Genetic evaluation procedures at sperm banks in the United States
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1 Genetic evaluation procedures at sperm banks in the United States Lauren Isley, M.S., C.G.C. a and Pamela Callum, M.S., C.G.C. a,b a Assisted Reproductive Technology and Infertility Special Interest Group, National Society of Genetic Counselors, Chicago, Illinois; and b California Cryobank, Los Angeles, California Objective: To assess how genetic evaluations of sperm donor applicants are performed in the United States. Design: A questionnaire was designed to assess: 1) the professionals involved in the family history evaluation and genetic screening; 2) the genetic testing, counseling, and informed consent processes; and 3) how the results of genetic evaluations and new risk information is communicated to donors. Setting: Semen donor facilities. Participant(s): Representatives of semen donor facilities. Intervention(s): None. Main Outcome Measure(s): Descriptive data. Result(s): Thirteen responses were received. All of the facilities assessed donors family histories; eight of the facilities (62%) routinely informed donors about the results of these evaluations. At the majority of facilities (10/13), informed consent for genetic testing is obtained as part of the overall contract to be a sperm donor. Genetic counselors are employed full-time at two facilities and part-time at five others. Conclusion(s): There is variability in the education and informed consent processes for semen donor applicants, including variable communication about the limitations of genetic tests and the potential implications for the donors own children. Further research into the best practices for education and consent for sperm donor applicants may be beneficial to ensure the well-being of the donors and their future offspring. (Fertil Steril Ò 2013;99: Ó2013 by American Society for Reproductive Medicine.) Key Words: Semen donor, sperm donor, genetic screening, informed consent Discuss: You can discuss this article with its authors and with other ASRM members at fertstertforum.com/isleyl-genetic-screening-semen-sperm-donor/ Use your smartphone to scan this QR code and connect to the discussion forum for this article now.* * Download a free QR code scanner by searching for QR scanner in your smartphone s app store or app marketplace. Genetic screening for reproductive purposes is recommended before conception whenever possible, so that patients can benefit from the greatest number of options and time for decision making regarding genetic testing and pregnancy management (1 3). An underlying principle of genetic testing is informed consent (4 6). It is a process through which an individual makes a decision or takes an action based on his or her individual needs and preferences, given a full understanding of the options available and the consequences of each decision. As such, reproductive genetic testing is traditionally performed on the biologic parents of a pregnancy, once they have been informed of appropriate testing recommendations and options and the risks, benefits, and limitations associated with specific tests and had the opportunity to make the decisions that are best for their families. Genetic testing of reproductive tissue donors differs because the donors Received April 26, 2012; revised January 10, 2013; accepted January 11, 2013; published online February 5, L.I. has nothing to disclose. P.C. is employed by California Cryobank, one of the sperm banks invited to participate in this study. Supported by the Assisted Reproductive Technology and Infertility Special Interest Group of the National Society of Genetic Counselors. Pamela Callum is employed by California Cryobank, one of the sperm banks invited to participate in this study. Reprint requests: Lauren Isley, M.S., C.G.C., 5555 Conner Avenue, Suite 1100, Detroit, Michigan ( lauren.j.isley@gmail.com). Fertility and Sterility Vol. 99, No. 6, May /$36.00 Copyright 2013 American Society for Reproductive Medicine, Published by Elsevier Inc. provide gametes for offspring that they will not parent. Therefore, the donors preferences regarding genetic testing may not be the predominant factor determining which evaluations are performed on these individuals. The genetic screening of a donor may, alternatively, be performed based on ethnic background and/or specific indications in his or her family history, tissue donor screening regulations (7, 8), gamete donor screening guidelines (9, 10), general population carrier screening guidelines (11 16), and/or an individual sperm bank s policies. In addition, the recipients of donor gametes are likely to have a greater interest in the genetic evaluations that are performed on the donors than the donors themselves may have. However, it is likely that these evaluations would identify specific genetic risks for some donors, because many reproductive screening VOL. 99 NO. 6 / MAY
