Template for Cyber IRB Initial Protocol Submission

The purpose of this template is to give you a sense of what you will be required to enter into Cyber IRB when submitting an initial IRB protocol. This may be a useful tool for graduate students and other staff to use while drafting IRB protocols, so that PIs may offer feedback on this word document before the information is copied and pasted into Cyber IRB.

Researchers may also find it helpful to save a draft of this document to keep an editable record of what they have submitted through Cyber IRB.

  1. Log in to Cyber IRB:
  2. Click the “initial submission” box on the left side of the screen
  3. You will be prompted to fill in the following boxes below:
  1. Title
  2. Study title
  3. Today’s date
  1. Principal Investigator
  2. You will be asked to list the PI’s name, address, school, department, email, and phone number
  3. Are you: faculty, staff, undergraduate student, graduate student (select one)
  4. Date of IRB training certificate
  5. Buttons for attachments: investigator’s CV and investigator’s training certificates
  6. Question asks if PI is a student. If yes: faculty supervisor name, phone, and email required. If No: department chair or dean name, email, and phone number required
  1. Research Risk
  2. Does the research pose greater than minimal risk to participants? (yes/no)
  3. Does the research include prisoners? (yes/no)
  4. Level of review: please select a level of review and the appropriate category that corresponds to that level of IRB review: (select exempt, expedited, or full board)
  1. General Study Information
  2. Funding: none, university funded, external, federal (select one). Boxes for sponsor award number and BC award number are available, if known.
  3. Is BC the primary awardee for the grant? (yes/no). If no, list primary awardee
  4. Are there subcontracts? (yes/no) If yes, list sub-contractors.
  5. Participant recruitment numbers: (box to list number of males and females)
  6. Participant ages (check all that apply): 0-7, 8-11, 12-17, 18-65, 65+
  7. Estimated project duration: start date and end date
  8. Why is this project being conducted (select one): faculty/staff research, undergraduate coursework, master’s thesis, doctoral dissertation, other
  9. Will this study involve long-term follow-up with participants (yes/no)
  10. Special study populations (check all that apply): minors, pregnant women/fetuses or products of labor and delivery, prisoners, physically or mentally challenged, diminished capacity for consent, other, no special study populations
  11. Does this study involve any of the following? (check all that apply): deception or punishment, use of drugs, covert observation, induction of mental and/or physical stress, procedures which may risk physical/mental harm to the participant, materials/issues commonly regarded as socially unacceptable, information relating to sexual attitudes, sexual orientation, or practices, information relating to the use of alcohol, drugs, or other addictive products, procedures that might be regarded as an invasion of privacy, information pertaining to illegal conduct, genetic information that may be linked to a participant’s health status, information normally recorded in a patient’s medical record, information pertaining to an individual’s psychological wellbeing or mental health, information that if released could reasonably damage an individuals’ financial standing/employability (if any of these are checked, you are asked to provide rationale on how they are integral to the study in a text box)
  1. Research Summary
  2. Introduction and background:
  3. State the problem and hypothesis
  4. Provide the scientific or scholarly reason for this study and background on the topic
  5. Specific aims/study objectives
  6. List the purpose of the study
  7. Materials, methods, and analysis
  8. Describe data collection methods
  9. Describe the specific materials or tools that will be used to collect the data
  10. Describe timeline of the procedures and how long each procedure will last
  11. Describe how you will analyze your data
  12. Research population and recruitment methods
  13. Describe inclusion and exclusion criteria
  14. What is the scientific or scholarly justification for the number, gender, age, or race of the population you intend to recruit?
  15. How did you choose the source of participants or data?
  16. Recruitment procedure; including who will recruit participants, and if applicable, how any conflict of interest/coercion, undue influence will be mitigated
  17. Tools that will be used to recruit (recruitment tools should be uploaded as an attachment)
  18. Research incentives and payments: please specify what form of payment you will be using and how it will be documented
  19. Informed consent procedure
  20. Who will perform the informed consent procedure, and how will that person be trained?
  21. How will the prospective participant’s competence or understanding of the procedures be assessed; will participants be asked questions about the procedures, or encouraged to ask questions?
