The Revised Human Subjects Research (Common Rule) regulations go into effect on January 21,2019. Communications from the Human Subjects Office\IRB will be utilizing the following terms when referring to the regulatory changes:
- Pre-2018 Regulations – regulations current IRB approved research will continue to follow
- Revised Common Rule Regulations – regulatory changes that go into effect 1/21/19 for research approved on or after this date
Below is a summary of how these changes affect research under the oversight of the University of Iowa IRB-01 (Biomedical) and IRB-02 (Social\Behavioral) boards.
Major Regulatory Changes
Activities not Considered Research
There are no changes to the University of Iowa process in determining whether or not a research project meets the regulatory definition of human subjects research. When a formal IRB determination is necessary, follow the current process for obtaining a Human Subjects Research Determination. Four new activities have been added to the federal regulatory definition of Research (45 CFR 46.102(l)) that are always deemed not to be research.
- 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.
Exemption Categories and Limited IRB Review
There are no changes to the University of Iowa IRB review process in determining whether or not a research project meets the federal regulatory definition of human subjects research requiring IRB review. If a project is deemed to require IRB review and approval, an eResearch (HawkIRB) submission remains required, even for a project meeting an exemption category under 45 CFR 46.104. The Revised Common Rule regulations revised several of the categories found under 45 CFR 46.104 and has replaced criteria under 45 CFR 46.104(3). These changes include
- Adding a limitation under 45 CFR 46.104(1)
- Research in a common educational setting must not adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction.
- Expansion of criteria under 45 CFR 46.104(2)
- Now allows for visual or auditory recording as part of the research
- Completely revised category under 45 CFR 46.104(3)
- New Benign Behavioral Intervention
- Expansion of criteria under 45 CFR 46.104(4)
- Allows for retrospective and prospective secondary use of data originally collected for research purposes
- Expansion of criteria under 45 CFR 46.104(5)
- Research approved under this category must be posted on a Federal website
- Two new, optional, criteria added under 45 CFR 46.104(7) and (8)
- The University of Iowa IRB has not adopted these optional criteria
- Introduction of Broad Consent
In addition to the changes in the exemption criteria, the IRB is required to conduct a limited review for select exemption categories. The IRB will require the current content of the exempt selection under IV.1 of the HawkIRB application in order to ensure there are adequate provisions to protect the privacy of subjects and maintain confidentiality of data. Federal guidance is expected to clarify the criteria for ensuring privacy and confidentiality of research data however, this guidance has not been released to date. An exemption tool has been created to assist you in determining if your research qualifies under one of the exemption categories.
The revised common rule requires several changes to the criteria for obtaining informed consent under 45 CFR 46.116. The first is that “key information” be presented to a potential subject prior to the full informed consent document. The University of Iowa IRB has previously implemented the use of a Consent Summary in March 2017 for all non-federally funded, clinical trials. This requirement is consistent with the Revised Common Rule regulations and will now be extended to federally funded research, including research subject to the FDA regulations. A minor revision to the existing consent summary has been made to fully address the key information criteria. A copy of the revised consent summary can be downloaded from the attachments page of the HawkIRB application. The “key information” criteria include:
- Information that a “Reasonable Person” would want in order to make an informed decision;
- Presentation of key reasons he/she may/may not choose to participate in research; and
- Requirement that key information essential to that decision be presented immediately prior to the full informed consent document and conversation
Required and Additional Elements of Consent
There are several required and additional elements of consent under 45 CFR 46.116 that now, if applicable, must be included as part of the informed consent document and conversation. The University of Iowa informed consent template has been updated to include template language for all the required and additional elements of consent. These new criteria are also available for research under FDA regulations. A copy of the revised informed consent template can be downloaded from the attachments page of the HawkIRB application. Collection of Identifiable Private Information or Biospecimens 45 CFR46.116(b)(9): The required element includes:
- A statement indicating whether identifiers may\may not be removed from the identifiable private information or identifiable biospecimens and
- A statement indicating whether the identified\deidentified information or biospecimens may\may not be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the LAR, if this might be a possibility
The additional elements, when applicable, include:
Commercialization 45CFR46.116(c)(7): 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
Clinically Relevant Research Results 45CFR46.116(c)(8): A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions
Whole Genome Sequencing 45CFR46.116(c)(9): For research involving biospecimens, a statement whether the research will (if known) 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)
Waivers and Alteration of Consent
Waiver of Consent- New Criterion
A new criterion under 45 CFR 46.116(f)(3)(ii) has been added to the waiver and\or alteration of elements of consent. The IRB may waive the requirement or approve an alteration of elements of informed consent certain criterion are met. This new criterion is that the research could not practicably be carried out without accessing or using information or biospecimens in an identifiable format. Researchers will need to provide rationale for why identifiers must be retained in order to conduct the research. If identifiable data elements are retained, this must be stated in the IV.12 of the HawkIRB application. The rationale for why the research cannot be conducted without the identifiers must be included in IV.15 of the HawkIRB application.