2 ORIGINAL ARTICLE: ANDROLOGY tests are designed to detect individuals who carry mutations for common genetic disorders that are inherited in an autosomal recessive manner (11 16), and donors are just as likely as any other individual to test positive on these tests. Even though the donors may not have personal preferences regarding the genetic screening performed on them at the time of their participation in a donor program, the results of these evaluations can have significant implications for them and their family members and for their future reproduction. Therefore, it is important that they are informed of these possibilities before testing and educated about the results of their tests. In the present study, we examine the processes by which genetic evaluations are performed on sperm donors in the United States to determine if the donors receive the same education and opportunities to provide informed consent that are recommended for those individuals who are planning their own pregnancies (4 6). Specifically, we evaluated: 1) the professionals involved in the family history evaluation and genetic screening of donors; 2) the genetic testing, counseling, and informed consent processes for sperm donors; and 3) if and how the results of genetic evaluations and newly acquired risk information is communicated to these men. MATERIALS AND METHODS A questionnaire was designed to evaluate the characteristics of the sperm donor programs, including the routine processes for genetic evaluation of sperm donor applicants, the informed consent and genetic counseling practices, and the procedures for managing test results. Semen banks in the United States were identified by internet and literature searches. Twenty-six facilities were identified, including the employer of one of the authors (P.C.). All facilities were invited to participate in a study regarding genetic screening practices at sperm banks. Each facility was contacted by telephone and asked to provide a contact name and address for an individual to whom it was most appropriate to send an online questionnaire on the genetic screening practices at that facility. The questionnaire (Supplemental Fig. 1, available online at was distributed through an online survey tool. Recipients were asked to forward the survey to an appropriate staff member if they were not the individuals who could most accurately address the survey questions. Four weeks after the survey was distributed, the facilities were contacted by telephone to remind them of the opportunity to participate if they had not yet had the chance to do so. Institutional Review Board (IRB) approval was not obtained, because data on human subjects or private identifiable information was not gathered; the data focused on policies and protocols. RESULTS Responses were received from 13 of the 26 facilities (50%). The individuals who responded to the study had a variety of roles at the semen banks, as presented in Table 1, and included both clinical and nonclinical professionals. The level of TABLE 1 Staff members who responded to the survey. Staff member n Donor coordinator (nonclinical) 3 Lab manager/supervisor 2 Tissue bank director 2 Physician 2 Genetic counselor 1 Nurse practitioner 1 Registered nurse 1 Medical technologist 1 genetics education achieved by the respondents is presented in Table 2, and ranged from no formal genetic training to advanced degrees in genetics. Both anonymous donor and directed donor services were available at 12 of the 13 facilities (92%); one facility offered only anonymous donor services. All results presented below pertain to anonymous semen donation practices unless stated otherwise. Donor Applicant Family History Risk Assessment All facilities collect a three-generation family history from each of their donor applicants. At ten facilities (77%), the family history was collected as part of a consultation with the donor applicant either in person or over the telephone. At three facilities (23%), the family history was collected from the donor but evaluated separately, without the donor present for clarification. The applicants family histories were reviewed by a variety of professionals, including nurse practitioners, reproductive endocrinologists, medical geneticists, genetic counselors, and medical directors. The level of genetics education achieved by these individuals was unknown; only two of the individuals who completed the questionnaires were the same staff members who performed the family history evaluations. At eight out of 13 sperm banks (62%) it was routine practice to inform donors of the results of their family history risk assessments. Four facilities provided a consultation to donors only when they thought there was a specific indication to do so, and one facility did not inform donors of the findings from these assessments. These consultations were performed by genetic counselors at four centers and by medical directors at three other facilities. Medical technologists, donor TABLE 2 Highest level of genetic education completed by respondents. Extent of genetics training n No formal genetics training 4 Single genetics course during medical or graduate training 3 Continuing education in genetics 3 More than one course in genetics 1 Degree in genetics VOL. 99 NO. 6 / MAY 2013
