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Policies, Procedures and Processes

Definitions

“Policy” is a written statement that mandates, specifies, or prohibits behavior in order to express basic values of the University/School, enhance the University/School mission, ensure coordinated compliance with applicable laws and regulations, promote operational efficiency, and/or reduce institutional risk. A Policy includes criteria as mandated by the Office of Ethics and Policy document templates and must have a single Issuing Officer.

The decision to write a Policy is ultimately up to the Unit (ESOP) responsible for administering the Policy. Best practice is to write Policies that address “significant organizational problems with reasonably clear causes.”1 Organizational problems can be internal (e.g. bad behavior, human error) or external (e.g. regulation, public opinion, or liability).

Policies should be written in response to organizational problems that occur repeatedly and/or are consequential. Policies should not be written “in response to extreme events, to a handful of people, or even to a particular employee.” Policy=University Policy

Units must not create a Unit Policy:

  • when the Unit is prohibited from doing so by an existing UNC System or University policy; or
  • when the proposed Unit policy is inconsistent with, or less restrictive than, Board of Trustees, Board of Governors, UNC System, or University policies.

“Procedures” are the guidelines required to accomplish an action necessitating specific instructions. Procedures are not intended to be a detailed “help guide”, but instead are higher-level process documents which can then point to specific and detailed instructions maintained by the appropriate Unit. Procedures often pertain to implementing Policy. Procedures may also provide guidance for behavior on issues that are not dictated by Policy. Procedures are created and changes to them are made at the School level. Procedure=School Policy

“Process” is the step-by-step detailed instruction to implement or follow a Procedure. Processes are developed to ensure that all impacted parties have proper knowledge to execute a Procedure. Processes can be developed at the Division or Lab level by School Faculty or Staff with proper review and approval by Compliance and a ranking member of the impacted group. Process=”How To” for Procedures

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Purpose:

The University provides contract negotiation services for the Departments to enable research grants, educational initiatives, and service.  As part of the process, third parties often require changing the University’s standard contract language to move forward.  The University allows contractual language changes if the Department is willing to accept the risk of contractual challenges due to the changes and agrees to bear the responsibility for any litigation costs, fines, or penalties that may occur as part of the contract.

UNC Eshelman School of Pharmacy Procedure:

As the School is the Department per the University definition, the Office of Strategic Risk Management will review all requests to the School to accept modifications of the contract and the resulting risk and will provide recommendations to the Chief Operating Officer for final decision.

In the event litigation, fines, or other penalties occur in connection with the contract and the changes to it and are charged to the School, the School will first utilize faculty startup funds or available trust accounts, then utilize Division accounts prior to using School funds.

Background:

The UNC-CH Policy and Procedures on Responding to Allegations of Research Misconduct (the “Research Misconduct Procedure”) clearly defines steps, identifies who should be involved, and how to report allegations of research misconduct. https://policies.unc.edu/TDClient/2833/Portal/KB/ArticleDet?ID=132346  To provide some guidance to the ESOP faculty and staff for personnel management when a research integrity incident arises, the following guidance should be applied.

Proposed ESOP Research Misconduct Management Process:

  1. When a UNC ESOP faculty, staff, or student identifies a potential research integrity issue, that individual should immediately inform their supervisor. The supervisor is required to inform the Division Chair, Director of Compliance and the Associate Dean of Research and Graduate Education (“Required Notifications”). If the supervisor is the subject of the possible violation, they should inform the Required Notifications. These individuals will notify the Institutional Research Integrity Officer (the “RIO”) and initiate the Research Misconduct Procedure.
  2. The Research Misconduct Procedure is designed to afford all persons who may be in violation an appropriate and unbiased due process procedure to evaluate the situation. Once the issue has been reported to the individuals in Step 1, all subsequent actions should be done with a focus on risk management and without assuming that any outcome is predetermined.
  3. No action should be taken with respect to the employment or job responsibilities of the subject(s) in question that would imply a predetermined outcome and could create liability for the School. Once the RIO has been engaged, he/she will start the review of the incident and will work directly with IT, HR and any other ESOP teams as needed in order to secure all data, electronic communications and determine any immediate actions that need to be taken with respect to the subject(s) to ensure the continuation of an appropriate work environment for all impacted employees that also minimizes the possibility of School liability.
  4. In the event the incident creates an environment where there is a danger to the individual(s) in question or to other employees or staff, to any animals or to property, action can be taken to remove this threat in consultation with the RIO, HR and, if necessary, University Security.
  5. Once the investigation is complete, the RIO will provide a summary and a recommendation for any action to the Dean. A copy of this summary and recommendation will also be provided to the subject(s) of the investigation. Once the report is delivered to the Dean, the Dean will make a final decision on what course of action, if any, should be followed.

If the above guidance is followed in all cases of suspected violations of research integrity, the RIO will make recommendations within approximately 3 months from the start of the Research Misconduct Procedure. A focus on ensuring the subject(s) has due process as part of the investigation will minimize the potential for School liability with respect to general HR or EEO issues. No actions should be taken that imply a presumption of guilt prior to the completion of the Procedure. If any faculty, staff, or students have questions or need guidance, they should consult the Director of Compliance.

As faculty retire, some data, including data contained in lab notebooks, may need to be archived for a required period of time. Faculty should consult with the Office of Research and the School’s IET team regarding this matter as they prepare to retire. Faculty are responsible for depositing scanned copies of lab notebooks or other research records and certifying that the scanned copy is a complete and accurate copy of the original record prior to leaving the University. Once the data are converted to an electronic format, the physical record should be appropriately destroyed by the PI.

Review and answer the following questions regarding the lab notebooks:

  1. Does the notebook contain information linked to a current licensing agreement? If so, please consult with the ESOP Director of Compliance (currently Nathan Simms) for any required next steps.
  2. Does the notebook contain data connected to a pending patent application? If so, please consult with the ESOP Director of Compliance for any required next steps.
  3. Does the notebook contain information linked to a contract with an industry partner? If so, please note the length of time the sponsor requires the materials to be stored. This information can usually be found in the contract agreement. If the archival period is not known, it is the faculty member’s responsibility to reach out to the industry partner to obtain that information. Please communicate the information by email to the School’s Office of Research (currently Arlo Brown).
  4. Does the notebook contain protected health information? If the sponsored project includes HIPAA covered information, the PI should communicate this to the School’s Director of Compliance, IET team and the Office of Research. HIPPA data is subject to different storage requirements.

For laboratory notebooks not covered in the above scenarios that include any records required by the terms and conditions of a federal grant/contract and/or any records that may reasonably be considered pertinent to a federal grant/contract, the recipient must retain records for 3 years from the date of submission of the final financial report. Note that the date of the final financial report may differ from the end of the award period. If your laboratory needs help identifying when the final financial report was submitted, please contact your grants administrator.  If a notebook is already more than three years past the final financial report, the PI should appropriately dispose of those records before leaving the University. Notebooks containing data solely from unfunded proposals are not required to be saved. The School will only retain data until the designated date of destruction. The following information must be provided with the electronic record to the School’s Office of Research.

  1. PI Name
  2. Grant or Contract Reference #
  3. Date of final financial report
  4. Note about HIPPA (if needed)