The Reproductive Medicine Network (RMN) is comprised of a nationwide series of clinical sites and a data coordination center (DCC). It is charged with designing, implementing, and publishing the results of high quality clinical research in reproductive medicine. Various specimens have been and continue to be collected as part of the ongoing research activities of this network. Additional aliquots of samples are often retained for additional analyses and new tests as they are introduced. Specimen collection is conducted under the auspices of each local Institutional Review Board (IRB), with attainment of participants’ consent detailing whether use will be allowed for future projects that are either related to the initial project and/or other fields of medicine as outlined in the accompanying manuscript Casson et al. 2011
. Because of the ongoing rapid advance of genome technologies such consent must be mindful of whether genetic information could be collected and used.
Samples derived from randomized controlled trials in well-defined populations, represent a valuable resource for future research endeavors, both inside and outside the RMN. With the increased availability and capabilities of the rapidly evolving genome-wide-technologies, the biology of the system underlying the trial results now becomes accessible. Progress is often first revealed with the introduction of a suite of biomarkers [Sistare et al. 2010
]. These advances are poised to markedly change clinical practice as we know it today while moving towards personalized systems medicine.
Sample acquisition protocols along with repositories continue to be described [Ayers et al. 2007
; Ennis et al. 2010
; Gohagan et al. 2000
; Ugolini et al. 2008
]. One is referred to best practice resources of the International Society for Biological and Environmental Repositories [ISBER 2008
] and the National Cancer Institute Best Practices for Biospecimen Resources [National Cancer Institute 2007
]. Within this framework, the RMN established a biorepository that provides access to a source of clinically well-characterized human reproductive samples. These samples will be collected as part of three studies, which will be complemented by biorepository specimen storage as summarized in . All will have blood specimens collected including card blood spots, whole blood, serum, and the residual blood clot. Additionally, the Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation (AMIGOS) trial will collect semen for biorepository storage. Anonymized specifics of the study populations and clinical characteristics can be obtained from the DCC. It is projected that in total this will include at least 10,000 serum samples, 15,000 samples of whole blood, 7,500 FTA blood spot cards, 1,000 Oragene® recovered saliva samples, and 7,500 sperm samples. A description of the methods by which the samples are being collected and stored is outlined below in this Applications Note.
RMN studies, their primary hypothesis, and biorepository specimens to be collected.
Before initiating a collection
Prior to beginning any collection of human specimens for research and/or when beginning any novel research protocol, approval must be obtained from the local IRB committee [Baranzini et al. 2010
; Roach et al. 2010
]. Informed consent by participants must then be obtained before collecting any biological samples for research purposes and personnel must be appropriately trained in sample collection and personal biosafety. As discussed in the Casson et al. 
paper, it cannot be overemphasized that the informed consent must be robust as to withstand continued scrutiny of the IRB regarding the use of these samples as our ability to extract other information continues to grow. In addition, the shipment of biological specimens must be certified and certification programs are available through Saf-T-Pak (http://www.saftpak.com
). Compliance is federally mandated.
Collection of Whole Blood
The protocols were adopted from standard clinical practice to ensure ease of implementation and compliance across collection sites. All procedures are carried out at room temperature unless otherwise noted. While the site-specific protocol may vary slightly, maintenance of cellular integrity is maintained and thus non-biological variance is assumed to be minimal. Similarly, although not definitive, there is no reason to expect that this methodology will alter the epigenetic signature in an unusual manner compared to standard clinical practice. Although the primary objective of the RMN’s sample collection is to utilize whole blood for DNA extraction, samples retrieved and stored in this manner could also provide a source of proteins, RNA, and metabolites. Routine methods of cellular recovery include venipuncture, heel stick, and buccal swab. Venipuncture is typically used for adult collections compared to buccal swabs for infants and children. While heel sticks are an integral part of standard newborn screening programs, their primary use is dedicated to providing early assessment and a baseline of newborn health status immediately following birth. Logistically, buccal swab collection may be preferred as the samples are directly purposed. Accordingly, the DNA prepared from these samples should be suitable for most analyses including, SNP, genotyping, and methylation analysis as well as direct sequencing which is becoming economically feasible. FTA cards were adopted as a medium since they offered long-term stable cost effective room temperature storage in minimal space. They have even been used previously to store cervical cells [Gustavsson et al. 2009
] and provide a means to immediately freeze the sample in biological time, thus preserving integrity.