September 2, 2011
Inpatient Nursing Clinical Research Study Requirements
Introduction
A Nursing Summary form (see Attachment A) is required for all inpatient research
studies using bedside nursing resources (excluding Clinical & Translational
Research Center nursing resources) for any reason including, but not limited to,
administering oral or IV medications, obtaining biological samples and laboratory
specimens, identifying research subjects, obtaining or recording clinical data, etc.
The purpose of this form is to:
1. Assist principal investigators (PIs) to plan how to appropriately use nursing
services involved in their research
2. Review protocols to assess potential training needs for staff nurses
participating in the protocol;
3. Determine resource needs and associated costs above and beyond the
standard of care for a nursing unit;
4. Provide a quick, accessible reference for nursing responsibilities on the
protocol.
Planning
PIs are responsible for completing the Nursing Summaries and assuring that
adequate nursing resources are available to conduct the study. Nursing
summaries are completed as part of the eIRB submission process. Please
complete the Nursing Summary form as completely as possible. When
describing the potential side effects or adverse experiences for the nursing staff,
copying the side effects section of the consent form is not sufficient. Tailor this
section specifically to issues affecting nursing care of the research subject.
Some inpatient nursing activities will be associated with additional costs to the
study. Any expected additional costs should be included in the budget for the
study. Such items include:
 Extensive training requirements for nursing staff, i.e., >15 minutes (see
training section below)
 Required services beyond standard nursing care
Please contact Deborah Eldredge, PhD, RN, Director for Quality, Research &
Magnet for questions regarding nursing workflow issues or nursing service costs
beyond the standard of care.
Training
It is the responsibility of the PI to communicate all details regarding protocol
specific nursing activities to involved staff, including providing any required
special training to bedside nursing staff. The PI must determine if all nurses
need to be trained or just a subset of nurses need to be trained (determined by
the likelihood of each RN having contact with patients on the trial). For services
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beyond the time, skill or knowledge (i.e., standard of care) provided by inpatient
nursing staff, the PI is responsible for hiring and training research staff to support
these activities.
Training suggestions to assure smooth study conduct include:
 Nursing study initiation meeting with Nursing Manager and/or Professional
Practice Leader
 Just in time nurse training
 Placing packets of study related materials on the nursing unit
 Performing 5-10 minute bedside and/or shift change training
 Posting research related information on unit bulletin boards
Study Conduct
Subjects may not be enrolled in studies until all issues regarding the details of
the nursing summary, associated costs for nursing activities, and all necessary
nursing staff education are complete in addition to obtaining Institutional Review
Board (IRB) approval. Should patients be enrolled prior to satisfactory
completion of these activities, Dr. Eldredge will notify the OHSU Research
Integrity Office (ORIO). Under these circumstances, IRB approval may be
reconsidered.
All clinical activities conducted by inpatient nursing staff (medications, laboratory
draws, and frequency of vital signs above the standard of care) will require a
physician, nurse practitioner, or PA order. If nursing services are to be charged
to a research account/industrial account, a down-time form must be generated at
the time the bedside nurses begin to provide research-directed patient care.
In addition, it is required that the study Nursing Summary be made available to
bedside nurses as they plan and execute nursing care to support the research for
each subject enrolled in the study by placing an Inpatient Research Nursing
Communication Order containing the Nursing Summary after each subject is
admitted. This can be done by any research staff with Epic inpatient order
access or research access. Instructions for placing an Inpatient Research
Nursing Communication Orders including the study Nursing Summary are
provided in Attachment B.
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Attachment A
Clinical Research Study: Nursing Summary Form
Study Title: Click here to enter text.
Study IRB Number: Click here to enter text.
Principal Investigator: Click here to enter text.
Study Contact Name and Phone Number: Click here to enter text.
24 Hour Emergency Name and Phone Number: Click here to enter text.
1. Describe intervention/drug:
Click here to enter text.
2. Describe expected side effects of the intervention/drug:
Click here to enter text.
3. Describe potential side effects or adverse events for which nursing staff
should monitor patients:
Click here to enter text.
4. Describe any drug incompatibilities:
Click here to enter text.
5. Describe any patient restrictions (diet, activity or position, etc.) related to this
study:
Click here to enter text.
6. Describe any activities bedside nurses must perform (such as medication
administration, frequency of vital signs, specimen collection, laboratory
draws):
Click here to enter text.
7. Describe any nursing documentation requirements (beyond standard clinical
forms, if applicable):
Click here to enter text.
8. Describe any nursing skills, certifications, or special training required:
Click here to enter text.
If questions about study medication, please contact Research Pharmacy
Services at 4-6865, pager # 11932
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Attachment B
Instructions for Placing Inpatient Nursing Research
Communication Orders Containing the Study Nursing Summary
Form
1. Prior to initiating the study, create a smartphrase containing the completed
Study Nursing Summary Form for the study as follows:
 Open the completed Study Nursing Summary Form, preferably from
eIRB study documents
 Highlight the entire form (Ctrl A) and copy it (Ctrl C).
 Open Epic, open the Smartphrase Manager
(Tools/SmartToolEditors/My Smartphrases), click “add”, and paste the
text of the Study Nursing Summary Form into the smartphrase (Ctrl V).
 Name the smartphrase “RNXXXX”, where “XXXX” is the IRB number
for the study.
 Save the smartphrase and share it with any other research staff that
may need to place Inpatient Research Nursing Communication Orders
when subjects are admitted.
2. Directly after each admission of a subject on the study to OHSU, place an
Inpatient Nursing Research Communication Order containing the Study
Nursing Summary form for that study as follows:
 Go into the subject’s record.
 Open an Inpatient Nursing Research Communication Order (for
instructions on placing an inpatient nursing research communication
order please refer to the Epic Instructional Guide).
 In the order, type “.RNXXXX” where “XXXX” is the IRB number for the
study.
 Complete the order.
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