RESEARCH PROTOCOL

The research protocol is the plan for the researcher’s project, or what they will accomplish when they start the study with their research team. It describes the reasoning behind and the process of the research project, including what the researcher hopes to accomplish and how they will accomplish it.

In drafting a research protocol, the researcher must answer a few questions:

1. What: What is the research question? What methods will be used to answer the research question?

2. Where: Where will the research project take place?

3. When: When, or over what period of time, will the research project take place?

4. Why: Why is this research project/study being conducted?

5. How: How will the research question be answered? How will the research project be conducted?

Elements of a Research Protocol

1. Project title and date

2. Personal information: of the primary investigator and their co-investigators

3. Background and rationale: The background and rationale are equivalent to the introduction in a research report.

 The background describes the studies, results and references that are relevant to the design and conduct of the study.

 The rationale specifies the reasons for conducting the research project.

4. Research Objectives and Hypothesis: This section states the precise objectives of the study in the form of a hypothesis. The rest of the protocol should be designed to answer the hypothesis posed here.

5. Study design: The study design describes the type of study proposed (observational, RCT, etc.). It also describes the sequence of the study. It includes information on the type of study, the research population or the sampling frame, who can take part, and the expected duration of the study.

6. Methodology: The methodology section is the most important part of the protocol. It should include detailed information on the procedures to be used, measurements to be taken, observations to be made, etc.

7. Safety Considerations: Safety aspects of the research should always be kept in mind and information must be provided on how the safety of research participants will be ensured.

8. Follow-up (applies to RCTs)

9. Data Management and statistical analysis: The statistical methods proposed to be used for the analysis of data should be clearly outlined. For qualitative data, specify in sufficient detail how the data will be analyzed.

10. Expected outcomes of the study

11. Quality assurance and ethical considerations

Protocol vs. Proposal

A research proposal describes an idea for a project. It focuses on the research question the researcher hopes to answer. A research proposal tells how a researcher might attempt to answer the question, and how they will obtain the data they need. It may also include a focused literary search, and might include the results of a pilot project.

A research protocol is the next stage, representing a detailed road map showing how the researcher will successfully complete the project. It answers more questions than the research proposal, like the duration of the project and where it will be conducted. A research protocol also further elaborates on how the research question will be answered, and what methods will be used.

Protocol and ethical approval form Institutional Review Board

Institutional review board:

It’s a group federally mandated to review and monitor research involving humans to ensure protection of their rights and welfare as research participants.

IRB approval is required for all research involving human participants, whether living individuals, data, or specimens.

Mostly include researchers, but also, include community members and persons who are known about ethical and legal issues of research.

The IRB missions

Ensure that the research is ethically acceptable and that the welfare and rights of research participants are protected.

The approval of research protocol by IRB

Each local committee has its federal regulations according to its discipline and the type of research that need the approval, but there are some ethical issues should be determined by IRB when approving the research protocol:

 Participants’ autonomy through their informed consent or their representatives after explaining all things about the expected results of these studies.

 Maximizing the benefits for participants.

 Minimizing the harms and risks.

 Selection of participants is equitable.

 Confidentiality is adequately maintained.