Human Subjects Research Regulations Update and Temporary Freeze on Applications
After several years in development and multiple extensions for implementation, revisions to the Federal policy governing the use of human research subjects (The Common Rule) are set to go into effect on January 21, 2019. All protocols reviewed as of this date will be required to follow the revised policy, which can be read in full here. The Federal Office of Human Research Protections (OHRP) has also created a website with resources and FAQs regarding revisions to The Common Rule.
For studies that are not on a fixed timeline, the IRB recommends that investigators submit applications for review on or after January 21, 2019 so that the revised regulations can be used for the review process. This approach offers some key advantages for investigators, including the elimination of the continuing review requirement for studies reviewed through expedited review procedures. The IRB will accept applications for new research protocols under the expiring exemption and expedited review procedures through December 14, 2018 and for full review through November 26, 2018 for the December meeting. The review process for these applications must be completed by January 18, 2019. Investigators with applications in review are advised to consistently monitor email and promptly respond to questions and/or requests for changes. In the event that a study cannot be approved by January 18, 2019, the investigator will have to be asked to resubmit an application for review under the new guidelines. The submission window will re-open for new applications under the Revised Common Rule on January 21, 2019. For investigators who wish to work on application materials in advance for submission on or after January 21, 2019, application forms and resources will be published in early January.
The revisions to the regulations are intended to provide improved protections for human research subjects while also reducing administrative burdens for both investigators and Institutional Review Boards (IRBs). The EKU IRB has revised application forms, consent documents, and resources in order to ensure compliance with the revised regulations. In doing so, additional updates were made to clarify requirements, provide guidance, and improve efficiency of the submission process for investigators.
Important highlights from the revisions to the regulations include the following:
Updated definition of “human subject”:
“Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
Changes to consent requirements:
New focus on meeting a “reasonable person” standard by providing the information a reasonable person would want to know in deciding whether to participate in a study
Requirement to provide “key information” at the beginning of the consent form – afocused presentation that addresses five types of information: (1) the fact that consent is being sought for research and that participation is voluntary; (2) the purposes of the research, the expected duration of the prospective subject's participation, and the procedures to be followed in the research; (3) the reasonably foreseeable risks or discomforts to the prospective subject; (4) the benefits to the prospective subject or to others that may reasonably be expected from the research; and (5) appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject
Revisions to consent requirements related to the collection of biological specimens
New requirement for consent forms for clinical trials to be posted on a public Federal website
Revisions to categories of exemption, including the use of a new “limited review” process:
For a detailed description of the revisions to the exemption categories, please review the Exemptions section of OHRP’s Companion Q&As about the Revised Common Rule.
EKU will continue to require that a determination of exemption be made by the IRB. All studies will be reviewed for exemption using the same limited review process.
New exemptions 7 and 8 apply only to research covered under a broad consent process. Adopting the use of broad consent procedures requires an infrastructure for the secure storage of biospecimens that is not current present University-wide. In addition, the tracking requirements are burdensome for both the investigator and the IRB. Because of this, the EKU IRB does not intend to implement the broad consent option at this time, and therefore, Exemptions 7 and 8 are not included in the list of exemption categories for the limited review application. There are several other options for research using biospecimens, and no negative impact is expected from not using a broad consent process.
Expedited Review categories published by the HHS Secretary and updated regularly (at least every 8 years):
The current list is available online and has not changed. The categories listed in the Application for Expedited Review will be updated as revisions are published to the list of categories.
Elimination of a standard annual continuing review requirement for studies approved through expedited review procedures:
Annual continuing review will no longer be a requirement for studies reviewed through limited or expedited review procedures. The requirement still applies to studies reviewed through full review, which will be approved for a one-year period and can be renewed through continuing review for up to two additional years. The continuing review can take place through an expedited review procedure completed by the IRB Chair unless the IRB votes to require full committee review for the continuing review process.
Elimination of requirement to review research proposals for funded studies:
When a study is conducted as part of a grant or contract award, the IRB is no longer required to review the grant or contract research proposal as part of the IRB review process. This attachment requirement has been eliminated from the new application forms.
New “Single IRB” requirement:
Beginning in January 2020, a new “single IRB” requirement will be in effect for collaborative research. This change will require that one IRB be appointed to review studies that involve multiple institutions, eliminating duplicative review processes.
This requirement is already in effect for studies funded by the National Institutes of Health.
If you have questions that are not addressed in this notice or the links provided here, please contact Sponsored Programs.
Published on November 19, 2018