Quick Reference Guide [1]
Table was taken from Public Responsibility in Research and Medicine’s (PRIM&R) quick reference guide and modified to include the possible impact of the changes.
Category | Topic | Details | UO Impact |
IRB operations |
Single IRBs for multisite research (“cooperative research”) (46.114) | Single IRBs generally required; however, some flexibility is provided in determining and documenting when a single IRB is not appropriate |
Single IRBs for multi site research compliance date is January 20, 2020. U.S. Institutions engaged in cooperative (multi-site) research must rely upon approval by a single IRB. The lead IRB is determined via proposal by the lead institution subject to acceptance of Federal Dept. or agency supporting the research. RCS is already actively signing agreements with other institutions to accept or cede IRB approval. PI's should endure that conversations and agreements are made to determine the lead IRB. UO is a participating institution of SMART IRB [2]. |
External IRBs (46.103) | Reliance arrangement with non-institutional IRB must be documented |
Non-institutional IRB must certify proposed research study covered by the assurance has been reviewed and approved by the IRB prior to initiation of the research. As noted above, RCS is already completing authorization agreements. It may impact the PI specific to time required for approval of the project, dependent on other sites completion of agreements. |
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Checking the box (46.101) | Option for FWA holders to check the box has been eliminated |
The option to “check” or “uncheck” the box on Federal Wide Assurances (FWA) has been eliminated. The changes to the Common Rule preamble notes that Institutions will have flexibility in determining whether or not to apply the Common Rule to all IRB projects regardless of funding. Since we have previously “unchecked,” the box we believe this will have little impact on current processes (i.e. reporting noncompliance, unanticipated problems, adverse events to OHRP only for projects that are federally funded). |
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Continuing review (46.109 & 46.115) | Continuing review of research is no longer required under various circumstances |
Unless the IRB determines otherwise, continuing review will no longer be required for: projects under expedited categories, projects requiring limited IRB review, or projects that have progressed to data analysis (including analysis of identifiable private information or identifiable biospecimens). This will decrease PI and IRB staff time. |
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Informed consent |
New language/clarity (46.116) | Consent forms must be clearer and more focused; many changes added to emphasize that information provided must facilitate a potential subjects’ understanding of why one would participate or not |
Subsection.116(a)(4) is new and states that subjects must be provided with the information that a “reasonable person” would want to have in order to make an informed decision and subjects must be provided an opportunity to discuss that information. |
Basic and additional elements of informed consent (46.116) | New basic element on collection of identifiable private information or identifiable biospecimens; three new additional elements on commercial profit, return of clinically relevant research results and whole genome sequencing |
Section .116 is one of more extensively modified sections, primarily due to added regulations for the use of biospecimens in research. The unnumbered list of conditions appearing in the old “preamble” before .116(a) has been separated and the conditions numbered as .116(a) (1-3) and (6). Subsection .116(b) now contains the basic elements of consent and .116(c) the additional elements. A new subsection .116(a) has been added that is essentially a table of contents, which states that broad consent may be obtained in lieu of informed consent only with respect to the storage, maintenance, and secondary research uses of private information and identifiable biospecimens. Organizational SOPs, consent templates and checklists will have to be updated and investigators and IRB members trained for the new biospecimen and general consent requirements. This will be a major change and will impact PI and IRB time. Further information will be provided to the UO research community through training presentations and website updates. |
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Broad consent (46.111 & 46.116) | Broad consent is an option for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens |
Subsection .116(d) is new and addresses elements of “broad consent” for the storage, maintenance, and “secondary research use” of private information or identifiable biospecimens. Broad consent for secondary research use is permitted as an “alternative” to the standard informed consent requirements. |
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Recruitment/screening waivers (46.116) | Allows waiver of informed consent for subject recruitment or screening, under certain conditions |
Subsection .116(f) addresses “general” waivers or alterations of informed consent. Subsection .116(f)(1) cautions that if an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of information or biospecimens and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use. |
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Clinical trials consent forms (46.116) | Some clinical trials must post consent form online |
Subsection .116(h) is new and adds a requirement for posting clinical trial consent forms on a publicly available federal website that will be established (i.e., not yet a reality- likely clinicaltrials.gov) as a repository for consent forms. According to subsection .116(h)(3), one consent form for each study must be posted on the federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject. The responsibility for posting is the awardee or the federal department or agency component conducting the study. This will not have a large impact at UO. We are estimating a small number of current or future projects will have to meet this requirement. However, please review the revised definition of a clinical trial below. |
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Electronic consent (46.117) | Electronic consent is ok; must provide written copy |
Subsection .117(a) now specifically allows electronic signatures for consent documentation and specifies that a written copy must be given to the person signing the consent form. This will take time for the IRB and PI’s to understand and implement. Organizational SOPs, templates and checklists will have to be updated and investigators and IRB members trained for the new waiver and consent requirements. Further information will be provided to the UO research community through training presentations and website updates. |
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Legally authorized representatives (46.102) | If no law, institution can designate a representative |
Legally authorized representative (LAR) means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research. This will not have a large impact at UO. The IRB will work with General Counsel, as necessary, to define under what parameters UO would designate someone as an acceptable LAR. |
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Scope |
Definition: Research (46.102) | Defines what’s NOT research: certain journalistic, public health surveillance, and criminal justice or intelligence activities |
The following activities are deemed not to be research: (1) 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. |
Definition: Human subjects (46.102) | Includes “information or biospecimens” obtained from through intervention and interaction OR “identifiable private information or identifiable biospecimens” |
Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i)Obtains information or biospeciments 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. |
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Definition: Clinical trial (46.102) | Clinical trials are now specifically defined |
Clinical trial means a 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 the interventions on biomedical or behavioral health-related outcomes. |
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Definition: Identifiable biospecimen/identifiable private information (46.102) | Will be re-examined within one year and every four years after | An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. | |
Definition: Vulnerable populations (46.111) | Pregnant women and “handicapped” removed; replaces “mentally disabled” with “individuals with impaired decision-making capacity” | Vulnerable populations are individuals that are vulnerable to coercion or undue influence, such as children, prisoners or individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. | |
Tribal law (46.101, 46.114, 446.116) | Tribal law applies where applicable; added throughout | More clearly defines where Tribal law applies. | |
New guidelines for exemptions |
Additional exemptions for low-risk studies (46.104- see also 46.103, 46.109, 46.110, 46.111) | Exemptions added for secondary research on identifiable private information and identifiable biospecimens under various circumstances and regulatory requirements, such as limited IRB review and broad consent, may apply | Additional exemptions and new categories along with limited IRB review have been added.
This will take time for the IRB and PI’s to understand and implement. Organizational SOPs, checklists, and IRB members will require time for updating and training. Further information will be provided to the UO research community through training presentations and website updates. |
Compliance dates | 1 year (1/19/18), 3 years for multisite (1/20/20) (46.101) | Previous Rule applies to research approved prior to 1/19/18; new rule to approvals 1/19/18 or laterThis will be accomplished via notification to campus regarding policy changes to meet the compliance deadlines. |