Revisions to the Federal policy for the protection of human participants in research (the "Common Rule") are in effect starting January 21, 2019.
Summary of Common Rule Changes Affecting Cornell Research
Our detailed guidance document is the most complete source of information about how the changes will affect Cornell research with human subjects.
- Exemption categories. More research qualifies for exemption under the New Common Rule, including: secondary use of identifiable, sensitive data; research using "benign behavioral interventions" (e.g., playing a game, solving a puzzle).
- No renewal requirement for most studies. The annual renewal requirement is eliminated for the vast majority of expedited studies (and for full board research, when remaining activities are limited to data analysis).
- Changes to informed consent. New elements are added to the basic information to be communicated during consent and, for federally-funded clinical trials, consent materials must be posted to ClinicalTrials.gov.
- Expansion of clinical trials. The concept of a "clinical trial" is expanded to include some basic biomedical and behavioral health-related research. A new guidance document details compliance obligations specific to clinical trials, and provides basic information on how to register and provide updates on ClinicalTrials.gov.
- Single IRB ("sIRB") requirement: Multi-institution studies must use a sIRB for review starting in January 2020. For NIH studies, a version of the sIRB requirement has been in effect since January 2018.
Common Rule Changes to Informed Consent
The Common Rule includes new requirements for the informed consent process. In most cases no changes will be needed for consent documents that have already been approved by the IRB. For new studies, researchers should use the updated consent templates.
New Required Elements of Informed Consent
The IRB's consent templates have been revised to reflect these new requirements:
|For research that involves...||Informed consent must now indicate|
|Collection of identifiable private information or identifiable biospecimens||Whether identifiers may be removed, and if de-identified information or biospecimens may or may not be used or shared for future research|
|Use of biospecimens||Whether biospecimens may be used for commercial profit, and if the subject will share in that profit|
|Clinically relevant results||Whether clinical results, including individual research results, will be returned to the subject, and under what conditions|
|Whole genome sequencing*||That the research will or might include whole genome sequencing|
*Sequencing of a human germline or somatic specimen with intent to generate the genome or exome sequence of that specimen.
A "Concise Statement"
In addition to the new required information, consent documents approved under the New Rule must begin with a concise and focused presentation of "key information" to assist prospective subjects in understanding why they might or might not want to participate. (46.116(a)(5)(i)). The IRB's new consent templates are designed to help researchers draft language that satisfies this requirement.
Required Public Posting on Certain Consent Forms
Beginning on January 21, 2019, for all studies that are federally-funded and fit the definition of a "clinical trial", a consent form must be posted online "after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject..." For multi-site studies, the consent form from only 1 site is required to be posted. The Office for Human Research Protections (OHRP) has identified two federal websites that will satisfy the posting requirement. The Cornell IRB strongly recommends that researchers fulfill this requirement by posting to ClinicalTrials.gov.
How do these Changes to the Consent Process Affect Studies Approved Before the New Common Rule Took Effect?
In most cases no changes will be needed. Given their simplicity and brevity, the typical 1-3 page consent forms and scripts used in social and behavioral research and based on Cornell IRB-approved templates, will satisfy the new requirement. On a case-by-case basis, the IRB may determine that changes are needed. If so, IRB staff will identify affected studies and work with the PI to revise the consent. Participants in ongoing studies will not need to be re-consented as a result of these changes.