How to Access Samples from the Immune Mediated Disease Registry

How to access samples from the Immune Mediated Disease Registry.

Access to either samples stored in the IMD repository or fresh blood samples from participants in any of the IMD Registry modules is available to any BRI investigator. Access to this resource is based on the availability of the samples and /or access to donors and whether the proposed use of the samples is consistent with the IMD Registry IRB approved protocol.

Two steps are required to access to samples. 1) We must submit a study modification of the 7109 IMD Repository IRB for each funding source which uses IMD samples. This will be used for the entire period that you will have the funding source. This modification undergoes expedited review by the IRB chair. a. To do this we have created a study modification form for this purpose (create a link), it should be filled out completely and sent electronically to Thien-Son Nguyen in the clinical core. He will circulate this form for signature by the clinical investigators who’s subjects/samples are to be used in the study and will then submit it to the IRB. It should contain a description of the hypothesis tested and how samples will be used does not need to be long, but does need to clearly state what is being asked, what is being tested and how the samples will be used in a manner which will allow the IRB Chair to determine if the samples will be used in a manner consistent with the IMD registry protocol and consent. An important point is that the description should be broad enough to apply to any samples that you will need related to this grant, for the duration of the grant. A letter from grants noting that your grant has been approval via this study modification to be part of the 7109 IRB protocol will be part of your the IRB documents you give to any funding agency. 2) For each group of samples requested we have a Gatekeeper form- this will relate to each group of samples that will be pulled from freezers, or those that are drawn from patients. This is a much more detailed form and will address specifically the type and quantity of the samples, to whom in your lab they will be given, and the associated clinical information that will be needed. For example for one study you may make 3 different gatekeeper form requests over 1 year: a. You could request that 20 serum samples from subjects with RA and 20 serum samples from controls to be pulled from the core for an Ab assay. b. You may request fresh samples from control subjects on a weekly basis for 6 months to test response to type II collagen. c. You may want to do a pilot study requesting heparinized blood from 5 subjects with RA using T1D subjects matched for HLA as controls.

Each of these requests could be generated from the same grant and would use the already existing study modification linked to that grant, but each request would have a unique gatekeeper form- this will help the clinical core staff and coordinators keep track of what is needed. When subjects with diseases are used, the clinical PI of the module that recruits these subjects will be asked to approve the use of the samples, and may want to discuss study design and type of subjects requested.

3) How to arrange for sample delivery: a. Once the IRB has approved a study modification, and a gatekeeper form is complete fresh samples can be requested via the Translation Research Calendar- this calendar allows researchers to enter the type of sample they would like on a given date- then the clinical coordinator will note on the calendar that they have identified a subject to be drawn that day. b. Frozen Samples will be identified in the clinical core then transferred the the scientist who has requested them.

Each sample will come with a transmittal form- this form will note the sample ID number, and any information that is required at the time the samples is used. The sample ID can be used when further linked clinical and research data are needed on any subject.