Writing a Research Protocol

What is a Research Protocol?

A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical evaluation of the data, and organization of a clinical research project.

A well-written protocol will facilitate the process of obtaining institutional and ethical approval for your research and increase your chances of obtaining funding for your project.

A Good Research Protocol

- Forces the investigators to clarify their thoughts and to think about all aspects of the study, conduct, analysis of the data.

- Forms guidelines for a team working on research – help ensure study is performed similarly by different people over time

- is essential if study involves research on human subjects or on experimental animals, in order to get institution institution’s ethical approval

- is an essential component of a research proposal submitted for funding

- is used to start writing a manuscript when study completed

Developing a Research Protocol

Start with a good question - one for which the answer matters either to other researchers in the field, practicing clinicians, or patients

Convert the question to a hypothesis by asserting a position

Construct the protocol

Generate measures of exposure (treatments) and outcome

Test the hypothesis by making a comparison in two or more groups

Develop a plan for data collection and management

Determine the statistical methods for analysis, consult with statistician

Estimate the magnitude of expected difference between the two groups, as a basis for determining sample size (power calculation)

Assess feasibility of the study:

Can enough people be obtained for the study?

Can the outcome events be observed and suitably analyzed?

Research Protocol Format

Project title

Project summary

Project description

Rationale

Objectives

Subjects to study: Inclusion/ Exclusion criteria

Methodology

Data management and analysis

Sample size needed for the study

Ethical considerations

Risks and Benefits of the study

Recruitment plans, Compensation (if any)

Informed Consent, Approvals (DRB and IEC)

References

I] Project Title

Should be descriptive of the study, but concise

Clear, non-ambiguous

Arouse interest

Keep it short and Simple and Sweet

II] Project Summary

Why is the project necessary?

What do you aim to do?

What methods will you use for carrying out the project?

What will be the project outputs?

What is the projected impact of the project?

(An approximate word count: 500 words)

III] Project Rationale (Research Question)

Sets the stage for why the research project should be done. Cite appropriate references.

The condition to be studied

Treatments currently available, note gaps present

Specific treatment to be studied

Preliminary data for treatment in the condition to be studied

Purpose of the study

Discuss the anticipated results and potential pitfalls.

Describe the significance of the research including potential benefit for individual subjects or society at large.

IV] Research Objectives (Aims)

The purpose of the study (research questions and / or study objectives) should be clearly and precisely stated.

Objectives should be simple, specific, and stated in advance of performing the research.

In experimental designs, objectives will be stated as hypotheses to be tested.

Be short but complete and Be specific.

Objectives should be attainable, measurable and realistic

V] Procedures

A. Research Design

The research design should be identified and should be appropriate to answer the research question(s) under study.

Describe the type of research proposed (e.g. experimental, correlational, survey, qualitative) and specific study design that will be used (e.g. pre-test /post / test control group design, cross-sectional design; prospective longitudinal cohort design; phase III double-blind randomized control group design).

The research design, methods and procedures should help answer your research question(s) as written in your study objectives and aims

B. Sample/ Subjects/ Participants

Describe the sampling approach. For experimental designs, include justification for sample size determination.

Identify the procedures that will be used to recruit, screen, and follow study volunteers.

Specifically define the study sample (number of subjects to be enrolled, characteristics of subjects to be included in and excluded from the research).

In intervention studies, how will subjects be allocated to the treatment and comparison groups?

What are the criteria for discontinuation?

C. Measurement/ Instrumentation/ Intervention

Identify the variables of interest and study endpoints (where applicable).

Justify measurement techniques selected.

Provide validity and reliability data for selected measures.

If an intervention is performed, a description is given of the drugs available, or devices to be used, and whether they are already commercially available, or are in phases of development

D. Detailed study procedures

Methods for study data collection and for avoiding / minimizing subject risks should be included.

Include a timeline for subject evaluations and the duration of subject participation in the project.

Identify the plans the proposed safeguards for subject confidentiality (plans for coding data and for securing written and electronic subject records).

Indicate how long personal information will be stored once the study is completed.

Methods will vary with the research approach used (qualitative, quantitative).

The selected methods should be sufficiently described to justify the use of the approach for answering the defined research question.

Methods should also be described in adequate detail so that IEC members may assess the potential study risks and benefits.

Observations

What observations will be made, how they will be made, and how frequently will they be made.

Make a pilot study where required.

E. Internal Validity

Threats to internal / external validity should be considered.

Identify confounders.

Describe measures that have been taken to avoid study bias.

F. Data Analysis

Specify the analytic techniques the researcher will use to answer the study questions.

Indicate the statistical procedures (e.g. specific descriptive or inferential tests) that will be used and why the procedures are appropriate.

For qualitative data, specify the proposed analytic approaches.

VI] Sample Size

The protocol should provide information and justification on the sample size – the number of patients needed to be studied

A larger sample size than needed to test the research hypothesis Increases the cost and duration of the study and will be unethical if it exposes human subjects to any potential unnecessary risk without additional benefit

A smaller sample size than needed can also be unethical if it exposes human subjects to risk with no benefit to scientific knowledge

Calculation of sample size has been made easy by computer software programs. The principles underlying the estimation of the software sample size should be well understood

VII] Ethical considerations

Risks, Benefits of the study

Recruitment plans

Compensation for subjects in study

Informed Consent and procedure, IEC Approval

Conflict of Interest

Privacy

VIII] GCP Guidelines: https://gcp.nihtraining.com/

IX] Universal Guidelines:

CONSORT - CONsolidated Standards Of Reporting Trials

STROBE - STrengthening the Reporting of OBservational studies in Epidemiology.

X] Others:

Logistics – List of equipment/ tools required

Time Schedule – Gantt Chart

Action Plan – Procedural actions with durations

Budget – Self funded/ Sponsored

XI] Bibliography

Include a reference list of literature cited to support the protocol statement.

Vancouver Format/ APA format

XII] Registration

CTRI – Clinical Trials Registry of India

http://ctri.nic.in/

XIII] Forever Avoid Scientific Misconduct

Gift Authorship

Redundant Publication

Plagiarism

Fabrication

Falsification

References:

1. Fathalla MF. A Practical Guide for Health Researchers. WHO Regional Publications Eastern Mediterranean Series 30

2. Research Protocol. THE OHIO STATE UNIVERSITY Institutional Review Board

3. Parkman H. Writing a Research Protocol. WHO | Recommended format for a Research Protocol. http://www.who.int/rpc/research_ethics/format_rp/en/ [Viewed on Dec 14, 2015]

4. Guidelines on Writing a Research Protocol. Faculty of Health Sciences. University of Pretoria