What Is Research Protocol?

A research protocol is a detailed set of instructions written by scientific researchers that outline the procedures for conducting the experiment and collecting data. Grant applications and ethics board approval require research protocol submission. Any researchers using human subjects must create a research protocol, although these documents are also used by scientists in other fields.

Purpose

• The purpose of a research protocol is to serve as a reference document used by laboratory employees and other research groups. If questions about specific procedures arise, laboratory workers consult the research protocol to determine the appropriate course of action. The document also serves as an information source for grant review boards, who determine whether the project is worth funding. Ethics boards review research protocols to ensure the safety of human and animal subjects used in research.

Initial Considerations

• Before writing a research protocol, an author must consider the main research question and have a clear question and specific hypotheses about the results of the study. She then determines the methods used to answer the question. It is essential that the methodology be clear to readers and provide an answer to the research question. The specific research methods and procedures must be safe and appropriate for both research subjects and laboratory workers.

Protocol Structure

• According to the World Health Organization, a research protocol begins with a project summary that states the main question of interest, the justification for the project and study objectives. The experimental design and methodology are then described in detail. These are followed by a plan for data analysis and publication of results. Research protocols also include a timeline for the study and copies of the informed consent form given to all subjects. These must be approved by ethics boards in human subjects research.

Included Information

• All research protocols include detailed information about the design and methodology of an experiment. Authors of these protocols present descriptions of laboratory techniques, clinical interventions and treatment of research subjects. Safety considerations must be addressed, especially if human subjects are put at minor or moderate risk. Protocols also must include a graphical representation and detailed description of the experimental design. This allows readers to understand the justification for the study and the structure of the experiment.

Misconceptions

• Many scientists think that after a research protocol is submitted it is complete. In fact, research protocols are constantly changing documents. If any change to a study procedure is made, it must be approved by an ethics board if human subjects are used. Scientists amend research protocols to include up-to-date information about procedures and techniques. They also include any revisions to informed consent forms and other documents used during the study. Keeping all records current is essential to appropriate and ethical completion of a research study.