforts; d. any safeguards to be used. 4. The number of subjects involved in the study (locally and nationally, if multi-center study). This number should be a single number, rather than a range. 5. Describe any benefits to subjects or others that may reasonably be expected from the research. 6. Briefly discuss alternative procedures or courses of treatment, if any, that might be advantageous to the subject. 7. Include a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that the subject's identity will be held in confidence including reports in which the results of the study may be published, and databases in which results may be stored. Also note to what extent others (study investigator and his/her research associates, the IUPUI/Clarian Institutional Review Board or its designees, study sponsor, and (as allowed by law) state or federal agencies (specifically the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) [for FDA-regulated research and research involving positron emission scanning], the National Cancer Institute (NCI) [for research funded or supported by NCI], the National Institutes of Health (NIH) [for research funded or supported by NIH], etc.) may need to access the subjects medical and/or research records. Note: If you obtain an informed consent, you must also obtain an authorization from the subject if the study involves the use or disclosure of health information. (For more details, see the Authorization form, as well as the IUPUI/Clarian SOP for Subject Confidentiality and Privacy). The investigator should also note when access to outside medical records will be necessary and that the subject gives the investigator permission by both informed consent and authorization to access the subject’s outside records until such time as permission is revoked in writing. 1
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8. Explain any costs, compensation, or medical treatment for injury that is available. a. Cost Statement: Include a statement that clearly explains whether there are any costs to the subject for taking part in the study: 1. State who will pay for any costs of tests, procedures, drugs, office visits, etc. that are researchrelated costs (not standard-of-care costs). OR 2. If there are no costs to subjects for participation in the study, that should be clearly stated. 3. If appropriate, state that all standard-of-care procedures, drugs, tests, etc. will be the responsibility of the subject or his/her insurance company. 4. If appropriate, state that, if during the course of the study, [name of study drug or device] becomes commercially available, the subject may have to pay for the amount of drug needed to complete the study. b. Payment Statement: Include a statement as to whether or not subjects will be paid for participating in the research. If they will be paid, include details and any conditions of payment. c. Injury Statement: Explain whether medical treatment or compensation is available if injury occurs, and if so, whether the costs of such treatment are to be the subject’s responsibility and where further information can be obtained. 1. If a source of funds for payment of treatment costs is not available, include the following statement: "In the event of physical injury resulting from your participation in this research, necessary medical treatment will be provided to you and billed as part of your medical expenses. Costs not covered by your health care insurer will be your responsibility. Also, it is your responsibility to determine the extent of your health care coverage. There is no program in place for other monetary compensation for such injuries. However, you are not giving up any legal rights or benefits to which you are otherwise entitled." 2. If a source of funds for payment of treatment costs is available, the source and conditions for payment of those costs should be identified to the subject. 9. Include the investigator's name and telephone number for subjects to call to ask questions and report any study related problems or research-related injury. Also include Research Compliance Administration’s number as an alternate number to call if the PI cannot be reached during business hours. It is recommended for all studies (and required for investigational drug studies), to add a 24-hour telephone number in addition to the investigator's telephone number as an emergency contact for subjects to use when they are unable to reach the investigator. At IUPUI the Indiana University Hospital Pharmacy number, 317/274-0362, may be used for emergencies, when drugs are involved. At Methodist Hospital, the Methodist Hospital Inpatient Pharmacy number, 317/962-5487, may also be used for emergencies, when drugs are involved. 10. Include contact information for subjects to discuss problems, concerns and questions, obtain information, offer input, or to find out about their rights. Include the following statement:

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“For questions about your rights as a research participant or to discuss problems, complaints or concerns about a research study, or to obtain information, or offer input, contact the IUPUI/Clarian Research Compliance Administration office at 317/278-3458 or 800/696-2949.” 11. Tell subjects that participation is voluntary and that they may refuse to participate without penalty or loss of benefits to which the they are otherwise entitled. Further, state that upon participating, subjects may withdraw, or be withdrawn, from the study at any time without jeopardizing the quality of the medical care to be given or the interest the investigator has in the subject. 12. Include a statement of consent to participate in the study. 13. Include a signature and date line for each of the following: a. subject b. person obtaining consent Additional Signature Requirements, as appropriate: Witness: The person signifying that the consent process occurred. The IUPUI/Clarian IRBs consider this person to be the “person obtaining consent” and do not require the witness to be impartial. An impartial witness need only be utilized if the subject or his/her legal representative is unable to read or if there is some concern about the subject’s level of understanding. Parent/Guardian: In the case of children, if the study is determined to fall under either category 1 or 2 for risk to children, only one parent/guardian signature may be required. If the study is determined to fall under either category 3 or 4, both parents or an appropriate guardian must sign and the relationship to the child must be stated underneath the signature. In these cases, if both parents are not available, an explanatory statement must be included. For additional information on child’s assent and informed consent requirements for research involving children, see 45 CFR 46, Subpart D. for the SOP for Children in Research. Although it is not mandatory, the IRB strongly recommends the use of an assent when children 7-14 years of age will be enrolled in a study. An assent template is included in the packet for reference. Include a date line for each signature. The consent form must be signed and dated by the subject or the subject’s legally authorized representative. When appropriate, one or more of the following additional elements of information should also be included in the informed consent statement: 14. A statement that the particular treatment or procedure may involve currently unforeseeable risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant). This is required if women of childbearing potential may participate in a study, which involves an investigational drug or which involves an approved drug that has not been well-studied in pregnant women. 15. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent. This is required if there is a possibility that the investigator would terminate a subject’s participation prior to completion of the study. An unexplained statement does not adequately inform subjects of anticipated circumstances for such withdrawal. A statement that the subject may be withdrawn if he/she does not “follow study procedures” is also not appropriate since subjects are not in a position to know all of the study procedures. Subjects can, however, be informed that they may be withdrawn if they do not follow the instructions given to them by the investigator.

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16. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject. This is required for studies involving treatments or procedures that could pose risk if they were terminated before completion of the study. An unexplained statement that the subject will be asked to submit to test prior to withdrawal does not adequately inform him/her why the tests are necessary for his/her welfare. NOTE: If a subject decides to withdraw from the research (including withdraw of consent and/or withdraw from participation) and the investigator wishes to continue to follow the subject’s health and to collect clinical data, the subject must be re-consented at the time of withdrawal with a separate informed consent document to allow this specific endeavor. 17. Any additional costs to the subject that may result from participation in the research. This is required if subjects may incur costs for any procedures or services that they would otherwise not incur if they were not participating in the study. 18. A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject. This is required for studies that have a potential of gaining significant information during the course of the study that may cause subjects to terminate their participation. 19. If bodily fluids, substances, or tissues are to be taken from the subject and used in the creation or maintenance of a culture or other product to be made commercially available to others or in investigations not involving the subject, the following statement regarding property rights should be included: "As this is a research institution, specimens obtained in medical situations may later be used for research purposes. The investigator intends to include specimens taken from you along with other specimens which may be used in an attempt to develop products to be sold, and it is not the intention of the investigator to enter into an agreement with you to become partners in sharing the profits or losses in the sale of those products." 20. If the investigator is planning on drawing and storing blood or other specimens for later research purposes, related or unrelated to the current protocol, subjects should be informed of the specific type of future research. If a statement of intention is not included or did not include a specific use for which the investigator now or later desires to use it, the sample cannot be used, or the subject would have to be reconsented for that additional purpose. If the specimens will be de-identified, a specific type of research need not be specified; however, the informed consent should clearly state that specimens will be de-identified. When specimen storage for future research purposes is an optional part of a larger study, subjects must provide consent separately from their consent for participation in the main study. One mechanism that can be employed is to include a separate section within the main informed consent document explaining this specimen storage and future research use with lines for the subjects to initial and agree or disagree to allow this additional use of their samples. Another mechanism that can be employed is to include a separate informed consent document that explains this specimen storage and future research for subjects to agree or disagree to this additional use of their specimens. 21. If a subject’s participation is contingent upon another person’s involvement in the research procedures (e.g. caregiver), a statement must be included to inform the subject regarding what will be expected of the other participant. 22. A statement that subjects will receive a copy of the informed consent document. NOTE TO INVESTIGATORS: In the event that a sponsoring agency or investigator wishes to include a statement in the informed consent statement which effectively requires a waiver of a subject’s right to participate in the commercial exploitation of products derived from cells or tissues, such a statement will not be approved by the Institutional Review Board. In compliance with Federal regulations, it is beyond the authority of the Institutional Review Board to approve 4
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statements requiring or asking subjects to waive their legal rights, whether those statements have been included as part of the informed consent document or as separate documents.

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