Here s how this whole external IRB thing works: A handbook for external IRB submissions

Transcription

1 Here s how this whole external IRB thing works: A handbook for external IRB submissions For all communication relating to external IRBs, call or CentralIRB.Office@aurora.org. External IRB means any IRB that is not the Aurora IRB. It refers to NCI CIRB, WIRB, or any other IRB that we might use at some point in the future. This is a supplement to the formal policy (RR409), and should help you figure out the exact details of the process and who needs to do what. Click on the links below to go to a specific section, or keep scrolling to review the entire process. Initial Submission... 2 What you need to do... 2 First, make sure it meets our requirements... 2 Completing the submission A... 3 Once you ve assembled your required materials... 3 What we do... 3 COIs... 4 Protocol Synopsis... 4 All that information in section IV of the Request form... 4 After your request is approved... 5 What you do... 5 What the external IRB does... 5 What we do... 5 Hooray! My study is up and running. Now what?... 5 Information for all studies:... 5 I need to change something v. 06 June

2 I have a problem. A really, big, serious problem I m confused about whose SOPs to follow It s continuing review time!... 7 What you do... 7 What we do... 7 When the study is over Initial Submission What you need to do Congratulations, you have a study that you want to submit through an external IRB! Now what? First, make sure it meets our requirements. The study must be: Open through the NCI CIRB; or A study where Aurora, as an institution, has a conflict of interest related to the research; or A study meeting all of the following criteria: 1. A Phase III or IV drug study or a device that has significant previous research in humans and an established safety profile; and 2. An industry or federal cooperative group sponsor; and 3. No investigators or key personnel have a disclosed conflict related to the research; and 4. Aurora is not the lead/coordinating site. If your study doesn t meet these qualifications but you really, really need it to go to an external IRB for some reason, contact the RSPP director to discuss. Completing the submission Once you re sure your study qualifies for external IRB review, you re going to need a few things in place before you can submit the request, so start putting those together. Rule #1: None of the items listed in this section can be pending in your request. We want to turn these requests around quickly, but there is simply no way for us to guarantee a 3-business-day turnaround if we have to wait on anything from you, so have everything ready. If it s not ready, wait to submit your request. Administrative approval from P-CR manager or Randy Lambrecht. You ll include this with your request. We aren t terribly specific in what we require, but at a minimum, it needs to have the name of the person giving approval and the study title. v. 06 June

3 Administrative approval from any other departments whose cooperation is needed to run the study. Don t actually send these to us, but just mark the box on the form saying you have them (or that none are required for this particular study). PI acknowledgement. We want to know that the PI is on board with submitting to an external IRB. An is fine, or if you want to get some kind of signature, that s fine too, but whatever you submit should have the study title and mention something about using an external IRB. Research certification for everyone who is going to be on the study. If it s pending for someone, hold off on submitting (and hound that person until you get it), or leave them off the study and add them via mod once they ve completed it. Conflict of interest (COI) for everyone who is going to be on the study. If it s pending for someone, hold off on submitting, or leave them off the study and add them via mod once they ve completed it. Protocol synopsis. This should be a short summary of the protocol that gives the basics, typically 3-5 pages. If you don t have one, ask your sponsor. Most sponsors have something along these lines. We don t want the full complete protocol unless you really have nothing else. We re trying to do a quick turnaround, and reading a full protocol won t help anybody. The exception to this is NCI studies, because we can log into NCI CIRB s website and look at all the protocols there ourselves. I can t stress this enough: none of these items may be pending when you submit your request. If we discover something is pending, we ll let you know that we are not processing your request. Re-submit it when everything is in place. If you re not sure if someone has research certification or a COI on file, feel free to call us and ask. We d be happy to look it up for you. 502-A: If you are going to look at medical records for research purposes, either preparatory to research (identifying potential subjects or pre-screening) or a HIPAA waiver, then you ll need to include a 502-A with your submission. Note: The 502-A is the only thing that may be submitted after the initial request. Why can this be pending? When you submit a study to the Aurora IRB, two functions are actually being fulfilled: 1) IRB and 2) HIPAA Privacy Board for research. When you use an external IRB, the HIPAA Privacy Board part of the role is still the Aurora RSPP s responsibility, and the review/approval of a 502-A is part of that role. It has nothing to do with whether the Aurora IRB or any other IRB review is the IRB of record. It s probably going to be simpler for everyone if you submit the 502-A at the same time as everything else, but the 502-A will not affect the decision of whether to approve the request. Once you ve assembled your required materials Complete the Request to Rely on an External IRB form, which can be found on our website. Send it, along with all your attachments, to CentralIRB.Office@aurora.org. What we do When your submission comes in, we will send an acknowledgement . This will basically say that we will review the submission and get back to you within 3 business days. v. 06 June

