Revised Common Rule
In January of 2017, the U.S. Department of Health and Human Services (HHS) published the Final Rule, which is a revised version of the Common Rule (45 CFR 46) first published in 1991 and last amended in 2005. After some delays, the new Final Rule will be implemented with a general compliance date of January 21, 2019. Below you will find a description of the major changes to this Rule, a description of how UTHSC will implement these changes, and links to additional resources.
Note that our revised policies (Standard Operating Procedures), Researcher Tools & Guides, and Board Member Tools & Guides are now posted on their corresponding webpages. Revised consent form templates, required for new project submissions reviewed by the IRB on or after January 21, 2019, were posted on our Consent Forms webpage on December 1, 2018.
On this page, the 1991 Common Rule will be referred to as the “previous Common Rule.” The new version will be referred to as the “revised Common Rule.” Please note that UTHSC will generally follow the revised Common Rule requirements described below for all studies. However, for FDA-regulated studies, FDA regulations will be followed when they are more restrictive than the revised Common Rule, because the FDA has not yet accepted the revised Common Rule changes. See “Implementation at UTHSC: New Studies approved on or after January 21st, 2019” below for more information.
Major Changes to the Regulations
The definitions for “human subject” and “research” were revised as outlined below. All projects that were previously acknowledged to be NHSR will remain Not Human Subjects Research (NHSR). Please note that our NHSR or Exempt Status: Determination policy still states that it is the responsibility of the IRB, not the investigator, to determine whether a project qualifies for NHSR status.
Human subject (45 CFR 46.102(e)(1)) means a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens through intervention or interaction with the individual, OR
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Research means a systematic investigation, including research development, testing and evaluation, that is designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
The following activities deemed not to be research were added in the revised Common Rule (45 CFR 46.102(l)):
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
- Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
The existing categories of exempt human subjects research have been revised and some new categories have been added (45 CFR 46.104(d)). A short description of each category is provided below, along with a note about whether it is new, revised or unchanged from the previous Common Rule. A full description including the required criteria for each is outlined in our revised NHSR or Exempt Status: Determination policy. Please note that our NHSR or Exempt Status: Determination policy still states that it is the responsibility of the IRB, not the investigator, to determine whether a project qualifies for NHSR status.
- Revised- Research conducted in established or commonly accepted educational settings, involving normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Revised- Research that only includes interactions involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording).
- New- Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and the confidentiality of the information is properly protected.
- Revised- Secondary research use of identifiable private information or identifiable biospecimens originally collected for other purposes, whether collected before the study or after the study is initiated.
- Revised- Research and demonstration projects, which are conducted or supported by or subject
to the approval of Federal department or agency heads (or the approval of the heads
of bureaus or other subordinate agencies that have been delegated authority to conduct
the research and demonstration projects), and that are designed to study, evaluate,
improve or otherwise examine:
- public benefit or service programs, including procedures for obtaining benefits or services under those programs;
- possible changes in or alternatives to those programs or procedures; or
- possible changes in methods or levels of payment for benefits or services under those programs.
- Unchanged- Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed, or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
- New- Storage or maintenance for potential secondary research use of identifiable private information or identifiable biospecimens originally collected for other purposes, provided that broad consent for research use is obtained.
- New- Secondary research on identifiable private information or identifiable biospecimens stored or maintained after broad consent for research use was obtained under exemption (7).
Under the previous Common Rule, Expedited (XP) and Full Board (FB) projects must be re- approved by the IRB on an annual basis (at a minimum). However, under the revised Common Rule (45 CFR 46.109(f)(1)), expedited projects granted initial approval (or approval pending provisos) on or after 1/21/19 do not require annual continuing review by the IRB.
Further, if a Full Board project granted initial approval (or approval pending provisos) on or after 1/21/19 has progressed to the point that it only involves one or both of the following, then it will not require annual continuing review unless the IRB determines otherwise. However, you still must submit a final Form 3: Continuing Review to notify the IRB that your study status meets one of the two criteria below (for further instructions, see the section on this page entitled “Implementation at UTHSC: Continuing Review”):
- Remaining study activities are limited to data analysis, including analysis of identifiable private information or identifiable biospecimens, or
- Remaining study activities only involve accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
For studies that meet criteria (1) or (2) above, the UTHSC IRB may determine that your study still needs a continuing review if there have been any unanticipated problems, changes in the investigator’s status with the university, problems consenting subjects, or any other changes since the previous review that would alter the risk-benefit ratio. For more information, see “Implementation at UTHSC: Continuing Review” below.
The UTHSC IRB main and repository consent form templates have been significantly revised to incorporate the changes in the revised Common Rule which are outlined below. These new templates were posted on our Consent Forms webpage on December 1, 2018. (Note that we will no longer have a genetic consent form template; genetic language is now included in the main and repository consent form templates.)
- A new regulation states that “Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research” (45 CFR 46.116(a)(5)(i)). The revised consent templates explain what must be included in this summary of key information.
- The revised regulations have added new required elements of informed consent which
include:
- A statement about whether identifiers will be removed from private information or biospecimens used in the research, and after such removal, the information or biospecimens could be used or distributed for future research studies,
- An explanation of whether biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this profit,
- Clarification of whether the research involving biospecimens will or might involve whole genome sequencing, and
- Notification of whether clinically relevant research results, including individual research results, will be disclosed to subjects and if so, under what conditions.
