INSTITUTIONAL REVIEW BOARD
Phone: (617) 557-2006
Fax: (617) 973-1102
RESEARCH PROTOCOL GUIDELINES
Instructions: All Human Subjects Research Applications (HSRA) must be accompanied by a research protocol.
Please note dissertation proposals or grants that include the components listed below may be substituted for a
research protocol. We recommend you complete the research protocol first and application second as some of the
questions in the application may be answered by copying and pasting from the research protocol. A research
protocol is meant to detail a study’s methodology in a straightforward fashion; it is not a persuasive document. It is a
document that reflects a detailed set of instructions that outline the procedures for conducting the experiment and
collecting data and can be used as a guide for the rest of the research team. Please be sure to use 12 point font size
or larger, number all pages and include the date the protocol was last revised.
Components of Research Protocol: Typically, a research protocol outlines the rationale for the study, its objective,
the methodology used and how data will be collected, managed and analyzed. All of the following components
should be included in your research protocol.
Project Title and Date:
Enter the title of the protocol. The title should be descriptive and concise; this is the same title as in
the HSRA.
Name of Principal Investigator and Address:
Enter the name of the Suffolk University faculty or staff who will be the principal investigator for the
study. Provide the on campus address to be used.
Site(s):
Enter the location(s) where the study will be conducted.
Introduction:
Provide a concise summary of the protocol and the study purpose. Describe the background,
including human subjects research and references that are relevant to the design and conduct of
the study. If this research involves untested techniques or procedures, please include a description
of the pilot data, theoretical rationale or preliminary work. .
Objectives/Hypothesis:
State the precise objectives of the study in the form of a hypothesis. The protocol should be
designed to answer the research questions posed by the objectives.
Study Design and Methodology:
Provide detailed information on the study design, the use of research subjects, interventions
introduced and observations to be made. This section should include:
 Research Design: Describe the choice of the design (e.g., randomized, cohort, case-control,
etc.). The study design must allow the investigator to answer the research objectives. The
statistical section should clearly outline how the data will be evaluated in relation to each of
these objectives.
 Primary and Secondary Endpoints: The primary endpoints need to be determined before
the study begins. They are used to measure results at the end of a study to see if a given
treatment or procedure is effective. For example, researchers might look at survival or risk of
recurrence as primary endpoints. Secondary Endpoints are additional events of interest, but
which the study is not specifically designed to assess.
 Study Treatment, Interventions or Observations: Describe the treatment, intervention used
or observations to be made in the research study. This section should provide specific
information about the instruments to be used, rationale for selecting a particular instrument,
including the instrument validity and reliability and estimated time required for completing each
instrument in selected subject. The nature of any behavioral intervention should describe
detailed procedures employed in the development and pilot testing of the intervention.
Suffolk University Office of Research and Sponsored Programs
Research Protocol Guidelines, Version 3/1/2012
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INSTITUTIONAL REVIEW BOARD
Phone: (617) 557-2006
Fax: (617) 973-1102
Information should be provided about the observations to be made, how they will be made,
and how frequently they will be made.
 Study Procedures: Outline the study sequence and procedures including recruitment,
screening, enrollment and consent procedures. Give detailed procedures for treatment and/or
randomization procedures, if applicable. If deception is used, describe how subjects will be
deceived and/or debriefed.
Human Subjects Protections:
 Selection and Withdrawal of Subjects: Provide the inclusion criteria that must be met by the
research subject to be able to participate in the study and the exclusion criteria that would
prevent a potential research subject to be in the study. Explain under what conditions a
research subject will be withdrawn from the study. In intervention type studies, include a
description of how subjects will be allocated to groups and measures taken to minimize bias.
State the rationale for research subject selection.
 Risks and Discomforts: Describe any potential risks (physical, psychological, social, legal or
other) and assess their likelihood. Include a description of any anticipated reactions that may
be expected as a consequence of being in the study such as distress or anger. Explain
procedures for protecting against or minimizing such risks or reactions and assess their likely
effectiveness. Where appropriate describe the provisions for monitoring the data collected to
ensure the safety of subjects.
 Benefits: Describe any potential benefits to subjects and/or to society in general that may
reasonably be expected from the research and discuss why the risks are reasonable in
relation to these anticipated benefits.
 Consent Process: Describe in detail the circumstances in which consent will be obtained,
who will seek it, the nature of the information to be provided to prospective subjects, and
method of documenting consent. Every protocol involving children should include a discussion
of how parental permission and assent will be obtained
 Compensation: If applicable, describe what compensation research subjects will receive.
Compensation may be provided for their time and inconvenience, and for their travel and
escort needs while participating in the protocol.
Statistical Analysis:
Provide the evidence to support that the proposed design will allow investigators to achieve the
principal objectives of the study and the analytic plan for each objective. Include sample size,
statistical power or precision associated with the sample size, the length of time required to accrue
an adequate number of subjects to the study, plans for handling incomplete or missing data, level
of significance to be used, criteria for terminating the study and procedures for reporting deviations
from original plan. If applicable, include statistical methods including interim analysis.
Appendices:
Supplemental documents such as flow diagrams or work-up tables may be added to the protocol.
Appendices should include copies of all instruments to be used, letters to potential participants or
their physicians, scripts as well as any other study materials to be seen by the participant.
References:
Provide a list of references numbered according to the order of their appearance in the text and
cited in the text by the number in parenthesis.
Suffolk University Office of Research and Sponsored Programs
Research Protocol Guidelines, Version 3/1/2012
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