Frequently Asked Questions

Why was my study chosen?
Studies are chosen for different reasons. All studies that use humans as subjects and are approved through the University of Minnesota's IRB can be chosen for a compliance review. See the Compliance Review Selection and Process page for more information.

What will happen during the compliance review?
The compliance officer will meet briefly with the PI to ask/answer questions regarding the study and/or the compliance review. The compliance officer will review all of the study materials and documentation. A final report of the findings will be written after the compliance review. More details are available on the Compliance Review Selection and Process page.

What materials will be reviewed?
The materials reviewed are those which the ICH Good Clinical Practice guidelines state should be available for research studies. A general list is available on the Compliance Review Selection Process page.

How long will the compliance review take?
The meeting with the PI should take 20-30 minutes depending on the number of questions that need answers. The amount of time needed to review the study materials varies greatly depending on the number of subjects, the extent of IRB/sponsor correspondence and regulatory documents.

What happens after the compliance review?
The compliance officer will write a report of the findings from the compliance review. The compliance review will be considered closed if no follow up is needed. Either the ORA or IRB will determine the need for follow-up and notify the PI of what needs to be done.

What if my schedule does not allow me to meet for several weeks?haton a big That is o.k. Please inform the compliance officer of your situation and a date in the future can be arranged for the compliance review. For many of the compliance reviews, there is no deadline.

Is a signed consent form sufficient documentation of the consent process?

• Informed Consent is a process that includes the signed consent form document

• The consent process begins when a potential subject is interested in participating in a research study and it continues until the end of the follow-up

What is often recommended is keeping a separate log sheet for each subject and documenting the processes such as:

• The date when consent was obtained

• Specific/relevant questions and answers given to subjects.

The reason for the consent process documentation is to:

1. have a record of all their concerns and the answers given, if in case there are any issues during the study.  There is no reason to document everything, but documenting significant questions about stopping other medications, etc. is very important.

2. help prove that there was no coercion or pressure to join the study.

3. have enough evidence (back-up) to prove that consent was properly obtained, if you loose or misfile the consent form.

What should be done when there is a "PI's Signature" line on the consent form, but the PI is not present when consent is obtained and the subject signs the consent form?

1.  Regulatory Affairs will not give a citation for failure of a PI's signature and date since it is not required by the code of federal regulations that the PI should sign the consent form. However, depending on other circumstances and the type of the study, we might mention that issue in the report and suggest corrective actions, such as a note to file explaining the situation.

2.  As a general rule, the signature of the person obtaining the consent from the subject is highly recommended.  So, if you are submitting the consent form to the IRB with changes, it is recommended that instead of the "PI's Signature", change the language to "Signature of the Person Obtaining the Consent" or "Signature of the Research Staff Obtaining the Consent".

3.  Having a signature line for the PI and not complying with it can be misconstrued as poor research management practice, which can easily be avoided.

When protocols require procedures at specific times but do not identify acceptable windows around those precise times (for example, the protocol says blood will be drawn 12 hours post drug intake but does not clarify +/- 2 hours as acceptable), is it a protocol deviation if the procedure does not happen at the exact time?

FDA's response*:

It is truly unrealistic to expect samples to be drawn at exactly the same time or day prescribed when working with a number of individuals, and protocols therefore usually include acceptable windows.  Noting the file might be sufficient to allow for satisfactory inclusion of all subjects when the study results are analyzed.  However, it would be best for the sponsor-investigator to first consult with a biostatistician as to the widest reasonable window that would allow for the data collected to be considered medically and statistically equivalent.  While the sponsor-investigator might want to retain all the data collected to date, some may not be acceptable for analysis if the window was to wide.

*This information does not necessarily represent the formal position of the FDA but rather is an informal communication which represents the best judgment of the employee providing it.