POSTED July, 14, 2020
HUMAN SUBJECT REGULATIONS DECISION CHARTS: 2018 REQUIREMENTS
SCOPE: The following graphic charts are intended to aid those who need to decide if an activity is research involving human subjects that must be reviewed by an institutional review board (IRB) and whether informed consent or the documentation of informed consent can be waived under the 2018 Requirements found for the U.S. Department of Health and Human Services (HHS) at 45 CFR part 46, Subpart A.
TARGET AUDIENCE: IRBs, institutions, investigators, and others.
CONSIDERATIONS: These charts are necessarily generalizations and may not be specific enough for particular situations. Other guidance documents are available related to specific topics at: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/index.html. OHRP cautions that the full text of an applicable regulatory provision should be considered in making final decisions. The charts do not address requirements that may be imposed by other organizations, such as the Food and Drug Administration, the National Institutes of Health, other sponsors, or state or local governments.
(NOTE: This guidance is consistent with the 2018 Requirements (i.e., the revised Common Rule). For use after January 20, 2019.
EFFECTIVE JANUARY 19, 2018: CHANGES TO THE COMMON RULE
What are the Implications for IRB Review and the Protocol Submission Process?
The Department of Health and Human Services has finalized revisions to the Common Rule. The final Rule was published on January 19, 2017 and goes into effect on January 19, 2018.
The purpose of revising the Common Rule is to better protect human research subjects while reducing administrative burden and delay in the IRB approval process. It is anticipated that the revised Common Rule will simplify and enhance the current institutional review board process.
Important information for researchers and staff regarding the Common Rule revisions will be disseminated in the following ways:
- The Office of Regulatory Affairs at the University of Pennsylvania will be providing information about the Common Rule revisions and how the IRB submission and review process will change. This information will be disseminated through enhancing content on the ORA website and by ORA staff offering in-service activities. The date, time and place for the next ORA in-service will be posted in the PSC Newsletter.
- The PSC website will be updated before January 1st to include direct links to important websites such as Penn’s ORA and the Office of Human Research Protection where relevant slides, documents and other information may be obtained. The PSC website will be updated to include a summary of the revisions to the Common Rule with information about the implications for preparing protocols for IRB review.
- A PSC in-service will be offered to faculty, post docs, graduate students and staff to discuss the regulatory implications for previously approved studies and new protocol submissions and to answer research specific questions. The date to be determined and notice posted in the PSC Newsletter.
Two examples of Common Rule revision that have positive implications for PSC research:
Continuing review for minimal risk research: Effective January 18, 2018 continuing review applications will no longer be required for (1) minimal risk research determined to be eligible for expedited review, categories 1-7, and 9 and (2) greater than minimal risk where it only involves data analysis, including analysis of identifiable data and specimens and collecting follow up data from procedures that subjects undergo as part of clinical care. IRB approval will not expire for (1) and (2). Modifications and reportable events should be submitted for (1) and (2).
Previously approved studies: After January 18, 2018 current protocols reviewed under an expedited mechanism may be eligible for exemption. Researchers will not have to do anything. The studies should proceed under the old Common Rule and at the time of the next continuing review or modification the IRB will determine if the study meets the regulatory criteria for exemption and send a letter.
There are many revisions to the Common Rule that will impact PSC research. More information to come. Please feel free to reach out to Jan Jaeger, PhD for questions. firstname.lastname@example.org
Institutional Review Board Submission Process Guidance:
Institutional Review Boards (IRBs) are charged with the responsibility of protecting the rights of human research subjects. Faculty and students at the Population Studies Center who are planning to conduct research involving human research subjects must submit to the Office of Regulatory Affairs (ORA) an application for review by an IRB.
The University of Pennsylvania has eight IRBs which meet to review proposals once a month. All IRBs are housed in the ORA and managed by its staff. IRB # 8 is the only IRB dedicated to the review of social and behavioral protocols. Almost all of the Population Studies Center research protocols will be reviewed by this IRB. To see a schedule of IRB meetings refer to the ORA website which provides a meeting calendar.
The ORA website contains the pertinent information that researchers will need to know to prepare an application for IRB review. The website includes guidance on protocol and informed consent preparation, worksheets for level of IRB review determinations, forms and templates, IRB meeting schedules, staff contact information and is the site for the electronic protocol submission process and tracking. Researchers must access this site to acquire the appropriate documents and templates and to submit an IRB proposal. Human subject research is a complex endeavor with changing policies, regulatory codes and standards of conduct that must be satisfied before research begins and while research is ongoing. The ORA provides the most current information regarding policies and procedures and may serve as a valuable resource.
All faculty and students conducting research with human subjects at the University of Pennsylvania must be certified to do so. Proof of certification must accompany IRB applications. Penn requires that researchers take the CITI training and certification exam. To take the CITI training and certification exam log on to PennEra.
Included in the CITI training is information about Health Insurance Portability and Accountability Act (HIPAA) requirements. Proposals must confirm whether HIPAA protected information is part of the research and if so, how it will be protected.
General Instructions for Research Involving Vulnerable Populations:
The CFR requires that vulnerable populations are afforded an extra level of protection. Regulations guiding research with vulnerable populations, such as prisoners and children and research in the developing world are found in the CFR and on the websites of the OHRP and ORA or contact Jan Jaeger, RN, Ph.D. at email@example.com or at 856-313-8524.
Please see the IRB & Human Subjects Frequently Asked Questions page for additional details and see this page of Resources for links to other important information.
For assistance in preparing applications for IRB review or for questions about IRB submission not covered above, please contact the Population Studies Center IRB advisor:
Jan Jaeger,IRB/Human Subjects Consultant