Emory IRB Biomedical Protocol Outline
For Investigator-Initiated Studies

Notes:

  • For studies involving secondary data analysis only, please use either the “Retrospective Chart Review Protocol Outline” or the “Secondary Analysis Protocol Outline” instead.
  • This document can become your protocol if you have not already developed one. Otherwise, please use this to ensure that all of the applicable points are addressed in your existing protocol document or in a supplemental document.
  • Grant applications normally may not be submitted to the IRB in lieu of a protocol document.
  • If unsure whether IRB review is required for your project, please start by using our website tool at “Does My Project Need IRB Review?”
  1. Title Page:
  • Full study title
  • Short study title
  • Name, Title(s), and Department of Principal Investigator
  • Sponsor(s) (if non-Emory; any Emory sponsorship is internal and does not need to be listed)
  • Protocol version number and version date
  1. External (non-Emory) Collaborators (if applicable):
  • Name, Title(s), Institution, and Department of External Collaborators
    (For each entry, please indicate whether that institution’s IRB will review [or has already reviewed] that individual’s engagement in human subjects research activities)
  1. Precis/Abstract: A brief (usually 400 words or fewer) description of the study objectives, population, design, and outcome measures
  1. Introduction and Background: A summary of the primary hypothesis, purpose, scholarly rationale, and prior literature.
  1. Objectives: The primary and secondary aims and outcome measures.
  1. Study design and methods:
  • The procedures to be performed (distinguish between the procedures performed for diagnostic or treatment purposes and those for research) – include a table of study visits and their procedures, if helpful;
  • Risks/discomforts and potential benefits if any to subjects, patient class, science/society (whether direct or indirect) – these should be listed in order of probability (most common first) with probabilities quantified to the extent possible;
  • What type of information will be collected;
  • What specimens will be collected, if any;
  • Randomization and blinding
  1. If applicable: if data/samples collected for this study will be saved/banked/archived for future use, describe plans, who may use the material, and for what purposes (may require a separate repository-specific IRB submission).
  1. Community Participation: For studies aimed at addressing issues that affect a certain community or group: How, if at all, will this study involve people from the target community in the design of the study? Conduct of the study? How will the results of the research be shared with the participants and/or the target community/ies?
  1. Participant selection:
  2. Requested sample size and expected refusal or withdrawal rate;
  3. Inclusion/exclusion criteria with justification;
  4. Subject recruitment plan;
  5. Screening for eligibility (if any identifiable data will be collected from subjects during screening, then screening consent/authorization is likely necessary);
  6. Procedures when a subject withdraws from a study
  1. Informed Consent Process:
  • How will you obtain consent from participants or their legally authorized representatives? (In person, online, via phone, verbally or through written signature…)
  • Do you need to request a waiver of any of the elements of consent and/or HIPAA authorization (e.g., because you need to withhold some elements of the study design, or you wish to waive signed documentation of informed consent)? If so, which elements, and why?
  • If you are studying a vulnerable group (children, prisoners, pregnant women/fetuses, people with cognitive impairment, students, employees), how will you ensure freedom from coercion or undue influence? Examples: allow for subjects to discuss with others before deciding; conduct consent discussion privately; consent process conducted by someone who does not already have a relationship with the subject; require assent in addition to permission from parent or legal guardian; give legally-authorized representative guidance on how they should act in the best interest of the subject/patient; ensure that compensation or gifts are in line with effort and time required for the study, ensure that there are alternatives if applicable [e.g. other projects if recruiting students in exchange for course credit]…)
  • How will you ensure comprehension of the informed consent information? (Examples: allowing time for questions, verbally summarizing the material with the subject instead of just having them read it, asking subjects to answer a few questions to gauge understanding…)
  • If a person-to-person interaction:
  • Where will the informed consent discussion take place?
  • Who will conduct the discussion and obtain consent?
  • If you are requesting a waiver of signed documentation of informed consent, how will you document consent?
  1. If applicable (e.g. for studies involving scans and/or panels of exploratory testing on specimens): Incidental Findings –
  2. Plan for managing the types of findings that might arise. This should include any secondary findings that are being sought actively, findings that might be anticipatable, and findings that might be un-anticipatable.
  3. Plan for recognizing, analyzing, and handling incidental findings and how incidental findings will be communicated to participants during the consent process. If the plan is not to disclose any findings, then this should be included. This plan might include the option for participants to opt out of receiving incidental findings.
  4. Description of the research team’s responsibilities following disclosure of a finding. This should detail educational information about the nature of the finding, how to seek care from a clinician or specialist, obtaining health insurance to secure treatment, and/or referral to a clinical specialist, if one is required.
  5. (Also include language in the consent form to let the subject know your plans for this – see Modular Language for Informed Consent Forms on IRB website)
  1. Compensation for time and effort:
  • How much? What kind? Reimbursement for expenses/travel?
  1. Statistical analysis: Sample size determination and power; interim monitoring and early stopping; analysis plan; and statistical methods.
  1. Data and Safety Monitoring and Reporting: Description of plan for notifying the IRB of reportable events; whether the sponsor requires reporting above and beyond the Emory IRB reporting requirements, and if so, a description of the requirements and plan for meeting them; plan for periodically reviewing data for safety (if more than minimal risk); site monitoring plan for ensuring accuracy and completeness of documentation. See guidance.
  1. Confidentiality:
  • What are your plans to protect subjects’ privacy during the course of their participation in the study? [SMR1]
  • What are your plans to establish and maintain confidentiality of subjects’ identifiable data[SMR2]?
  • Description of any linkages from study data to identifiers
  • Will you destroy identifiers (includes audio/video files)? If so, at what stage?
  1. References/bibliography

Emory IRB Version 6/8/151

[SMR1]“Privacy” in this case refers to interaction with subjects in a private setting.

[SMR2]This refers to data used to establish eligibility and data used to conduct the study.