Office of Research Integrity
Frequently Asked Questions
Q1.1 What happens after I submit my IRB application?
Q1.2 I plan to conduct my research at another institution. Does MUSC's IRB need to review my research proposal?
Q1.3 Why am I unable to upload documents to the electronic application?
Q1.4. If I am obtaining the HeLa cell line, do I need to submit to the IRB?
Q1.5 If I am obtaining culture cell lines from ATCC that do not have personal identifiers, codes or linkages maintained by ATCC, do I need to submit to the IRB?
Q1.6 At what point does a quality improvement project require submission to the IRB?
PI Statement of Assurance
Q2.1 Can I fax a copy of the signed PI Statement of Assurance or do I need to bring/mail the original?
Q2.2 Who has to sign the PI Statement of Assurance?
Q2.3 When do I submit the PI Statement of Assurance?
Q3.1 What is informed consent and when is it needed?
Q3.2 Which waiver of consent should I use?
Q3.3 Can I use the sponsor-provided informed consent forms?
Q3.4 Do I have to use the MUSC informed consent format?
Q3.5 Do we have to use the MUSC standard paragraphs in the informed consent document?
Q3.6 Can my sponsor change the wording of the MUSC standard paragraphs?
Q3.7 Do I need a separate DNA HIPAA?
Change In Personnel on Study
Q4.1 How do I add personnel to a study? Can I add/delete more than one person from a study using the same amendment?
Q4.2 How do I delete someone from a study who is no longer at the University and does not have a NetID?
Q9.1 Why am I not able to log in?
Q9.2 Who can be the PI on a study?
Q9.3 My study has multiple PIs listed. How can I indicate multiple PIs in the system?
Q9.4 I cannot find the name of one of my study team members.
Q9.5 I am a study coordinator and I have completed the application. However, the system will not allow me to submit the application/amendment/continuing review/reportable event.
Q9.6 I am a study coordinator & have completed the application. Is the Pi notified that it's ready to be sent to the IRB?
Q9.7 The PI has submitted the study to the IRB but it doesn't seem to have gone to the IRB. What is the hold-up?
Q9.8 I am not receiving e-mails about my study from the eIRB system. What may be the problem?
Q9.9 I have logged into "my personal workspace" and I am on the "My Home" page but I still do not see any of my studies.
Q9.10 I am working with an ancillary department on campus & understand the department will receive notice of my study. Does this complete my submission to that ancillary department?
Q9.11 What is a watermark and when is it needed?
Q9.12 How can I find out the status of my study's approval?
Q9.13 Where can I locate my IRB approved consent form?
Q9.14 Where can I locate my study's original approval letter?
Q9.15 The primary study contact for IRB submissions is on an extended absence. Chan I change the primary IRB contact for my studies?
Q9.16 I was adding/revising the personnel list and clicked the continue button. Now I don't have access to continuing editing the study?
Q9.17 How can I revise a document I uploaded?
Q9.18 Why can't I complete an amendment for my study?
Q9.19 Where is the stamped copy of my ad?
Q9.20 Where is my stamped HIPAA?
Q9.21 Where is the approval letter for my study?
Q9.22 Which documents are IRB approved and stamped?
A1.1 When a new application is received in the IRB office it is screened for completeness and readiness for review. An IRB staff person contacts the researcher if additional information is needed. Once a completed application has been received review will begin.
A1.2 If any part of the project includes MUSC patients, families, staff (as research subjects) or facilities the MUSC IRB reviews it.
A1.3 There are two common reasons for problems uploading to ERMA:
- The name of the file must be alphanumeric, symbols (ex. -&%#~) are not allowed
- The file has to be saved to My Documents, not as a shortcut.
A1.4 No. The cell line is from a deceased individual.
A1.6 There is often confusion in determining whether Quality Improvement (QI) activities fall under the jurisdiction of the IRB. 45 CFR 46.102 (d) defines research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
The Office of Human Research Protections (OHRP) has cautioned that research should be defined conservatively; the IRB provides guidance to investigators, and retains the final authority in the classification of projects as research, or not research. In general, a contribution to generalizable knowledge could include a journal publication, conference presentation, or dissertation, although this is not the sole factor in making the determination.
