Approval of Research Involving Nursing or Nursing Resources

Approval of Research Involving Nursing or Nursing Resources

This Approval of Research form is to be completed when:

A study will rely on the use of Johns Hopkins Health System (JHHS) nurses to conduct any procedures e.g., blood draws, handing out educational materials, hanging medication, etc.
JHHS nursing staff will be recruited as study participants.

Before submitting the form, please speak to nursing leadership on the unit(s) where your study is active, You will be asked to include their names, then complete Sections I-IV of this online form and upload the eFormA protocol. The JHHS Nurse Scientist will review the protocol and obtain required signatures.

The completed Approval of Research form with required Department of Nursing signatures will be returned to the Principal Investigator (PI); the PI should upload the completed form into the eIRB application, Section 11-8.

* Indicates a required field.

Questions? Contact the Center for Nursing Inquiry at nursinginquiry@jhmi.edu

Nursing Leadership Confirmation:*

Before submitting the Approval of Research form, please speak with nurse managers and nursing leadership on the unit(s) where your study will be active and confirm that they are aware of your study team's request.

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Follow Up with Nursing Leadership

Confirming your request with the director(s) of nursing before submitting your Approval of Research Involving Nursing Resources form will speed up the approval process.

If you are not sure who to speak with about your study, please email nursinginquiry@jhmi.edu.

Nursing Leadership Contacts:*

If you've already spoken with nursing leadership, please enter the name(s) of the nurses you connected with, including the director(s) of nursing.

Section I

STUDY INFORMATION

1. Study Title:*

2. Principal Investigator:*

3. Principal Investigator Contact Information

Telephone:

Email*

Additional Study Contacts

4. Contact 1*

Name and email

5. Contact 2

Name and email

6. Contact 3

Name and email

7. Study Length

Anticipated start and end dates.

Start Date*

End Date*

8. Location:

Site(s) where JHHS nursing staff will be involved:

All Children's Hospital

Bayview Medical Center

Howard County Medical Center

The Johns Hopkins Hospital

Sibley Memorial Hospital

Suburban Hospital

Johns Hopkins Care at Home

Johns Hopkins Health System

Johns Hopkins Ambulatory

Is this a student project?*

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If this is a student project, please enter information about your advisor, institution, and degree.

Advisor's Name

Advisor's Telephone Number

Advisor's Email

Advisors Institution

Degree Pursued

Section II

NURSING AND CLINICAL RESOURCES REQUIRED

In this section, you will need to describe and quantify nurses' time. Please review this section's information before completing Section II.

Utilizing nursing resources should be considered within the context of the nurses’ existing workload. If the required tasks amount to increased burden on the nurses’ typical workflow, the study team might consider employing a study nurse to carry out the protocol requirements. Proper education, orientation, and support for the nurses ensures adherence to the protocol and reduces the risk of protocol events.

Questions to consider:

1. Have you approached the units you intend to have study participants on to ensure feasibility?

2. Have you considered having a clinical nurse as part of your study team to act as a full-member, consultant, champion, or liaison?

3. Does your study team have a collaborative relationship with the staff on the units where the study will occur?

Examples for quantifying nurses’ time (this is not all-inclusive):

Administering medications - 10 minutes minimum
Monitoring vital signs - 5 to 10 minutes
Drawing blood -10 to 15 minutes
Obtaining urine/stool/sputum samples -10 minutes
Hanging blood products -1 hour minimum
Filling out study forms (nurses cannot obtain consent unless part of the study team) - 10 minutes.

*If any protocol requires multiple interventions e.g. drawing blood and monitoring vital signs, please combine the amounts when accounting for the time required by each nurse.

1. Indicate the type(s) of activities (e.g. administering medications, monitoring vital signs, drawing blood, etc.) that nursing staff will be responsible for within research study protocol.

*Be sure to note if the study unit uses nurses or phlebotomy for blood draws

Study Participants

Documentation

Specimen Collection*

Data Analysis

Study Form Completition

Data Collection

Study Recruitment

Other

Please briefly describe the other activities you will be asking nurses to perform.

