Table 2.
Text verbatim corresponding to the three deductive categories identified in the consent forms for gamete donors from the study by Ma et al.
| Category | Relevant quotationsa |
|---|---|
| Sensitive nature of the study | “Germline gene editing is a controversial topic currently being discussed by a range of stakeholders; including scientists, national leaders, ethicists, academics, and many more individuals. Consensus amongst these groups calls for basic science experiments to be conducted in order to provide sufficient evidence regarding the safety and efficacy of gene editing tools. The knowledge gained from basic research studies, like this one, will add scientific data to the continued discussion of whether gene editing tools should be used in a clinical setting.” |
| Whole exome/genome sequencing | Purpose:b |
| Form for oocyte donation: | |
| “During this study, your donated eggs, cumulus cells (the cells that surround your eggs), skin, fibroblasts from your biopsy and blood cells will undergo genetic testing. These tests will help researchers better understand human reproduction and development as it relates to embryonic stem cell research.” | |
| “A portion of the blood collected for these hormonal assays will be used for genetic analysis and to confirm the presence of DNA mutations.” | |
| Form for sperm donation: | |
| “During this study, your donated sperm, skin fibroblasts from your biopsy, and blood cells will undergo genetic testing. These tests will help researchers better understand human reproduction and development as it relates to embryonic stem cell research.” | |
| Both forms: | |
| “Skin biopsy … Genetic tests will be conducted to verify or identify genetic disease.” | |
| Procedure: | |
| “We will draw blood from a vein in your arm. We will collect about 2 tablespoons of blood. Your sample may be frozen and later thawed and used for future experiments. Genetic tests will be conducted.” | |
| Return of results: | |
| “Subject access to genetic information: | |
| The results of these studies will not be made available to you because the research is still in an early phase and the reliability of the results is unknown. If we discover new information that is important for your health care, either in this study or the future, you will be asked whether you wish to receive the results. You will be required to have the test repeated in a clinical laboratory; results from your donation are performed in a research laboratory and therefore are not considered a clinical diagnostic tool. If you choose to receive these results they will be presented to you by one of the physicians approved in this research protocol; because genetic information is complex and sensitive, the results should further be discussed with a genetic counselor or your primary care giver who can answer your questions or discuss your concerns. If you consent to this procedure, we may contact you again in the future to update your information or inquire about your specific health care history. | |
| Whole exome/genome sequencing | _______Yes, I would like to receive the results of this non-clinical laboratory results if it is important for my health care. I understand this is not a clinical diagnosis and must be repeated by my own health care professional. |
| _______No, I would not like to receive the results of this non-clinical laboratory results.” | |
| Confidentiality and use of genetic information: | |
| “Genetic Testing: | |
| Although we have made every effort to protect your identity, there is a small risk of loss of confidentiality. If the results of these studies of your genetic makeup were to be accidentally released, it might be possible that the information we will gather about you as part of this study could become available to an insurer or an employer, or a relative, or someone else outside the study. Even though there are discrimination protections in both Oregon law and federal law, there is still a small chance that you could be harmed if a release occurred. | |
| A federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for most insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. Be aware that this new Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. GINA also does not protect you against discrimination if you have already been diagnosed with the genetic disease being tested.” | |
| “Confidentiality and privacy of your protected health information: | |
| We will take steps to keep your personal information confidential, but we cannot guarantee total privacy. Neither your name nor your identity will be used for publication or publicity purposes. As part of this study we may share a small amount of information about your genetic code and mutation in papers we write about this study. This could mean that others could identify that you were in this study, but they could only do so if they also had your DNA so that they could “match” your genetic code to what was published. Other people would not be able to tell anything about you (such as your hair or eye color) from the small amount of your genetic code that we may publish. We will create and collect health information about you as described in the Purpose and Procedures sections of this form. Health information is private and is protected under federal law and Oregon law. By agreeing to be in this study, you are giving permission (also called authorization) for us to use and disclose your health information as described in this form. The investigators, study staff, and others at OHSU may use the information we collect and create about you in order to conduct and oversee this research study and store in a repository for future research. We may release this information to others outside of OHSU who are involved in conducting or overseeing research, including: | |
