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HS-IRBs News October 2017
Health Sciences and Minimal Risk IRBs, IRB News/Volume 9, Number 10, October 2017
Some revisions to the Common Rule (aka the Federal Policy for the Protection of Human Subjects) are expected to go into effect January 19, 2018 and the UW-Madison IRBs are proactively preparing for these changes. The revised Common Rule reduces IRB and other oversight for many research studies involving human subjects that can be classified as minimal risk. Of note, the Food and Drug Administration (FDA) has not issued revised regulations and thus any FDA-regulated research will not be affected by the revisions to the Common Rule. To learn more about these changes, please sign up for one of our upcoming information sessions:
- Thursday, November 16: 1:30pm - 3:00 pm, 1325 HSLC, register here
- Thursday, December 14: 11:30am - 1:00 pm, 1220 HSLC, register here
The Department of Health and Human Services requested a delay in implementation of some of the proposed revisions to the Common Rule, but has not identified which aspects of the revised Common Rule would go into effect in 2018 and which would be delayed, if the request is approved, until 2019. The UW-Madison IRBs will begin applying those components of the revised Common Rule that will go into effect in 2018 to new studies approved on or after January 19, 2018 and that are not FDA-regulated. IRB staff will work closely with study teams to identify the best implementation strategy for each initial review submission.
In the past CoCs were issued by NIH upon request. Usually CoCs would be required when study teams planned to collect identifiable information for research purposes that could put individual subjects at risk for criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement. As of October 1, 2017, NIH will automatically issue CoCs as a condition of award when a study, exempt or non-exempt, involves identifiable, sensitive information involves the collection or use of identifiable, sensitive information. Note that NIH defines “identifiable, sensitive information” as cases when subjects can be identified, biospecimens are collected or used and either are identifiable or have a risk of being identifiable, the research involves the generation of individual level human genomic data, or the research involves any other information that might identify a person. In addition, the NIH is retroactively covering ongoing research funded by NIH as of December 13, 2016.
When a CoC was specifically applied for, the NIH required specific language
to be included in consent documents which identified the limits of the CoC’s protections. The UW IRBs will work with study teams to include appropriate language in consent forms for new or already approved studies that fall under this policy change. This may require study teams to revise consent documents in some cases.
NOTE: The UW IRBs can still require CoCs for studies that are not NIH-funded. In these cases, the institution will need to apply for the CoC to cover that study rather than a CoC being automatically issued.
New Guidance Documents
The HS-IRBs Office has two new guidance documents available for study teams to use:
- Documenting Consent Electronically or for Remote Subjects Guidance: This document provides guidance on documenting consent obtained from subjects utilizing methods other than pen and paper. Electronic documentation of consent may be used when researchers conduct the consent process with participants in person, as well as when potential participants are not physically present during the consent process.
If you have questions about this guidance, please contact the Informed Consent Working Group (ICWG) via AsktheIRB@medicine.wisc.edu.
- Understanding the NIH Genomic Data Sharing (GDS) Policy: This document addresses common questions associated with the NIH GDS Policy, which applies to all NIH-funded research that generates large-scale genomic data. If study teams are wondering whether GDS policy applies to their study, what to do if it does, and the overall process for institutional certification, answers to these questions and others can be found in this document.
If you have recommendations for additional new guidance, please contact Tesha Zimmerman at firstname.lastname@example.org
Documenting the Use of Non-Investigational Drugs and Biologics for Research Purposes
IRBs are required to analyze all of the procedures and risks associated with study participation. Any time a procedure happens only
because of someone’s participation in a research study, even if the procedure is performed consistent with standard clinical practice
, the IRB must evaluate the procedure and associated risks.
This means that, when using non-investigational drugs or biological agents, a description of the use of the drug/agents and associated risks should be provided in the ARROW application. This would include selecting “Drugs” box on the Special Procedures page, providing a copy of the agent’s package insert, and providing a description of potential risks of the agent in the application and consent form.
Examples of situations that require supporting documentation in ARROW include the use of dilating eye drops, administration of albuterol prophylactically or as a rescue medication, the use of lidocaine as a numbing medication, or the administration of any drug or biologic that is protocol mandated. This is the case even if the agent is FDA-approved, and even if it is not the focus of an investigation in the research study.
When research activities are associated with clinical care, such as in treatment studies, only the drugs or biologic agents that are under investigation or are protocol mandated need to be included in the application. Information on drugs provided to mitigate side effects would not need to be included unless required by the protocol.
If you have questions about whether to include documentation of biological agents, or how to do so, please email AsktheIRB@medicine.wisc.edu
Inaugural HIPAA Compliance News
The UW Madison HIPAA Office, part of the Office of Compliance, has released the first Updates
document to share FAQs, information about new resources and technology, updated forms, and training.
For more information about HIPAA, please see the Compliance HIPAA webpage