IRB#2 INITIAL PROTOCOL APPLICATION INSTRUCTIONS

 

PART I, page 1

  

  1. Please be advised that STUDENTS  click here are not permitted to serve as a Principal Investigator.  They may be listed as Co-Investigators only and must complete Page 13 of the application (or Attachment C if there is more than one).
  2. Personal Information:  Complete all requested information, if this is a student-generated research protocol give the student's name.
  3. As part of the requirement for submission, you must include: A) a copy of your CV, B) current license, and C) Board Certification information for the purpose of verification of credentials.

 

PART I, page 2,3

 

  1. Research Experience:  Please answer all questions concerning your research experience.  You must also list the (2) most recent studies in which you have been involved.  If you have not been involved in any previous studies then put N/A.
  2. 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).  Definitions of what constitutes a Conflict of Interest can be found in the Conflict of Interest SOP. click here
  3. 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 sign a copy of the Attachment C form located at the end of the Initial Application.  The following items must be included for each research staff member when submitting this application to the MU IRB:  (1) a signed Attachment C form, (2) a copy of their CV/resume, current license and Board Certification (if applicable), and (3) copies of CITI education completion report.
  4. 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

 

  1. Protocol Description:   Insert the Title of the protocol.  Complete all requested information.
  2. Sponsor or Participating Agency:  If the study is sponsored then complete this section.  If it is not applicable then put N/A.
  3. Study Subjects and Procedures: The total number of anticipated subjects is the number that you would like to have participate in the study.  Also insert the minimum and maximum number of participants that you would allow.
  4. Recruitment: This section must be completed.  If any of the questions are not applicable to your study then put a checkmark in the N/A box.

  5. Informed Consent/Assent and Parental Permission Forms:  If your study protocol does not require a Consent Form, please answer N/A.  If your study protocol will be using a consent, please refer to the Informed Consent SOP click here on the ORI website for the correct format for a written consent.     

  • Assent and Parental Permission Forms:  If your study protocol will be using children under 18 years old, you must submit an assent and a Parental Permission Form. Please refer to the Informed Consent SOP for additional information and templates. click here

  1. Confidentiality:  Please provide the information as to where the original consent form will be filed (i.e. the principal investigator's office). 

  2. Privacy:  You must describe the provisions to protect the privacy interests of participants.

  3. Monetary Issues:  Each question in this section must be answered.  If there are no subject charges the checkmark the N/A box.

  4. Abstract:  Please provide a brief abstract of your proposed research (500 words or less). It must be written in lay terms since an IRB member (i.e. Community Representative) may not have a background in medical terminology or be familiar with this field of medicine. 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.    
     

PART III, page 8

 

  1. Training: 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.  Please follow the instructions carefully.  The CITI site is located on the ORI website under the Education link.
  2. MU ORI Educational Coordinator : The MU ORI Educational Coordinator is Mr. Bruce Day. He is available for questions from 8 a.m. to 4:30 p.m., 5 days a week. Mr. Day can be reached at (304) 696-4303 or day50@marshall.edu.

  

PART IV, page 8

 

  1. 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 complete the Exempt Checklist on page 10 and 11.

                - Expedited:  If you request Expedited you must complete and include the Expedited Protocol Assessment Form click here and the Expedited

                    Checklist on Page 12.

                - Convened: You must complete and include the Initial Protocol Assessment Form. Click here

   

PART V, page 9

 

  1. Certification and Assurance:  As the Principal Investigator for this research, you are required to sign this verification and assurance of the following:  (1) All training has been completed, (2) All Co-Investigators and Research staff have completed the required training and signed the Attachment C, (3) All information presented in this application is accurate and correct, (4) You will notify the IRB of ANY proposed changes to the protocol, (5) You have reviewed the MU HRPP Standard Operating Procedures, (6) You will abide by the informed consent process, and (7) YOU WILL PROTECT THE RIGHTS AND WELFARE OF EACH SUBJECT TO THE BEST OF YOUR ABILITY.
  2. Protocol Submission Deadlines: The Protocol application, Initial Protocol Assessment Form (if requesting full board review), Funding information, Training certificates, Co-Investigators/Research Staff training certificates, Copies of all research personnel CVs and licensure information, and all other protocol related information must be submitted at least 30 days in advance of the next scheduled IRB meeting.  Submission dates and meeting dates can be located on the ORI website.  In preparation for submission of the initial protocol information to the ORI, the following number of copies must be submitted for the appropriate category of review required. (Complete packets include: Initial Application, PI/Co-PI/ Research Staff CVs, study protocol, consents/assents (if applicable), advertising materials, surveys, study abstract, Initial Assessment Form (if applicable), protocol funding information (if applicable), signed Attachment C Forms, training documentation for all research staff)

 

Exempt Review        

2 complete packets

Expedited Review

2 complete packets

Full Convened Review

3 complete packets and 16 copies of the following: (abstract,

 protocol, consent/assent, advertising material, and surveys)

 

 

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 the Initial Assessment Form for submission to ORI/IRB.  This process may delay the review of the submitted protocol on the meeting date desired. 

