Protocol Standard Format – Page 5
INSTITUTIONAL REVIEW BOARD
at
TALLAHASSEE MEMORIAL HEALTHCARE
STANDARD FORMAT FOR PROTOCOLS
for submission with Initial Review Application
In order to avoid the submission of incomplete protocols which may lead to delay in the IRB review and approval process, all new protocols should include the following sections. If some sections do not apply, state “not applicable.” However, all protocols must include a section “Human Subject Protections” (see item (VIII.) below) and a section on how adverse events will be handled and reported (see item (VIII. C.) below).
Study Title:
Sponsor:
Sponsor Contact:
Principal Investigator:
(Contact Information)
Co-Principal Investigator:
(Contact Information)
Study Center(s):
Protocol Number:
Date of Issue:
Date(s) of Amendment(s):
Version Number:
I. Protocol Summary. Provide a description of the objectives, study population, design, and outcome parameters.
II. Introduction: Describe the background, including human subject or animal research and references that are relevant to the design and conduct of the study. Where new techniques or procedures are to be used, a description of preliminary or early work should be provided. If an FDA Investigational New Drug (IND) is to be used, animal data on the drug should be included. If the study is one for which a Clinical Investigator's Brochure (CIB) is provided, one copy of the CIB must be available to the IRB when the protocol is reviewed and one copy must be available to the hospital pharmacy. A summary of the relevant features of the CIB should be included in the protocol.
III. Objectives: State the objectives of the study, whenever possible, as hypotheses.
IV. Study Design and Methods:
· Describe the involvement of human subjects (see section (VIII.), below) including initial evaluation procedures and screening tests, phases, procedures and sequence of the study.
· Separate standard (routine care) and experimental aspects of the study as much as possible.
· Describe alternatives to experimental therapy if they exist.
· Give detailed procedures for treatment, dose adjustments, etc.
o Drugs/Substance/Devices
§ Include the rationale for choosing the drug or substance dose or for choosing the device to be used.
§ Include a summary of preclinical and early human studies for Investigative New Drug (IND)/Device Exemption (IDE).
§ Provide the justification and safety information if Food and Drug Administration (FDA) approved drugs will be administered for non-FDA approved indications or if doses or routes of administration or subject populations are changed.
§ Provide justification and safety information if non-FDA approved drugs without an IND# will be administered.
· Describe the randomization procedure, including justification for blinding or not blinding the trial or for why subjects will not receive standard care or will have therapy stopped or for inclusion of a placebo or non-treatment group, if applicable.
· State the duration and number of study visits required of research subjects.
· Include a definition of treatment failure or subject removal criteria.
· Describe what happens to subjects with therapy when study ends or if a subject’s participation in the study is ended prematurely.
· Address the experience of investigators if procedures are to be performed for which the investigators have not been specifically credentialed.
V. Inclusion and Exclusion Criteria: These must be included in the protocol including how subjects will be identified and recruited. If research involves study of existing samples/records, describe how authorization access samples/records will be obtained.
VI. Monitoring Subjects and Criteria for Withdrawal of Subjects from the Study: Describe the types, frequency and duration of tests, admissions, outpatient visits. Consider specifying a monitor if the study involves a blinded design. Define stop points and criteria for withdrawing subjects from the study.
VII. Analysis of the Study: Statistical plan includes a justification for the sample size. Delineate the precise outcomes (primary and secondary outcome variables) to be measured and analyzed. Describe how these results will be measured and statistically analyzed. Delineate methods used to estimate the required number of subjects. Describe power calculations if the study involves comparisons. Identifies the early stopping rules.
VIII. Human Subject Protections: Protocols without this section will not be accepted for IRB review.
A. Rationale for Subject Selection:
The protocol must include (1.) a rationale for research subject selection based on a review of gender/ethnic/race categories at risk for the disease/condition being studied; (2.) strategies/procedures for recruitment (including advertising, if applicable); and (3.) justification for exclusions, if any. If the protocol involves subject enrollment at multiple sites, describe plans for ensuring appropriate IRB review and approval at each site.
