Guideline for Preparing a Research Protocol - Surveys

TITLE PAGE
Include the protocol title, product name, IND number (if applicable), author/sponsor/monitor names,
investigator name/site, any external IRB name/address, may also include signatures of investigator/sponsor
representative.

Full name, title, department, box number, telephone number, FAX number, email address, beeper ID
number.

TABLE OF CONTENTS- Optional

FOOTER
Include a version date and page numbers.

INTRODUCTION/BACKGROUND MATERIAL/PRELIMINARY STUDIES AND SIGNIFICANCE

Describe and provide the results of previous research work by yourself or others, including pilot studies,
previously published research on the topic, and any pre-clinical and/or clinical studies. Include information
as to why you are conducting the study and how the study differs from what has been previously
researched.

0BJECTIVE(S)/SPECIFIC AIMS AND HYPOTHESES

A concise statement of the goal(s) of the current study. Include, specific objectives of the study. The goals
and the hypothesis to be tested should be stated.

DESIGN
This section should contain a detailed description of all procedures to be performed for this study. Include
information as to whether or not the survey will be anonymous and how the survey will be distributed. If the
survey will be completed more than once, provide information on the number of times the survey will be
completed.

Sample Language: We have designed an anonymous survey which will be distributed at

SUBJECT SELECTION ELIGIBILITY CRITERIA

Describe the characteristics of the subject population, including their anticipated number, age, ranges, sex,
ethnic background, and health status. Identify the criteria for inclusion or exclusion of any subpopulation.

Explain the rationale for the involvement of special classes of subjects, such as fetuses, pregnant women,
children, prisoners or other institutionalized individuals, or others who are likely to be vulnerable.
Similarly, detail exclusionary criteria: age limits, special populations (minors, pregnant women, decisionally
impaired), use of concomitant medications, subjects with other diseases, severity of illness, etc.

RECRUITMENT PROCEDURES
Recruitment methods (e.g. advertisements) should be detailed. A copy of any advertisements (flyers, radio
scripts, etc.) should be submitted along with the protocol. If monetary compensation is to be offered, the ICF
should include the amount the subject is to receive.

INFORMED CONSENT
Detail instructions for obtaining legally valid written informed consent from each prospective study
patient/subject.

Detail the procedures maintaining informed consent. Describe the consent procedures to be followed.
Include the circumstances under which consent will be sought and obtained, who will seek it, the nature of
the information to be provided to prospective subjects, and the method of documenting consent.

Generally, in studies where only an anonymous survey is used (survey will not contain any protected
health information such as name, DOB, MR#, etc.), documentation of informed consent can be waived.
Version: Page 1 of 3
Investigators can request a waiver of documented consent (section B on the Application for a Waiver of
informed consent and HIPAA authorization form), as by filling out a survey someone is agreeing to
participate in a research study

Sample Language: Our research is based on completion of a survey. Subjects will be given a cover letter
with the survey to explain their participation in the research study. By completing the survey, it is implied
that a person agrees to participate in the study. Thus, since this research presents no more than minimal
risk of harm to subjects and it does not involve procedures, for which consent is generally obtained outside
the research context, we are requesting a waiver of consent documentation.

DISCOMFORTS AND RISKS

Describe any potential risks and discomforts to the subject (physical, psychological, social, legal, or other).
Discuss why the risks to subjects are reasonable in relation to the anticipated benefits and in relation to the
importance of the knowledge that may reasonably be expected to result.

Describe the procedures for protecting against or minimizing any potential risks, including risks to
confidentiality, and assess their likely effectiveness. Also, where appropriate, describe the provisions for
monitoring the data collected to ensure the safety of subjects.

SAMPLE LANGUAGE: The risks of participating in this study are minimal. There is a risk of loss of
confidentiliaty, [IF THE SURVEY IS ANONYMOUS ADD]: However, we are trying to eliminate this risk by
making the survey anonymous.

POTENTIAL BENEFITS
Survey studies usually have no benefit to the research subject. However, the benefits to society, of the
knowledge gained from this research, should be described in this section.

DISCONTINUATION OF STUDY/SUBJECT WITHDRAWAL

A description of conditions under which subjects may withdraw from and/or be withdrawn from the study
and procedure for their replacement (if applicable).

A statement that the study may be discontinued at any time. Also discuss reasons for withdrawing any
participant from the study (incomplete survey, etc.)

SAMPLE LANGUAGE: The study participants are free to withdraw from the study at any time by
discontinuing completion of the survey. Their choice to withdraw will not affect their employment/health
care benefits (CHOOSE WHICHEVER IS APPLICABLE) in any way.

CRITERIA FOR EVALUATING RESPONSE/STATISTICAL ANALYSIS

Data analysis will most likely by qualitative. Indicate methods used to analyze the data: Include the kinds of
data you expect to obtain and the means by which you will analyze or interpret the data to attain your
objectives.

A statement of the types of data to be analyzed and, to the extent possible, the statistical methods to be
employed. Indicate sampling and statistical plan.

DATA SAFETY MONITORING

Discuss who will monitor data and safety, with emphasis on data integrity and patient safety concerns
including: review of adverse events, recommendations concerning continuation or conclusion of the study,
protection of the confidentiality of the trial data and the results of monitoring, review of data and study
quality. Monitoring activities should be appropriate to the study, study phase, population, research
environment, and degree of risk involved

CONFIDENTIALITY
Describe/Indicate:
Methods for preserving subject confidentiality.
How data will be kept confidential,
Whether research documents will be coded,

Version Date: Page 2 of 3

 Whether research documents will be stored in hard copy (and how will they be protected),
Whether research data will be maintained electronically (and how will they be protected),
What types of protected health information (PHI) may be used for purposes of the research.

DATA DISCLOSURE/PUBLICATION
A statement of Company policy regarding publication and of other disclosure of the data collected during the
study. Indicate what protected health information (PHI) will be shared with entities outside of NSLIJ health
system for purposes of the research. List all outside entities to whom PHI may be disclosed.

CONFLICT OF INTEREST
The investigators are responsible for stating whether or not they have conflicts of interest with respect to the
research study. All conflicts should be disclosed to the IRB and sponsor.

REFERENCES/BIBIOGRAPHY
Provide a reasonable list of references directly related to the study. Any diagrams for new medical devices
or brief reprints from journals might also prove useful.

APPENDICES- Include if applicable

Tables, figures, description of special procedures, etc. (optional)

Version Date: Page 3 of 3