1. Purpose
To describe the policies and procedures for developing, reviewing, revising, and distributing standard operating procedures (SOPs) for the Institutional Review Board (IRB) and Office of Human Research Protections (OHRP) at West Virginia University (WVU).
2. Overview
This SOP applies to all policies and procedures reviewed by VPR (Institutional Official or IO), WVU OHRP Director, WVU OHRP Assistant Director (OAD), WVU OHRP Continuous Improvement Manager (CIM), WVU OHRP staff, and approved by WVU IRB Leadership, the Vice President for Research (VPR), and any WVU administrative offices to which the SOP applies.
3. Procedures
Procedure for Writing New Standard Operating Procedures
3.1. The WVU OHRP Director, with advice from IO, OAD, CIM, WVU OHRP staff,
IRB Chairs, IRB Vice Chairs, IRB members, and/or PIs (as applicable), determines
when a new SOP needs to be established. Designated OHRP staff are responsible for
writing SOPs.
3.2. Any OHRP Staff member may draft an SOP based on his or her specialization.
All SOPs should comply with federal, state, and institutional regulations.
3.3. As appropriate, the WVU OHRP staff distribute copies of newly drafted
SOPs to designated IRB Chairs, IRB Vice Chairs, IRB members, and/or OHRP staff
members for review.
3.4. If the SOP involves coordination with another WVU administrative
office, the WVU OHRP Director or WVU OHRP staff cooperate with the administrative
unit involved in drafting the SOP and route the SOP to the appropriate individual
representing that office for approval.
3.5. The WVU OHRP staff ensure each SOP designates the most recent revision
date, which serves as the currently effective date for the SOP.
3.6. Each SOP contains a version number, which indicates how many times
since its origination, WVU OHRP staff have revised an SOP.
3.7. The IRB Chair(s), WVU’s VPR, and any appropriate coordinating officials
(when necessary) review the new or revised SOP. The SOP approval documentation
is used to track new and revised SOP approvals. The SOP approval documentation
will denote which SOP(s) were reviewed and approved, along with the original version
number. The date that the VPR (IO) reviews and approves the SOP(s) should match
the currently effective date of an SOP.
Dissemination of Standard Operating Procedures
3.8. The OAD or designee monitors the SOPs and disseminates new SOPs to
all WVU OHRP staff members and to the IRB Chairs, Vice Chairs, or members if the
SOP involves their activities.
3.9. WVU OHRP staff and/or IRB Chairs or designees are responsible for
reviewing the new SOP, documenting their review, and returning it to the OAD within
a reasonable amount of time.
3.10. The WVU OHRP maintains the most recent versions of all approved
SOPs on the WVU OHRP website.
3.11. According to SOP 003 (Investigator and Key Personnel Responsibilities,
Qualifications, and Training), PIs are responsible for reviewing and complying
with ethical codes, IRB guidance documents, and WVU OHRP/IRB SOPs relevant to them,
to professional practice, and to other applicable regulatory requirements (e.g.,
45 CFR 46.114 – Cooperative Research Provision).
Revisions to Standard Operating Procedures
3.12. The WVU OHRP Director, with advice from VPR (IO), OAD, CIM, WVU
OHRP staff, IRB Chairs, Vice Chairs, and/or IRB members, determines when to revise
an existing SOP. In most cases, the OAD revises the SOP. The OAD may make minor
administrative corrections without revising an SOP (e.g., typographical, formatting,
or grammatical error). Any WVU OHRP staff member may draft revisions to an SOP
based on his or her specialization. All SOP revisions should comply w ith federal,
state, and institutional regulations.
3.13. In revising SOPs, WVU OHRP staff may consult with IRB Chairs and/or
IRB members on IRB-related issues.
3.14. As appropriate, the OAD or designee circulates copies of newly revised
SOPs to IRB Chairs, IRB members, and/or WVU OHRP staff for review.
3.15. If the revised SOP involves coordination with another WVU administrative
office, the OAD or designee routes the SOP to the appropriate individual representing
that office for review and approval.
3.16. The revised SOP is effective when the SOP documentation is approved
by the WVU VPR (in coordination with IRB Chairs and any other coordinating officials
[as necessary] on the date indicated).
3.17. The CIM or designee places an updated copy of a revised SOP in the
WVU OHRP Sharepoint secured site where effective SOPs and SOP approval documentation
are stored.
3.18. The CIM or designee informs WVU OHRP staff members of all changes
in the SOPs relevant to their jobs.
3.19. The CIM or designee informs IRB members of all changes in SOPs relevant to their responsibilities and provides this information via virtual or in-person meetings, email, communication, presentations, and/or the OHRP website.
3.20. If an SOP impacts PIs or study personnel, the CIM or designee provides
this information to them through the WVU OHRP website and may disseminate changes
through various educational initiatives (e.g., emails, listserv announcements,
newsletters, presentations, etc.).
Temporary Addendums for Transitional Periods or Emergency Situations
3.21. The WVU OHRP Director or designee has the authority to implement
temporary contingency procedures that may veer from designated SOPs in emergency
situations or during transitional periods.
3.22. The WVU OHRP Director or designee will document temporary contingency
procedures and the period in which they are in effect via an SOP addendum to the
applicable SOP. The addendum will be confirmed in writing (electronic or paper)
by the WVU OHRP Director or designee.
Review of Standard Operating Procedures
3.23. The OAD or designee conducts a periodic review (once every three
years or according to workload/need) of the continuing suitability of the SOPs.
3.24. WVU OHRP staff may review SOPs at any time for accuracy/applicability.
The WVU IRB/OHRP staff obtain information necessary to update procedures through
monitoring of sources including, but not limited to, the US Food and Drug Administration
website and the Department of Health and Human Services.
3.25. If significant or applicable changes to procedures become necessary,
the WVU OHRP Director, OAD, or designee revises the SOP in question as soon as
possible, and the OAD or designee distributes the revisions to the IRB, WVU OHRP
staff, and appropriate individuals representing coordinating administrative offices
in a timely manner following the procedures outlined above. (See the section on
Revisions to Standard Operating Procedures.)
Suspension or Deletion of an SOP
3.26. Upon consulting with IRB Chairs, the WVU OHRP Director or designee
has the authority to suspend or delete an SOP in such circumstances as major policy
deliberation, changes in institutional administration, or reorganization of departments,
offices, or divisions with which the WVU OHRP and IRB have coordinated relationships
or joint procedures.
3.27. When an SOP is suspended or becomes obsolete, the CIM or designee
deletes the SOP, informs appropriate staff and/or IRB members, and ensures that
WVU OHRP staff remove the SOP from the WVU OHRP website and database, and archive
or delete it, as appropriate, and within WVU’s institutional data destruction policies.
Record Keeping
3.28. The CIM or designee maintains copies of all current SOPs on the
WVU OHRP Website and OHRP Sharepoint secured site. (See SOP 039: IRB Records and
Data Information Management.)
4. References
Not applicable.