3 Fertility and Sterility coordinators, tissue bank directors, and nurse practitioners, including two of the respondents, provided these consultations at other facilities. The utilization of genetic counseling services at the sperm banks was evaluated. Genetic counselors were employed fulltime at two facilities and part-time at five others. One facility required that every donor receive a consultation with a genetic counselor. A genetic consultation was available for donors at eight facilities (62%), and was offered to all donors at two facilities (15%). Of note, seven centers (54%) offered a consultation with a genetic counselor to the recipients who were to use the specimens; this included both donor facilities that offered genetic counseling services to all of their donors. Genetic Testing All sperm banks reported that they voluntarily follow the genetic screening guidelines of at least one professional organization, including the American Association of Tissue Banks (AATB; 12/13), American Society of Reproductive Medicine (ASRM; 11/13), American College of Medical Genetics (ACMG; 5/13), and American College of Obstetricians and Gynecologists (ACOG; 5/13). In addition to these guidelines, nine out of 13 centers (69%) stated that the donor s family history could prompt additional genetic testing. It is unknown if the other practices excluded applicants from participation based on an indication for additional testing or if they identified or pursued indications for additional testing. All facilities reported that they would also perform additional genetic testing on donors if requested by recipients, and all of the centers contacted donors after they had left the program to see if they would participate in additional genetic testing. The volume of requests and types of tests performed based on recipient requests were not evaluated as part of the present study. Donors were informed of their genetic test results in person and/or over the telephone. However, at least one facility informed the donor of the results only if they were abnormal. Four sperm banks confirmed that they distributed specimens from donors who were known to carry mutations for genetic conditions that are inherited in an autosomal recessive manner, and two of these facilities indicated that the specimens were from directed donors; all stated that counseling by a physician or genetic counselor was recommended for the recipients before use of gametes from these donors. Genetic testing was performed with the use of a multiplex screening tool at four facilities. Several other facilities indicated that they were considering the use of these technologies for future screening practices. Consent Process At 11 of 13 facilities, donors received a consultation about the genetic testing that would be performed on their DNA. At the majority of centers (10/13), consent for genetic testing was obtained as part of the overall contract to be a sperm donor. At three facilities, consent for genetic testing was obtained separately from the donor program consent process. The professionals who were involved in the informed consent process for genetic testing are presented in Table 3 and include six of TABLE 3 Staff members who obtained informed consent for genetic testing of donor. No. of facilities Staff member (n [ 13) Donor coordinator (nonclinical) 6 Medical technologist 2 Registered nurse 2 Genetic counselor 1 Tissue bank director 1 Not applicable; no informed 1 consent for genetic testing the individuals who responded to the survey. Table 4 presents the results of survey questions regarding which items were discussed as part of the consent process at these facilities; these were the only items that we specifically asked about in the survey. Follow-Up All but two facilities documented the number of pregnancies and/or births resulting from use of their donors specimens. All 13 centers documented reports of medical problems in the offspring of their donors, and ten (77%) informed recipients of newly identified medical risk information involving their donors, such as a medical condition in the donor, his family members, or an offspring conceived through the donor program. DISCUSSION Semen donor applicants may not have strong interests in the genetic evaluations performed on them at the time of their participation in a gamete donor program; however, the results of their genetic evaluations may have significant implications for them, their family members, and their own future children. As such, there is no obvious reason that gamete donors should not be given the same genetic counseling and opportunity for informed consent that is recommended (4 6) before genetic testing if they were planning their own pregnancies. In the absence of specific regulations as to how and by whom these processes should be performed, each sperm bank currently determines individually if and how they address these issues. The present study documents the variability in TABLE 4 Items discussed with donor applicant before genetic testing. No. of facilities (n [ 13) Likelihood of positive test results 12 Possibility of ambiguous test results 11 Test limitations (i.e., residual carrier 8 risk, limited detection rate) VOL. 99 NO. 6 / MAY
