Revised Common Rule (45 CFR 46)
The revised version of the regulation governing human subjects research (i.e. 45 CFR 46 also known as the Common Rule) became effective January 21, 2019. Due to this revision, several IRB forms, templates, and policies have been modified. Always refer to the HSPP web site to ensure you are using the most recent version of a form.
The following sections contain a summary of those changes.
- The Consent Form Template and Consent Checklist were revised to incorporate seven new elements of consent for federally funded/supported research. For those approved federally funded/supported research studies that are actively enrolling subjects, investigators should submit either at the time of continuation or through a request for modification a revised consent form with the new required elements. Until such time as this review occurs studies are considered grandfathered under the current version of the Common Rule. Subjects will not be required to be re-consented based solely on these changes. For federally funded/supported studies that are closed to new enrollment the consent form will need to be revised only if there is another reason that triggers a change to the document. For example if new risks are being disclosed, at the time the consent is revised to incorporate the new risk the consent would also have to be brought into compliance with the new requirements. For previously approved non-federally funded/supported research, no changes are necessary; however, these new elements will be used as the guiding principle of consent elements moving forward.
- Waiver/Alteration of Consent: If the research involves using identifiable private information or identifiable biospecimens, the investigator will need to explain in the waiver document why the research could not practicably be conducted without access to and use of the identifiable private information/biospecimens.If a waiver is necessary for federally funded/supported studies investigators must be sure to address the additional element describe above at the time the study is transitioned to the revised rule. Waiver of Documentation of Consent: There is a new provision for allowing for waiver of documentation of consent. Documentation of consent may also be waived if the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
- Changes to Continuing Review Requirement: Unless otherwise required and justified by the IRB, continuing review will no longer be required for non-FDA regulated federally funded research that meets the criteria for expedited review. Investigators who have non-FDA regulated federally funded research that qualifies for expedited review will be asked to provide an expected completion date of the research, which will become the expiration date of IRB approval. For previously approved research this may be provided as part of one last request for continuation (e.g. if IRIS has already generated a continuing review due task) or as part of a request for modification. The PI will be required to submit a request for modification to extend this expected completion date if necessary. The IRB may require justification for the expected completion date as it deems appropriate. Note: Continuing review is still a requirement for all FDA regulated research even if all subjects are in long-term follow-up or the research is in data analysis.
Any study that does not requires continuing review still need to submit a modification to the IRB prior to implementing changes to the conduct of that study except when the change is necessary to eliminate immediate hazards to subjects. Modifications include, but are not limited to, change in design, removal or change to survey tool, change in funding source, change to recruitment materials, adding or removing investigators, changing the title of the project, requesting additional subjects beyond the original approved number, changes to informed consent forms, or other correspondence with potential or current subjects.
4. Changes to the Initial Application Form in IRIS: The IRB application form in IRIS was edited. The request for Exempt status categories and Expedited review categories were removed from the application and are now described in two separate word documents to be attached to the application form in IRIS. The following forms have been published in the IRB website and should be submitted when requesting a determination for exemption or review under an of the expedited categories:
5.The following IRB forms have been updated and published in the IRB website:
- Checklist for Initial and Continuing Review Expedited .doc
- updated to reference the request for expedited review form
- Checklist for Initial Exempt Application .doc
- (updated to reference the request for exemption form
- Consent Checklist – Addendum to Transition to Revised Common Rule.doc
- created to list only new elements of 45 CFR 46 to incorporate into previously approved consent forms
- Human Subject Research Determination Form.doc
- based on updated definitions and activities that are deemed not to be research
Points to Remember When Relying on an External IRB
- With the exception of reporting changes in study personnel, once the determination is made to accept the external IRB as the IRB of Record, from that point forward the UConn Health investigator only deals with the IRB of Record for the review of continuations, modifications, unanticipated problems and non-compliance.
- The Principal Investigator is responsible for knowing and following the requirements of the reviewing IRB, inclusive of requirements for reporting subject complaints, non-compliance, unanticipated problems and outcomes of audits and inspections. The PI is responsible for ensure that the research team is also aware of and follows such.
- Research for which IRB oversight has been deferred to an external IRB may still be subject to audit by the UConn Health Research Compliance Monitor.
Difference between Privacy and Confidentiality
Privacy applies to the individual and confidentiality applies to the data obtained from the individual.
According to the IRB Guidebook, published by the Office for Human Research Protections (OHRP 1993): “Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others, in ways that are inconsistent with the understanding of the original disclosure without permission.”
Therefore, the privacy of the subjects in a research study can be maintained by conducting the consent process, interviews, and procedures in a private room. The confidentiality of the subjects’ data can be protected, for example, by storing the data on encrypted password protected computers.
Expanded Definition of “Clinical Trial” & ClinicalTrials.gov
The Revised Common Rule expanded the definition of “clinical trial” with the intention of harmonizing with the National Institutes of Health’s definition. The expanded definition includes any “research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on biomedical or behavioral health-related outcomes.” Importantly, the revised definition includes studies that had not previously been considered clinical trials, like social and behavioral research.
What if my study meets the expanded definition of a clinical trial?
1) If your clinical trial is funded by a Federal department or agency, the Revised Common Rule requires that your consent form be posted on a public platform, like ClinicalTrials.gov, after the trial is closed to recruitment, and no later than 60 days after the last subject visit.
2) If your clinical trial evaluates at least one drug, biological, or device product regulated by the FDA (See this decision checklist for more details), regardless of funder, you are required to register and post results on ClinicalTrials.gov.
3) If your clinical trial is NIH funded, in whole or in part, you are required to register the study and report results on ClinicalTrials.gov.
4) Regardless of funder, if you wish to comply with the ICMJE policy (followed by the BMJ, JAMA and many others journals) requiring registration as a condition of consideration for publication, you may voluntarily register your study with ClinicalTrials.gov.
For assistance with ClinicalTrials.gov, see our webpages and contact UConn Health’s ClinicalTrials.gov Administrator, Ellen Ciesielski (860-679-6004) in Research Integrity and Compliance Services.