Explain the rationale for the involvement of special classes of subjects, if any, such as fetuses, pregnant women, children, cognitively impaired individuals, prisoners or other institutionalized individuals, or others who are likely to be vulnerable. Reference the appropriate Federal Regulations Subparts (hyperlink to http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm and http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50) as necessary when discussing the research involvement of these subjects. Discuss what, if any, procedures or practices will be used in the protocol to minimize their susceptibility to undue influences and unnecessary risks (physical, psychological, etc.) as research subjects.
B. Evaluation of Benefits and Risks/Discomforts:
Describe the potential benefits to subjects or to others that may reasonably be expected from the research. If volunteers are involved, specify details of compensation for subjects including possible total compensation, proposed bonus, and any proposed reductions or penalties for not completing the protocol, free testing., if applicable.
Describe any potential risks – physical (Medical risks, listing all procedures, their major and minor risks and expected frequency.), psychological, social, legal (breach of confidentiality), or other -- and assess their likelihood and seriousness. Where appropriate, describe alternative treatments and procedures that might be advantageous to the subjects. Describe the procedures for protecting against or minimizing any potential risks, such as violations of confidentiality, and assess their likely effectiveness. Where appropriate, discuss provisions for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects. Describe in detail any study procedure(s) or drug(s) or substance(s) to subjects and identify who will pay for them. Also, where appropriate, describe the provisions for monitoring the data collected to ensure the safety of subjects.
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.
C. Adverse Event Reporting and Data Monitoring:
Provide a plan for reporting adverse events to the IRB (see Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS). (January 15, 2007). Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events. Retrieved May 28, 2007 from http://www.hhs.gov/ohrp/policy/AdvEvnt Guid.htm#Q1). Also, describe the provisions for monitoring the data collected to ensure the safety of subjects.
D. Collection and Storage of Human Specimens or Data:
All IRB-approved research protocols in which researchers intend to collect and store human specimens or data must include a written description of:
· the type samples/specimens/data to be collected,
· the amount collected written in ml/cc and teaspoons/tablespoons,
· the possible side effects of collecting the sample/specimen or data,
· the intended use of the samples;
· how they will be stored;
· how they will be tracked;
· how they will be labeled;
· what will happen to the unused portions of the samples/specimens/data at the completion of the protocol,
· how the subject may request that the specimen be destroyed or returned;
· an explanation if DNA will be obtained from the specimen;
· how will confidentiality be protected;
· if the subject and physician will be provided with information about findings related to testing of the specimen(s)?
· will the specimens be retained for future testing?
· if future testing is done on the specimen, will the information be able to be linked back to the subject;
· will findings from future testing be shared with the subject and his/her physician; and
· what circumstances would prompt the PI to report to the IRB loss or destruction of samples.
E. Consent and Assent Processes and Documents:
Describe the consent procedures to be followed, including the circumstances in which consent will be sought and obtained, who will seek it (e.g., contract staff, Principal Investigator, etc.), the nature of the information to be provided to prospective subjects, and the method of documenting consent.
The proposed consent document must be attached. It should be written in the second person, in language understandable to someone who has not completed high school. The consent must contain the elements required by the appropriate Federal subparts (hyperlink to http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm and http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50).
Children are generally not legally empowered to give consent, but depending on their age, they may have the ability to give assent ("assent" means a child's affirmative agreement to participate in research). Every protocol involving children (those individuals under age 18) should include a discussion of how assent will be obtained for the particular study.
IX. Confidentiality:
Describe the procedures to be used to protect the confidentiality of the data collected and stored for research purposes. If sensitive information (illicit drug use, illegal activity, etc.) will be collected, indicate whether a Certificate of Confidentiality will be obtained. Describe where the information will be stored, for how long, when it will be destroyed, how it will be destroyed and who will have access to it.
X. References: Include selected references which highlight methods, controversies, and study outcomes.
XI. Additional considerations: (e.g., ionizing radiation; collaborative research; IND, other. Discuss contract or study conduct arrangements. State if these considerations do not apply). If a study is being conducted under contract, describe the role of contract staff as well as study staff.
Origin Date 5/28/07