PART I, page 1
Please be advised that STUDENTS and RESIDENTS (including FELLOWS) are not permitted to serve as a Principal Investigator. They may be listed as Co-Investigators only and must complete the Attachment C on pages 13 &14 of the application (or Attachment C if there is more than one).
Personal Information: Complete all requested information, if this is a student-generated research protocol insert the student’s name under that question. As part of the requirement for submission, you must include: A) a copy of your CV, B) current applicable license, and C) Board Certification information for the purpose of verification of credentials if applicable.
PART I, page 2,3
Research Experience: Please answer all questions concerning your research experience.
Conflict of Interest: All Conflict of Interest questions must be answered. If you answer “Yes” to any question you must complete the Significant Financial Disclosure Form (SFID) which is located in the Forms and Templates library on IRBNet. Definitions of what constitutes a Conflict of Interest can be found in the Standard Operating Procedures (SOP) Manual (also located in the IRBNet library).
Research Staff: Please include the names and position of all co-investigators and research staff personnel who will be directly involved with this study. All personnel listed will be required to complete the required training and must also acknowledge any conflicts-of-interest. All listed co-investigators and research staff are required to submit a copy of the Attachment C form located in the IRBNet library. The following items must be included for each research staff member when submitting this application to the MU IRB: (1) an Attachment C form, (2) a copy of their CV/resume, current license and Board Certification (if applicable), and (3) copies of current CITI certificates.
List the external sites where the research will be conducted (e.g. schools, business, and health care facilities). Note: You must obtain written permission from the external sites prior to study approval.
PART II, page 4, 5, 6, 7
Section A
Protocol Description: Answer these questions concerning whether or not the study involves minimal risk.
Section B
Sponsored Studies: If the study is sponsored then complete this section. If it is not applicable then click N/A. Please provide sponsor contact information for billing purposes.
Section C
Study Subjects and Procedures: Enter the minimum and maximum number of anticipated subjects for the study. Also insert the minimum and maximum number of participants that you would allow. Include the minimum and maximum ages of participants. If there is no maximum age then just enter N/A. Be sure to answer each question in this section. If your study only involves records review then you can skip this section and proceed to Section D.
Section D
Recruitment: This section must be completed. State where your study subjects or records will be drawn. If any of the questions are not applicable to your study then put a checkmark in the N/A box. All advertisements must be submitted and approved. Keep in mind that finder’s fees (as described on the application) are not permitted.
Section E
Informed Consent: If your study protocol does not require a Consent Form, please click N/A and proceed to Section F. If your study protocol will be using a consent, please refer to the consent templates in the IRBNet library. If the consent form will be translated into a foreign language then you must provide both the English and Foreign language copies of the consent.
Assent and Parental Permission Forms: If your study protocol will be using children under the age of 18 years old, you must submit an assent and a Parental Permission Form. Please refer to the Informed Consent chapter of the SOP for additional information. Templates are available in the IRBNet library.
Section F
Confidentiality: Please provide the information related to confidentiality. Remember that this information pertains to how you will protect the data of the participants.
Section G
Privacy: You must describe the provisions to protect the privacy interests of participants. Remember that this information pertains to how you will protect the privacy of the subject (i.e. interview/survey participant in private).
Section H
Monetary Reimbursement: Each question in this section must be answered. If there are no subject charges the checkmark the N/A box and skip to the next section.
Abstract: Please provide a brief abstract of your proposed research in 1-2 pages maximum. It must be written in lay terms since an IRB member (i.e. Community Representative) may not have a background in your particular scientific field. The outline format for the abstract should be written as follows: (1) The Purpose of the Research (Objectives), (2) The Scientific or Scholarly Rationale (Research Plan), (3) Procedures to be Performed (Methods), (4) A Description of What Procedures Were Being Performed Already for Diagnostic or Treatment Purposes (if any), (5) Risks and Potential Benefits of the Research (include safeguards provided), and (6) Complete Inclusion/Exclusion Criteria can be submitted separately.
PART III, page 8
- As a requirement for the submission of this application, all personnel directly involved with this research protocol MUST complete the CITI Educational training BEFORE submitting this protocol to the MU IRB for review. CITI registrations are available on the Education page of the ORI website. For questions about the CITI course you can contact Dr. Bruce Day. He is available for questions from 8 a.m. to 4:30 p.m., 5 days a week and can be reached at 304-696-4303 or day50@marshall.edu.
