Human Research Protection Program Newsletter - Fall 2017

Revised Common Rule Resources

Though the outcome of the Revised Common Rule is still unclear, it is likely that some or all of the changes will go into effect January 19, 2018. The HRPP is working to prepare campus for these changes by revising policies, preparing guidance, updating ARROW, and hosting informational sessions. The UW-Madison IRB offices each have a webpage dedicated to the Common Rule Revisions containing information and links to the sessions:

Education Needs Assessment Survey

A cross campus education working group has been working to expand the educational offering to UW-Madison researchers. A survey was created to gauge the training needs of our research community. Your input will help us to prioritize the creation of these new opportunities. If you have not yet had a chance to complete this survey, it can be accessed here.

HRPP Training Events Calendar

The HRPP Training Events Calendar combines the educational sessions hosted by various HRPP entities (UW-Madison IRBs, Office of Research Compliance, RSP, etc.) into one calendar. This calendar is updated as new or recurring sessions are scheduled and will include any new sessions that are created as a result of the needs assessment survey above.

Updated NIH Policy for Certificates of Confidentiality

The NIH has issued a updated policy regarding Certificates of Confidentiality (CoC). In the past, 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, or educational advancement, and study teams were responsible for requesting a CoC from the NIH. As of October 1, 2017, NIH will automatically issue CoCs as a condition of award when a study, exempt or non-exempt, 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. For NIH funded researchers, this policy update will remove the burden associated with the CoC application process.

The campus IRBs will work with study teams to determine when this policy applies to their research to ensure that consent forms contain appropriate language and that all members of the research team (including any outside collaborators) are aware of the protections afforded by the CoC.

For non-NIH funded research requiring a CoC, the NIH will still accept applications for a CoC. The NIH CoC website has a "Select Your Funder" menu bar where the application process is described. Assistance with the application process can be found here.

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The two campus IRB offices maintain newsletters with information and announcements relevant to their researchers.

  • For researchers conducting research approved by the Education and Social Behavioral IRB, an archive of the ED/SBS newsletter can be found here.
  • For researchers conducting research approved by the Health Sciences or Minimal Risk IRB, an archive of the HS/MR IRB newsletter can be found here.