Content below is for review purposes only. Our web-based consent process is initiated during checkout for any of our genetic analysis services.
Consent to participate in research is optional and not required for participation in GenePeeks' services.
Informed Consent for GenePeeks
Introduction. This form describes the purpose, benefits, risks, and limitations of reproductive risk analysis through GenePeeks, Inc. in the context of sperm or egg donor selection. This is a voluntary service intended to avoid sperm or egg donors whose DNA information, when analyzed in combination with your DNA information, presents a potential for increased risk of certain genetic conditions in hypothetical offspring. Information about GenePeeks’ services is always available to you through GenePeeks’ website in addition to direct phone and e-mail communication. Please read this form carefully before making your decision about receiving GenePeeks’ services.
Purpose. GenePeeks’ services are intended to identify genetic risk specific to hypothetical offspring of a recipient-donor match or multiple recipient-donor matches. Recipient (“recipient”) describes the participant whose gametes (sperm or egg) shall be used in combination with donor gametes for reproduction. GenePeeks computes and analyzes the unique gene combinations of each potential recipient-donor pairing to determine the risk of certain genetic conditions in hypothetical offspring. The genes analyzed are associated with a specific panel of inherited genetic conditions. Recipient-donor pairs that show evidence of reproductive risk in excess of predetermined thresholds are flagged for avoidance. GenePeeks’ analysis is designed to complement and not replace your other efforts to protect the health of your future family.
Process and Services. Genetic counseling to discuss GenePeeks’ analysis is available by telephone at any time in the GenePeeks process and is encouraged prior to sample submission. A saliva sample will be submitted by you and sent to GenePeeks or GenePeeks’ designee. The saliva sample will be processed by a laboratory that GenePeeks has arranged to read your DNA information and transmit the data to GenePeeks. GenePeeks will then electronically combine your DNA information with the DNA information of a single potential donor many times over to produce hypothetical, or “virtual,” offspring genomes. GenePeeks may repeat this process for multiple applicable donors in the GenePeeks network.
Data Generation and Analysis. GenePeeks does not generate any diagnostic reports regarding you or your virtual offspring, and it does not generate any information about risks to your own health or disease-specific risk to your virtual offspring. Rather, the genetic risks associated with virtual offspring are estimated from an automated analysis of DNA information and knowledge of gene function, and is based on the gene panel and information and data available at the time of GenePeeks analysis. Every recipient-donor pair is interpreted independently and designated as being above or below certain risk thresholds. If a recipient-donor pair exceeds those risk thresholds, the donor will be flagged for avoidance and/or removed from the personalized donor catalogue that you will receive after the analysis is completed. You will receive no information about specific conditions associated with a particular pairing. The reading of your DNA information, the combination of your DNA information with that of potential donors, the analysis of genetic risk in virtual offspring, and the use of this information and/or your DNA sample to improve GenePeeks’ services is referred to in this document as “GenePeeks Analysis.
Data Protection.
Genetic Information: The laboratory processing your saliva sample will generate your DNA information for analysis by GenePeeks to determine your virtual progeny’s genetic risks. The laboratory will not process your saliva for any biological or chemical components, markers, or agents other than your DNA.
Account Information: When you sign up for GenePeeks’ services, GenePeeks will collect and store information about you. This information includes contact information and is maintained separately from your DNA information. Account information will be used to complete your purchase and may be used to improve GenePeeks’ services and develop new features. See GenePeeks’ Privacy Statement for further details on data usage and protection.
Security: GenePeeks employs strong security measures to protect against unauthorized access to or unauthorized alteration, disclosure, or destruction of data. GenePeeks’ security program includes regular audits of its security measures and systems. As with any security system, GenePeeks cannot guarantee that its systems will never be breached.
Privacy of Information: GenePeeks will never release your individual-level genetic information and/or self-reported information to any third party without asking for and receiving your explicit consent to do so, unless required by law.
