November 11, 2002

Dear Colleagues:

I am writing to remind you of the steps that should be followed when participation of clinical nursing staff is required to conduct a human subjects research project at the Johns Hopkins Hospital (JHH).

Appropriate allocation of nursing resources requires that the JHH Department of Nursing be aware of, and approve, any additional use of these resources. This is not a new policy but, with the extreme shortage of nurses available for clinical care, it is especially important that investigators keep in mind the need for consultation with Nursing.

The Nursing Approval Process allows the Department of Nursing to ensure that an appropriate standard of nursing care is maintained for all patients (including research patients), that the necessary competencies, training, and equipment are in place, and that involved nursing staff have received appropriate communication regarding research activities.

The use of nursing time includes any activity beyond the nursing standard of care for a patient care area. Examples include:

• Collection of patient assessment data (e.g., vital signs, monitoring), including the processes used to collect these data, as well as the frequency with which these data are collected and documented;
  
  
• Performance of patient care interventions, including the procedures and products used as part of these interventions, as well as the evaluation of responses to research procedures;
  
  
• Entering data into an additional medium other than the usual clinical documentation (form, computer entry, verbal report);
  
  
• Transport of patients to alternate or unfamiliar areas;
  
  
• Use of equipment or performance of tasks that are not standard for the patient care area in which the nurse has been trained.

The Department of Nursing is committed to safety in patient care, research, and education. The Nursing Approval Process has been developed to enhance collaboration with investigators. The Nursing Approval process and approval form can be accessed through the JHM IRB Qeb site (http://www.hopkinsmedicine.org/irb/jhmirb/).

This approval includes discussion with the manager at the unit level, approval from the Functional Unit Nursing Director, and the Department of Nursing Nurse Researcher. It is intended for both funded and non-funded projects. Questions regarding this policy should be directed to Robin Newhouse at 4-2805.

Thanks for your help.

Sincerely,

Michael J. Klag, M.D., M.P.H.
Vice Dean for Clinical Investigation