- Broad consent may be obtained for the storage and maintenance for secondary research use of identifiable private information and identifiable biospecimens originally collected for other purposes (exempt category 7). Secondary research use of such materials may occur under exempt category 8. The new elements of informed consent required by the regulations for broad consent are now incorporated into the repository consent form template, and those projects that qualify for exemption category 7 must use the repository consent form. For more information, see our NHSR or Exempt Status: Determination policy.
- The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one IRB-approved consent form used to enroll subjects must be posted on a publicly available federal website by the awardee or the Federal Department or agency. HHS has indicated that there are two publicly available federal websites that will satisfy the consent form posting requirement: ClinicalTrials.gov and Regulations.gov. HHS has also indicated that they are developing further instructions, which has not yet been issued.
The UTHSC IRB currently maintains both several general reliance agreements and numerous narrow reliance agreements for single studies. On January 25, 2018, the National Institutes of Health (NIH) implemented the single Institutional Review Board (sIRB) policy which states that, “all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.”
The revised Common Rule has added the same requirement for single IRB review (45 CFR 46.114) for federally conducted or supported cooperative studies whereby the Federal department or agency chooses the single/reviewing IRB, but this regulation will not become effective until January 20, 2020.
Please note that, as with any IRB reliance agreement, even when the UTHSC IRB is not the reviewing IRB, you still have obligations to interact with the UTHSC IRB because the UTHSC IRB (as the relying IRB) has responsibilities under each specific agreement and under UTHSC’s Federalwide Assurance (FWA) with HHS. Therefore, you must submit a short, initial registration application for your study in iMedRIS, attaching all of the initial IRB approval documents and determination letter. Furthermore, continuations, revisions, unanticipated problem reports, etc., and associated determination letters must be submitted to the UTHSC IRB in a timely manner for the life of the study.
Implementation at UTHSC: New Studies approved on or after January 21, 2019
If a new study proposal is reviewed ON or AFTER January 21, 2019 and receives approval, or approval pending a satisfactory response to administrative provisos, the study will fall under either:
- the revised Common Rule; OR
- the revised Common Rule AND the FDA regulations, if the study is FDA-regulated.
Any studies approved under both sets of regulations will be required to adhere to the more stringent regulations of each set where they differ. For example, continuing review will be required per the FDA regulations, and use of the new consent form templates would be required per the revised Common Rule.
Please note that the revised new study application (form 1) and other revised forms (Form 2/Revision, Form 3/Continuation, and PI Response form) were published in iMedRIS on January 18, 2019. Investigators will be prompted by iMedRIS to convert the study application or other form to the newest version when opening your draft or revised version of your application or other iMedRIS form. For new application submissions, you also must revise consent forms and other applicable study materials to meet the revised Common Rule.
If you wish to revise a study that has already been approved under either the previous Common Rule or the revised Common Rule, you will still need to submit a Form 2: Change Request and Amendments to the IRB in the same manner as formerly required (see SOP: Revisions in Approved Studies).
Note that if your study was approved as exempt under the previous Common Rule and you create a revision to your study application, you will be prompted by iMedRIS to convert your study application to the newest version, which includes new questions that pertain to the exempt categories of the revised Common Rule. However, the exempt category (of the previous Common Rule), under which your study was originally approved, will not change.
If your Expedited or Full Board study was reviewed BEFORE January 21, 2019 and received initial approval (or approval pending a satisfactory response to administrative provisos), you are still required to submit a Form 3: Continuing Review for review and approval prior to the study’s assigned expiration date until you submit a Form 7 (Study Closure) to close the study with the UTHSC IRB.
If your Expedited or Full Board study is FDA-regulated and was approved (or approved pending a satisfactory response to administrative provisos) ON or AFTER January 21st, 2019, you are still required to submit a Form 3: Continuing Review for review and approval prior to the study’s assigned expiration date until you submit a Form 7 (Study Closure) to close the study with the UTHSC IRB.
If your study is not FDA-regulated, qualifies for Expedited status, and is approved (or approved pending a satisfactory response to administrative provisos) ON or AFTER January 21st, 2019, you will NOT receive an expiration date at the time of initial approval. Rather, you will receive an annual reminder notice that you must submit revision requests, unanticipated problem reports, communications from the study sponsor, etc., and a study closure request to the IRB. Further, as with any other IRB-approved study, the IRB may perform a random or for-cause audit at any time.
If your study is not FDA-regulated and is approved (or approved pending a satisfactory response to administrative provisos) by the Full Board ON or AFTER January 21st, 2019, you will receive an expiration date at the time of initial approval. You will be required to submit a Form 3: Continuing Review for review and approval prior to the assigned expiration date until the IRB determines that it is no longer required (based on the 2 criteria in the revised Common Rule) or until the study is closed with the IRB, whichever occurs first. If the IRB decides that your Full Board study has reached the point that continuing review is no longer required under the revised Common Rule, you will receive an annual reminder notice that you must submit revision requests, unanticipated problem reports, communications from the study sponsor, etc., and a study closure request to the IRB. Further, as with any other IRB-approved study, the IRB may perform a random or for-cause audit at any time.
- The definition “research”
- Elimination of continuing review requirement for no more than minimal risk research
- Elimination of IRB requirement to review grant applications.
The UTHSC IRB decided NOT to implement these provisions early as final guidance regarding the procedures for utilizing these provisions had not been issued by HHS, and iMedRIS did not have notification capabilities for studies that would no longer require continuing review.