Researcher Instructions

Instructions & Forms for Accessing EPR /Samples

The NIEHS is pleased to announce the availability of a repository of DNA samples collected as part of the Environmental Polymorphism Registry (EPR). The EPR is an ongoing DNA repository established by the Office of Clinical Research to help NIEHS and other scientists screen for genetic polymorphisms in “environmentally sensitive genes”. The DNA samples in the EPR are coded but linked to the participants’ identities, thus allowing investigators to re-contact individuals with “genotypes of interest” for follow-up studies. Genotyping can be conducted on the coded samples under the existing EPR IRB approvals, but follow-up studies that will require sample identification will require their own IRB and other relevant approvals (scientific, OMB, etc.).

Genotyping and Sample Requests
Genotyping of the samples will be the responsibility of the individual requesting investigator. Investigators wishing to use the EPR DNA samples for genotyping must do the following:

1. Apply to the Office of Clinical Research by completing the attached Genotyping Project Request Form ( (http://www.niehs.nih.gov/research/resources/databases/epr/docs/project-request.pdf))   (125K).

2. Provide a written brief Genotyping Project Overview of the project including the information listed below. This should be no longer than three pages:
   
   
   1. background information on the candidate gene(s)
   2. specific genotypes that will be assayed and their relevance to a clinical trait or disease
   3. genotype prevalence in populations, if known
   4. describe previous genetic studies
   5. study hypothesis
   6. other supporting data
      
      
3. If the recipient of the EPR DNA samples is a non-NIEHS investigator, he or she will be required to sign a Material Transfer Agreement ( (http://www.niehs.nih.gov/research/resources/databases/epr/docs/mta.pdf))   (1M).

Submit the Genotyping Project Request Form and attached Genotyping Project Overview to Michael Spencer, Clinical Program Coordinator (ext. 1-1168, spencermi@niehs.nih.gov).

Genotyping applications will be reviewed by the Core EPR steering committee. These studies can be performed without additional IRB review, since the genotyping of coding samples in the EPR has already been approved by the NIEHS, NIH, UNC and Rex IRBs. The Core Steering Committee consists of the NIEHS EPR principal investigators (Drs. Perry Blackshear and Pat Chulada); Dr. Paul Watkins, Director of the General Clinical Research Center, UNC; and Dr. Douglas Bell, Senior Investigator, Laboratory of Computational Biology and Risk Analysis (LCBRA). Depending on whether a relationship has already been established with potential investigators, requests might be reviewed by all four committee members or only by selected members. Subject matter experts can be added to the Core Steering Committee if needed.

If approved, the investigator will receive a limited amount of DNA in coded form from the full EPR or one of its subgroups. Any investigator at the NIEHS or at an outside research institution who receives DNA samples from the EPR agrees to retain control over the samples at all times. The investigator further agrees not to transfer one or more EPR samples to other people not under his or her direct supervision, unless first obtaining permission from the Core Steering Committee. The investigator also agrees to dispose of the EPR samples as directed by the NIEHS EPR PIs once the project is completed or after three years have elapsed.

There will be a charge for receiving the EPR samples. This helps to defray the costs of sample collection, preparation, and distribution.

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Sample Identification and Follow-up Studies
Once genotyping and data analysis are complete, if the investigator wishes to have samples identified and conduct a follow-up study, she or he must do the following:

1. Obtain scientific approval based on the rules and regulations of his or her own laboratory, branch or institution.

2. Apply to the Office of Clinical Research by completing the Pre-IRB Study Approval Project Request Form ( (http://www.niehs.nih.gov/research/resources/databases/epr/docs/preapproval.pdf))   (14K).

3. Provide the standard IRB Study Protocol.

• IRB Study Protocol Form

• IRB Study Protocol Form

• NIEHS IRB Information(http://www.niehs.nih.gov/about/orgstructure/boards/irb/info.cfm)

Submit the Pre-IRB Study Approval Project Request Form and attached IRB Study Proposal to Michael Spencer, Clinical Program Coordinator (ext. 1-1168, spencermi@niehs.nih.gov).

The applications for follow-up studies and sample identification will first be reviewed by an expanded Full EPR Steering Committee. This also will serve as the pre-IRB scientific and statistical review (for NIEHS scientists only). The committee will consist of the EPR PIs (Drs. Perry Blackshear and Pat Chulada); Dr. William Schrader, the Deputy Scientific Director; Dr. David Resnick, Bioethicist; and Dr. Paul Watkins, Director of the UNC General Clinical Research Center. Depending on the complexity and scope of the study proposed, other individuals might be added to the Full Steering Committee and can include a medical and/or scientific subject matter expert, a biostatistician, and others relevant to the specific study. These can be extramural or intramural scientists. Once the application is approved, the investigator can then submit his or her proposal for IRB and other relevant approvals (OMB, etc.). Proof of all relevant approvals must be submitted back to the Clinical Program Coordinator before contact information on the EPR subjects is released.

Note - The IRB will not review any project which has not first been cleared by the EPR Steering Committee. Steering committee clearance does not substitute for IRB approval

For questions concerning these applications, contact Michael Spencer (ext. 1-1168, spencermi@niehs.nih.gov). For questions concerning the EPR, contact Pat Chulada (ext. 1-7736, Chulada@niehs.nih.gov).

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