Common Rule Changes as of January 2019
The Protocol Summary Form (PSF) should be amended to indicate that procedures may be conducted remotely in the following sections: Consent Procedures, Study Procedures, Risks and Confidentiality.
The study procedures section of the PSF should include the following Investigator Attestation:
I attest to follow the COVID-19 Safety Guidelines for Columbia Psychiatry and NYSPI Re-Entry outlined in the NYSPI Director's June 1st memo, which include but are not limited to:
- Infection Control/PPE - Guidelines
- Research participants will only come on-site if absolutely necessary for study procedures.
- Clinical research teams will screen their participants for COVID symptoms (night before and day of onsite visit, documenting this in the chart), and escort them in and out of the building.
- COVID/COVID-like symptoms of participants will the be reported to the IRB via PRISM as an SAE.
The Consent Procedures section of the PSF should include that the risks of travel for in-person visits during covid-19 will be discussed during the consent discussion AND a consent procedure note should include this.
Some suggested language for the consent discussion: "You should exercise caution when traveling in public and follow public health guidelines, such as wearing masks in public and avoiding crowds. It is important for you to stay informed about public health recommendations and guidelines regarding COVID-19, such as those issued by the Centers for Disease Control (CDC.gov) and local government guidelines and directives. If you have any questions about how you will travel for appointments, or do not feel safe traveling, please let us know, and know that you can call to reschedule visits."
The Consent Form (CF) should be revised to state, "Some of your visits may be conducted remotely using the telephone or HIPPA-compliant video teleconferencing."
It is important to document consent for remote clinical or research procedures, and the consent discussion process should include discussion of the technology HIPAA-compliant platforms to be used and any concerns the patient may have, such as access to private space in which to take calls, or accessibility--access at home to adequate devices, cell signal, or wifi.
The NYSPI Remote Communication Guidelines should be referenced to ensure compliance with the approved platforms and processes for remote procedures. The Confidentiality sections of the PSF and CF should reference the ways confidentiality is protected (e.g., HIPAA-compliant videoconferencing and web-based platforms, encrypted email communications, etc.).
Revised common rule new requirements: Effective January 21, 2019
**Only studies approved or altered after 1/21/19 will be governed the new rule.
For approved existing studies: the below noted consent form changes will need to be incorporated at the next Continuing Review or with the next Modification only if the modification being submitted is in fact already about revising the CF in another way, whichever comes first.
New consent requirements:
Change #1. Four new required elements of consent. These new items of information must be included in the consent form or (if there is no consent form) covered during the consent process.
Required for all studies that collect identifiable private information or identifiable biospecimens
- A statement about whether subject’s private information or biospecimens could be used for future research studies or distributed to another investigator for future research studies, with or without identifiers.
Required when appropriate to the study
- 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 (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).
Change #2. Key information. The consent form (or consent process, if there is no consent form) must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate in the research. This part of the consent form or process must be organized in a way that facilitates comprehension.
Key Information Elements
The image below displays the five elements identified in the preamble to the revised Final Rule (link is external) as suggested key information. The Key Elements include a concise summary of study activities, risks, and benefits presented to research participants in advance of the body of the consent document. This can be accomplished either by adding a section entitled Key Elements at the start of the consent form OR by using the Consent Summary page (see Guidance under the Investigator tab). The IRB will not require re-consent, except when other significant changes are made.
Change #3. Criteria for granting a waiver of consent. A new criterion has been added.
- No more than minimal risk to subjects.
- The research could not practicably be carried out without the waiver.
- The waiver will not adversely affect subjects’ rights and welfare.
- The subjects will be provided with any additional pertinent information after participation.
- NEW 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.
Change #4. Criteria for granting a waiver of documentation of consent. A third set of criteria has been added, meaning that there are three different reasons why a waiver of documentation of consent can be granted.
- The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. OR
- The research involves no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. OR
- NEW If the subjects are members of a distinct cultural group or community in which signing forms is not the norm, the research involves no more than minimal risk of harm, and there is an appropriate alternative mechanism for documenting that consent was obtained.
Change #5. Posting of clinical trial consent form. For each clinical trial conducted or supported by a federal agency that has signed the revised Common Rule, one IRB approved consent form used to enroll subjects must be posted on a publicly available federal website that is established as a repository for such consent forms. This is the responsibility of the researcher or the federal agency. Currently, there are two publicly available federal website where consent forms can be posted: Clinicaltrials.gov and a docket folder at Regulations.gov (Docket ID: HHS-OPHS-2018-0021). Please visit the HHS.gov site for further information regarding Clinical Trial Informed Consent Form Posting (45 CFR 46.116(h)).
Other changes under the revised rule:
Continuing Review is the requirement for the IRB to review a study annually and renew the IRB approval.
The change. The following types of studies will no longer need to go through Continuing Review at all. However, the NYSPI-IRB will require a brief progress report once a year. The requirement to submit amendments and reportable safety events to the IRB has not changed.
- Studies whose initial application was reviewed by the “minimal risk” process, called expedited review
- Studies whose remaining research procedures consist solely of:
- Data analysis (including analysis of identifiable private information or identifiable biospecimens), and/or
- Obtaining clinical care data from records, for follow-up purposes
This does not apply to studies that are:
- Regulated by the Food and Drug Administration (FDA)
- Funded by the federal Department of Justice
Unlike all of the other changes, this change is implemented on January 20, 2020.
The change. For studies that involve more than one institution or organization, the same IRB must conduct the review for all of the institutions. This “Single IRB” requirement only applies to research that is funded by any of the federal agencies that adopted the revised Common Rule:
|Agency for International Development (USAID)||Department of Homeland Security|
|Central Intelligence Agency||Department of Housing and Urban Development|
|Consumer Product Safety Division||Department of Labor|
|Department of Agriculture||Department of Transportation|
|Department of Commerce||Department of Veterans Affairs (VA)|
|Department of Defense||Environmental Protection Agency (EPA)|
|Department of Education||National Aeronautics and Space Administration (NASA)|
|Department of Energy||National Science Foundation (NSF)|
|Department of Health and Human Services||Social Security Administration (SSA)|
PRISM changes are underway to reflect the new requirements. If you have any questions, please contact firstname.lastname@example.org.