4 After that, we review the request and materials. If you forgot to include something, we ll tell you what the problem is and we will put review of your request on hold until that missing piece is received. Please note: if anything is missing, the time we spend waiting on you to send it in does not count towards our 3 business day turnaround time. Here s a breakdown of some of the specifics we re looking for and how we handle them: COIs: In the RSPP office, we keep a spreadsheet that lists every person who has completed a COI related to research. The spreadsheet has all kinds of fun information like the person s name, address, date the COI was completed, whether there are disclosures, and the sponsor name(s) for any disclosed conflict(s). There are no financial details about the conflict on this spreadsheet. Everyone s information is confidential. For every study, we do a search for each investigator / key personnel. We make a list of everyone who has a conflict disclosed and which sponsor the conflict is with. We then review the submission/protocol synopsis for any reference to those companies. If the disclosed conflicts obviously have nothing to do with the study, we re good to go. If Joe Smith has a conflict with ABC Pharmaceuticals, and the study sponsor is ABC Pharmaceuticals, then Lori would review the submission and the specific details in Joe Smith s COI disclosure to determine whether a Research Integrity Committee (RIC) management plan would be needed. If anyone on the study has a COI disclosure that requires a RIC management plan, we will deny your request to use an external IRB. The study will have to be reviewed by the Aurora IRB instead. While we will do everything we can to stay within our expected 3 business day turnaround, the time required to thoroughly review and evaluate a COI disclosure could delay our response time. If you ever want to know whether the investigators/key personnel on your study might have a related COI before you submit, just call us up and ask. We can check the spreadsheet and let you know. However, we won t provide any financial details. Protocol Synopsis What we re looking for: anything that we think would pose a significant ethical concern for our IRB. Example: if you re enrolling minors with psychiatric illnesses or doing experimental brain surgery, we may deny the request and have you submit through the Aurora IRB. Your run-of-the-mill Phase III trial for subjects with hypertension is probably fine to go. All that information in section IV of the Request form Why do we ask for all these things? IND/BB-IND number: We are required to keep a central record of the INDs for all investigational drugs in use at Aurora. IDE number: Similar to INDs, we are required to keep a record. But we also use this information to flag for an additional administrative approval: Device credentialing. We in the RSPP office contact Device Credentialing to ask about privileges for physicians on all device studies. We can t check this ourselves; we have to wait until we hear back, which means that our overall response time may be delayed. v. 06 June

