Bumc irb consent form

If you have an IRB-related question, others probably do too! This column is an opportunity to answer your questions. Check in each month to see the answers to some of the most common questions asked by the research community. To find more questions from previous months, click here to search the archive.

Please send your questions to crtimes@bu.edu.

Questions:

• I am planning on obtaining consent from subjects who don’t speak English. What do I need to do?
• I am the PI on several IRB protocols. I got a new job at a different institution and am moving there. What happens to my research here?
• Is there a way for me to check the status of my submission without calling the IRB? If I could check online, it would save time for both of us!
• I had an Analyst who reviewed all my studies, and now that person doesn’t work at the IRB anymore. Who’s my new Analyst?
• I created the consent form using the INSPIR consent form builder, but when I downloaded it to my Mac, the headers and footers were not there. How can I get them to show up on my consent form?

1. Submit your protocol to the IRB with the consent form in English (written as clearly and simply as possible).
2. BUMC IRB approves the English version of the consent.
3. Submit the protocol with the English version of the consent that has been approved by the BUMC IRB to the local/international IRB.
4. Local IRB approves the English version of the consent.
5. Final English version of the consent is given to a “qualified translator” for translation.
6. The English version and the translated version are given to a second person who serves as a “verifier”. The “verifier” compares both versions and verifies that the translation is an accurate reflection of the English consent. The verifier signs the attestation form.
7. PI submits, as an amendment to the protocol, a copy of the translated consent form with the attestation form.
8. The IRB validates (stamps) the translated consent form and now it is ready for use.
9. The study staff in the field is instructed to only use English consents and translated consents that are validated (stamped by the IRB) and have NOT expired.
10. BUMC IRB should give a new validation (date stamp) for all consents (English and translated) at the time of each continuing review.

• Q: I am the PI on several IRB protocols. I got a new job at a different institution and am moving there. What happens to my research here? Can I keep my studies open here and also work on them at my new job? Can I stay on as the PI at BUMC?

A: Congratulations on your new job. As for your move from BU/BMC, the general rule is that only persons whose prime appointment is at BU/BMC can serve as the PI on BU/BMC IRB protocols. Also, if the study involves any HIPAA Protected Health Information (PHI), then you must ensure that you remain compliant with the HIPAA requirements. This usually means that you may not remove the data from this institution without IRB review of the HIPAA Authorization /HIPAA Waiver of Authorization. Here are some guidelines for your move.

The Options

Current/open /ongoing studies:

• You can close those studies here at BU/BMC.
• You can transfer the studies to your new institution and close them here. (You will need to consult the grants office /general counsel’s office about moving data and funding to another institution.)
• You can appoint a new (qualified) BUMC PI to take over the study. You can remain a co-investigator if you continue to have a BUMC appointment, but you will probably need to get IRB approval from the new institution. If the funding is being transferred to the new institution, especially if the new institution will be the prime recipient of the award, then you will absolutely need IRB approval there (the prime awardee institution is automatically engaged in the research even if all the activities involving human subjects only occur at sub-award sites).

Studies in data analysis:

• You can transfer these studies to another BUMC PI (though the IRB is going to request that some of these studies that have been open forever for data analysis be closed).
• You can “de-identify the data” by destroying the master code and remove all identifiers (including complete dates) from the data set. Then, the IRB protocols can be closed and you can keep the anonymous data for future secondary analysis.
• You can open a repository protocol and place all the data from multiple studies into the repository for future analysis. There will need to be a PI with a primary BU/BMC appointment to serve as the PI for the repository.
• You can transfer the data to your new institution for continued data analysis. You will have to submit an amendment for each individual study to request to move the data. If the data being moved contains identifiers or you want to retain the master code, then it will likely require a Data Use Agreement with a HIPAA Limited Data Set and a new IRB protocol at the new institution.

Instructions for changing PI in INSPIR:

• Submit an Internal Study Personnel Change form requesting to change the PI. **This is actually a different form than a standard change amendment form. The internal staff change amendment can be submitted at any time--even when another amendment or progress report is pending.
• This form needs to be signed off via INSPIR by the current/existing PI (that would be YOU).
• Once it is submitted, the IRB will process this change.

• Open the study in INSPIR. Under the SUBMISSIONS tab, click on SUBMISSION HISTORY.
• This will bring you to the (current) SUBMISSION IN PROCESS.
• In the 4th column on this page, you will see a column called TRACK LOCATION. Click on the icon next to the submission item in this column.
• This will bring you to a page showing you the entire progress of that submission item, when it was received by the IRB, and when /if assigned to a reviewer/panel.
• If it hasn’t been assigned to a Panel yet, that only means that it is in the queue, but there are other studies ahead in line awaiting pre-review assignment.
• If you see that it’s assigned to a Panel and says, “Full Board or Expedited,” please know that this is a determination that has been made during the pre-review phase. This determination is based on a cursory review of the study. It is possible that after an in-depth review, that the review path determination might change.
• Once you see that it has been assigned to an individual Analyst or to a Panel, then that is the person/persons that you may contact with any specific questions/concerns regarding the protocol.

• Panel Green: predominately biomedical studies; oncology and dental protocols
• Panel Blue: social-behavioral and biomedical protocols; international studies
• Panel Orange: social-behavioral research; genetic and repository protocols
• Panel Red: expedited and exempt protocols (biomedical and social-behavioral)
• Panel Purple: continuing reviews. Panel Purple focuses on reviewing progress reports for the other panels. Studies are not, as a rule, assigned to Panel Purple for initial review or amendments.

A: INSPIR II creates and downloads the consent form in Rich Text File (RTF) format. This RTF consent form needs to be opened on your Mac in Microsoft Word for the headers and footers to be included. Instead, Macs by default open RTF files using “TextEdit” which strips the file of any advanced Word features. The only solution is to tell the system to “Open with” MS Word all RTF files by default. To do so, first click on the “Downloads” icon on your screen (at the bottom) and then select “open in Finder”. In the “Finder”, locate the RTF consent file and right-click on it (on a touchpad, click with two fingers). Select “Get Info” from the dropdown list. In the “get Info” popup, under “Open with”, select “Microsoft Word”, and then click on the “Change All…” button to set it as the default. Now when you open the RTF consent form, it should open in MS Word, and the headers and footers should be there.