  1. MU IRB Coordinator:  The MU IRB#2 Coordinator is Mr. Bruce Day.  He is available for questions from 8 a.m. to 4:30 p.m., 5 days a week.  Mr. Day can be reached at (304) 696-4303 or day50@marshall.edu .

 

ATTACHMENT A, page 10, 11

 

  1. 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 and documented at the next IRB meeting. The IRB Chairperson or his/her designee will initial their agreement or disagreement with the category indicated.

    

ATTACHMENT B, page 12

 

  1. 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 and documented at the next IRB meeting.  The IRB Chairperson or his/her designee will initial their agreement or disagreement with the category indicated.

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 ATTACHMENT C, page 13

 

  1. 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 signed by all individuals that are listed as research staff for this protocol.

 

PROTOCOL SUBMISSION INFORMATION

 

  1. Protocol Submission:  If the protocol application and all requested additional documents have been received on time at the ORI Office, a notification of acceptance will be sent to the principal investigator or study coordinator.  A file will be created in the ORI Office which will include all documents associated with the protocol. 
  2. Chairperson Review:  The IRB Chairperson or their designee will review the protocol and will make the final determination if it qualifies for Exempt Status, Expedited Review or a Full Board Review.  If the protocol qualifies for Exempt or Expedited Review, a letter stating (1) approval, (2) approval with changes or (3) disapproval, will be sent to the principal investigator from the IRB Chairperson.  The letter will include information concerning the status of the protocol and when the protocol will be due for continuing review, if applicable.  If the protocol requires a Full Board Review, the Primary and Secondary Reviewers will determine if the PI will be required to attend the next scheduled IRB meeting to present additional information about their study protocol.  The ORI will contact the PI of this request to present at the meeting and schedule an appointment.
  3. Full Board Review Process:  After the meeting, a letter will be forwarded to the principal investigator stating that the protocol was (1) approved with no changes, (2) approvable with minor changes, (3) approvable with substantial changes, (4) deferred pending receipt of additional substantive information, (5) disapproved.  If a consent/assent and Parental Permission form will be used, it will be color-stamped with the date of its approval. ONLY this color-stamped informed consent/assent or Parental Permission Form may be used to make copies for subjects.  A copy will be kept in the investigator¡¯s study file in the ORI Office.

IMPORTANT MISCELLANEOUS IRB INFORMATION

 

 

  1. 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 inform the ORI Office immediately in writing and the protocol will be closed at the next convened IRB meeting.  For more information about Continuing Review, please refer to the Continuing Review Application Instructions located on the ORI website.
  2. 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 AE/SAE/Problem Report Form click here located on the ORI website.  You can also read more information concerning this subject in the associated SOP. click here  The form must be completed and signed by the principal investigator.  The completed form and all information concerning the AE/SAE must be submitted to ORI.
  3. Periodic Protocol File Surveys:  ORI will be conducting random surveys of all ACTIVE protocols.  If your protocol is selected to be surveyed, the principal investigator will be sent a letter asking them to review a Protocol History Form for the selected protocol.  The information listed on this History Form will include all information that has been forwarded to the IRB for acknowledgement and review.  The principal investigator will be asked to review the form and assure that all information is correct and complete.  In the event that the information on the History form is not correct, the principal investigator will be asked to forward any missing information or the corrected information to be acknowledged and approved by the IRB.  It is very important that the principal investigator protocol files have the same information that is in the ORI protocol files.
  4. Periodic Study Subject Surveys:  ORI conducts random surveys of ACTIVE study subjects for all ACTIVE protocols.  The use of these surveys will generate the following types of information:  (1) Did the subject understand the study, (2) Was the subject given sufficient information about risks and benefits to be able to reach an informed decision, (3) Did the subject understand that they were being asked to volunteer to participate and that they had the right not to participate.  There will also be random surveys for recently closed protocols.