November 2018 HSPO update: Revised Common Rule key changes and Consent Form revisions
Penn State College of Medicine’s Institutional Review Board/Human Subjects Protection Office (IRB/HSPO) regularly shares updates to keep faculty and research staff informed of new information and changes. Updates are generally emailed and are also posted online.
Revised Common Rule (2018 Common Rule)
Final revisions to the Federal Policy for the Protection of Human subjects (also known as the “Common Rule”) were issued by the Department of Health and Human Services on Jan. 18, 2017. The majority of changes are scheduled to go into effect Jan. 21, 2019. The revised Common Rule is often referred to as the “2018 Common Rule.”
The major regulation changes that will affect researchers include:
- Exemptions: New categories and clarifications of existing categories. Some exemption categories may require a “limited IRB review” (similar to an expedited review process).
- Continuing review: No longer required for some minimal-risk research.
- Informed consent: A new “Key Information” section and new required and required elements of consent.
- Posting of clinical trial consent forms: A new requirement for clinical trials supported by a Common Rule agency for posting the consent form on a publicly available federal website.
- Single IRB Review: Collaborative research projects located in the United States and funded by a Common Rule agency will be required to use a single IRB starting Jan. 20, 2020.
For details, see the “2018 Common Rule Summary of Changes” section below.
On Jan. 21, 2019, the CATS IRB system will be updated to include all 2018 Common Rule requirements along with the pre-2018 Common Rule requirements.
- Research approved or in the post-approval status in CATS IRB prior to Jan. 21, 2019, may continue through completion based on the pre-2018 Common Rule.
- Research approved on or after Jan. 21, 2019, will need to comply with the 2018 Common Rule. Exception: FDA-regulated/supported and research funded by the Department of Justice.
- Research funded by the Department of Justice will need to comply with the pre-2018 Common Rule.
- Research subject to FDA regulations will continue to be approved according to FDA regulations. These generally match the pre-2018 Common Rule requirement. FDA-regulated studies receiving funding from a Common Rule agency will have to apply the informed consent changes in the 2018 Rule.
The following links provide more detailed information about the 2018 Common Rule changes:
Revisions in HRP-580 – HSPO Consent Form Template
The 2018 Common Rule includes a new requirement for informed consent to begin with a “concise and focused presentation of the key information” that would assist subjects in deciding why they may or may not want to participate in the research. In addition, items have been added to the required and additional elements of informed consent. HRP-580 HSPO Consent Form template has been revised to incorporate all of these changes for informed consent.
Upcoming IRB workshops
The HSPO will be offering several training sessions on the 2018 Common Rule in December 2018 and January 2019. See a list of upcoming IRB workshops here.
For questions regarding IRB/HSPO updates, please email the College of Medicine Human Subjects Protection Office at HSPO@pennstatehealth.psu.edu.
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2018 Common Rule Summary of Changes
The Department of Health and Human Services (HHS), along with other federal agencies, published a final rule revising the Federal Policy for the Protection of Human Subjects, also known as the “Common Rule.” The Common Rule provides ethically based regulations for the review and conduct of human research studies. The HHS Office for Human Research Protections (OHRP) issued these changes to modernize, strengthen and streamline the Common Rule.
Note: This revised Common Rule will be referred to as the “2018 Common Rule” or the “2018 Requirements” and the current Common Rule will be referred to as the “pre-2018 Common Rule” or the “pre-2018 Requirements.”
Things that will change:
- New and revised definitions
- Changes to exemption categories
- Elimination of continuing review for some minimal-risk research
- Revised informed consent requirements
- Single IRB review
Details on each of these changes are available below.
The 2018 Common Rule has an effective date of Jan. 21, 2019, except for the compliance requirements for single IRB review of cooperative research, which will become effective Jan. 20, 2020.
The 2018 Common Rule provides new and revised definitions for several terms, including: “clinical trial,” “human subject,” “intervention,” “private information,” “identifiable private information,” “identifiable biospecimen,” “research,” and “written or in writing” (to include electronic formats).
- Human subject: The 2018 Common Rule expanded the definition of “human subject” to cover the collection of biospecimens. (This does not include non-identified biospecimens.)
- Research: The 2018 Common Rule amended the definition of “research” to include four new activities that are deemed not to be “research” and that do not require IRB review:
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research and historical scholarship);
- Public health surveillance activities;
- Collection and analysis of information, biospecimens or records for criminal justice or criminal investigative purposes; and
- Certain activities in support of intelligence, homeland, security, defense or other national security missions.
For details on exemption categories, see the Exemption Categories Tool.
The 2018 Common Rule eliminated continuing review for many minimal risk studies.