Screening, Recruiting, and\or Determining Eligibility
The IRB may approve research under 45 CFR 46.116(g) in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent if either of the following conditions are met:
- The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, OR
- The investigator will use identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
Researchers can address this new criterion by one of several options:
- If the research is proposing to conduct a review of UIHC medical record information to determine subject eligibility, a partial HIPAA waiver of authorization would normally be required by indicating as such under VII.D.1.
- Rationale should also include whether the researcher plans to conduct any screening, recruiting, or determining eligibility through either oral or written communications with the subject OR accessing identifiable biospecimens. This rationale can be described in VII.D.3-4 of the HawkIRB application.
- The researcher can elect to request a waiver of documentation of informed consent if screening, recruiting, or determining eligibility through oral or written communications. In this instance VII.D.19 should indicate yes. VII.D.16 should also indicate yes. In this scenario, an information sheet containing the elements of consent would be required to be presented to the subject prior to any oral or written communications. In this scenario, the IRB would grant a waiver of documentation of consent for the collection of the screening information. A full, signed, informed consent document would be required if the subject meets eligibility requirements to continue.
- The researcher can elect to request a waiver of informed consent by indicating a waiver or alteration of informed consent will be obtained for some subjects in Section IV of the HawkIRB application.
Waiver of Documentation of Consent
A new criterion under 45 CFR 46.117(c)(1)(iii) has been added in granting a waiver of documentation of consent. The IRB may waive the requirement to obtain signed consent 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.
This criterion has been added under the current rationale provided by the research team for why waiver of documentation of consent is appropriate. This is question VII.D.17 in the HawkIRB application. The IRB would expect to see supporting documentation for this criterion to be met via a local context review form or other in country ethic committee documentation for research occurring internationally.
The University of Iowa IRB has previously implemented the elimination of the requirement for a continuing review for all non-federally funded, clinical trials in October 2018. This requirement is consistent with the Revised Common Rule regulations under 45 CFR 46.109 and will now be extended to federally funded research. Research subject to FDA regulations are not eligible for the elimination of the requirement for continuing review under the Revised Common Rule changes.
Use of a Single IRB of Record
Multi-site research will be required to use a single IRB for review beginning January 19, 2020. Research subject to this requirement will follow the current University of Iowa reliance process in place for NIH funded multi-site research administering the same protocol to all research locations.
Posting of the Informed Consent Document
Clinical trials (as defined under 45 CFR 46.102(b) ) will be required to post an IRB approved version of the informed consent document. This Revised Common Rule requirement will only apply to research studies with a federal funding source. There are two locations available for posting the informed consent document.
- For those clinical trials that meet the FDAAA definition of an Applicable Clinical Trial (ACT), the informed consent document can be uploaded to the relevant clinicaltrials.gov record.
- For clinical trials that are not an ACT, the informed consent document can be uploaded to a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021).
The informed consent form must be posted on one of the Federal Website options after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol. The University of Iowa ClinicalTrials.gov PRS Administrator will provide assistance for University of Iowa researchers to ensure fulfillment of this regulatory requirement. To better track the timing of the posting requirement, a new question for federally funded clinical trials has been added In HawkIRB under VII.B.1.c to document the estimated date of the last subject visit.
Which Regulatory Agencies Have Adopted the Revised Common Rule?
All but two of the Common Rule Agencies have adopted the revised Common Rule. As of 1/21/19, all federally funded research but two agencies will follow the revised Common Rule. These two agencies are:
- Department of Justice (DOJ)
- Food and Drug Administration (FDA)
Research subject to the DOJ will follow the pre-2018 regulations. Per guidance issued by the FDA in October 2018, research subject to the FDA cannot be inconsistent with FDA’s current policies and guidance found under 21 CFR parts 50 and 56. Only two of the Revised Common Rule regulations will be applied to University of Iowa IRB-01 approved research under FDA purview:
- Key information 45 CFR 46.116(a)(4), (a)(5)(i), and (a)(5)(ii)
- New required elements of consent 45 CFR 46.116
Transition Plans for Research at The University of Iowa
Current IRB approved research projects
Pending research projects
Draft and\or New research projects
The Office of Human Research Protections (OHRP) has several resources available to review on the Revised Common Rule changes.