4 ORIGINAL ARTICLE: ANDROLOGY how these responsibilities are managed at sperm banks across the United States. Although the individuals that responded to the study may not perform all of the genetic screening evaluations, we expect that the responses accurately describe their genetic screening practices, owing to our efforts to distribute the study to the most appropriate individual at each facility. Unfortunately, the study design did not allow us to adequately assess the genetic education of those individuals who evaluate the family medical histories or provide genetics education to the donors, because the respondents did not perform those tasks in most cases. However, the results did indicate that there are many different professionals involved in these processes and variation in these roles and responsibilities at each donor facility. Of significance, the results showed that many nonclinical staff members are involved in these processes, and this presents several concerns. Individuals who are not trained in medical genetics may not be able to adequately educate donors about the tests that will be performed, including the risks, benefits, and limitations of each test. Consequently, the donors may be unable to make informed decisions about participating in testing. In addition, the staff members may not be able to prepare a donor for managing all possible results and may not be skilled in providing support to the donor for sharing this information with his at-risk relatives. The consent and education processes can be performed most appropriately by an individual who is trained in medical genetics and who can explain the evaluations, the possible results, and limitations of each genetic test. A trained individual can also answer the donor s questions and assess the donor s understanding and ability to provide truly informed consent. The sperm banks frequently cited the guidelines of tissue banking and reproductive organizations, such as AATB and ASRM, rather than the relevant guidelines of genetic or obstetric organizations, such as ACMG and ACOG. Of significance, although the majority of facilities followed the guidelines of ASRM, which directly reference ACOG guidelines, few of those same facilities reported actually following ACOG guidelines. The sperm bank facilities could benefit from specific clear practice recommendations from AATB or ASRM for consistency in the genetic evaluation of sperm donors; however, adherence to those guidelines remains voluntary, which contributes to the variability in genetic screening of donors across the United States. The majority of sperm banks obtained consent for genetic testing as a part of the overall contract to be a sperm donor rather than during a separate genetic consultation. The contracting for overall donor participation is likely performed at the beginning of the donor program. If the donor has not yet had a family history evaluation at the time of this contracting, it is unlikely that he can provide informed consent for the genetic testing, especially because the majority of the facilities stated that they may perform genetic testing based on specific indications in a donor s family history. These needs may not be identified before the contracting, in which case the donors are not informed about these specific tests and cannot provide consent to participate in them. Consent for genetic testing would be most appropriately obtained when all genetic risks are identified and the specific tests to be performed on that donor can be clearly established. Further research may help to determine if there is a single best time and practice for a genetic consultation for education and informed consent purposes for gamete donors. It is inappropriate to withhold any individual s genetic testing results. If a donor is not informed about the results of his genetic testing, he may assume an absence of risks in his own future pregnancies. In addition, donors might learn of their test results through third parties, such as social networks, that are subject to misinformation and misinterpretation. It is a disservice to donors that their personal genetic information may be revealed in this way. Therefore, even if donors do not appear to be invested in knowing their results, genetic evaluation results should always be offered to the donor unless he specifically declines this information. In these cases, the results should always be available to him on future request. The evolution of multiplex platform technologies for general population carrier screening drives further attention to the need for improvements in education and informed consent and the role of genetic providers in the gamete donor setting. Multiplex platform tools present cost-effective genetic screening options but often involve testing for many more