{"id":510,"date":"2011-04-18T14:41:09","date_gmt":"2011-04-18T18:41:09","guid":{"rendered":"http:\/\/www.marshall.edu\/ori\/?page_id=510"},"modified":"2019-01-16T09:58:37","modified_gmt":"2019-01-16T14:58:37","slug":"irb1-initial-protocol-application-instructions","status":"publish","type":"page","link":"https:\/\/www.marshall.edu\/ori\/office-of-research-integrity\/human-subject-research\/institutional-review-boards\/institutional-review-board-1-medical\/irb-1-initial-application-package\/irb1-initial-protocol-application-instructions\/","title":{"rendered":"IRB#1 Initial Protocol Application Instructions"},"content":{"rendered":"

PART I, page 1<\/strong><\/p>\n

Please be advised that STUDENTS<\/strong>\u00a0and RESIDENTS<\/strong> (including FELLOWS<\/strong>) are not permitted to serve as a Principal Investigator.\u00a0 They may be listed as Co-Investigators only and must complete Attachment C on pages 13 &14 of the application (or Attachment C if there is more than one).<\/p>\n

Personal Information:\u00a0 <\/strong>Complete all requested information, if this is a student-generated research protocol insert the student’s name under that question. \u00a0As 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.<\/p>\n

If you will be conducting this research protocol at the Huntington VAMC, you must also attach the proper VA forms.\u00a0 VA forms are located on the VA page of the Office of Research Integrity (ORI) website.<\/p>\n

PART I, page 2,3<\/strong><\/p>\n

Research Experience<\/strong>:\u00a0 <\/strong>Please answer all questions concerning your research experience.<\/p>\n

Conflict of Interest:\u00a0 <\/strong>All Conflict of Interest questions must be answered.\u00a0 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.\u00a0 Definitions of what constitutes a Conflict of Interest can be found in the Standard Operating Procedures (SOP) Manual (also located in the IRBNet library).<\/p>\n

Research Staff:\u00a0 <\/strong>Please include the names and position of all co-investigators and research staff personnel who will be directly involved with this study.\u00a0 All personnel listed will be required to complete the required training and must also acknowledge any conflicts-of-interest.\u00a0 All listed co-investigators and research staff are required to submit a copy of the Attachment C form located in the IRBNet library.\u00a0 The following items must be included for each research staff member when submitting this application to the MU IRB:\u00a0 (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.<\/p>\n

List the external sites where the research will be conducted (e.g. schools, business, and health care facilities).\u00a0 Note:<\/strong> You must obtain written permission from the external sites prior to study approval.<\/p>\n

PART II, page 4, 5, 6, 7<\/strong><\/p>\n

Selection of Facilities:<\/strong>\u00a0 Please select all facilities where this research will be conducted. (If you select the Huntington VAMC, there will be additional documents to complete.\u00a0 This information will follow as it pertains to different areas of the protocol submission process.)<\/p>\n

Section A<\/strong><\/p>\n

Protocol Description:\u00a0\u00a0 <\/strong>Answer these questions concerning whether or not the study involves minimal risk.<\/p>\n

Section B<\/strong><\/p>\n

Sponsored Studies:<\/strong>\u00a0 If the study is sponsored then complete this section.\u00a0 If it is not applicable then click N\/A.\u00a0 Please provide sponsor contact information for billing purposes.<\/p>\n

Test Article:<\/strong> If the study involves investigational drugs or devices you must complete this section and attach a description of the procedures that will be followed so that only authorized individuals will be able to access the investigational drugs or devices and that they will only be used for individuals who are participants in this research protocol.\u00a0 Also provide the IND# and IDE# if applicable.<\/p>\n

Section C<\/strong><\/p>\n

Study Subjects and Procedures:<\/strong> Enter the minimum and maximum number of anticipated subjects for the study.\u00a0 Also insert the minimum and maximum number of participants that you would allow.\u00a0 Include the minimum and maximum ages of participants.\u00a0 If there is no maximum age then just enter N\/A.\u00a0 Be sure to answer each question in this section.\u00a0 If your study only involves records review then you can skip this section and proceed to Section D.<\/p>\n

Section D<\/strong><\/p>\n

Recruitment: <\/strong>This section must be completed.\u00a0 State where your study subjects or records will be drawn.\u00a0 If any of the questions are not applicable to your study then put a checkmark in the N\/A box.\u00a0 All advertisements must be submitted and approved.\u00a0 Keep in mind that finder\u2019s fees (as described on the application) are not permitted.<\/p>\n

Section E<\/strong><\/p>\n

Informed Consent:<\/strong>\u00a0 If your study protocol does not require a Consent Form, please click N\/A and proceed to Section F.\u00a0 If your study protocol will be using a consent, please refer to the consent templates in the IRBNet library.\u00a0 The consent must either contain all elements of HIPAA or a HIPAA consent must also be submitted separately.\u00a0 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.<\/p>\n

If the consent will be used at the Huntington VAMC, the consent must include 10-1086 forms.\u00a0 If you desire assistance on the proper format for a VA consent, please refer to the VA consent templates.\u00a0 The 10-1086 form and the consent template can be located on the ORI website. If the consent form will be translated into a foreign language then you must provide both the English and Foreign copies of the consent.<\/p>\n

Assent and Parental Permission Forms: <\/strong>\u00a0If 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.\u00a0 Templates are available in the IRBNet library.<\/p>\n

Section F<\/strong><\/p>\n

Confidentiality:<\/strong>\u00a0 Please provide the information related to confidentiality.\u00a0 Remember that this information pertains to how you will protect the data of the participants.<\/p>\n

Section G<\/strong><\/p>\n

Privacy:<\/strong> \u00a0You must describe the provisions to protect the privacy interests of participants.\u00a0 Remember that this information pertains to how you will protect the privacy of the subject (i.e. interview\/survey participant in private).<\/p>\n

Section H<\/strong><\/p>\n

Monetary Reimbursement:<\/strong>\u00a0 Each question in this section must be answered.\u00a0 If there are no subject charges the checkmark the N\/A box and skip to the next section.<\/p>\n

Abstract:<\/strong>\u00a0 Please provide a brief abstract of your proposed research in 1-2 pages maximum.\u00a0 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:\u00a0 (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.\u00a0\u00a0\u00a0\u00a0
\n<\/strong><\/p>\n

PART III, page 8<\/strong><\/p>\n

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  1. As a requirement for the submission of this application, all personnel directly involved with this research protocol MUST<\/strong> complete the CITI Educational training BEFORE<\/strong> 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<\/a>.<\/li>\n
  2. The MU Standard Operating Procedures (SOP) is available in the IRBNet library. You are required to familiarize yourself with our procedures.<\/li>\n<\/ol>\n

    PART IV, page 8<\/strong><\/p>\n

    Type of Review Requested<\/strong>:\u00a0 Please review Attachments A and B, which list the criteria for Exempt and Expedited review.\u00a0 Please indicate which type of review you believe your protocol should receive.\u00a0 If this protocol does not meet the criteria for Exempt or Expedited review, the protocol must receive a full board review.\u00a0 The IRB Chairperson or their designee will make this Exempt or Expedited determination.<\/p>\n