Greenville Hosiptal System

eIRB Submission Instructions - Page 1 of 11

Rev 8: October 2013

GREENVILLE HEALTH SYSTEM

INSTITUTIONAL REVIEW BOARD (IRB)

SUBMISSION INSTRUCTIONS

The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research participants recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy.

Qualifications to Perform Human Research (HRPP Policy 901)

The Greenville Health System (GHS) Office of Research Compliance and Administration (ORCA) decides who can perform any research study involving human subjects at GHS. Prior to approving any study the ORCA, or affiliate IRB, is required to assure that the Principal Investigator (PI), any co-investigators, the study sponsor/representative and the research staff possess appropriate qualifications and general resources to conduct the research project and to assure that the rights and welfare of subjects are protected.

The GHS (ORCA) requires the PI to have the appropriate background and training to conduct the research required for each study. The ORCA, or affiliate IRBs, will decide on the qualifications for PIs. PIs maybe members of the GHS medical professional staff, nursing staff, employees of GHS, or a member of the faculty of one of the institutions affiliated with GHS. Professionals in training (i.e. medical students, nursing students, students of affiliate institutions, or resident physicians) are not permitted to be Principal Investigators. Fellows may be principal investigators if they have medical staff privileges at GHS.

Additionally, the GHS IRB may require that a physician with admitting privileges and appropriate expertise be substantially involved with the research project, particularly if the research study or procedures are greater than minimal risk.

New Study Submission Instructions

Unless otherwise noted, new study submission instructions outlined within this document are applicable to both expedited and full-board review.

1.  All researchers (principal investigators, co-investigators, other research staff and students) involved in human subject research must complete training before a requested study protocol is approved and/or before research is conducted. This requirement must be accomplished via the CITI Training Course. Instructions for initial and continuing research education requirements can be found under the Research and Innovations/Research Compliance link at GHS.ORG http://www.ghs.org/continuingresearcheducation

2.  If your study involves interaction and/or intervention with patients, a GHS physician must be listed as an investigator.

3.  Any person(s) involved in conducting the study must be listed as study personnel in the appropriate category, depending upon his/her role.

4.  As soon as you know you have a new study to submit to the IRB please register for an eIRB account as outlined below. Please contact Jean Winter at 864-522-2098 or to discuss any issues.

Registration Instructions for GHS Personnel

•  Select ‘eIRB’ at the top of the GHSNet home page or click on the following link, https://eirb.healthsciencessc.org , to access the eIRB site.

•  Enter your GHS network USER ID and password or, if a physician, your SMS number and password to be routed to the registration page.

•  Complete the required fields and click ‘Register’ at the bottom right of the screen.

•  Once registered, Jean Winter will receive automatic notification from the eIRB system and will validate your account.

Registration Instructions for Persons Outside GHS

•  Contact Jean Winter at 864-522-2098 or ; Jean will arrange for an account to be set-up for you.

Lost or Forgotten eIRB USER IDs and/or Passwords

·  Contact the GHS Service Center at 864-455-8000, 24hrs/7 days a week to have your password reset and/or to obtain your forgotten USER ID. GHS personnel will use the USER ID and Password they normally use to log on to any GHS computer/module. Outside users will have a USER ID and Password assigned to them from the GHS IS department.

5.  In order to provide adequate review, the IRB can only review six (6) new studies each full-committee meeting. Items are placed on the agenda on a first-come, first-served basis. Attached for each IRB Committee is a list of meeting dates, as well as submission deadlines. Deadlines are strictly enforced.

6.  New studies submitted for expedited review are processed in the order received.

7.  Attached you will find a checklist, which outlines the requirements for a new study submission.

8.  If your study utilizes a consent form, it must be pre-screened by the IRB Office prior to submission to the IRB for approval. This can be done by emailing the consent form directly to the IRB coordinator. This pre-screening process will identify any omissions and help streamline the review. For studies requiring full-committee review, the attached schedule lists the dates that the consent must be sent to the IRB Office for pre-screening. For your convenience, the GHS IRB consent form template, as well as a guidance/word preferences document, can be found on the ORCA website http://www.ghs.org/eirb .

9.  If your study involves storing specimens (tissue, blood, bone marrow, etc.) for any future research, please use the Specimen Consent Form along with the treatment consent form. For your convenience, a copy of this consent form template can be found on the ORCA website http://www.ghs.org/eirb .

10.  Several departments within GHS may be impacted by your research study. Since all parties involved need to be aware of the requirements related to your study, you must obtain approval from each impacted department head. Each department head’s approval must be given, via the eIRB, prior to IRB submission. The IRB does not have access and cannot review your study without the required ancillary approvals.

Listed below are departments that are usually impacted by a research study. Please list the applicable department on your eIRB application, (listed under Impacted Services). If the department is not listed, a standard form for Impacted Services is available on the ORCA website http://www.ghs.org/eirb and can be utilized for this purpose and uploaded to the eIRB application prior to submission. Because adequate time is needed for review, be sure your study is submitted for this review before the deadline dates (full-committee review studies only).

§  GHS Pharmacy – The Department of Pharmacy Services of GHS is responsible for overseeing the storage, distribution and control of all medications administered to patients throughout the system including investigational medications. The Joint Commission, DHEC, and the South Carolina Board of Pharmacy mandate this responsibility. Office-based outpatient studies may be exempt. If your study requires the administration of any medication, you must contact the Director of Pharmacy Services to determine if pharmacy services will be required. If required, you must indicate them as an Impacted Service on the eIRB new study application. Once submitted by the PI, the application form, along with protocol and all attachments will go directly to the designated approver for department review and/or approval of their participation. Once the designated reviewer has approved their participation the study will come to the IRB office for review. Since the department approval must done prior to the application being routed to the IRB office, please remember to give the department approver adequate time to review the application (at least 2 weeks prior to IRB submission deadline). Please contact the Pharmacy, Charles Gregory PharmD, at Email: or telephone 864-679-3983 to discuss any issues.