disorders than would be specifically recommended due to risk factors identified in a specific individual s family history. They can also be accompanied by low detection rates and other limitations about which a donor should be informed. The range of potential disease and disability associated with a particular diagnosis, the reciprocal carrier screening options on the other biologic parent of any future pregnancy, and the limitations of each testing option are significant items for discussion. In addition, as these tools become standard of care for screening of gamete donors, this may change the acceptance patterns for donors. Exclusionary testing would reduce the pool of donors, because a significant number would be expected to screen positive as a carrier on a large mutation panel. The alternative is for sperm banks to increasingly release specimens from donors who are known to be carriers of mutations for specific recessively inherited diseases. A positive trend in the contributions of trained genetic professionals in sperm banks was noted in the present study. In 1996, Conrad et al. (17) revealed that six out of 16 donor facilities (37.5%) had a genetics professional on staff. In the present study, the contributions of genetic professionals are documented in more than one-half of the facilities, although mostly in part-time positions. Because new genetic technologies are already being applied to donor screening practices, there will likely be an increasing need for the contributions of genetic professionals in this field. This study indicated the need for future research regarding how recipients of donor gametes are educated about their donors screening results, especially because of the increasing use of multiplex screening tools. In addition, recipients may rely on the genetic evaluation of the donors and not consider the contributions of their own family medical histories. A genetic evaluation for gamete recipients offers an opportunity to address the contributions from both biologic parents and develop a plan for management of an individual pregnancy. However, it is unclear if the recipients education is the 1590 VOL. 99 NO. 6 / MAY 2013
5 Fertility and Sterility responsibility of the sperm banks or the recipients own health care providers, or how they may share these roles. Evaluation of this part of the gamete donation process is warranted so that a full, integrated education and counseling program can be developed to meet the needs of all parties. The results of this study are significant to gamete donors, their family members, and future offspring. Investment in their well-being requires that donors are fully informed about the genetic screening practices at the semen bank, including the specific tests that will be performed on their DNA and the possibility and likelihood of positive, negative, and ambiguous results. In addition, a professional trained in medical genetics should inform the donors of the results and their implications, assess the donors understanding and concern, and address the donors needs relevant to this information. This will benefit donors as well as the sperm banks, so that donors preferences are elicited and respected and there is clear communication between these parties. REFERENCES 1. American College of Obstetricians and Gynecologists. Committee opinion no. 478: family history as a risk assessment tool. Obstet Gynecol 2011; 117: Pletcher BA, Bocian M. American College of Medical Genetics. Preconception and prenatal testing of biologic fathers for carrier status. Genet Med 2006;8: Pletcher BA, Toriello HV, Noblin SJ, Seaver LH, Driscoll DA, Bennett RL, et al. Indications for genetic referral: a guide for healthcare providers. Genet Med 2007;9: American College of Obstetricians and Gynecologists. Committee opinion no. 363: patient testing: ethical issues in selection and counseling. Obstet Gynecol 2007;109: American College of Medical Genetics. Committee opinion no. 390: ethical decision making in obstetrics and gynecology. Obstet Gynecol 2007;110: American CollegeofObstetricians andgynecologists. Committee opinionno. 410: ethical issues in genetic testing. Obstet Gynecol 2008;111: Division of Human Tissues, Office of Cellular, Tissue and Gene Therapies, U.S. Department of Health and Human Services, Food and Drug Administration Center for Biologics Evaluation and Research. Guidance for industry eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) Available at: Vaccines/GuidanceComplianceRegulatoryInformation/Guidances/Cellularand GeneTherapy/ucm htm. 8. Part 52 of Title 10 (Health) of the official compilation of codes, rules and regulations of the state of New York. Available at: org/labcert/regaffairs/clinical/part52.pdf; guidelines for gamete and embryo donation: a Practice committee report. Fertil Steril 2008;90:S American Association of Tissue Banks. Standards for tissue banking. 