SOP: Creating and Revising University Policies and SOPs

Purpose

This SOP outlines the steps involved in creating or revising research administration policies and SOPs, as outlined in Policy: Developing, Revising, and Posting Research Administration Policies.

Scope

This SOP must be followed during the creation, revision, and approval of all policies and SOPs owned by research administration departments in the OVPR stem. For purposes of this SOP, the OVPR stem includes: 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 SOP does not apply to the office of Graduate Student Life and Environmental Health and Safety.

This SOP does not apply to University policies, faculty policies, academic policies, or to policies that apply to a particular department or school outside of the OVPR stem. 

Relevant University Policy/(ies) 

• Policy: Developing, Revising, and Posting Research Administration Policies
• Lehigh University Policy Structure

Procedure

Identifying the Need for a New Policy or Major Revisions to an Existing Research Administration Policy 

Any individual or OVPR department who identifies the need for a new policy or SOP or revision to an existing policy or SOP, should contact the Director of Research Policy and Compliance. The Director of Research Policy and Compliance coordinates the process of developing, reviewing, approving, and posting research administration policies and SOPs. 
The Director of Research Policy and Compliance can, if needed, help to identify an appropriate Policy Sponsor. The Director of Research Policy and Compliance provides the Policy Sponsor with the following information:

• An overview of the policy, SOP, and form development and approval process and the Policy Sponsor’s role in the process, as outlined in the Policy: Developing, Revising, and Posting Research Administration Policies.
• For a new policy or SOP: the appropriate document template.
• For revisions to an existing policy or SOP: an editable version of the existing document.
• The identities of other known policies or SOPs, or stakeholders that the Policy Sponsor should be aware of because they may affect or be affected by the new or revised policy or SOPs. 
   

Proposing a New Policy or Major Revisions to an Existing Research Administration Policy

Every new research administration policy, or major revision to an existing research administration policy, begins with the development, submission, and approval of a formal proposal using the Policy Proposal Form. Policy proposal are not required for minor revisions to existing research administration policies. The Policy Sponsor develops a policy proposal that contains, at minimum, the following information:

• Background establishing the need for a new or updated policy, including an outline of the events or conditions that give rise to the new policy or update.
• A policy statement that includes the requirement(s) of the university community that establish the need for a new or updated policy, and that may also include the university’s commitment to a relevant principle.
• The reason for the new or updated policy, including any legal, regulatory, financial, operational, accreditation, technological, and/or social requirements the policy addresses, and any advantages the policy will bring to the university.
• An overview of the policy content, including the problem the policy addresses, the way the policy solves the problem, and a general outline of the policy’s scope.
• The likely impact of the university, including identification of the resources (human, financial, physical, operational, technical, etc.) that will be needed to implement and maintain compliance with the policy; identification of changes to Lehigh’s culture or behaviors that may be involved, and; identification of operational activities that may be affected.
• The stakeholders (those who will be affected by the policy, as well as subject matter experts) to be consulted when drafting the policy.
• The planned timing for implementation of the policy.
• The Responsible Official(s) and Policy Sponsor, as defined in Policy: Developing, Revising, and Posting Research Administration Policies. 

The Policy Sponsor presents the policy proposal to the Responsible Official and the Director of Research Policy and Compliance. The Policy Sponsor considers all comments and incorporates revisions, as appropriate, prior to proceeding to the next step. Only after approval by the Responsible Official and the Director of Research Policy and Compliance may the Policy Sponsor proceed to the drafting phase. 

Drafting a New Policy

After a policy proposal for a new policy is finalized and approved by the Responsible Official and the Director of Research Policy and Compliance, the Policy Sponsor is responsible for:

• Drafting the new policy and working with the Director of Research Policy and Compliance to set a schedule for completion.
• Obtaining input from stakeholders during the drafting phase.
• Seeking assistance from the Director of Research Policy and Compliance with any of the tasks involved in developing the draft policy, including researching, writing, reviewing, editing, establishing timelines, and arranging meetings with stakeholders.
• Apprising the Responsible Official of progress and issues, as appropriate.
• Indicating to the Director of Research Policy and Compliance when the draft is ready to present to an appropriate advisory committee.

The draft of a new policy should be prepared with the research administration policy template. The research administration policy template includes full instructions on the type of information that may be needed for each research administration policy and the appropriate layout to ensure consistency among research administration policies. Only include the sections that are relevant to the specific policy. 

Making Major Revisions to an Existing Research Administration Policy

For a policy with major revisions, after the policy proposal is finalized and approved by the Responsible Official and the Director of Research Policy and Compliance, the Policy Sponsor is responsible for:

• Drafting the revised policy and working with the Director of Research Policy and Compliance to set a schedule for completion.
• Obtaining input from stakeholders during the drafting phase.
• Seeking assistance from the Director of Research Policy and Compliance with any of the tasks involved in developing the revised policy, including researching, writing, reviewing, editing, establishing timelines, and arranging meetings with stakeholders.
• Apprising the Responsible Official of progress and issues, as appropriate.
• Indicating to the Director of Research Policy and Compliance when the draft is ready to present to an appropriate advisory committee.

Revisions to an existing policy are only permitted after obtaining a current, authorized, editable document from the Director of Research Policy and Compliance. Revisions to other documents are not accepted. 

