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

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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 anonymoussurvey is used (survey will not contain any protected health information such as name, DOB, MR#, etc.),documentation of informed consent can be waived.

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,
  • 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)

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