12th ed. AATB; Gross SJ, Pletcher BA, Monaghan KG. Carrier screening in individuals of Ashkenazi Jewish descent. Genet Med 2008;10: American College of Obstetricians and Gynecologists. Committee opinion no. 318: screening for Tay-Sachs disease. Obstet Gynecol 2005;106: American College of Obstetricians and Gynecologists. Committee opinion no. 432: spinal muscular atrophy. Obstet Gynecol 2009;113: Watson MS, Cutting GR, Desnick RJ, Driscoll DA, Klinger K, Mennuti M, et al. Cystic fibrosis population carrier screening: 2004 revision of American College of Medical Genetics mutation panel. Genet Med 2004;6: Langfelder-Schwind E, Kloza E, Sugarman E, Pettersen B, Brown T, Jensen K, et al. Cystic fibrosis prenatal screening in genetic counseling practice: recommendations of the National Society of Genetic Counselors. J Genet Couns 2005;14: Prior TW. Carrier screening for spinal muscular atrophy. Genet Med 2008; 10: Conrad EA, Fine B, Hecht BR, Pergament E. Current practices of commercial cryobanks in screening prospective donors for genetic disease and reproductive risk. Int J Fertil Menopausal Stud 1996;41: VOL. 99 NO. 6 / MAY
6 ORIGINAL ARTICLE: ANDROLOGY SUPPLEMENTAL FIGURE 1 1. Please define your profession/role by selecting all of the following that apply: a. I am a Physician trained as a clinical geneticist b. I am a Physician trained as a reproductive endocrinologist c. I am a Physician in another specialty (please specify) d. I am a Genetic Counselor e. I am a Registered Nurse f. I am a Nurse Practitioner g. I am a Donor Coordinator (nonclinical) 2. What is the highest level of genetic education you have completed? a. No formal genetics training b. One course on human genetics during medical or graduate school c. Continuing education course in medical genetics d. Professional degree related to medical genetics e. Other (please specify) 3. Does your facility provide donor semen specimens to the public? If no, thank you for taking the time to start the survey. The rest of the questions are applicable only for facilities with sperm donation programs. Your participation is complete. 4. In what types of sperm donation does your facility participate? a. Anonymous b. Directed c. Anonymous and directed 5. Does your facility follow the American Society for Reproductive Medicine (ASRM) guidelines that limit the number of births from each donor to no more than 25 births? 6. If yes, what is the maximum number of births permitted for an individual donor at your facility? 7. If you responded No to question #3 above, does your facility have maximum limits as to how long or how often a donor may participate in your program? c. Not applicable 1591.e1 VOL. 99 NO. 6 / MAY 2013
7 Fertility and Sterility SUPPLEMENTAL FIGURE 1 Continued 8. Does your facility follow the ASRM guidelines for an upper age limit for sperm donors of 40 years of age? If no, what is the upper age limit at your facility? 9. Does your facility have a lower age limit for men who apply to your program? If yes, what is the lower age limit? 10. Does your facility allow deviations in age limits for directed donors? 11. Does your facility have genetic screening requirements for your sperm donors? 12. Does your facility follow genetic screening guidelines of any of the following professional organizations (choose all that apply): a. American Society of Reproductive Medicine (ASRM) b. American College of Medical Genetics (ACMG) c. American Association of Tissue Banks (AATB) d. American College of Obstetrics and Gynecology (ACOG) e. Other (please specify) 13. Multiplex carrier screening is a term used to refer to a single test that evaluates an individual for multiple genetic disorders. Do you use a multiplex carrier screening tool to screen your donors? c. Not applicable; no screening performed 14. If no, are you considering using a multiplex screening test within the next 12 months? c. Not applicable; multiplex tool already being used d. Not sure 15. Are the recipients or intended parents involved in decision-making regarding which genetic tests are performed on the donor? VOL. 99 NO. 6 / MAY e2
8 ORIGINAL ARTICLE: ANDROLOGY SUPPLEMENTAL FIGURE 1 Continued 16. Does your facility perform additional genetic testing on donors if requested by a recipient or intended parent? 17. Does your agency offer genetic testing on your recipients or for the individual providing the egg? 18. Do you complete a family history risk assessment for each sperm donor applicant? 19. If yes, do you collect a three-generation family history from each of your donor applicants? c. Not applicable 20. Who evaluates the family history? a. Donor Coordinator (non-clinical professional) g. Not applicable; family history is not evaluated 21. Please indicate how the evaluation is performed: a. With each donor in-person b. Over the telephone with each donor c. Either in-person or over the telephone with each donor d. By evaluating family history information reported by the donor, without the donor included in the evaluation e. Not applicable; family history is not evaluated f. Other (please specify) 22. Do your sperm donors receive a consultation regarding the results of their family history risk assessment? c. Sometimes, depending on the specific indication 1591.e3 VOL. 99 NO. 6 / MAY 2013
