Institutional Review Board for the Protection of Human Subjects (IRB)
**Implementation and Transition to the New Common Rule**
Revised Institutional Review Board (IRB) Federal Regulations
The revised federal Common Rule is effective January 21, 2019
In order to ensure compliance with the correct set of applicable regulations, the corresponding institutional policies will also change effective January 21, 2019. These policy changes will only apply to research protocols reviewed and approved on or after January 21, 2019, or to protocols that are approved as part of the Continuing Review process.
Continuing review (annual renewal) is no longer “required” for minimal risk research
- Currently, open minimal risk studies (i.e., initially approved by Expedited Review) will transition at next renewal.
- The IRB may require CR for some minimal risk studies. If so, this will be communicated to the researcher during the initial approval process.
New Requirements for Informed Consent (guidance can be found here):
Final consent forms will now require a concise summary of study activities, risks, and benefits presented first in the consent form.
Existing studies affected by the new requirement will transition at the next renewal or consent-related amendment after January 21, 2019.
“Key information” to be presented at the beginning of the consent form: This part of the informed consent must be organized and presented in a way that facilitates comprehension, and provide sufficient information that a “reasonable person” would want to have. You must address the following five elements:
- That consent is being sought for research and that participation is voluntary
- The purposes of the research, duration of participation, and study procedures
- Foreseeable risks or discomforts
- Potential benefits to subjects or others
- Alternatives to participation
The concise and focused introduction is meant to be brief, but the amount of information that should be included will depend on the nature of the research. For some minimal risk studies, the concise introduction may require only four or five paragraphs. For more complex research trials, up to two pages may be required. In general, the introduction should not be more than two pages. To facilitate brevity, information may be provided in bulleted lists or in the form of an outline. Sample concise summaries from Duke University.
There are several new elements of informed consent:
Required: disclosure that de-identified data or biospecimens may be shared for future research (or not).
1) Biospecimens will be used for commercial profit and whether subjects will share in profit.
2)Clinically relevant results will be returned.
3) Research will involve whole genome sequencing.
4) Researchers may still request a waiver or alteration of the required elements of informed consent with their IRB application (process does not change).
Review by a single IRB is required for some federally-funded multisite studies
- Common Rule agency sponsored research with multi-institutional collaborators must be
reviewed by only one IRB, which will serve as the IRB of record for all collaborators.
- Required January 20, 2020 for NIH and all other Common Rule agencies.
Revised definition: vulnerable populations
Revisions to the regulations and policy clarify that vulnerability to coercion or undue influence, and no other considerations related to vulnerability, are the focus of IRB review. This refers to one’s ability to make an informed decision about participating in research.
References to pregnant women and “handicapped” individuals have been removed.–Subpart B corresponds, so research with pregnant women, fetuses, and neonates is still subject to the additional requirements in Subpart B.
Term “mentally disabled persons” replaced with “individuals with impaired decision making ability”.
Revised definition: clinical trial
Federally-sponsored research that investigates 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 those interventions on health-related biomedical or behavioral outcomes.
Requires public posting of consent form (e.g. on clinicaltrials.gov).
Revised definition: human subjects (New language added)
Living individuals about whom an investigator obtains info or biospecimens through intervention or interaction, and uses, studies, or analyzes the info or biospecimens –OR –obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens
Unchanged: Research is a systematic investigation designed to develop or contribute to generalizable knowledge
New -the regulations specify what is not research: Scholarly or journalistic activities –oral history, journalism, biography, literary criticism, legal research, historical scholarship –when the collection of information is focused on the individual, and the activity does not otherwise qualify as a “systematic investigation designed to develop or contribute to generalizable knowledge”.
Guidelines and Forms
The Office of Research and Sponsored Programs (ORSP) is pleased to announce the adoption of the industry leading IRBNet suite of tools, accessible via the National Research Network, bringing electronic protocol management, on-line submissions and many other important research oversight features to The University of Scranton's research community.
IRBNet and IRB meeting schedule
Beginning on April 1, 2016, all protocols (including new protocol, revisions and renewals) must be submitted electronically via IRBNet, using newly revised (03/16) forms, which can be found in the IRBnet system. IRB Applications can be found on IRBnet.org
At this time, submissions to Departmental Review Boards (DRBs) will continue to be routed directly to DRB chairs, and protocol review will follow current DRB guidelines. Additional information pertinent to the implementation of IRBnet for processing of DRB protocols is forthcoming. Note: If your department has a Departmental Review Board (DRB), contact your department chair for procedures.
All IRB Protocols are due seven (7) days before the meeting dates. Protocols should be submitted through IRBNet by 4:30 pm on due dates. See IRB Committee and Meeting Schedule above for due dates.
IRBNet Training Energizers to help you get started can currently be found at the following link: http://www.irbnetresources.org/tresources/vd/r1.html.
When prompted, please enter the institutional login -- Username: scranton and Password: training. You may log in to the training system at any time to begin training.
IRBNet Training Energizers for creating a subsequent package (revisions to original, starting on page 9) can be found here
Required IRB Training:
This online training program is offered to the University of Scranton community through a contract with the CITI (Collaborative IRB Training Initiative) program. Click here to read about the CITI program. University personnel and students have unlimited access, so we encourage faculty members to use this online training for Research Methods Classes.
Additional IRB Information:
OHRP - Office of Human Research Protections, DHHS Comprehensive site for all federal regulations and guidance
HIPAA - Health Insurance Portability and Accountability Act, DHHS Health records privacy regulations and information
- Do you or your students conduct surveys with any persons or institutions outside of the University of Scranton community?
- Do you or your students use members of the University of Scranton community outside of your own classes?
- Do you or your students plan to publish the results of your project?
- Have you been contacted by any persons outside of the University who wish to use members of the University of Scranton community as research subjects?
- If you answered YES to any question above - YOU DO NEED THE IRB!
All research projects using human subjects, classroom assignments as well as individual research, must be submitted for review. No phase of a project may begin until approval is obtained.