IRB operations

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.

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.

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).

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.

Informed consent

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.
Subsection.116(a)(5)(i) is new and states that the informed consent process must begin with a concise and focused presentation of the “key information” that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate in the research. This subsection also requires that this part of the informed consent be “organized and presented in a way that facilitates comprehension.” Presumably further guidance will explain what that means and how to achieve the goal along with what qualifies as a concise and focused presentation.
Subsection .116(a)(5)(ii) is also new. It takes the form of an admonition to present informed consent information in sufficient detail and organize and present the information in a way that does not “merely provide lists of isolated facts, but rather facilitates the prospective subject’s … understanding of the reasons why one might or might not want to participate.”
Subsection .116(b), the basic elements of consent, has no change to the eight (8) previous elements. Added is a requirement to include one of two statements about the collection of private information or identifiable biospecimens for future research (either that identifiers might be removed and the de-identified information or biospecimens used for future research without additional informed consent from the subject; or, that the subject’s information or biospecimens will not be used or distributed for future research studies even if identifiers are removed).
Subsection .116(c), the additional elements of consent, has no change to the six (6) previous elements, but three new requirements have been added. Subsection .116(c)(7) requires a statement that 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.
Subsection .116(c)(8) requires a statement about whether clinically relevant research results, including individual research results, will be disclosed to subjects. Subsection .116(c)(9) requires a statement about whether the research project might include whole genome sequencing.This will impact both the PI and IRB with regard to time in order to understand and implement the changes to informed consent requirements. In addition, the IRB will be drafting or revising template language to assist in this area along with awaiting further guidance on how best to implement these requirements from now until the effective date of January 19, 2018.

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.

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.
Subsection .116(d)(1) still requires risks, benefits, confidentiality, voluntary statement, commercial profit, and whole genome sequencing elements be included. Subsection .116(d)(2) requires a general description of the types of research that may be conducted.
Subsection .116(d)(3) requires a description of the information or biospecimens that might be used in future research; whether sharing might occur; and, the types of institutions or researchers that might conduct research.
Subsection .116(d)(4) requires a description of the length of time that the information or biospecimens may be stored, maintained and used.
Subsection .116(d)(5) requires a statement either that subjects will or will not be informed of the details of any specific research studies that might be subsequently conducted.
Subsection .116(d)(6) requires a statement that research results either will or will not be disclosed to subjects.
Subsection .116(d)(7) requires contact information to be provided in the broad consent. The usefulness and ethics of broad consent remains to be further elucidated in guidance.This will again impact PI and IRB Office time to understand and implement the changes. Further information will be provided to the UO research community through training presentations and website updates.

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.
Subsection .116(f)(2) addresses alterations (partial waivers) of informed consent. Two new conditions/restrictions are included. An IRB may not omit or alter any of the .116(a) general requirements for informed consent requirements. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required, i.e., alteration is not permitted.
The four existing waiver conditions are included unchanged in subsection .116(f)(3), but added for research that involves accessing or using private information or identifiable biospecimens, is a requirement that the research could not practicably be carried out without accessing or using such information or biospecimens in an identifiable format.
Subsection .116(g) is new. It addresses waivers of informed consent to obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects. One of two conditions must be met: the information will be obtained through oral or written communication with the prospective subject or by accessing records or stored biospecimens.This will again impact PI and IRB Office time to understand and implement the changes.  Further information will be provided to the UO research community through training presentations and website updates.

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.

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.
Subsection .117(b)(1) specifically allows consent forms to be read to the subject.
Subsection .117(b)(2) requires that, when using the short form to document consent, the informed consent must begin with a concise and focused presentation of the key information to assist a prospective subject in understanding the reasons why one might or might not want to participate in the research. This subsection requires that this part of the informed consent must be organized and presented in a way that facilitates comprehension.
Subsection .117(c) still addresses waivers for the requirement to obtain a signed consent form and maintains the two pre-existing exceptions. Importantly a third category is added that allows waiver if the subjects are members of a distinct cultural group or community in which signing forms is not the norm.

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.

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.

Scope

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.
(2) 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).
(3) 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.
(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

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.

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.

New guidelines for exemptions

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.