Page 20 - Research Compliance Welcome Package (1.4.19)

Revised Common Rule — DHHS 45 CFR Part 46 Subpart A
The Federal Policy for the Protection of Human Subjects, frequently referred to as “The Common Rule,” has been formally revised for the first time in over 25 years. These revisions, known as “The 2018 Requirements” became effective on July 19th, 2018 and must be implemented by January 21st, 2019—quite the undertaking when you consider that these regulations are consistently applied to all human research at
BSWH. The BSW Research Institute has been working to ensure these modifications will be implemented in the most effective way for our local human research protection program, so keep an eye out for communication of any changes that may impact you. In the meantime, here is a quick look at the major changes.
The revised Common Rule:
• establishes new requirements regarding the information that must be given to subjects during the consent process;
• allows for the use of broad consent for the storage, maintenance, and secondary research use of biospecimens (unspecified future research);
• establishes new exempt categories of research based on risk profile;
• creates a requirement for the use of a single IRB, with some exceptions, for research projects involving more than
one institution (effective January 2020); and
• removes the requirement to conduct continuing review of certain kinds of ongoing research. 
To learn more, complete the voluntary Revised Common Rule course now available through the CITI Program.
Welcome to our newest team member!
We are pleased to welcome Michelle Edens, JD, CCRC, to the Research Compliance team. She joined the Research Institute in 2012 and has now transferred to Corporate Compliance as a Compliance Consultant. In her new role, she will be part of the team that conducts audits of BSWH research projects and educates research personnel on the responsible conduct of research. Please join us in making Michelle feel welcome!
Responding to an Internal Research Compliance Audit
Responding to an audit report may not always be as straightforward as you might think. Some issues require complicated and multifaceted corrective action plans; some cannot be fixed and require only preventive action or education. Here are some reminders that can help you draft a comprehensive response:
• The “How to Respond to an Internal Research Compliance Audit Tip Sheet” is included when we issue a draft audit report. Take a few minutes to read through it before tackling the response as it has detailed instructions and tips.
• Draft reports contain blue text prompts (e.g., Click here to address recommendation #1, Responsible Parties, Date #1) to indicate each individual field that requires a response. These are usually numbered for clarity and must all be addressed or a draft report may be returned for additional input.
• If multiple individuals or groups are involved in correcting or preventing an issue (e.g., Sub-Investigators, Research Regulatory Affairs), be sure to include them in the Responsible Parties list for that finding.
• Communicate with the Corporate Compliance Consultant who conducted the audit. She knows the types of responses likely to be accepted and is available to talk through and assist in developing a suitable response.
• An audit report response is an official document that, when finalized, will be sent to upper leadership and summarized for the Corporate Compliance Committee, so responses should be in professional language.
• Keep in mind that many individuals included in the final report distribution are not familiar with the study, so develop responses that are detailed and clear without the need for additional explanation.
Research Compliance audits are conducted to proactively identify and resolve any non-compliance internally when possible. Education should be a key component of the audit process, and along with the above tips, should help you successfully respond to an audit report and prevent an unnecessarily prolonged process. 
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