| Responsible Office | Office of Research Integrity |
|---|---|
| Originally Issued | 30-Nov-2018 |
| Last Revised | n/a |
| Author | N. Coll |
Policy Statement
Research administration policies, standard operating procedures (SOPs), and forms promote the efficient use and effective and stewardship of University resources in support of the University’s mission and minimize the risk of non-compliance with relevant laws and regulations. This policy provides standards for development, approval, distribution, and maintenance of research administration policies, SOPs, and forms in research administration.
This policy defines and governs the process for creating, revising, and approving policies, SOPs, and forms owned by the following research administration offices: Office of the Vice President and Associate Provost for Research and Graduate Studies; Office of Research and Sponsored Programs; Research Integrity, and Office of Technology Transfer. This policy also applies to all university-wide policies pertaining to the planning, funding, conduct, and reporting of research. In the University Policy Structure, Research administration policies are classified as Administrative Policies, and as such, this policy conforms to Policy Structure requirements for Administrative Policies.
Reason for Policy and Underlying Principles
This policy exists to ensure that the University formally approves, issues, and maintains research administration policies and related documents in a cohesive, user-friendly, and consistent format. Those engaged in developing and maintaining research administration policies, SOPs, and forms must follow the requirements outlined in this policy for drafting, approving, revising, and withdrawing such documents.
Definitions
| Term | Definition |
|---|---|
| Policy | Policies are clear and concise statements of intent in conduct of research administration activities. Policies provide a set of guiding principles that inform decision-making and facilitate achievement of goals. |
| Standard Operating Procedure (SOP) | Standard Operating Procedures (SOPs) describe the steps involved in implementing a policy. SOPs generally indicate who is responsible for each step by role or position, including steps accomplished using electronic systems. |
| Form | Forms are created to provide an easy and uniform way for users to enter, submit, document and utilize information. Forms are intended to minimize burdens on users in providing information and to support efficient and reliable processes. Forms should allow the user to enter information electronically directly into the form. |
| Research Administration Policy website | The Research Administration Policy website houses all OVPR policies. It serves as the central repository and can be found at the Lehigh University: Research and Research-Related Policies website. For purposes of this policy, the OVPR policies include those developed by the Office of the Vice Provost for Research; Office of Research and Sponsored Programs; Research Integrity, and; Office of Technology Transfer |
| Policy Proposal | A document that proposes a new research administration policy or major revision to an existing research administration policy. The document describes the background, justification, and likely impact of the new or revised research administration policy. It is presented by the Policy Sponsor (as described below) to the Responsible Official and the Director of Research Policy and Compliance. |
| Responsible Official | The Responsible Official is typically the Director of the department or office that owns the policy and is responsible for the process governed by or affected by the policy. |
| Policy Sponsor | The Policy Sponsor is the staff person in the department or office responsible for the policy or process. A Responsible Official may act as a Policy Sponsor. |
| Major Revision | A revision to a Policy, SOP or Form comprising any substantive change or addition to (a) responsibilities of offices or individuals or (b) information needed to carry out those responsibilities. Contact the Director of Research Policy and Compliance for assistance determining whether a revision is major or minor. |
| Minor Revision | A revision to a Policy, SOP or Form that is not a Major Revision. Minor Revisions include those undertaken to improve clarity and usability without affecting roles and responsibilities or what responsible parties need to know, as well as updates such as new contact information, position titles and website addresses. Contact the Director of Research Policy and Compliance for assistance determining whether a revision is major or minor. |
Procedures
Policy Proposals
Every new Research Administration policy, or Major Revision to an existing research administration policy, begins with a policy proposal. The policy proposal explains the need for the new policy or revision, and identifies stakeholders to be consulted in drafting, approval and communications processes. The contents of the policy proposal are described in full in SOP: Creating and Revising Research Administration Policies, Procedures, and Forms. The Policy Proposal is prepared by the Policy Sponsor and is presented to the Responsible Official and the Director of Research Policy and Compliance for review, comment, and approval.
Policy proposals are not required for Minor Revisions.
Drafting New or Revised Policies
Once the Responsible Official and the Director of Research Policy and Compliance approve the policy proposal, if such approval is required per item above. The Policy Sponsor is responsible for ensuring that the policy is drafted in consultation with the identified stakeholders. The Policy Sponsor and Responsible Official are responsible for the content of the policy. Every research administration policy must contain all information required to ensure compliance with relevant laws and regulations, as well as consistency with existing research administration and any other applicable university policies. During the drafting phase, the Policy Sponsor keeps the Responsible Official apprised of progress and issues, as appropriate. The Director of Research Policy and Compliance provides technical, editorial, and project management support to the Policy Sponsor during the drafting process.
Reviewing and Approving New or Revised Policies
New policies and major revisions to existing policies must undergo a formal review and approval process that includes consideration of the purpose of the addition or revision, impacts on stakeholders, and impacts on compliance with applicable law and obligations to research sponsors, as detailed in SOP: Creating and Revising University Policies, Procedures, and Forms. This process includes conferral with the Research Policy Review Committee (RPRC) or other appropriate advisory committee and stakeholders, as appropriate. The Responsible Official must approve the final draft of a policy. The Director of Research Policy and Compliance coordinates the review process.