You must submit your QI project to the IRB if any of the following are true:
- there is an intent to use the data to contribute to generalizable knowledge
- there is a random assignment of participants to compare outcomes
- the activities are not normally done as part of standard operating procedures
- results will be used to apply knowledge to other programs
- the project is subject to peer review (designed to be used outside of the institution)
- subjects or groups of subjects may be randomized to different interventions or treatments
- anonymity of participants cannot be assured
- the activities involve more than minimal risk to participants
- If still unsure, consult with the IRB. The IRB is prohibited from granting retroactive approval.
PI Statement of Assurance
A2.1You may fax, mail or deliver the signed PI Statement of Assurance.
A2.2. The PI, his/her Department Chair and in some cases the Associate Provost for Research must sign the PI Statement of Assurance. If the PI is a student of trainee, his/her Mentor must also sign.
A2.3. There are two situations for when the PI Statement of Assurance would be submitted:
- when you have completed the electronic submission for an initial study
- when there is a change in the PI for an approved study.
A3.1. In almost all cases, consent must be obtained from the research participants or their legally authorized representatives before participation in research begins.
The informed consent process is a basic ethical obligation for researchers. It consists of providing adequate information to the subject about the study, giving the subject the opportunity to consider options, responding to questions the subject may have and ensuring that the subject or the legal representative understands the information. In addition, the process includes obtaining the subject's voluntary agreement to participate in the research, indicated by the subject's signature on the written consent document. After the subject's signature is obtained the informational process should continue as the situation or the subject may require both during and after the study.
The IRB may approve a waiver of consent in limited circumstances. Consent may be waived if the IRB determines:
- That no more than minimal risk to research participants would be involved.
- That the rights or welfare of participants would not be adversely affected.
- That the research could not be practicably conducted without a waiver.
- Additionally, regulations require that if appropriate there be a plan to provide research results to subjects after conclusion of the study.
A3.2. The waiver of consent is generally used for retrospective chart reviews and the waiver of signed consent is generally used for survey research. Please contact your IRB Administrator for more information about the waivers.
A3.3. No, you must use the MUSC consent form.
A3.4. Yes. Guidelines for Standard Informed Consent
A3.5. Yes, the MUSC standard paragraphs must be used. The MUSC standard paragraphs can be found on the IRB website Guidelines for Standard Informed Consent
A4.6.No, the wording cannot be changed.
A3.7.No, you may use the same HIPAA for the study.
Change In Personnel on Study
A4.2. Select Personnel Amendment and click Next.
Check the "Not MUSC personnel" checkbox and click Save to move to the next screen.
Complete the required fields and click Next.
Select "TO AMENDMENTS LIST" at the bottom left to return to the list of amendments and click submit.
A5.1. Yes, you need to complete the CITI basic training, followed by a refresher course every 3 years. See the Education and Training page.
A5.2. Yes, all study personnel listed on the IRB application must complete the CITI training. See the Education and Training page.
A5.3. The Human Subject Research Training (CITI Miami) page contains the link "Printing Your CITI Certificate.
A6.1. There is a fee for corporate sponsored and non-sponsored studies.
A7.1. Follow the Link to the Charleston VA Research Service.
A7.2 Yes. While your study may have been approved by the MUSC IRB, you MAY NOT begin work on your research study at the VAMC until you have received VAMC R&D Committee Approval.
A8.1. The IRB is happy to help. Please feel free to contact the Administrator or Coordinator for your Board. See the IRB Contacts page.
- Please make sure when entering your username you are entering your MUSC NetID name. Then enter your password.
- If you continue to have log in issues, you may need to be registered in the eIRB system. This may be the case for someone who has just been assigned a NetID and has not yet been added into the eIRB system. If this is the case, the 1st time a new user logs into the system, a registration screen will be displayed. Fully complete the requested information. Note: Non-faculty member study PIs will require a mentor to be able to be listed in eIRB with PI rights. To ensure this, check the box that indicates you are a student, as this is the mechanism to grant you this PI access right. After the registration form is complete and the user clicks ok, an email is sent to the MUSC eIRB administrator. The site administrator will complete the registration (about a 24 hour turn-around timeframe), assign the user roles appropriate to the user’s research activities and activate the account. The user will receive an email notification of account activation. This process can take up to 24 hours; however, if registration is required sooner, contact the eIRB systems administrator.
