Frequently Asked Questions (FAQs) about the Revised Clinical Research Guidelines and Research Processes at Advocate Health Care

1. What do I do when I am contacted by a sponsor about participation in an adult clinical trial?

Schedule a meeting with the PI, project coordinator, sponsor representatives and anyone else you would usually involve at this stage of the project. Also include the Director of Research Services at your site. Since the Director will be the person who will ultimately complete and process the budget, the contract, the IRB submission/informed consent and work with the inhouse oversight representative, it is in the best interests of the timely move-ahead of the project to involve the Director for your site from the very beginning of the project.

2. Do these new guidelines (July 2004) apply to all clinical trials at Advocate Health Care?

Yes, the new guidelines apply to all clinical research - including funded trials - both adult and pediatric - that occur across the Advocate Health Care System.

3. Do the Directors of Research Services have responsibilities outside of clinical trials?

Yes. The Directors also work with residents and fellows to help them design and carry out the research they are required to do while at Advocate Health Care. While they do not do data collection, or input data itself, they will work with the physican to help them complete those activities, helping them identify and use the resources available to them at their site.

4. Do the Directors of Research Services conduct research activities for attending physicians other than those related to sponsored clinical trials?

Yes. We can be available to investigators for help with projects other than funded clinical trials. We can consult with investigators regarding the development of the research protocol, and procedures for data collection, management and analyses.

5. How long will it take to get the trial approved (i.e., we will be able to begin enrollment)?

The IRB application can be submitted during the same time we are negotiating the contract and the budget. The qualifying statement here is that the sponsor must agree to pay the costs of the IRB review whether or not the negotiations for the contract and budget are ultimately completed. Sponsors are likely to be agreeable to that proviso. Given these time constraints, coupled with inhouse sign-off processes by oversight personnel, it will usually take 5-7 weeks to get a study up and running from the time we receive the proposed contract, budget, and study protocol from the sponsor.

6. I already have a study coordinator hired to do data collection, but I do not have an administrative research person on my staff. How and when does the Director of Research Services fit into this picture?

If your study coordinator would prefer - and you would also prefer that person - to continue doing all of that initial paperwork, then they should work closely with the Director to make sure that all of the new guidelines and procedures are being followed. The Director will be able to advise your coordinator on how to overcome difficulties that may arise. Remember that freeing your clinical research coordinator from these administrative start-up responsibilities will likely free that person to complete the data collection and regulatory activities in a more timely and efficient manner.

7. Shouldn't we ask for more than 25% for our reimbursement for indirect costs for some sponsored trials?

The federal government controls the amount we can ask for. Presently 25% is nearly maximum for F&A costs for clinical trials. We will annually monitor what other institutions are receiving for industry-sponsored research to make sure our costs are in line with what others are receiving.

8. Why so much for administrative costs such as contract and budget negotiations?

It takes a lot of time to review each provision of a clinical trials agreement and to negotiate to make sure we protect the intellectual rights of Advocate Investigators and that we are obtaining appropriate indemnification from the sponsor. We have to make sure that budgets are properly negotiated in "real time" and that they are appropriately negotiated and agreed upon before attaching them to the contract. In many instances we have to learn the costs that will accrue to Advocate Health Care so those will be accurately reflected in the budget. Frequently we will have to negotiate several line items within a budget. All of that takes time.

9. Who will negotiate the different budget from the one proposed by the sponsor and the one developed by the Director of Research Services?

The Director at your site will do that negotiation - as well as the contract negotiation - working closely with project personnel.

10. Can anybody in the Advocate system call and have you negotiate their budget and contract and help get their research up and going?

Please see FAQ #6 above. If you already have personnel dedicated to the preparation of these documents, then that personnel will likely continue to do that work. However, they will be asked to use the new budgeting format that has been adopted within the Research Guidelines. The Guidelines outline the step by step processes within the new guidelines for the type of research you are initiating. The Director of Research Services will help your staff work through any unfamiliar processes and will also help your administrative personnel work through the use of the new budgeting template. Please click here for the Clinical Trial Budget Template and Clinical Trial Budget Justification/Explanation.

11. Is Advocate Health Care trying to make a profit from clinical trials?

No. We are just trying to be as certain as possible that Advocate Health Care does not lose money on its participation in these projects.

12. I already have an administrative staff whose job is to negotiate my contracts and budgets, as well as do my data collection activities. How will your staff work with them? Will you do my contracting and budgeting?

Yes we will work closely with you in regard to contract and budget negotiations. Please see answers to FAQs 6 and 10 above. We will work with your staff to help them understand the use of the new budgeting template, however. We will also be available to answer inquiries about the new research guidelines.

13. The IRB has an initial filing fee of $1500.00 for the review of an initial funded research application. Who will bill the sponsor for that fee?

Even though the fee itself is included on the template for the study budget, the AHCIRB will bill for the fee, unless the sponsor indicates they will only accept statements from the Study Coordinator. In that latter instance, the Study Coordinator will prepare the bill and forward it to the sponsor. A copy of the statement should also be sent to Finance at OBSC.

14. Are there other standardized forms for adult research in addition to the budget template for research?

Yes. Those forms are at the Medical Education and Research website.

15. What happens to funds that may be left over at the end of a research project?

This is a post-award issue and all questions relating to distribution of project funds should be directed to Susan Toler at OBSC (52-5192).

16. Do the Advocate Research Guidelines cover other research projects than clinical trials?

Yes. In addition to industry-sponsored clinical trials, the guidelines also cover investigator-initiated projects, projects funded by sponsors such as the National Institutes of Health, or sub-contracts that are signed with other institutions (such as the University of Illinois at Chicago). There are also provisions for the conduct of cancer cooperative trials and for non-funded projects. In one way or another each of those projects involves budgeting and contracting (even if that "contract" is as simple as a letter of agreement) and are subject to the business sign-off procedures of the research guidelines. Processes are outlined in the Guidelines for both adult and pediatric research projects.

17. May we include in all research budgets charges for activities such as preparation of IRB applications, preparation of reports to the IRB (for example to report an adverse event), and preparation of annual reports to the IRB?

No. These preparation fees are only applied in the instance of sponsored (funded) studies, such as clinical trials or sponsor-funded investigator-initiated research. At the present time, unless outside funding is available, there is no mechanism within Advocate Health Care to reimburse the investigator of the project for these very valid and appropriate project-related charges.