  22. Please describe the process by which informed consent will be obtained.
  23. Confidentiality:
  24. Where will the data be stored, and who will have access to the data and the area?
  25. How will the data be stored, and in what format?
  26. Will the participants’ identity be coded? Will the codes to identify participants be stored with the data?
  27. HIPAA: Are you using protected health information or working at a HIPAA covered institution? (yes/no)
  28. Statement of potential risks to subjects
  29. Indicate the type of risk that may result from participation
  30. Consider the likelihood and magnitude of the risks or discomforts occurring. Are they unlikely or likely to occur and what effect would the discomforts or risks have on the individual should they occur?
  31. How will you minimize the risks? Some examples include informed consent, adequate staff training and experience, debriefing, and monitoring adverse effects on participants.
  32. Statement of potential research benefits to subjects
  33. Indicate the type of benefit that may result from participation. Consider psychological or emotional benefits, learning benefits, physical benefits and discuss if participant will benefit directly or if the benefit is largely to gather generalizable knowledge that may benefit society.
  34. Consider the likelihood of benefits. Will all or some participants benefit?
  35. Investigator experience: CV of the PI must be attached
  1. Informed Consent
  2. If the project qualifies for exempt review or if informed consent is not applicable, a box can be clicked so that you can skip to section IX.
  3. Are you requesting an alteration or waiver? (yes/no). If yes, a waiver consent box will open. You will need to check whether you are asking for a partial or total waiver of consent, and whether you are asking for a waiver of the documentation of consent. A text box will allow you to describe the elements you are waiving and your rationale.
  4. If you are not requesting an alteration or wavier, you will be asked to attach your consent forms and check that you have included all of the standard elements of consent. Please see our sample forms page to see what should be included in your consent. You will also be asked to ensure that the consent form is written at a reading level appropriate to the population being studied. We provide links to 3 readability tools, and you will need to use one of those to generate a readability comprehension level.
  1. Research with Minors (only fill out this section if you are using minors in your research)
  2. Please provide a scientific or medical rationale for the inclusion of minors
  3. Federal regulations classify research with minors into four categories based on the degree of risk. Please pick the appropriate category for your research (check one):
  4. Research involving minimal risk to minors
  5. Research involving greater than minimal risk to minors with the prospect of direct benefit to the child
  6. Research involving greater than minimal risk with no direct benefit to the minors but it is likely to yield generalizable knowledge about the subject's disorder or condition
  7. Research not meeting the criteria for Categories 1-3 that involves greater than minimal risk to healthy minors and presents no direct benefit to them but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health and welfare.
  1. Research Sites
  2. Are you conducting research at a site? (yes/no)
  3. If yes, do they have an IRB? (yes/no) Will IRB approval be sought from that institution? (yes/no)
  4. Name of site
  5. You will be asked to include a site permission/approval letter
  1. Acknowledgement
  2. You will be asked to read a statement on the definition of scientific misconduct.
  3. You will be asked to read a statement on conflict of interest and check a box (yes/no) stating whether you or a family member derived income within the past year of $5,000 or more in publicly-traded or non-publicly traded entities.
  1. Co-PIs
  2. You will need to list each Co-PI’s name, contact information, school, department, and IRB training date by moving them over from the “available individuals” box to the “assigned co-PI
    box.” To have names available on your protocol, you will first need to add Co-PIs through the “My Contacts” tab. There is a button that will allow you to upload their CITI or NIH training certificates.
  1. Research Assistant
  2. You will need to list each research assistant’s name, contact information, school, department, and IRB training date by moving them over from the “available individuals” box to the “assigned research assistant” box. To have names available on your protocol, you will first need to add Co-PIs through the “My Contacts” tab. There is a button that will allow you to upload their CITI or NIH training certificates.
  1. Signatures
  2. The PI will be asked to electronically sign the protocol.
  3. If a student is the PI, the faculty research supervisor will also need to electronically sign the protocol.
  4. For faculty research, the department chair or dean will need to electronically sign the protocol.