Informed Consent

1. Informed Consent Basic and Additional Elements

2. Who must obtain consent? Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence. VA Handbook 1200.5

3. Basic Elements of Consent • The following 20 elements are required in all VA consent forms per VA Handbook 1200.5: • a statement that the study involves research • an explanation of the purposes of the research • the expected duration of the subject’s participation • a description of the procedures to be followed and identification of those being done for research purposes • identification of any experimental procedures

4. Basic Elements of Consent (cont.) • a description of any reasonably foreseeable risks or discomforts to the subject • a description of any benefits to the subject or to others, which may reasonably be expected from research a disclosure of appropriate alternative procedures or courses of treatment (if any) that might be advantageous to the subject • a statement describing the extent (if any) to which confidentiality of records identifying the subject will be maintained • a statement that the FDA may inspect the records

5. Basic Elements of Consent (cont.) • for research involving more than minimal risk, an explanation as to whether any compensation exists if injury occurs • for research involving more than minimal risk, an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of or where further information may be obtained and an explanation of whom to contact in the event of a research-related injury to the subject • an explanation of whom to contact for answers to pertinent questions about research and research subjects’ rights. At least one contact’s name and phone number must be other than the investigator’s or study personnel.

6. Basic Elements of Consent (cont.) • a statement that participation is voluntary • a statement that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled • a statement that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

7. Basic Elements of Consent (cont.) • Eligibility for medical care is based upon the usual VA eligibility policy and is not guaranteed by participation in a research study. • A copy of this consent form will be placed in your VA medical record. • Your records may be reviewed by quality assurance and federal regulatory authorities as well as the Institutional Review Board. • do not include any exculpatory language through which the subject or the subject’s legally authorized representative is made to waive or to appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

8. Additional Elements of Consent The following types of studies require additional elements of informed consent: • any study that involves currently unforeseeable risks to the subject (or to an embryo or fetus, if the subject is or may become pregnant) should include information about these risks in the informed consent document stating these risks. This is especially true with studies conducted under an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE). • any study in which the protocol outlines circumstances under which the subject’s participation may be terminated by the investigator, without regard to the subject’s consent, requires a statement identifying these anticipated circumstances under which the investigator may terminate the subject’s participation. An unexplained statement that the investigator and/or the sponsor may withdraw subjects at any time does not adequately inform the subject of anticipated circumstances of withdrawal. • if subjects may incur additional costs because they are participating in research, the costs should be explained. Some insurance and/or other reimbursement mechanisms may not fund care that is delivered in a research context.

9. Additional Elements of Consent (cont.) • when withdrawal from a research study may have deleterious effects on the subject’s health or welfare, the informed consent must explain any withdrawal procedures necessary for the subject’s safety and state why they are important to the subject’s welfare. • any study in which the subject’s participation is expected to continue over a period of time during which new findings may become available requires 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. • if the IRB determines that the number of subjects in a study is material to the subject’s decision to participate, the informed consent document must state the approximate number subjects involved in the study. This is particularly true in studies involving small numbers of subjects, as in Phase 1 and 2 studies. If the IRB considers and documents its conclusion that the additional element is not required for a particular protocol - even if the protocol meets the criteria described above - the element is met for that protocol.

10. Additional Elements of Consent (cont.) • The 6 additional elements are as follows (per VA Handbook 1200.5): • a statement that the particular treatment or procedure may involve risks to the subjects (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable • anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent • any additional costs to the subject that may result from participation in the research, consistent with the Federal laws concerning veterans’ eligibility for medical care and treatment

11. Additional Elements of Consent (cont.) • the consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject • 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 • the approximate number of subjects involved in the study

12. Payment to Subjects • According to VA Handbook 1200.5, the following information must be included if subjects are being compensated for participation: • include information concerning the amount of payment to subjects • include information concerning the schedule of payments to subjects • include information concerning the method of payments to subjects

13. Waiver or Alteration of Informed Consent • An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that: • The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and • The research could not practicably be carried out without the waiver or alteration.

14. Waiver or Alteration of Informed Consent (cont.) • An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that: • The research involves no more than minimal risk to the subjects; • 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. VA Handbook 1200.5

15. General Information • The informed consent requirements in this policy are not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective. • Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law. VA Handbook 1200.5