Research Fellows in Human Subjects Research

Several faculty have contacted the JHM IRBs regarding the institutional policy governing participation of research fellows in human subjects research. To make sure that the current policy is applied consistently, Dr. Mike Klag, Vice Dean for Clinical Investigation recently provided the following guidance to the JHM IRBs about this policy:

"The following points should guide IRB deliberations:

Research fellows and clinical research fellows may participate in human subjects research except for physical contact with research subjects. For example, they may administer questionnaires, conduct interviews, obtain consent, and analyze data. They may not have physical contact with subjects. Thus, they cannot, for example, measure blood pressure, perform phlebotomy, insert devices, administer medications--experimental, prescription, or over the counter. Only clinical fellows may have physical contact with research participants."

Dr. Levi Watkins, the Associate Dean for Post-Doctoral Programs, agrees with the above interpretation. As you may know, Dr. Watkins has convened a group to reconsider the policy concerning participation of research fellows in human subjects research. Until the current policy is revised, the above statement will be used by the IRBs.

Nursing Staff and Human Subjects Research

Please remember 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 Web 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.

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