Changes to the Common Rule

UPDATE January 21, 2019:

Human Subjects Common Rule Changes Implemented.

Effective January 21, 2019, the U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies implemented the revised Federal Policy for the Protection of Human Subjects (also known as the Common Rule). The Final Rule is on public display by the Office of the Federal Register and can be accessed here.

Please review the following documents for additional information:

A list of all UNL IRB updates regarding the delay in implementation of changes to Common Rule are available here.

Welcome! We have created this web page to communicate the changes to human subjects research regulations. Feel free to contact us with any questions you may have: irb@unl.edu or 402-472-6965.

Changes to regulations governing human subjects research, as outlined in the Common Rule, 45 CFR 46, were published in the Federal Register in January 2017. The majority of rule changes have been delayed and will now be effective on January 21, 2019. The amended rules are the first significant changes to human subjects regulations since 1991. While some changes reduce the burden on researchers and institutional compliance areas, many of the new requirements come with additional responsibilities.

What has been done to prepare for these changes?

We have met with Department Chairs, faculty and staff members from the following areas to gain perspective on the changes and transition:

A Nebraska IRB working group was formed and met several times in 2017 for discussion between IRB Administrators at UNL, UNMC, UNK, Creighton University, and Methodist Hospital. This has helped strengthen collaborative ties, communications between the offices and establish similar interpretations of the new regulatory criteria.

We met with a Subcommittee of our IRB, the Institutional Official, and NUgrant/Bolero representatives on a bi-weekly basis (March – September 2017) and identified policies, guidance, timelines and NUgrant changes described as follows:

New and/or Revised Policies:

Campus Training Sessions

With these significant changes, we recognize the importance of providing training to the campus and held in-person training sessions in order to help ensure everyone was informed about the impact of the changes. While the below training sessions have passed, we have provided a training video to the campus via email and will make it available to those affiliated with UNL upon request.

-November 30th 1pm – 2pm, City Union. Registration Closed.

-September 21st 9:00am-10:30am, Nebraska Union, City Campus, Jackie Gaughan Multicultural Center Unity Room. Registration Closed.

-October 20th 2:00pm-3:30pm, Nebraska Union, East Campus, Arbor Suite. This session will include a webcast for those members of our campus unable to attend in person. Registration Closed.

-November 8th 9:30am-10:30am, Nebraska Union, City Campus, Georgian Suite. Registration Closed.

Clarifications

Faculty subcommittee members have informed Research Compliance Services of various articles or dissemination of information among disciplines and peers regarding the regulatory changes. Specifically, they have notified us of discussion surrounding IRB exemption determinations along with a proposed exemption decision tool. To try and help provide clarity to the UNL research community and to prevent any confusion, we provide the following:

  • While the proposed changes to the Common Rule included commentary regarding an exemption decision tool for researchers to utilize in making their own exemption determinations, this is not part of the published Final Rule.  Exemption determinations will continue to be made by UNL IRB staff.
  • Further, we would like to clarify the definition of “Exempt.” Exempt research is research involving less than minimal risk and falls into one of six current categories. An exempt categorization does not mean the project is exempt from review by the IRB. Rather, this means the research is exempt from meeting some of the regulations present at 45 CFR 46 (Common Rule).
  • The Office of Human Research Protections (OHRP) guidance recommends that the investigator should not be the one making the exemption determination.

What does this mean for me as a human subjects researcher?

We strongly recommend that you familiarize yourself with the regulatory changes in order to understand how they may or may not impact your current or future human subjects research projects.

Please review the updates to our UNL policies, templates, guidance, and NUgrant changes. If you would like further information, please contact us.

What will impact me now?

The majority of the changes have been delayed until January 21, 2019. Please be aware of the January 20, 2020 compliance deadline for multi-site/single IRB research requirements.

Where can I learn more?

The below table was taken from the Public Responsibility in Research and Medicine’s (PRIM&R) quick reference guide and modified to include the possible impact of the changes at UNL.  Please note, this table only includes the most significant changes but provides a good overview of the most important information. PRIM&R also provides many other helpful resources on their website.

Council on Governmental Relations (COGR) also provides similar summaries and information on the changes.

Please also view the official published version of the changes to the Common Rule in the Federal Register.

Category Topic Details UNL 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. This will impact PI’s to ensure conversations and agreements to identify the lead IRB is completed ahead of time between UNL and the other sites.
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.
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).
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.
 

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.
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.
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 UNL research community through training presentations and website updates.
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.
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 UNL research community through training presentations and website updates.
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.
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 UNL research community through training presentations and website updates.
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 UNL.  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.
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.
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 UNL research community through training presentations and website updates.
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 UNL. The IRB will work with General Counsel, as necessary, to define under what parameters UNL would designate someone as an acceptable LAR.
 

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.
(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.
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.
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.
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 UNL 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 later This will be accomplished via notification to campus regarding policy and NUgrant changes to meet the compliance deadlines.

Additional Information

In January, PRIM&R hosted PRIM&R’s Primer on the Revised Common Rule, a webinar to introduce the human subjects research community to the changes present in the revised Federal Policy for the Protection of Human Subjects. Presented by P. Pearl O’Rourke, MD, and Heather Pierce, JD, MPH, this webinar provided an overview of the noteworthy changes from the current rule, as well as a discussion of various possible fates of the revised Common Rule under the new presidential administration.

Below are some of the questions discussed after the webinar that the UNL human subjects research community may find helpful. Please be aware, under the Congressional Review Act of 1996, there is still potential that these regulatory changes could be overturned by the Presidential Administration; however,  the UNL Research Compliance Services Office will continue to monitor and move forward with plans toward implementing the changes to ensure we are able to meet the compliance deadline.

