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.

Q1.2 I plan to conduct my research at another institution. Does MUSC's IRB need to review my research proposal?

A1.2 If any part of the project includes MUSC patients, families, staff (as research subjects) or facilities the MUSC IRB reviews it.

Q1.3 Why am I unable to upload documents to the electronic application?

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.

Q1.4 If I am obtaining the HeLa cell line, do I need to submit to the IRB?

A1.4 No. The cell line is from a deceased individual.

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?

A1.5 No. Cultured cell lines without personal identifiers, codes or linkages do not constitute human subject research as defined by federal regulations (45 CFR 46.102(f)).

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?

A2.1You may fax, mail or deliver the signed PI Statement of Assurance.

Q2.2 Who has to sign the 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.

Q2.3 When do I submit the PI Statement of Assurance?

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.

Informed Consent

Q3.1 What is informed consent and when is it needed?

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.

Q3.2 Which waiver of consent should I use?

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.

Q3.3 Can I use the sponsor-provided informed consent forms?

A3.3. No, you must use the MUSC consent form.

Q3.4 Do I have to use the MUSC informed consent format?

A3.4. Yes. Guidelines for Standard Informed Consent

Q3.5 Do we have to use the MUSC standard paragraphs in the informed consent document?

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

Q3.6. Can my sponsor change the wording of the MUSC standard paragraphs?

A4.6.No, the wording cannot be changed.

Q3.7 Do I need a separate DNA HIPAA?

A3.7.No, you may use the same HIPAA for the study.

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?

A4.1. You may add/delete more than one person from a study using the same amendment. The Change in Personnel amendment is submitted using the ERMA database.

Q4.2 How do I delete someone from a study who is no longer and at the University and does not have a NetID?

A4.2. Select Personnel Amendment and click Next.

When prompted to enter NetID for personnel to be changed, type 'not_MUSC' and click Save.

Complete the required fields and click Save.

On the next page, click Edit and then Add More.

Check the 'Not MUSC Personnel' box.

Training

Q5.1 Do I need to take a training course?

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.

Q5.2 Do others listed on my study need to complete a training course?

A5.2. Yes, all study personnel listed on the IRB application must complete the CITI training. See the Education and Training page.

Fees

Q6.1 Is there a fee for submitting to the IRB?

A6.1. There is a fee for corporate sponsored and non-sponsored studies.

VA

Q7.1 How do I contact the VA R&D committee?

A7.1. Follow the Link to the Charleston VA Research Service.

Contact Information

Q8.1 I have some questions about my IRB submission. Who can I talk to?

A9.1. The IRB is happy to help. Please feel free to contact the Administrator or Coordinator for your Board. See the IRB Contacts page.

Office of Research Integrity

Institutional Review Board for Human Research

Frequently Asked Questions

IRB Application

PI Statement of Assurance

Informed Consent

Change In Personnel on Study

Training

Fees

VA

Contact Information

IRB Application

PI Statement of Assurance

Informed Consent

Change In Personnel on Study

Training

Fees

VA

Contact Information