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Research Protocol Guidelines

The Research Institutional Review Board (Research IRB) will consider your proposal based on the items listed in this protocol. It is necessary, therefore, for your research protocol to be thorough and clear on all of these points.

1. Basic Protocol Information
The protocol should have:

  • A title
  • Name of principal and collaborating investigators
  • Organizational affiliation of investigators

2. Rationale/Background/Introduction

  • A background of the problem you are studying should be included in this section.
  • A thorough review of relevant literature should be included in this section (literature searches can be facilitated by Mary Free Bed's Office of Medical Education and Mercy Health Saint Mary's library).
  • Describe the relevance of the topic you are studying to current clinical practice.

3. Objective(s)
This section describes precisely what you are trying to evaluate in the research protocol.

  • You may have primary and secondary objectives; however, try and keep the topic you are researching narrow and measurable.

4. Methodology//Design/Plan
Depending on the methodology and design of the study, this section should include:

  • Who will serve as research subjects, including demographics such as age/age range, gender, and patient populations (diagnoses).
  • Sample size – how many participants you will be including.
  • Number of participant visits and length of subject participation.
  • A description of how participants will be recruited (for prospective studies).
  • A description of the randomization process (if applicable).
  • A description of what treatments/procedures will occur, or in the case of retrospective studies, what treatment has occurred for the group being studied.
  • A description of how you will measure your research objective. You may want to consider using a standard tool recognized throughout your discipline, e.g., the FIM instrument. If a standard tool doesn't fit into your research question/objective it is suggested that a data collection tool be developed and submitted with your protocol.
  • A description of the persons involved in the study and their roles. (Example: the physician will see every 2 months for ________ and an occupational therapist will see every week for one hour for evaluation of ______.)

For assistance with research design development, it may be helpful to reference “Institutional Review Board Guidebook, Chapter 4, Consideration of Research Design.”

5. Statistical Analysis
A statistical analysis, including how sample size was determined, confidence levels, and standard statistical applications to be applied to the project should be present.

6. Time
If not specifically mentioned in a proceeding section, an estimation of the time the study will be conducted should be included.

7. Budget
A budget should be included if you are requesting Research IRB funds for this project.

  • Assistance with data analysis, including computer time, is available through the Research IRB. Consult the Office of Medical Education for the current cost of these services.

8. References

  • A complete reference of literature presented throughout the protocol should be included in the reference section.

9. Appendixes
Include in this section a copy of any applicable tools to be used in the study (e.g., standard tests, data collection forms).

  • You may include a copy of the informed consent, if applicable, in this section. Comments and suggestions may be forwarded regarding the informed consent by the Research IRB.

The following is a description of additional information that the Research IRB may need when evaluating your protocol:

1. If the protocol will involve the use of assistants or volunteers who are not hospital staff:

  • List each individual by name, along with the person’s hospital training and education.
  • Note that each individual must comply with the hospital’s regulations involving volunteers with patient contact.

2. If the project involves the use of assistants or volunteers who are hospital staff:

  • You must contact the appropriate hospital department and get their written approval to participate.

3. If the project involves active participation by patients:

  • The research protocol must be accompanied by a letter of cooperation from the attending physician (s). Note that approval of the Research IRB is still required.

4. If the project will be conducted in a clinic, department, or patient area:

  • The research protocol must be accompanied by a letter of cooperation from the department manager or person responsible for the clinical area involved.
  • The department manager is responsible for reviewing the protocol for feasibility and logistics within the current organizational infrastructure (i.e., can this be done and how will it be done). Use of departmental staff, donation in kind, or use of other departmental fiscal resources requires written approval from the departmental vice president.
  • Researchers are strongly encouraged to be fiscally responsible and seek funding for proposed research projects.

5. If any aspect of this research project is to be conducted during regularly scheduled work hours, hospital staff members must also submit a letter of cooperation from their department manager.

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