5 Recombinant DNA: If you are using this for your study, an Institutional BioSafety Committee will be required to oversee the research. Depending on the nature of the research, we may decide we prefer to keep these types of studies in house. Radioactive materials: Radiation Safety Committee approval is needed, in addition to other administrative acknowledgements. Depending on the nature of the research, we may decide we prefer to keep these types of studies in house. Questions about subjects protected health information: As the HIPAA Privacy Board for research, the Aurora RSPP is responsible for ensuring that subjects information is adequately protected. We have provided some convenient checkboxes, but of course if you are using other/additional protections, please list them here as well. After your request is approved What you do Create your ICF (of course, you can do this earlier, too). You must use the Aurora header, footer, signature pages, injury language, and HIPAA section. You can customize the rest according to the sponsor and/or external IRB s requirements. Submit the study to the external IRB, using their forms. What the external IRB does They will notify us when they have reviewed your submission, and the results of that review (e.g. approval, or approval with conditions). It s possible we will run into situations where the external IRB does not automatically notify us. In those instances, please be flexible and work with us to make sure we get notifications in a timely manner. What we do Once approval is received, we notify the Institutional Official, the Aurora IRB, and the Sr. VP of Research that the study has been ceded to an external IRB. Hooray! My study is up and running. Now what? Information for all studies: Violations: Keep a record of all noncompliance that does not require reporting to the external IRB (e.g. minor violations/deviations). Submit this log annually to CentralIRB.Office@aurora.org. To make it easier to remember, we recommend that you send this log to us when you submit your continuing review to the external IRB. v. 06 June

6 Quality Assurance: Your site may be selected for routine QA monitoring by Aurora personnel. QA audits are designed to identify any potential issues before they become audit findings by a sponsor or the FDA. QA monitoring applies to all Aurora studies, regardless of what IRB is overseeing them, because we want to ensure that we are conducting high-quality research and keeping our subjects safe. Continuing Education: All investigators and key personnel must fulfill all the continuing education requirements mandated by the Aurora RSPP (e.g., research certification). I need to change something. Changes to key personnel or study sites: Anytime you change investigators or key personnel, send us an to let us know first. We will check that the individual has the appropriate research certification, privileges, COI, etc. and update our records. Same goes for sites we will make sure the appropriate administrative sign-offs are in place. Once we ve checked everything out, we ll send you an either telling you what still needs to be done, or giving the ok to submit the change to the external IRB. Changes in a 502-A request: Although we are not the IRB of record, Aurora is the covered entity under HIPAA so we still act as the HIPAA Privacy Board for all Aurora studies. If you want to look at medical records for research purposes but you didn t originally request it, submit a 502-A. If there are any changes to a previously approved 502-A, submit that to us, too. the new/revised 502-A to us. Conflict of Interest: If any investigators or key personnel have changes in their conflict of interest disclosures, they must update their COI forms within 30 days. Changes to the study design, protocol, recruitment, or anything else that affects the regulatory criteria for approval: Submit to your external IRB only. We don t need to review these at all, unless it involves a change to our required HIPAA or injury language in the ICF. If it does, send us an to talk about it. I have a problem. A really, big, serious problem. Unanticipated Problems: If the unanticipated problem occurs at the local site and results in significant harm to the subject (e.g. Sentinel Events), report the event as soon as possible. You can send us a copy of the form you used to report the event to the external IRB. Serious or Continuing Noncompliance: We will receive automatic notifications from the external IRB of any findings of serious or continuing noncompliance. It s possible we will run into situations where the external IRB does not automatically notify us. In those instances, please be flexible and work with us to make sure we get notifications in a timely manner. I m confused about whose SOPs to follow. This question has come up primarily with relation to what types of violations and adverse events are reportable. Aurora s SOPs don t necessarily require the same reporting as an external IRB s. If there is a difference, follow the reporting requirements for the external IRB. However, any violations that do not meet the external IRB s reporting requirements should be added to your log that is submitted to us annually (see Violations above, under Information for all studies) v. 06 June

7 It s continuing review time! What you do Submit your continuing review to the external IRB. Once it has been approved, send us an letting us know the date of re-approval. This would be a great time to submit your log of minor violations. What we do We enter the new approval date into our ProIRB database and review the minor violation log. If there are any issues or concerns with violations, they will be referred to the Noncompliance Subcommittee for further review. If there are no concerns, we will simply file the information. When the study is over. Once your study is closed out with the external IRB, us to let us know. We will then notify the Institutional Official, the Aurora IRB, and the Sr. VP of Research. v. 06 June