- If you continue to have log in issues, you may need to contact OCIO at 792-9700 to ensure your Net ID is working properly.
A9.2. Answer: The PI on a study must be MUSC faculty, employee or mentee (student, resident or post-doctoral scholar). Co-investigators may be off-site to MUSC.
A9.3. eIRB only permits naming one PI. The other investigators will be required to be listed as Co-Investigators within the system. Also, the PI on a study must be MUSC faculty or employee. Co-Is may be off-site to MUSC.
A9.4. Personnel must be listed in MUSC’s system with a current NetID and must have been assigned particular roles within the eIRB. If the individual has not registered in the eIRB, have them follow the instructions outlined in FAQ 9.1 above. If they have registered and you are unsure of the roles they have been assigned, contact the eIRB administrator to discuss role assignment (i.e., why the personnel’s name is not found in a particular pick list) and to coordinate NetID assignment, if needed.
A9.5. A study coordinator may create these applications to the point of completion but the PI must submit it. The eIRB is designed as a paper-less environment, incorporating automated routing for approval and on-line access to documents, such as the Informed Consent Document. The ability to have this process is based on the on-line authentication of individual users. For the eIRB system, the PI logs into the system, and, once authenticated, indicates the PI assurance via submission of the activity. Because of this electronic verification mechanism, the eIRB system will only allow the Principal Investigator to submit the initial study, amendment, continuing review & reportable event applications.
A9.6. The system only generates e-mail notices for department reviews, when the IRB has comments or have reviewed the studies and when a continuing review is due. It will not generate a notice to the PI that a study is ready for IRB submission. This communication must occur outside of the eIRB system through your routine notification methods.
A9.7. Before a study is submitted to the IRB, approvals must be obtained by departments. In addition, depending upon the study, additional approvals may be required from the Protocol Review Committee and/or the Associate Provost for Research. The eIRB system automatically routes the study to the approving individuals along with a notification e-Mail. If required approvals are incomplete, the Current State of the study (see the study’s main page) will be "Department Review". In this case, the department reviewers may not have issued approved the study. Also, if this is an internally or non-sponsored study, the Associate Provost for Research will review & approve the study. Similarly, if you are using an ancillary service that must approve the study before it can go to IRB (i.e., Hollings Cancer Center Protocol Review Committee), this approval may not have been completed yet. To check on an approval required, locate the ‘Pre Review Status’ tab on the protocol’s main page. This will display an update of pending and received approvals.
A9.8. All emails from the eIRB system use the domain @eirb.healthsciencessc.org. One method to ensure delivery of these emails is to add @eirb.healthsciencessc.org as a safe domain. To do this through Microsoft Outlook:
- i. Click on one of the email messages that you have moved into your inbox
- ii. Click Actions (at the top of the screen)
- iii. Select Junk E-Mail iv. Select Add Senders Domain (@example.com) to the Safe Senders List
This should allow all email coming from @eirb.healthsciencessc.org to arrive in your inbox.
A9.9. In the Navigation Column on the Left Side of the Page, ensure that you are in the correct “Role” (i.e. Study Staff, Mentor, IRB Member). To see your studies, you must be in the Study Staff role. Select the correct tab that speaks to the status of the study or type of application you are attempting to view. The ‘Studies’ tab will also display all studies.
A9.10. No, eIRB only provides a notice that the study has requested this service and does not complete any submission review requirements of the ancillary department.
A9.11. eIRB requires all IRB-stamped approvable documents to contain specifically programmed merge fields in the document footer. These fields are contained within a text box called the ‘watermark’. This watermark is needed for informed consents, assent documents, HIPAA authorizations & other documents that must contain an approval stamp and must be placed within the document when submitting it to IRB. After you submit your application with these documents, eIRB automatically adds information to these fields during the review and approval process creating an electronic “Approval” stamp and makes the documents read-only. Documents that have not been created with or modified to include the appropriate fields will not be properly approved. The watermark in available on the IRB’s forms webpage.
