Instructions & Forms for Requesting Samples and Subject Identification
The NIEHS is establishing a repository of DNA samples collected as part of the Environmental Polymorphisms Registry (EPR). This is an ongoing project initiated 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 with unique identification numbers but these are linked to the subjects’ identities, allowing investigators to re-contact subjects with the “genotypes of interest” for follow-up studies.
Researchers can request DNA samples from the EPR by following the instructions below. NIEHS investigators are allowed to genotype the EPR samples under existing NIEHS IRB protocols (04-E-N053 and 02-E-N004). Outside investigators must follow the regulations of their own institution for obtaining IRB approval or IRB exemption in order to receive EPR samples for genotyping. Documentation of IRB approval or exemption will be required.
A major objective of the EPR is to facilitate studies that require ascertainment by genotype. Therefore, priority will be given to genotyping projects that are likely to lead to follow-up studies. However, follow-up studies will require their own IRB review and approval - no EPR samples will be decoded for follow-up studies until IRB documentation is provided. The instructions for requesting the identities and contact information of EPR subjects for follow-up studies are also below.
For non-NIEHS investigators there will be a charge for receiving the EPR samples. This helps to defray the costs of sample collection, preparation, and distribution. An estimate for the cost of the samples will be provided to the recipient by NIEHS.
Individual sample quantities are limited, so please request only the minimum amount required. The maximum limit is 1 μg DNA per sample. Samples can be requested by gender, race/ethnicity, age, and type of population (clinic or general population). For outside investigators who will seek IRB exemption, the key linking the samples back to the subjects’ identities can be completely destroyed after they are shipped, if requested.
Investigators requesting EPR DNA samples for genotyping must do the following:
- Complete the attached EPR Sample Request/Genotyping Project Overview Form (72KB) . The information for Item #11 should not exceed 2 pages. All information provided in this Form will be kept confidential.
- If the recipient of the EPR DNA samples is a non-NIEHS investigator, he or she will be required to complete and sign the EPR Material Transfer Agreement (MTA) (44KB) .
Submit the EPR Sample Request/Genotyping Project Overview Form to Shepherd Schurman (919-541-7736, firstname.lastname@example.org).
Applications will be reviewed by the Core EPR Steering Committee which consists of Shepherd Schurman, MD (EPR Principal Investigator), Nell Burch, PhD (Molecular Genetics Core Facility), Perry Blackshear, MD, PhD (Laboratory of Signal Transduction), Jack Taylor, MD (Epidemiology Branch), Fred Miller, MD, PhD (Environmental Autoimmunity Group) and Paul Watkins PhD, (Director, Hamner Institute). Subject matter experts might be added to the Core Steering Committee if needed.
If approved, the investigator will receive the required number and type of EPR DNA samples in coded form. Any investigator who receives EPR samples agrees to retain control of 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 EPR Steering Committee. The investigator also agrees to dispose of the EPR samples as directed by the Committee once the project is completed or after three years have elapsed. For outside investigators, these rules and responsibilities are also outlined in the mandatory EPR Material Transfer Agreement (MTA) (44KB) .
The Core EPR Steering Committee recommends and encourages that researchers publish all findings of new genotypes in dbSNP . Instructions for contributing SNP genotype data to dbSNP are available under the link.
Subject Identification for Follow-up Studies
Once genotyping and data analysis are complete, if the investigator wishes to have samples decoded in order to re-contact EPR participants for a follow-up study, she or he must do the following:
- Obtain scientific approval based on the rules and regulations of his/her own laboratory, branch, and/or institution.
- Obtain IRB approval from the appropriate IRB for their institution.
For NIEHS investigators, information for the NIEHS IRB can be found at: http://www.niehs.nih.gov/about/boards/irb/
- Submit the EPR Study Review Form (67KB) and IRB Study Protocol with documentation of IRB approval to Shepherd Schurman (919-541-7736, email@example.com).
Applications for follow-up studies and sample identification will be reviewed by the EPR Steering Committee. Once the application is approved, EPR samples can be decoded and contact information provided.
For questions concerning these applications or the EPR, contact Shepherd Schurman (919-541-7736, firstname.lastname@example.org).