- The MU Standard Operating Procedures (SOP) is available in the IRBNet library. You are required to familiarize yourself with our procedures.
PART IV, page 8
Type of Review Requested: Please review Attachments A and B, which list the criteria for Exempt and Expedited review. Please indicate which type of review you believe your protocol should receive. If this protocol does not meet the criteria for Exempt or Expedited review, the protocol must receive a full board review. The IRB Chairperson or their designee will make this Exempt or Expedited determination.
- Exempt: If you request Exempt then choose the applicable Exempt category on page 10.
- Expedited: If you request Expedited you must complete and include the Expedited Protocol Assessment Form located in the IRBNet library and choose the applicable Expedited category on page 12.
- Convened: You must complete and include the Initial Protocol Assessment Form.
Fees: Please read this section on applicable fees and waivers for sponsored studies.
PART V, page 9
Certification and Assurance: By electronically signing the study on IRBNet you giving your assurance of the times in this section.
Submission Information: There is also a submission list in the IRBNet library that indicates all the documents needed for a submission. If your study required full board review then the deadline for submission is 30 days prior to the meeting. The IRB#2 (Social/Behavioral) board meets the third Wednesday of each month. Exempt and Expedited studies can be submitted at any time since they only require Chair or Designee review and approval.
To comply with the ORI/IRB deadlines, it is very important that the principal investigator take the responsibility to review the exempt and expedited criteria checklists thoroughly to ensure that the correct type of review is selected and the correct documentation is submitted for review. The IRB Chairperson or his/her designee will make the Exempt or Expedited determination. In the event that a PI’s request for exempt or expedited review is not accepted by the IRB Chairperson or his/her designee, the PI will be notified immediately to complete, and attach on IRBNet, the Initial Assessment Form.
MU IRB Coordinator: The MU IRB Coordinator can be reached at the Office of Research Integrity at 304-696-4303. The Coordinator is available for questions from 8 a.m. to 4:30 p.m., 5 days a week.
ATTACHMENT A
Exempt Status: This checklist delineates all of the categories that qualify a protocol for exempt review. A study must fall into one of these categories to qualify as exempt. If a protocol receives exempt status, it will be reported as informational at the next IRB meeting.
ATTACHMENT B
Expedited Review Criteria: This checklist describes all of the categories that qualify a protocol for expedited review. In order for a protocol to qualify for this type of review, it must pose no more than minimal risk and fall into one of the 7 categories. If a protocol receives expedited approval it will be reported as informational at the next IRB meeting.
ATTACHMENT C
Co-Investigators/Research Staff Information and Certification: This is the verification form that is used by the co-investigators and research staff that assures that they have completed all required training, all conflicts-of-interest have been revealed, and that they will protect the rights and welfare of each subject to the best of their ability. This form must be completed by all individuals that are listed as research staff for this protocol. If you need addition Attachment Cs then you can find the form in the IRBNet library. Note: This form does not need to be completed by the principal investigator.
IMPORTANT MISCELLANEOUS IRB INFORMATION
Continuing Review: The Board will determine the frequency for continuing review for each protocol that is approved. It is the principal investigator’s responsibility to ensure that their protocol does NOT exceed the expiration date for their protocol. If this occurs, the study will be closed automatically and the investigator will have to re-submit the protocol as a new submission. This process will take place for every continuing review for the duration of the protocol. If at any time the protocol is CLOSED, please submit a closure request package immediately through IRBNet and the protocol will be closed. For more information about how to submit a Continuing Review, please refer to the IRBNet User Manual.
Ensuring Prompt Reporting of Unanticipated Problems Involving Risks to Participants or Others: All unanticipated problems involving risks to participants or others must be submitted to the IRB as soon as possible. To submit these problems, the principal investigator must complete an Adverse Event or Other Problem Report Form located in the IRBNet library. You can also read more information concerning this subject in the SOP. The form must be completed and electronically signed by the principal investigator.
Random Audits: ORI is tasked with conducting random audits of ACTIVE studies. If your study is selected for a random audit then the IRB Coordinator will contact you and set up and time and place for the audit. For cause audits are also conducted if necessary.