§  GHS Laboratory – If your study requires the services of the GHS laboratory you must indicate them as an Impacted Service on the eIRB new study application. Once submitted by the PI, the application form, along with protocol and all attachments will go directly to the designated approver for department review and/or approval of their participation. Once the designated reviewer has approved their participation, the study will come to the IRB office for review. Since the department approval must done prior to the application being routed to the IRB office, please remember to give the department approver adequate time to review the application (at least 2 weeks prior to IRB submission deadline). Please contact Ginger Smith at 864-455-8702 to discuss any services/issues involving the laboratory.

§  GHS Radiology – If your study requires the services of the GHS radiology you must indicate them as an Impacted Service on the eIRB new study application. Once submitted by the PI, the application form, along with protocol and all attachments will go directly to the designated approver for department review and/or approval of their participation. Once the designated reviewer has approved their participation the study will come to the IRB office for review. Since the department approval must done prior to the application being routed to the IRB office, please remember to give the department approver adequate time to review the application (at least 2 weeks prior to IRB submission deadline). Please contact David Hellams at 864-455-7913 to discuss any services/issues involving radiology.

§  GHS Surgery – If your study requires the services of the GHS Department of Surgery you must indicate them as an Impacted Service on the eIRB new study application. Once submitted by the PI, the application form, along with protocol and all attachments will go directly to the designated approver for department review and/or approval of their participation. Once the designated reviewer has approved their participation the study will come to the IRB office for review. Since the department approval must done prior to the application being routed to the IRB office, please remember to give the department approver adequate time to review the application (at least 2 weeks prior to IRB submission deadline). Please contact Erwin Stainback at 864-455-3072 to discuss any services/issues involving surgery.

§  GHS Pathology – If your study requires the services of the GHS pathology department you must indicate them as an Impacted Service on the eIRB new study application. Once submitted by the PI, the application form, along with protocol and all attachments will go directly to the designated approver for department review and/or approval of their participation. Once the designated reviewer has approved their participation the study will come to the IRB office for review. Since the department approval must done prior to the application being routed to the IRB office, please remember to give the department approver adequate time to review the application (at least 2 weeks prior to IRB submission deadline). Please contact Dr. David Schammel at or 864-455-3457 to discuss any services/issues involving the pathology department.

§  Nursing Research Council - If your study involves GHS nursing practice; the PI is a registered nurse; the PI is working on a nursing academic degree; and/or the nursing staff is the primary focus of the study you must indicate them as an Impacted Service on the eIRB new study application. Once submitted by the PI, the application form, along with protocol and all attachments will go directly to the designated approver for department review and/or approval of their participation. Once the designated reviewer has approved their participation the study will come to the IRB office for review. Since the department approval must done prior to the application being routed to the IRB office, please remember to give the department approver adequate time to review the application (at least 2 weeks prior to IRB submission deadline). Please contact Sue Bethel at 864-455-7007 to discuss any services/issues involving nursing.

§  Human Resources If your study involves a survey (electronic, paper, personal or telephonic) of some, or all, GHS employees you must indicate Human Resources as an Impacted Service on the eIRB new study application. A copy of the proposed survey, including methodology and timeframe must be attached to the application prior to department approval. Once submitted by the PI, the application form, along with protocol and all attachments will go directly to the designated approver for department review and/or approval. Once the designated reviewer has approved employee participation the study will come to the IRB office for review. Since the department approval must done prior to the application being routed to the IRB office, please remember to give the department approver adequate time to review the application (at least 2 weeks prior to IRB submission deadline). Please contact James Hayes, MD at 864-522-2097 to discuss any services/issues involving GHS employees.

§  Scans, or Other Study-Related Tests – Contact appropriate department head to discuss services/issues involving their department. Please use the Impacted Services form found on the ORCA website http://www.ghs.org/eirb for departments not listed on the eIRB. Once completed, this form can be uploaded to the eIRB application prior to submission to the IRB.

11.  For studies requiring full-board review, the IRB requires the principal investigator or a co-investigator to present his/her research study at the appointed IRB meeting. The investigator will be given approximately ten minutes to present his/her study, as well as answer any questions the Committee may ask. The IRB Coordinator will contact you to schedule this presentation.

All studies funded commercially are required to submit a $2000.00 IRB review fee upon submittal. This is a one-time only fee and covers any type of future IRB reviews. The check should be made payable to Greenville Health System Research Compliance. If you are unable to include the IRB review fee with your submittal, please provide a letter from the sponsor stating their intent to pay this fee. The Department of Research Compliance and Administration will provide an invoice, if required.

Amendment Submission Instructions

Please note that the attached submission deadline dates apply to amendments requiring full-committee review.

Continuing Review Submission Instructions

Please note that the attached submission deadline dates apply to continuing reviews requiring full-committee review.

For all studies utilizing a consent form, the last signed consent form must be uploaded to the ‘General Comments’ section of the continuing review submission. Please be sure to black-out the participant’s name and initials. DO NOT black-out the witness’ name/signature, the investigator’s name/signature, or any signature dates.

At continuing review, the GHS IRB must ensure that the criteria for IRB approval under HHS regulations at 45 CFR 46.111 and, when applicable, FDA regulations at 21 CFR 56.111, continue to be satisfied. A summary of all internal and/or external adverse events that occurred since the last continuing review must be submitted by the PI at continuing review.