Informed Consent Changes

Effective January 21, 2019 under the Revised Common Rule the requirements for informed consent will change with the addition of:

• “Key Information” to be presented at the beginning of the consent form
• General consent requirements
• New consent elements
• Changes to waiver criteria and documentation
• Screening, recruiting or determining eligibility

The preamble to the Revised Common Rule list 5 factors or “key information” which will likely assist potential subject in understanding the nature of the research project and in determining participation. The level of detail required for the “key information” section will depend on the complexity of the research project. The “key information” must include the following:

General informed consent requirements were added with the Revised rule are listed below in “quotes”. Further federal guidance is expected later for number 4,5, and 6.

1. "Before involving a human subject in research, an investigator shall obtain" the legally effective informed consent of the subject or the subject’s LAR
2. An investigator shall seek informed consent only under circumstances that provide the prospective subject or the LAR sufficient opportunity to discuss and consider whether to participate and that minimize the possibility of coercion or undue influence
3. The information that is given to the subject or the LAR shall be in language understandable to the subject or the LAR
4. "The prospective subject or the LAR must be provided with the information that a reasonable person would want to have to make an informed decision about whether to participate, and an opportunity to discuss that information"
5. "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."
6. "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 "
7. 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.

Additional basic element of informed consent

When your research involves the ……

The following statement should be added

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.

Additional elements of informed consent, as appropriate

When your research involves the ……	The following statement should be added
Use of biospecimen	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;
Clinically relevant results	A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions;
Whole genome sequencing	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)

Criteria for waiving or altering informed consent has been modified (new text is in "quotes")

1. The research or clinical investigation involves no more than minimal risk to the subjects;
2. The research or clinical investigation could not practicably be carried out without "requested" waiver or alteration;
3. "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;"
4. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
5. 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)

Screening, recruiting, or determining eligibility related to informed consent (new text is in "quotes")

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 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:"

1. "The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or"
2. "The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens."

Additional requirements for federally funded studies - For each clinical trial conducted or supported by a Federal department or agency, one IRB approved informed consent form must be posted to a publicly available Federal website (yet to be specified) after the trial is closed to recruitment and no later than 60 days after the last study visit by any subject.

MHC Transition and Implementation Process

The IRB has developed a new ICF template which complies with the revised Common Rule.

The updated informed consent compliant with Revised Common Rule will be required for new studies and continuing review applications submitted on or after January 21, 2019.

The MHC IRB will not require reconsenting subjects with the updated ICF, unless other significant changes are made.

For federally sponsored clinical trials ICF that are required to be posted a federal website, it is recommended that you contact the sponsor of the study to determine how best meet this requirement.

Note: HIPAA requirements still apply.