Risks. GenePeeks Analysis requires DNA, most often provided from a sample of saliva. There are usually no side effects of your giving a saliva sample, except for temporary dryness of the mouth.
Benefits. Your participation is expected to help you make more informed decisions in the sperm or egg donor selection process. GenePeeks’ services are expected to reduce the likelihood of a recipient-donor pairing that presents an increased risk of specific genetic conditions in virtual offspring arising from that pairing. GenePeeks’ methodology does not allow for the generation of diagnoses or diagnostic reports.
Limitations. Information obtained from this process cannot be considered to provide meaningful information about your health, and it should not be considered health information. It is the goal of GenePeeks to minimize risk in the sperm or egg donor selection process. However, this risk cannot be completely eliminated. Our analysis cannot detect rare spontaneous or de novo mutations that are not present in a parent's genome or risk for idiopathic birth defects of unknown cause. GenePeeks does not currently screen for X-linked genetic disorders, which are diseases caused by mutations in genes on the X chromosome (e.g., fragile X syndrome). Autosomal dominant genetic disorders, which are diseases caused by a mutation in a single copy of a gene on chromosomes 1-22 (e.g., familial hypertrophic cardiomyopathy), are also not currently included in GenePeeks Analysis. In addition, chromosomal anomalies like Down syndrome that typically occur during or after fertilization cannot be detected by GenePeeks’ methodology or any other pre-conception genetic analysis. Accordingly, there should be no expectation that GenePeeks Analysis, or any combination of screening methods, will guarantee the birth of a healthy child. GenePeeks Analysis is conducted on and determined by the genes covered on the sequencing panel, which is described in detail on our website. There should be no expectation that genetic conditions related to genes outside of the panel are a part of the GenePeeks Analysis.
Genetic Counseling. As a part of the GenePeeks service, a professional genetic counselor employed by GenePeeks is available to you by telephone at any point in the process if you would like to discuss and learn more about the benefits, risks, and limitations of GenePeeks Analysis. GenePeeks encourages you to contact GenePeeks’ genetic counseling team prior to sending your saliva sample to GenePeeks. You may contact GenePeeks’ customer service department at 1-855-DNA-PEEK (1-855-362-7335) should you wish to speak with a GenePeeks genetic counselor.
Optional Research Consent
GenePeeks has an ongoing interest in working with the broader scientific community to advance understanding of the genetic basis of inherited disease and, more broadly, the human genome. In pursuit of this goal, GenePeeks invites you to contribute your genetic and demographic information as well as your remaining sample (collectively, your “Materials”) for the purpose of enhancing scientific understanding of the human genome (“Future Research Use of Your Materials”). Any of your Materials used for these purposes will be anonymized and will not contain your name, contact information or other identifying personal information.
The results of these analyses may be included in scientific publications, and GenePeeks may use external laboratories or other facilities to perform these analyses and may collaborate with outside researchers and organizations. If so, GenePeeks will bind those external entities to honor the limits set forth in this section on Future Research Use of Your Materials. Your Materials will only be published or shared with third parties in a form that maintains the disassociation of your Materials from your name and contact information or other information that could readily identify you. Third parties will be required to agree to our strict privacy policies. Your Materials will be stored by GenePeeks or by a facility arranged by GenePeeks or its collaborators. Any such facility, however, would have no right to use your Materials for any purpose except Future Research Use of Your Materials, as defined in this form.
It is not expected that you will benefit personally from allowing Future Research Use of Your Materials. However, the use of your Materials for these purposes will help the scientific community to learn more about the human genome.
If you consent to Future Research Use of Your Materials, you understand that you will acquire no rights in any commercial products that may be developed by GenePeeks, its collaborating partners or other researchers through the uses of your Materials as described above, and as consented to by you. You further understand that you will not acquire any rights to publications resulting from these uses of your Materials. There are no plans to provide you compensation for any commercial products or publications that include or result from uses of your Materials described above.
Dropdown provided to indicate research participation selection
Printed Name and Signature Required, along with Date of Birth and Current Date