- Unless an IRB determines otherwise, continuing review of research is not required if the research:
- Is eligible for expedited review;
- Is reviewed by the IRB in accordance with the limited IRB review (new IRB regulatory category) procedure; or
- Only involves data analysis (including analysis of identifiable information or identifiable biospecimens) or access to follow-up clinical data from procedures that subjects would undergo as part of clinical care.
- The IRB must document the rationale for conducting continuing review if any of the above conditions are met.
- FDA still requires annual continuing review for FDA-regulated studies.
- New consent process requirements, including
- Subjects must be provided with the information a reasonable person would want have to make a decision about taking part in the research.
- Informed consent must begin a concise and focused presentation of key information to facilitate comprehension.
- Informed consent must present information in sufficient detail and must be organized and presented in a way that facilitates comprehension.
- One new basic element of consent: a new requirement to include one of two statements about the collection of private information or identifiable biospecimens for future research:
- Identifiers might be removed and the de-identified information or biospecimens used for future research without additional informed consent from the subject; or
- The subject’s information or biospecimens will not be used or distributed for future research studies even if identifiers are removed.
- Three new additional elements of consent:
- 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.
- A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
- For research involving biospecimens, 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).
There is a new requirement for clinical trials conducted or supported by a Common Rule department or agency for posting the consent forms on a publicly available federal website that will be established as a repository for clinical trial consent forms. For federally-funded clinical trials approved on and after Jan. 21, 2019, the consent form should be posted following the end of recruitment and no later than 60 days after the last study visit by any subject. At this time the following two publicly available federal websites will satisfy the consent form posting requirement:
- clinicaltrials.gov; and
- A docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021)
The 2018 Common Rule requires single IRB review for cooperative research (research involving more than one institution) that is funded by a Common Rule department or agency. This part of the 2018 Common Rule become effective Jan. 20, 2020.
Exempt human subject research is a subset of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.
Exemption category changes in the 2018 Common Rule:
- Most of the existing exemption categories have been revised.
- Category 1: Research in established or commonly accepted educational settings
- Category 2: Educational tests, surveys, interviews, public observation
- Category 4: Secondary research using data and/or biospecimens
- Category 5: Research and demonstration projects supported by a Federal agency
- Category 6: Taste and food quality (only unchanged category)
- Three new exemption categories have been added.
- Category 3: Benign behavioral interventions
- Category 7: Storage and maintenance of identifiable private information/with broad consent (Note: Penn State College of Medicine is not implementing broad consent at this time.)
- Category 8: Secondary research involving use of identifiable private information/biospecimens for which broad consent was required. (Note: Penn State College of Medicine is not implementing broad consent at this time.)
- Some of the exemption categories may require “limited IRB review” (similar to an expedited review process).
Under the 2018 Common Rule, researchers will continue to submit all human subject research to the IRB to determine any exemptions.
The Exemption Categories information included below may help advise your research. Note that this tool was adapted from the University of Kentucky.
Exemption category description: Research in established or commonly accepted educational settings that involves normal educational practices
New citation: 104(d)(1)
Exemption category description: Research only includes interactions involving educational tests, surveys, interviews, public observation, if at least one of the three criteria below are met.
New citation: 104(d)(2)
General conditions/allowances/limitations: Data collection only:
- May include visual or auditory recording
- May not include intervention
- Only includes interactions
Exemption category description: Research involving benign behavioral interventions through verbal, written responses (including data entry or audiovisual recording) from adult subject who prospectively agrees, and at least one of the criteria below is met.
New citation: 104(d)(3)(i)
(ii) BBI must be:
- Brief in duration
- Not physically invasive
- Not likely to have a significant adverse lasting impact on subjects
- Unlikely that subjects will find interventions offensive or embarrassing
(iii) No deception unless participant prospectively agrees.
Exemption category description: Secondary research for which consent is not required. Use of identifiable information or identifiable biospecimen that have been or will be collected for some other “primary” or “initial” activity, if at least one of the criteria below is met.
New citation: 104(d)(4)
General conditions/allowances/limitations: No primary collection from subjects for the research; allows both retrospective and prospective secondary use.
Exemption category description: Research and demonstration projects supported by a federal agency or department and designed to study/improve… public benefit or service programs.
New citation: 104(d)(5)
General conditions/allowances/limitations: Must be posted on a federal website.
Exemption category description: Taste and food quality
New citation: 104(d)(6)
Exemption category description:Storage and maintenance of identifiable private information/with broad consent
New citation: 104(d)(7)
Penn State College of Medicine is not implementing broad consent at this time, so exemption category 7 will not apply to College of Medicine researchers.
Exemption category description: Secondary research involving use of identifiable private information/biospecimens for which broad consent was required
New citation: 104(d)(8)
Penn State College of Medicine is not implementing broad consent at this time, so exemption category 8 will not apply to College of Medicine researchers.
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