Policy Review and Approval Process

Once the Policy Sponsor indicates to the Director of Research Policy and Compliance that a new or revised draft policy is ready for review, the draft policy undergoes the following review process:

• The Policy Sponsor submits the draft to the Director of Research Policy and Compliance
• The Director of Research Policy and Compliance reviews it for editorial content and to ensure proper formatting.
• The Director of Research Policy and Compliance checks for compliance with relevant laws and regulations and check for consistency with existing research administration and other applicable university policies.
• As appropriate, the Director of Research Policy and Compliance submits the draft to any relevant stakeholders for review and comment.
• When applicable, stakeholders return feedback, which the Director of Research Policy and Compliance relays to and discusses with the Policy Sponsor.
• When applicable, the Policy Sponsor incorporates the stakeholders’ feedback into subsequent revisions, as appropriate.
• When applicable, the Director of Research Policy and Compliance then re-submits the draft to any relevant stakeholders’ for review and comment, and the process is repeated until the Policy Sponsor is satisfied with the draft.
• The Director of Research Policy and Compliance coordinates with an appropriate advisory committee and sends the draft document(s) to the committee for review.
• Following submission of comments and/or discussion, the Policy Sponsor incorporate revisions as appropriate into a revised draft.
• As appropriate, the Policy Sponsor re-submits a draft to the Director of Research Policy and Compliance for review by an appropriate advisory committee. This process repeats until both the Policy Sponsor and the committee approve the final version. This process may be completed by email.
• The Policy Sponsor and the Director of Research Policy and Compliance submits the final draft to the Responsible Official for approval. Documentation of reviews conducted by email and/or meeting minutes are provided to the Responsible Official as needed.
• If the policy has the potential to have a major, campus-wide impact, or if it directly affects faculty, the Responsible Official, may choose, at their discretion, to discuss it with relevant University officers or a senior-level committee (or assign this task to a designee) before providing final approval.
• The Policy Sponsor submits the final approved draft to the Director of Research Policy and Compliance, along with a draft communication to the Lehigh community explaining the new or revised policy, pointing out any major changes, and inviting comments.
• The Director of Research Policy and Compliance posts the draft policy to the Policy Drafts section of the  website for a 30-day review period by the Lehigh community and issues a communication inviting review and comment.
• The Policy Sponsor and the Director of Research Policy and Compliance review the comments from the Lehigh community and as appropriate, revise the draft policy.
• If the Policy Sponsor or the Director of Research Policy and Compliance determine that the revisions are significant, the Director of Research Policy and Compliance will ask an appropriate advisory committee to review the document again to determine whether it should be re-posted to the Policy Drafts section of the policy website for another round of reviews. This process may be completed by email. If there are no comments, or if the Policy Sponsor and the Director of Research Policy and Compliance determine that revisions are minor, then no further review and approval is necessary.
• The Director of Research Policy and Compliance indicates to the Policy Sponsor that the draft policy is finalized and approved.

Issuance of Approved Policies 

Once the draft policy is finalized and approved, the Director of Research Policy and Compliance does the following:

• Posts the policy and any related SOPs.
• With input from the Policy Sponsor, or their designee, issues the appropriate form of communication informing the community of the new or revised policy. The type of communication may vary based on the impact of the new or revised policy.

The Director of Research Policy and Compliance drafts an executive summary for inclusion in the Research Essentials Handbook and updates the handbook with the new or revised policy as necessary

Making Minor Revisions to an Existing Research Administration Policy

Minor revisions to existing policies are not required to go through the formal review and approval process as outlined above in the Policy Review and Approval Process section. Minor revisions include, but are not limited to, clarifications, non-substantive changes, and updates to reflect, for example, new position titles, new contact information, or new website addresses. Minor revisions to existing policies are coordinated between a Policy Sponsor and the Director of Research Policy and Compliance.

Minor revisions to existing policies are only permitted after obtaining a current, authorized, editable document from the Director of Research Policy and Compliance. Revisions to any other documents are not accepted. The Director of Research Policy and Compliance is responsible for editorial content, formatting, and versioning.

Once the Policy Sponsor and the Director of Research Policy and Compliance approve the minor revisions, the Director of Research Policy and Compliance posts the revised policy.

New or Revised SOPs

Policies typically have associated Standard Operating Procedures (SOPs) to facilitate compliance with and accomplish the goals of the policy.

The Policy Sponsor creates and revises the SOP. Newly created SOPs should use the template to ensure consistency. Revisions to existing procedures are only permitted after obtaining a current, authorized, editable document from the Director of Research Policy and Compliance. Revisions to any other documents are not accepted. Director of Research Policy and Compliance is responsible for editorial content, formatting, and versioning. If an SOP has the potential to have a major, campus-wide impact, or if it directly affects faculty, the Responsible Official, may choose, at their discretion, to discuss it with relevant University officers or a senior-level committee (or assign this task to a designee) before providing final approval. Approval of such new or revised SOPs follows the process as detailed in the Policy Review and Approval section above.

Once the Responsible Official and the Director of Research Policy and Compliance approve the new or revised SOP, the Director of Research Policy and Compliance posts the revised policy. The Policy Sponsor, or their designee, drafts an appropriate communication to the university community about the SOP, determines whether any training is required, and coordinates the provision of any required training. The Director of Research Policy and Compliance ensures that the communication is distributed to affected parties.

Roles and Responsibilities