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Protocol Development
The starting point for a good study is developing a good research question and an appropriate study design. Thereafter it is important to write a good protocol or plan to follow. A research protocol is the detailed plan of the study and should be written as the process of writing it up will:
- Force the researcher to clarify their thoughts and to think about all aspects of the study;
- Provide a necessary guide for the research team and ensure that implementation procedures are formalised and standardised;
- Provide documentation for submission to the local human research ethics committee (also known as the Institutional Review Board [IRB]). Approval from the committee/ IRB is required for any study that involves research with human subjects or that involves experimental animals;
- Provide documentation used in the submission for funding.
A well-thought out and well-written protocol can be judged according to these main criteria.
- Is the study design appropriate and can the design adequately answer the research question(s), and achieve the study objective?
- Does the protocol describe ethical research as outlined by Good Clinical Practice and international standards (Nuremberg Code, Belmont Report)?
- Is the protocol feasible in the particular set-up for the study?
- Does the protocol provide sufficient detail to allow another investigator to replicate the study and arrive at comparable conclusions?
The protocol should outline the rationale for the study, its objective, the methodology used and how the data will be managed and analysed. It should highlight ethical considerations, and, where appropriate, how gender issues have been addressed.
WHO research protocol
The World Health Organisation has a 27-member Research Ethics Review Committee and has provided a recommended format for a ‘research protocol’ with the following headings:
Research protocol – Part 1
Project title
- Descriptive and concise.
Project summary
- Descriptive, concise and be able to stand on its own.
General information:
- Protocol title, protocol identifying number (if any), and date.
- Name and address of the sponsor/funder.
- Name and title of the investigator(s) who is (are) responsible for conducting the research, and the address and telephone number(s) of the research site(s), including responsibilities of each.
- Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s) and/or institutions involved in the research
Project description
Rationale & background information – Provides context for the project ie. why the research needs to be done and what will be its relevance.
- References (of literature cited in preceding sections)
- Study goals and objective
Methodology
The methodology section has to be thought out carefully and written in full detail. It is the most important part of the protocol.
The choice of study design should be explained in relation to the objectives of the study.
Depending on the type of the study, the following questions should be answered: – What are the criteria for inclusion or selection? – What are the criteria for exclusion? – In intervention studies, how will subjects be allocated to index and comparison groups? – What are the criteria for discontinuation?
Interventions:
If an intervention is introduced, a description must be given of the drugs or devices to be used, and whether they are already commercially available, or in phases of experimentation.
Observations:
Information should be provided on the observations to be made, how they will be made, and how frequently they will be made. If the observation is made in a questionnaire, this should be appended to the protocol.
- Sample size:
The protocol should provide information and justification about sample size. 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.
Safety considerations:
The safety of research participants is foremost. Safety aspects of the research should always be kept in mind and information provided in the protocol on how the safety of research participants will be ensured.
Follow-up:
The research protocol must give a clear indication of what follow up will be provided to the research participants and for how long. This may include a follow up, especially for adverse events, even after data collection for the research study is completed.
Data management and statistical analysis:
The protocol should provide information on how the data will be managed, including data handling and coding for computer analysis, monitoring and verification.
Quality assurance:
Quality control and the quality assurance system for the conduct of the study.
Expected outcomes of the study
The protocol should indicate how the study will contribute to advancement of knowledge, how the results will be utilized, not only in publications but also how they will likely affect health care, health systems, or health policies.
Dissemination of results and publication policy:
Scientific media, community, participants and dissemination to policy makers where relevant.
Duration of the project:
Specify the time that each phase of the project is likely to take; month by month breakdown for each activity to be undertaken.
Problems anticipated:
Anticipated challenges and possible solutions to deal with these difficulties
Project management
Roles and responsibilities of each member of the team.
Ethics
The protocol should have a description of ethical considerations relating to the study and should document the issues that are likely to raise ethical concerns.
It should also describe how the investigator(s) plan to obtain informed consent from the research participants (the informed consent process).
Informed consent forms:
The approved version of the protocol must have copies of informed consent forms (ICF), both in English and the local language in which they are going to be administered.
Research protocol: part 2
Budget
The budget section should contain a detailed item-wise breakdown of the funds requested for, along with a justification for each item.
Other support for the project
This section should provide information about the funding received or anticipated for this project from other funding organizations.
Collaboration with other scientists or research institutions
Links to other projects
Curriculum Vitae of investigators
The CV of the Principal investigator and each co-investigator should be provided. In general, each CV should not be more than one page, unless a complete CV is specifically requested for.
Other research activities of the investigators
The principal investigator should list all current research projects that he/she is involved in, the source of funding of those projects, the duration of those projects and the percentage of time spent on each.
Financing and insurance
Financing and insurance if not addressed in a separate agreement, and where relevant should be described.
Other things to consider:
- Submissions to human research ethics committees cost money and ongoing communications, including amendments, deviations, and annual approvals, can carry additional costs. This cost needs to be considered and budgeted for.
- When submitting your protocol, take note of your ethics committee’s guidelines on whether a protocol like yours will require a full committee review of if the review can be expedited. Full reviews can take longer and may need to be submitted on a particular date.
- At times, additional forms may be required, especially in the case where minors are involved, which are specific to your country or your ethics committee specific – familiarise yourself with the guidelines and requirements before submitting.
- Importantly, ethics committee review can take time (from weeks to months) and no work can be done prior to approval. The process can be further delayed if the committee has questions that require your response. The time for protocol development and review should be taken into account while planning your research and early submission is preferable in order to minimise the potential impact on implementation timelines.
BY YOLISWA NTSEPE (MA, PhD)
ADOLESCENT PROGRAMMES MANAGER
UPDATED NOV 22, 2023
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