Proposal

Institutional Review Board

Intervention/Interaction Detailed Protocol

CATEGORIES

• Background
• Purpose/Aims
• Design
• Analysis
• Implications to practice

Background and Significance (3-pages maximum)

INSTRUCTIONS

• Summarize relevant literature, data, and historical background
• Describe previous pre-clinical or clinical studies leading up to and supporting the proposed research
• Describe rationale behind the proposed research and significance to patients, society, and/or science

Specific Aims and Objectives (1 paragraph)

INSTRUCTIONS

• Specify objectives and hypotheses to be tested in the research project

General Description of Study Design (1-paragraph)

INSTRUCTIONS

• Explain the basic study design, e.g., parallel group, randomized controlled trial, open-label single arm study, cross over, adaptive, etc.
• Provide study schema as applicable (a schema is required for greater than minimal risk studies, and optional for minimal risk studies

Subject Enrollment (1-page maximum)

INSTRUCTIONS

• Describe any pre-screening procedures as applicable. Indicate whether subjects will be prescreened over the phone and/or will be asked to provide separate informed consent specific to screening procedures.

• Describe in a step-by-step procedure the consent process including:
  • When and where informed consent will be obtained (including description of any electronic consenting procedures)
  • A separate description for adults and children if applicable
  • The process for obtaining consent from non-English speakers if applicable
  • The process to determine capacity to consent and use surrogate decision makers if applicable
  • Procedures to minimize undue influence to enroll, particularly if recruiting the investigators’ own patients
• Describe post-consent intervention assignment and randomization method if applicable

Study Procedures (3-page maximum)

INSTRUCTIONS

Provide detailed description of all study visits, procedures, and data collections, including:

• Description of each study visit and procedures at each visit (include a schedule/table of study procedures)
• Description of specific data variables to be collected, including data collection methods, assessments, data collection sheets, and/or schedule of assessments (A schedule/table of study assessments is preferred)
• Description of planned genetic research as applicable (e.g., specific description of whole genome sequencing, creation of immortalized cell lines or induced pluripotent stems cells, and sharing of genetic material with collaborators and central repositories as applicable, etc.) 
• Definition of primary and secondary outcomes/endpoints. Note that outcome measures should be quantifiable and measurable.
• Local site restrictions or site-specific procedures as applicable, including:
  • Description of how study procedures (e.g. intervention or diagnosis) compare to standard of care, including description of alternative treatments, procedures, or methods of diagnosis
  • Remuneration as applicable. Indicate if payments to subjects are made upon completion of study visits/certain procedures and how remuneration is pro-rated, particularly for non-completers

Risks and Discomforts (1 paragraph)

INSTRUCTIONS

Provide detailed description of potential risks of each study-related procedure/intervention, including:

• Psychosocial risks
• Privacy/confidentiality risks
• Genetic research risks
• Radiation risks
• Include description of steps taken to decrease relevant risks, including the following:
  • How procedures used are consistent with sound research design and do not expose unnecessary risks
  • When appropriate, researchers use procedures already being performed on subjects for diagnostic or treatment purposes

Benefits (1 paragraph)

INSTRUCTIONS

Provide detailed description of potential benefits of study participation, including:

• Either describe potential benefits to participating individuals or clearly state that there is no direct benefit to individuals
• If multiple subject populations are to be enrolled, describe any differences between groups with regard to potential benefit (e.g. potential for benefit to an affected subject population versus no potential benefit for healthy controls, etc.)
• Potential benefits to society (e.g., increased understanding of disease process, etc.)

Statistical Analysis (1 paragraph)

INSTRUCTIONS

Describe plans for statistical analysis, including:

• Statistical methods/data analysis plan
• Power analysis (e.g., sample size, evaluable subjects, etc.)

Monitoring and Quality Assurance (1 paragraph)

INSTRUCTIONS

Describe the plans that will be followed by study staff for monitoring and quality assurance, including:

• Adverse event criteria and reporting procedures
• Outcomes monitoring, including planned frequency of review.
• Study stopping rules as applicable
• Internal monitoring of source data, protocol adherence, and recordkeeping, including which staff will be responsible and planned frequency of review
• Independent monitoring of source data as applicable

Privacy and Confidentiality  

INSTRUCTIONS

• Select the Privacy and Confidentiality measures that apply to this research by checking the box next to each statement (Check all that apply)
• Note that not all of the measures outlined below may apply to your study
• Do not delete statements that do not apply to your study; leave the boxes unchecked
• Describe any additional privacy and/or confidentiality measures that are not captured by the check box items in free text following the check boxes