Please provide a concise description of what nurses will do specifically to support the study.*

e.g. Draw blood three times during the study per subject.

2. In the sections below, please enter information about the role nurses will play in your study and the amount of time it will take to orient them and perform the activities that will support the study.

Please be brief, enter just the total amount of time needed for orientation and participation (e.g. 10 minutes, 1 hour). If needed, you can enter more information in the descriptions for nurse activities and orientations.

Will nurses be study participants?*

Select

How much time will orientation for nurse study participants take?*

How much time will be asked of nurse study participants during the study?*

Will nurses be collecting data/samples for the study?*

Select or enter value

How much time will orientation for nurses collecting data/samples take?

How much time will be needed from each nurse collecting data/samples during the study?

e.g. 10 minutes to hang a mini bag medication, twice per day = 20 minutes per nurse per participant. (see additional examples at the beginning of section 2):

Will nurses be asked to do other, additional, activities?*

These activities should be described in the 'other' field above.

Select or enter value

If these activities will require an additional orientation, how much time will the orientation take?

How much time will be needed from each nurse during the study to complete these additional activities?

a. Will there be any equipment involved in this protocol?

e.g. glucometers, vital signs monitors, IV pumps, etc.

Yes

If the answer is yes, please describe the equipment nurses will use.

b. Please describe how the study team will orient the nurses to the protocol. Include in your description:*

how nurses can contact the study team;
where completed consents for participants can be found;
what education on any specialized equipment needed for specimens or medication, etc. will be provided; and
how will needed education be provided? (e.g. present at staff meetings, discuss with nurse manager, make a study binder available, etc.)

3. Type(s) and number of nurses sought:*

4. Department where research will occur:*

e.g. Surgery, Medicine, Oncology

5. Clinical area(s) or unit(s) to be involved:*

6. Type(s) and number of patients sought:*

7. Time(s) of day when nursing resources will be required. Please check all that apply.

All shifts

Day Shift (7a - 3p)

Evening Shift (3p - 11p)

Night Shift (11p-7a)

AM Shift (7a - 7p)

PM Shift (7p - 7a)

Section III

FEEDBACK AND COMPENSATION

1. What are your plans for acknowledging contribution of nursing staff in subsequent publications:

Credit to unit for service

Acknowledgement naming nurse contributors

Opportunity to participate in writing papers

Other

Please briefly describe the other ways you will acknowledge the contribution of nursing staff:

2. Plan(s) for feedback of study results:

Discuss findings at nursing staff meetings on request

Send abstract of completed study to unit(s)

Other

Please briefly describe the other ways you will provide feedback:

3. Compensation for participation:

Grant or stipend to unit

Direct payment or gift

No payment or compensation will be provided

Other

Please briefly describe the other types of compensation you will provide:

Upon study completion, please provide to the Departmental Director of Nursing or CNO/Designee:*

Notification of study closure or ending of required nursing resources
Written summary of the study findings
Summary of nursing resources required (ex. total number of nursing hours needed)
Description of feedback and compensation provided to nursing staff

This summary will be sent on or about (date):

Section IV

PERMISSION FOR RELEASE OF PROPOSAL & REQUIRED SIGNATURES

Check the box below if copies of this proposal may be provided to nurses or students who are learning the research process.

Upload a pdf of the eFormA/study protocol.*

A copy of the protocol must be included in order for the Approval of Research Involving Nursing or Nursing Resources Form to be considered.

Drag and drop files here or

Check here to review form before signing (OPTIONAL):

When this box is checked a copy of the Approval of Research form will be emailed to the PI who can review and sign electronically.

Principal Investigator - Electronic Signature

I certify that the above information is correct. Typing my name below serves as my electronic signature.

Student Advisor - Electronic Signature

I certify that the above information is correct. Typing my name below serves as my electronic signature.

Send me a copy of my responses

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