Research Compliance Winter 2017 Newsletter

Your Ethics in Action Heroes

Lauren Ferrell of Viterbi and Shannon Hinojosa of Rossier have been named Ethics in Action Heroes by the Office of Culture, Ethics and Compliance.
The Office of Culture, Ethics and Compliance solicited nominations late last year, and Lauren and Shannon were selected as the winners from those nominated.

You can read more about Lauren and Shannon here.

HHS and NSF Office of Inspector General (OIG) FY17 Audit Work Plans

The HHS OIG posted its Work Plan for FY17 on November 10, 2016.  One item on the work plan is “Controls over Subcontracting of NIH Grant and Contract Work”.  NIH is planning to “determine whether colleges and universities effectively monitor the services subcontracted to other organizations and ensure that Federal funds are spent on allowable goods and services in compliance with selected cost principles and the terms and conditions of the grants and subcontracts.”  The OIG is currently auditing one university but is looking to audit additional institutions with respect to risk assessments and monitoring.

In addition, the NSF OIG plans to review universities internal controls, not just incurred costs, as a means to prevent repeat findings.  The NSF OIG’s Semiannual Report to Congress noted “inadequate monitoring of subawardees” as an area of concern arising out of last year’s single audit findings.  According to COGR, the NSF OIG is still in the early planning stages of an audit on this topic.

Please pay special attention, along with your PIs, to reviewing charges on invoices from subrecipients.  These charges should be reviewed in the same manner and detail for allowability, allocability and reasonableness as any other charge on a sponsored project.

To learn more about the roles and responsibilities of principal investigators, departmental administrations, and the Department of Contracts and Grants related to subrecipient monitoring, please visit the Office of Research website.

HHS OIG 2017 Workplan

NSF OIG 2017 Workplan

Regulations Affecting Research and the Regulatory Freeze

  • On January 20th, 2017, the Trump administration issued a memo to all federal agencies to freeze any new or pending regulations until they undergo a review by the new administration. A number of these regulations impact research, especially in the area of human subjects researchandclinicaltrialregistrationandreporting. Possibleimpacts of the freeze include:
  • In September 2017, NIH’s policy on the use of a single institutional review board for multi­site research went into effect.
    It is unlikely that the regulatory freeze will impact the implementation of the Rule.
  • On January 18, 2017, HHS’s Final Rule on registration of clinical trials and results information submission went into effect. While it is possible the Rule is overturned by Congress, it is not likely. On January 19, 2017, several agencies announced revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). It is unclear whether the regulatory freeze will impact the Common Rule, but there are recommendations from certain members of Congress to remove/eliminate the revised Rule.
  • On December 1, 2016, the Department of Labor’s Overtime Rule went into effect, which significantly raised the salary threshold for exemption from overtime pay requirements. There are several recommendations from Congress to target this rule for removal/elimination.

These regulations were covered in more detail in our Fall 2016 issue. The Office of Culture, Ethics and Compliance is tracking the regulatory freeze and will be in touch with any relevant updates.

Finally, the Council on Governmental Relations, or COGR, distributed an Excel spreadsheet of research ­relevant regulations and how they are affected by the memo, which you can find here.

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