9 Fertility and Sterility SUPPLEMENTAL FIGURE 1 Continued 23. If yes, who provides this consultation? a. Donor Coordinator (non-clinical professional) g. Not applicable, no consultation provided 24. Who makes **recommendations** about including or excluding a donor from participation based on factors in the donor s family history or abnormal genetic test results? a. Donor Coordinator (non-clinical professional) g. Recipient 25. Who makes **decisions** about excluding a donor from participating based on factors in the donor s family history or abnormal genetic test results? a. Donor Coordinator (non-clinical professional) g. Recipient 26. Have you ever excluded a donor applicant because of evidence of a disease in a family history if the disease does not have clear genetic implications? 27. Does the review of the donor's family history ever prompt genetic testing on the donor? If yes, for which conditions reported in an applicant's family history has your facility performed genetic testing? VOL. 99 NO. 6 / MAY e4
10 ORIGINAL ARTICLE: ANDROLOGY SUPPLEMENTAL FIGURE 1 Continued 28. If yes, which party pays for the genetic testing? a. Donor program b. Recipient(s) c. Other (please specify) 29. Have you ever used specimens from a donor who has a positive (abnormal) carrier screening result? If yes, please specify how this information was communicated to the recipient(s) and/or donor. 30. If yes, please indicate who educated the recipients or intended parents about the donor's results. a. Donor Coordinator (non-clinical professional) g. Recipient's healthcare provider who is not involved in the donor program h. Not applicable; no education provided i. Other (please specify) 31. Do your sperm donors receive a consultation about the genetic testing that will be performed on their DNA samples, prior to testing? 32. If yes, who provides this consultation? a. Donor Coordinator g. Not applicable, no consultation provided 33. Do you have a routine process for obtaining informed consent for genetic testing from sperm donors? 1591.e5 VOL. 99 NO. 6 / MAY 2013
11 Fertility and Sterility SUPPLEMENTAL FIGURE 1 Continued 34. If yes, who obtains consent from the donor? a. Donor Coordinator (non-clinical professional) g. Not applicable, no informed consent for genetic testing 35. That he may be informed of positive genetic screening results. 36. That he may be informed of ambiguous test results. 37. The test limitations, such as a limited detection rate and residual carrier risk. 38. Is consent for genetic testing obtained as part of the overall contract for a man to be a donor with your program, or is consent for genetic testing obtained in a separate process? a. As part of the overall contract b. A separate process c. Not applicable d. Other (please specify) 39. How are your donors informed of the results of their genetic tests? a. In-person b. Over the phone c. By letter/ d. Donors are not informed of their genetic test results e. Other (please specify) 40. Does your donor facility directly employ genetic counselors? If yes, how many genetic counselors are employed? 41. Please indicate if they are full-time or part-time employees. a. Full-time b. Part-time Both c. Not applicable 42. Is consultation with a genetic counselor required for all donors? VOL. 99 NO. 6 / MAY e6
12 ORIGINAL ARTICLE: ANDROLOGY SUPPLEMENTAL FIGURE 1 Continued 43. Is a consultation with a genetic counselor offered to all donors? 44. Is a consultation with a genetic counselor available for all donors? 45. Do you offer a consultation with a genetic counselor for recipients and/or intended parents? 46. Do you document the number of pregnancies and/or births resulting from use of your donors' semen specimens? If no, what percentage of pregnancies do you believe you receive data on? 47. Do you document reports of medical problems in offspring from your donors? 48. Do you inform recipients of newly identified medical information involving their donor after they have used specimens from that donor? 49. Do you ever contact your donors after they have left the donor program to see if they will participate in additional genetic testing? 50. If yes, are donors informed of this possibility prior to participating in the program? c. Not applicable, donors are not contacted 51. Are you interested in receiving information on how genetic counselors contribute to the genetic screening of gamete donors? 52. If yes, would you like to be contacted by a member of the National Society of Genetic Counselors (NSGC) Assisted Reproductive Technology and Infertility Special Interest Group? If yes, please provide contact information. 53. Would you be interested in additional information on new genetic screening technologies such as multiplex screening tools? 54. What other genetic information or education would you be interested in receiving at your practice? 55. Please provide other comments regarding this survey or your genetic screening practices. Questionnaire e7 VOL. 99 NO. 6 / MAY 2013
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