| • The Food and Drug Administration | |
| • The Office for Human Research Protections, a federal agency that oversees research involving humans | |
| Whole exome/genome sequencing | Those listed above may also be permitted to review and copy your records, including your medical records. We may also share your information with other researchers, who may use it for future research studies. A code number will be assigned to you, your cells and genetic information, as well as to information collected about you. Only the investigators named on this consent and authorization form and their research staff will be authorized to link the code number to you. Other investigators who may receive samples of your tissue and genetic information for research will be given only the code number which will not identify you.” |
| “We will not release information about you to others not listed above, unless required or permitted by law. We will not use your name or your identity for publication or publicity purposes, unless we have your special permission. When we send specimens or information outside of OHSU, they may no longer be protected under federal or Oregon law. In this case, your specimens or information could be used and rereleased without your permission. We may continue to use and disclose protected health information that we collect from you in this study indefinitely. | |
| Some of the information collected and created in this study may be placed in your OHSU medical record. While the research is in progress, you may or may not have access to this information. After the study is complete, you will be able to access any study information that was added to your OHSU medical record. If you have questions about what study information you will be able to access, and when, ask the investigator.” | |
| “If you withdraw your consent prior to the usage of your donated material by the researchers, your unused samples will be destroyed. Your identity and the data obtained from this study will be kept strictly confidential. Only the investigators listed above and their research staff will have access to identifying information and the data will be maintained indefinitely. | |
| If you no longer want your health information to be used and disclosed as described in this form, you must send a written request or email stating that you are revoking your authorization to: … Your request will be effective as of the date we receive it. However, health information collected before your request is received may continue to be used and disclosed to the extent that we have already acted based on your authorization.” | |
| Confirmation of clinically relevant results: | |
| “If the results are important for your health care, you will be asked to have the tests repeated in a clinical laboratory. The costs for the repeat testing and the counseling necessary to be certain that you understand what the results mean may be billed to you or to your third party carrier. Note that this will probably make the results available to the third party carrier and to your clinical record. You may choose to pay out of pocket instead.” | |
| Compensation | Form for oocyte donation: |
| Compensation Prorated Amount (information extracted from a table): | |
| Screening: $50 | |
| Ovarian suppression $50, $250 (on the first and last visit for ovarian suppression, respectively) | |
| Compensation | Ovarian stimulation: $1,500 (on the last, fifth visit for ovarian stimulation) |
| Egg retrieval: $3,000 | |
| Follow-up: $200 | |
| “Upon full completion of this study you will be paid $5,000 for egg donation and $50 for skin donation (if applicable) as compensation for your time and costs related to this study. If you stop participating or are removed from the study before all your visits are complete, a pro-rated portion of this amount based on the number of visits completed following enrollment, will be paid to you. Please see the table at the end of this form for details on how compensation will be prorated. For patients diagnosed with a DNA mutation enrolled in the current study, reimbursement for travel expenses incurred during the study participation period is negotiable and can be discussed and agreed upon during the initial screening process. No other compensation is offered. | |
| You may receive payment via a debit card. There may be fees (for example, if the card is inactive for more than six months), which will be deducted from the balance on your card. | |
| Details on how to use the card and any fees are included in the separate card member agreement and FAQ sheet. | |
| Payment received as compensation for participation in research is considered taxable income for a research subject. If payments are more than $600 in any one calendar year, OHSU is required to report this information to the Internal Revenue Service (IRS). Research subject payments exceeding $600 during any calendar year will result in a 1099 (Miscellaneous Income) form being issued to the research subject and a copy will be sent to the IRS.” | |
| Form for sperm donation: | |
| “Upon completion of this study you will be paid $100 for semen and $50 for skin donation (if applicable) as compensation for your time and costs related to this study. We will ask you for your social security number for this purpose. You may receive payment via a debit card. There may be fees (for example, if the card is inactive for more than six months), which will be deducted from the balance on your card. Details on how to use the card and any fees are included in the separate card member agreement and FAQ sheet.” |
a
Unless stated otherwise, the quotations were found in both forms: for oocyte and sperm donation.
b
Headings in bold are sub-categories identified by the authors.