Virginia Administrative Code › Title 22 - SOCIAL SERVICES › Agency 30 - DEPARTMENT FOR AGING AND REHABILITATIVE SERVICES › Chapter 40 - PROTECTIONS OF PARTICIPANTS IN HUMAN RESEARCH › Section 22VAC30-40-100 - Informed consent

Current through Register Vol. 40, No. 24, July 15, 2024
A. Except as
				provided elsewhere in this chapter, no investigator may involve a human being
				as a subject in research covered by this chapter unless the investigator has
				obtained the legally effective informed consent of the prospective human
				subject or the prospective human subject's legally authorized representative in
				accordance with this chapter. The investigator shall seek such consent only
				under circumstances that provide the prospective human subject or the
				prospective human subject's legally authorized 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 prospective human subject or the prospective human subject's legally
				authorized representative shall be in language understandable to the
				prospective human subject or the prospective human subject's legally authorized
				representative. The prospective human subject or the prospective human
				subject's legally authorized representative shall be provided with the
				information that a reasonable person would want to have in order to make an
				informed decision about whether to participate, and an opportunity to discuss
				that information. No informed consent, whether oral or written, may include any
				exculpatory language through which the human subject or the human subject's
				legally authorized representative is made to waive or appear to waive any of
				the human subject's legal rights, or releases or appears to release the
				investigator, the sponsor, the covered entity, or its agents from liability for
				negligence.
B. In seeking informed
				consent, the following basic elements shall be provided to each prospective
				human subject or prospective human subject's legally authorized representative:
1. A statement that the project involves
				research, an explanation of the purposes of the research and the expected
				duration of the human subject's participation, a description of the procedures
				to be followed, and identification of any procedures that are
				experimental;
2. A description of
				any reasonably foreseeable risks or discomforts to the human subject;
3. A description of any benefits to the human
				subject or to others that may reasonably be expected from the
				research;
4. A disclosure of
				appropriate alternative procedures or courses of treatment, if any, that may be
				advantageous to the human subject;
5. A statement describing the extent, if any,
				to which confidentiality of records identifying the human subject will be
				maintained;
6. For research
				involving more than minimal risk, an explanation as to whether any compensation
				and 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;
7. An explanation of who
				to contact for answers to pertinent questions about the research and the human
				subject's rights, and who to contact in the event of a research-related injury
				to the subject;
8. A statement that
				participation is voluntary, refusal to participate will involve no penalty or
				loss of benefits to which the human subject is otherwise entitled, and the
				human subject may discontinue participation at any time without penalty or loss
				of benefits to which the subject is otherwise entitled; and
9. One of the following statements about
				research that involves the collection of identifiable private information:
a. A statement that identifiers may be
				removed from the identifiable private information and that, after such removal,
				the information could be used for future research studies or distributed to
				another investigator for future research studies without additional informed
				consent from the human subject or the human subject's legally authorized
				representative, if this may be a possibility; or
b. A statement that the human subject's
				information collected as part of the research, even if identifiers are removed,
				shall not be used or distributed for future research studies.