a) General requirements that are added with the new rule are in red. We will follow-up with you in the near future regarding guidance on how to comply with concepts presented in #4, #5, #6.
- Before involving a human subject in research, an investigator shall obtain the legally effective informed consent of the subject or the subject’s LAR
- An investigator shall seek informed consent only under circumstances that provide the prospective subject or the LAR sufficient opportunity to discuss and 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 LAR shall be in language understandable to the subject or the LAR
- The prospective subject or the LAR must 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
- Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or LAR in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension
- Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or LAR’s understanding of the reasons why one might or might not want to participate
- No informed consent may include any exculpatory language through which the subject or the LAR 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.
b) An additional basic element of Informed Consent (this will be added to our consent template):
- One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
- A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
- A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
c) Additional elements of Informed Consent, as appropriate; these options will be added to our consent template)
- A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
- A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions;
- For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
d) Criteria for waiving or altering informed consent has been modified (new text is in red)
- The research or clinical investigation involves no more than minimal risk to the subjects;
- The research or clinical investigation could not practicably be carried out without requested waiver or alteration;
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
- Whenever appropriate, the subjects or LARs will be provided with additional pertinent information after participation.
This option applies to both FDA-regulated and DHHS-conducted or supported research (although FDA regulations do not have #3 included at this time)
e) NEW: Screening, recruiting, or determining eligibility
NOTE: Although this provision is not in FDA regulations, the FDA does not consider records review or oral communication with the subject prior to obtaining consent to be part of the clinical investigation, therefore waivers are not required.
An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject’s legally authorized representative, if either of the following conditions are met:
- The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
- The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.