A9.12. The eIRB system is state-based – which means at any point in time, anyone with edit access to the study can log into the eIRB system and see the state the study is in (Departmental Approval, IRB Staff Review and Changes Requested by IRB Staff being common examples) as well as view the history of the study showing when actions were taken on the study. The ‘Current State’ of the study will tell you where it is in the review process. The Current State is on the column entitled ‘State’ associated with your study on your homepage or on the upper left hand side on the main study’s workspace. The same is also true for amendments to a study, continuing reviews submitted and reportable events. Each will transition through various states from pre-submission to approve. Each will also have a tab showing the history of activity.
A9.13. On the study’s main page is a ‘Stamped ICF’ tab. The currently approved versions of consent forms are listed here. The previously approved versions are also located within this tab by clicking on the small icon next to the consent’s name. The draft version of these document are located in the ‘Attachments’ tab on the study’s main page.
A9.14. If your study has not yet been approved through a continuing review, you can access the letter by selecting the ‘View’ link in the Letter of Approval field on the main study workspace page. If your study has had at least one continuing review, you can still access the original approval letter from the Amendments tab on the protocol’s workspace and selecting the link under the title ‘Originally Approved Version’. The approval letter appears as the ‘View’ link in the Letter of Approval field.
A9.15. Yes, the eIRB communication coordinator can be changed by logging into eIRB, selecting the study and choosing ‘Edit Communication Leads’ in the My Activities section of the study’s main page. Indicate the alternate personnel by checking the name and saving. Note: all personnel with a check next to their name currently receive communication from IRB. Only personnel who have been granted edit rights will appear on the page.
A9.16. You may have removed/replaced yourself on the Study Team members listing within the eIRB Smartform page. Because of this, the system no longer recognizes you as someone with rights to the study and you may have been kicked out of the system with no access to that protocol. You can request someone who’s listed as personnel with edit rights to add you back onto the study. Or, this can be corrected by involving the eIRB Systems Administrators.
A9.17. If you want to perform this task when you are creating a study and BEFORE you have sent it to the IRB, delete the document and add a new one. However, if you are revising a document that has already been sent to IRB at any point (i.e., changing a document in response to IRB comments for a new study or you are changing a document through an amendment request), select the Upload Revision link next to the document name and DO NOT change the name of the document. In this way, the system will re-number the version date to make it consistent with the previous versions. If you click ADD, the system does not recognize that the uploaded document is an update to the prior version.
Q9.18 Why can't I complete an amendment for my study?
A9.18.You can only complete an amendment after the study has been IRB approved. Following that, the system will only allow one amendment at a time to be active. You may already be working on an amendment or there may be one already submitted to IRB. If already submitted to IRB, you will not be able to complete a new amendment until the current one has been IRB approved.
A9.19. At the bottom of the Attachments tab for your study, you will find a section titled "Ancillary Documents".
Documents in this Section have been approved by the IRB and contain the completed stamp.
A9.20.At the bottom of the Attachments tab for your study, you will find a section titled "Ancillary Documents".
The documents in this Section have been approved by the IRB and contain the completed stamp.
A9.21.The current Letter of Approval is located on the main page of your study.
A9.22.The MUSC IRB approval watermark/stamp indicates that the document has been reviewed and approved by the IRB, and displays the date the approval was granted. Commonly, the approval watermark/stamp is used for the following types of documents:
1) Consent documents
2) HIPAA Authorizations
3) Information sheets associated with the consent process
4) Advertisements/subject recruitment materials
The MUSC IRB does not review or approve manuals of operations/standard operating procedures or case report forms.
The MUSC IRB does not stamp study protocols, Investigator Brochures or surveys. Since some sponsors inquire as to which documents have been reviewed by the IRB, it is recommended that upon upload into the eIRB system, each document should be given a detailed title (i.e., Investigator Brochure dated May 31, 2011, version 2). The day after a study has been approved by the IRB, a “snapshot” is generated by the eIRB system detailing which documents were included under the IRB’s approval. The study snapshot may be found under the History tab; it can be printed and provided to the sponsor by the study team to satisfy any questions regarding which documents have attained IRB approval.