Q: With the effective and compliance dates a year away, what actions should institutions take now to implement the new rule? Should new research activities follow the requirements of the new rule or the existing rule?


A: The transition provisions of the final rule clarify which research activities must comply with the new requirements. Research studies (1) approved by an IRB, (2) granted a waiver from IRB review by a department or agency, or (3) determined to be exempt prior to January 19, 2018 are by default covered by the pre-2018 rule for the duration of the study. After January 19, 2018, case by case determinations can be made to apply the final rule, and the IRB must document that change. Research studies (1) approved by an IRB, (2) granted a waiver from IRB review by a department or agency, or (3) determined to be exempt on or after January 19, 2018 must follow the final rule. 

Note that the single IRB requirement has a three year implementation period, instead of the one year for all other provisions.

While it is a good idea to familiarize yourself with the new requirements and understand the impact they will have on your institutions and what policies and processes will need to change to comply with the new requirements, it’s important to remember that the rule was issued in the final days of an outgoing administration, and that the implementation details or date could be affected by this transition. We suggest waiting for at least 60 days into the new administration’s term for further clarity on whether this or any other recently issued regulation will be implemented as published or undergo further revision before taking any implementation actions.

Q: Once continuing review is eliminated for some reason (e.g. for research eligible for expedited review), how should an IRB keep track of that research’s progress?

A: The elimination of continuing review in circumstances that have long been recognized as low risk to research subjects is a welcome change. However, it does raise new questions for the IRB or research administration office about tracking, following, and closing studies. New processes will likely be needed to help an institution know when to revisit a study, when to mark it as completed or terminated, and how to ensure the IRB knows about important changes to the study. Guidance from the Common Rule agencies or community best practice sharing may be necessary.

Q: The final rule requires posting of informed consent forms for clinical trials. Who is responsible for posting the form, and does the posting have to be updated every time the form is revised?

A: This posting requirement in the final rule only applies to federally conducted or federally supported clinical trials as defined in the final rule. For federally funded clinical trials, the rule requires that the form be posted by the awardee, typically the institution. Although the relevant website hasn’t been created or identified yet, it appears likely from the preamble of the rule that the Department of Health and Human Services is strongly considering ClinicalTrials.gov as the appropriate place to house the forms. Only one form needs to be posted, and there is no requirement to update the posted form if it is revised, as long as the posted form was actually used to enroll subjects.

Q: What does it mean to say that Subpart D isn’t allowed for certain exemptions?
(Please note, in Nebraska, age of majority is 19 years old. Thus, we were already and will continue to be unable to categorize many projects involving children (including those “children” below 19 years of age) under an exempt category).

A: If Subpart D is not allowed, it means that the exemptions do not apply to subjects who are children. While most of the exemptions apply to children as well as adults, the following exemptions do not apply to subjects who are children:

  • (d)(3) benign behavioral interventions
  • (d)(2) interactions including educational tests, surveys, interviews, etc. if:
  • identifiable information is recorded
  • the investigator participates in the observations being observed

Q: When is broad consent required? When can it be waived?

A: Broad consent, a key new requirement that was included in the proposed rule, is available as an option and is never required under the final rule. Broad consent is a prospective option that investigators could use to store, maintain, and conduct secondary research with identifiable data or biospecimens. The current available options of (1) deidentifying the data or biospecimens, (2) getting study-specific informed consent, or (3) getting an IRB waiver of the informed consent requirement are all still available. Because broad consent is never required, it does not need to be waived, which is why the waiver instructions don’t apply to the broad consent requirements. Note that if you want to be able to use exemptions 104(d)(7) or (8) for secondary research, you must have previously obtained broad consent that includes all the elements in 116(d). Therefore, these two exemptions “require” broad consent, but if you aren’t trying to use those exemptions, you aren’t required to use broad consent.

Q: Does the single IRB requirement only apply to institutions that are “engaged” in research?  What would our obligation be if there was research taking place on our campus with students or faculty but in which we weren’t engaged?

A: We believe that the existing guidance on when an institution is “engaged” in research is still applicable. The single IRB requirement alone does not change the current rules with respect to whether activities on your campus need to be reviewed by an IRB.

Q: What types of studies are required to use a single IRB and who decides which IRB will be the single IRB?

A: The requirement to rely upon a single IRB applies to all research covered under the Common Rule “that involve more than one institution.” This requirement is not limited to clinical trials. The lead institution can propose which IRB will be the single IRB on which the other sites will rely, whether that is a central, commercial, or institutional IRB, and the funding agency will need to agree and accept that proposal.

Q: Can the single IRB requirement be waived by a federal agency? Can this be proposed or suggested by an institution where the context may be very different due to the nature of the subject pool?

A: Yes, the final rule allows any Common Rule department or agency to make and document a determination that “the use of a single IRB is not appropriate for the particular context.” Presumably that could include a situation where an institution makes a request to an agency about a particular study, but may also allow an agency to make a more sweeping determination that some types of research or studies with certain characteristics don’t ever have to rely on a single IRB.

Q: Will there still be an option to “check the box” through the federalwide assurance (FWA) process?

A: No, the preamble to the final rule makes it clear that the assurance process will no longer provide a mechanism for institutions to indicate that they apply the requirements of the Common Rule to all research, even that which is not federally supported and thus not under the Common Rule. Of course, nothing prevents institutions from stating in communications to patients and research subjects that all research conducted at the institution is conducted in accordance with the highest ethical standards and that the strength of protections afforded individuals who participate in research do not vary depending on the source of support for the research.

PRIM&R would like to thank Dr. O’Rourke and Ms. Pierce for developing this webinar and for taking the time to answer attendee questions after the webinar.