Formal review and approval is not required for Minor Revisions to existing research administration policies.
Posting Approved Policies
All approved University policies must be included to the Lehigh University Research and Graduate Studies: Research and Research-Related Policies website. The Director of Research Policy and Compliance is responsible for posting approved policies, and works with the Policy Sponsor and Responsible Official to ensure that the University community is informed of new and revised policies.
New or Revised SOPs and Forms
New or revised SOPs and forms are generally posted to the Responsible Office’s website once the Responsible Official and the Director of Research Policy and Compliance approve them. Two exceptions follow below:
- For new policies and Major Revisions, the associated SOPs also must go through the formal review and approval as detailed in section above, or;
- For new or revised SOPs with forms with significant impact or changes, the Director of Research Policy and Compliance may decide, at their discretion, that the procedures or forms should go through the process described in section above.
Regular, Periodic Review
Each research administration policy, SOP, or form is subject to regular, period review. Review of the entirety of each research administration policy, SOP, and form will be conducted at least every three years by the Responsible Official, measured from the most recent revision date. The Director of Research Policy and Compliance maintains the review cycle calendar and prompts the Responsible Official when review is due.
Special Situations/Exceptions
Any exceptions to this policy must be presented to and approved by the Director of Research Policy and Compliance. The Director of Research Policy and Compliance may refer requests for exceptions to the RPRC or other appropriate advisory committee, or to the Vice President and Associate Provost for Research and Graduate Studies, as appropriate.
Responsibilities
| Responsible Party | List of Responsibilities |
|---|---|
| Director of Research Policy and Compliance | Responsible for the administration of this policy through the management of the policy development, review, approval, dissemination, and maintenance processes. Provides technical and editorial support and consultation to Policy Sponsors during the policy drafting, review, approval, and posting phases. Maintains the OVPR policy repository website and posts approved policies. Collaborates with Responsible Officials to ensure that the university community is informed of new and revised policies. Chairs the RPRC or liaises directly with the existing Chair of standing committees when they are used as appropriate advisory committees for conferral on the development of new or revised research administration policies. Provides consultation to individual OVPR departments to conduct needs assessments and identify policy priorities. Oversees process for regular periodic review of existing Research Administration policies. Controls the versioning of all official policy documents and maintains history of all revisions. Reviews requests for exceptions to this policy, and refers requests to the RPRC or other appropriate advisory committee, or to the Vice President and Associate Provost for Research and Graduate Studies, as appropriate. |
| Policy Sponsors | The Policy Sponsor is the staff person in the department or office responsible for the policy or process. A Responsible Official may act as a Policy Sponsor. Prepare policy proposals to initiate new or major revisions to existing Research Administration policies. Accountable for the policy’s content, including consulting with the Responsible Official, the Director of Research Policy and Compliance, and other appropriate stakeholders to ensure that the policy complies with all relevant laws and regulations. Ensure proposed policies are drafted in consultation with the identified stakeholders. Keep the Responsible Official apprised of progress and issues, as appropriate, during the drafting phase. Collaborate with the Director of Research Policy and Compliance to review and approve new or revised SOPs or forms. Follow item 5 under the Procedures section above for exceptions that require SOPs and forms to undergo the formal review process described in item 3 under the Procedures section above. |
| Research Policy Review Committee (RPRC) or other appropriate advisory committee | Consists of senior-level representatives from academic and administrative areas who are, collectively, able to represent stakeholders and provided needed subject matter expertise as is needed to advise on policies in a given area. Standing committees may be used to serve as an advisory committee when appropriate. For example, the Conflict of Interest in Research Committee (CIRC), the Institutional Review Board (IRB), and the Institutional Animal Care and Use Committee (IACUC) are standing committees that serve as advisory committees in their respective areas. Applies subject matter expertise, stakeholder perspective, and interest in mission success to the review of draft policies and major revisions to existing policies. Reviews, provides comments/input, and confers on the development of new research administration policies, SOPs, and forms or major revisions to existing polies, SOPs, and forms. Reviews exceptions to this policy as appropriate. |
| Responsible Officials | The Responsible Official is typically the Director of the department or office that owns the policy and is responsible for the process governed by or affected by the policy. Responsible Official may act as a Policy Sponsor. Approve the final draft of a policy. Collaborate with the Director of Research Policy and Compliance to ensure that the university community is informed of new and revised policies, including developing and implementing appropriate training for those affected by a new or revised policy and ensuring compliance with a new or revised policy. Collaborate with the Director of Research Policy and Compliance to determine departmental policy priorities and participate in regular periodic reviews of existing Research Administration policies within their department. |
| Stakeholder | An individual, department, or function identified in the policy proposal affected by the policy or whose subject matter expertise relates to the subject of the policy. Stakeholders, and/or individuals or groups able to represent stakeholders’ perspectives, are consulted during the policy drafting stage. The RPRC or other appropriate advisory committee is a stakeholder for all research administration policies. |
Related Resources
Research Administration Policies and Documents
SOP: Creating and Revising Research Administration Policies, Procedures, and Forms
Form: Research Administration Policy Proposal
Lehigh University Research: Research and Research-Related Policies Website
Policy Style Guide (in development)
Other University Forms and Systems
Lehigh University Policy Statements webpage
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