Ethical Issues in Stem Cell - Research Paper Example

Ethical Issues in Stem Cell Research Introduction The term stem cells denotes biological cells that occur in a multicellular organism and can divide and undergo differentiation into a variety of cell types and undergo self-renewal to provide more stem cells. Adult stem cells and embryonic stem cells are the two broad categories of stem cells used in research. Adult stem cells are found in different tissues whereas embryonic stem cells are acquired from blastocysts, which form the inner cell mass of embryos. Progenitor cells and stem cells act as a repair for the body among adult organisms where they replenish adult worn tissues. In an embryo the stem cells have an ability to undergo differentiation into all types of specialized cells (pluripotency), but they are also able to retain a normal turnover over regenerative organs such as the intestinal tissue, skin and blood. Stem cell research is promising in terms of developing understanding of mechanisms that underlie differentiation and human development, as well as the possibilities of treating diseases such as Parkinson’s disease, spinal cord injury, myocardial infarction and diabetes-just to mention, but a few (Lo & Lindsay 204). Pluripotent cells have an ability to differentiate in culture into all specialized types of cells and scientists plan to differentiate these cells into cells that area specialized and could be applied to the process of transplantation. However, research on human stem cells (hSC) has significant political and ethical controversial issues (Lo & Lindsay 205). Deriving pluripotent stem cells from embryos and oocytes is riddled with ethical disputes in relation to the onset of human life and human reproduction. There are other less ethically disputed methods of deriving stem cells such as somatic cells reprogramming, which produce pluripotent cells through induction (iPS cells). This approach avoids ethical issues related to stem cells derived from embryos (Lo & Lindsay 208). However, these line of cells limit research possibilities and hence the use of embryonic stem cells becomes a necessity in some instances. On the other hand, hSC research presents difficult ethical challenges, which include oversight of research, clinical trials for hSC therapies and consent to donate hSC research material (Lo 127). Embryonic Stem Cell Research Ethics Cell lines of pluripotent stem cells are acquired from the cell mass of blastocysts that are 5 to 7 days old. However, research on embryo derived stem cells is politically and ethically controversial because of the destruction of life in the human embryos. The debate on when human life starts has raised a lot controversy in relation to embryonic stem cell research and this has been closely related to the debate on abortion. It is undisputable that embryos have the capacity to develop into fully grown human beings; if implanted at the right phase into a human uterus. A large number of people believe that an embryo has a moral status similar to a live-born child or adult, and therefore; it is a person. As a matter of moral conviction and religious belief, these people believe that the life of humans starts at conception, and an embryo is thus akin to a person. In accordance to this view, embryos have rights and interests, which should be respected. In view of this, the act of deriving embryonic stem cell lines from a blastocyst is akin to murder (The President’s Council on Bioethics) (Lo & Lindsay 209). A number of other people hold a different moral status view in relation to the embryo. For example, some believe that the embryo only attains personhood at a later development stage, which is not fertilization. Therefore, to such individuals the embryo is not a person yet at the early stages of fertilization. However, it is only a few that believe that the blastocyst or embryo is just a mass of cells, which can be used in research without any reservations. As such, there are many people that hold a moderate consideration that the early embryo should be accorded special respect as a human being because it has the potential to develop into one. However, they are also of the view that the embryos may be used for specific types of research as long as there is sound scientific justification, provision of informed consent by the couple of woman donating the embryos as well as careful oversight over the whole research process (Lo & Lindsay 207). The opposing forces in human embryo stem cell research (hESC) are many at times related to the “pro-life” movement and the opposition to abortion. However, the opposition to hESC research is not monolithic. Various pro-life leaders support hESC research that uses frozen embryos, which remain after couples of women that receive fertility treatment have accomplished their treatment and decided not to offer the embryos to another couple (Lo & Lindsay 207). The pro-life leaders believe that embryos, which remain from such circumstances, could be put to use in hESC research. This view is held by a number of pro-life leaders among them Orrin Hatch (U.S Senator) and Nancy Reagan (First lady). On her Senate website, Orrin Hatch states that: “The support of embryonic stem cell research is consistent with pro-life, pro-family values. I believe that human life begins in the womb, not a Petri dish or refrigerator …. To me, the morality of the situation dictates that these embryos, which are routinely discarded, be used to improve and save lives. The tragedy would be in not using these embryos to save lives when the alternative is that they would be discarded (Lo & Lindsay 207)” The use of existent embryo stem cells lines President Bush has a strong pro-life stand. However, in 2001 he permitted the National Institutes of Health (NIH) to fund human embryo stem cell research, which would only use embryonic stem cell lines already in existence during that time, while prohibiting funding by NIH for any research on newly acquired embryonic stem cell lines (Lo & Lindsay 208). This permission was granted due to the recognition of the important role that hESC research holds in the potential development of treatments for degenerative health conditions such as Parkinson’s disease. However, the policy was also meant to oppose further destruction of embryos through research. The NIH support was seen by most researchers as an important element for attracting scientists to make long-term commitments to the study of stem cell biology (Lo & Lindsay 208). This was important because without a firm basic science platform, therapeutic success would not be likely. The rationale for the policy was that the lines from which these embryos had been derived were already destroyed, and permitting research on the remaining lines would allow the derivation of some good out of the destruction. However, it was noted that the use of only existent lines would be scientifically problematic. This is exemplified by NIH’s ratification of funding for 60 hESC lines, most of which were later found unsuitable for use. Some of the ratified lines were found not to be truly pluripotent, whereas; other had become contaminated and others were not available for shipping. The ratification of only existent lines poses a challenge for researchers because while pursuing an ethical agenda through the policy, the existent lines introduce new limitations. For example, longstanding lines are known to accumulate mutations, and some of the mutations are known to predispose individuals to conditions such as cancer. As such, the few ratified long-standing lines may not be safe for human transplantation, and this may raise another ethical issue if they are put to use. Additionally, there are concerns about the consent acquisition on the derivation of some of the NIH-ratified lines (Streiffer 43). The pro-life ethical approach hinders progress on transplantation because of lack of access to new lines of embryonic stem cells (Alanso-Zaldivar & Kaplan 12). In order to attain greater success there is a need for acquisition of more lines from a variety of donors so as to allow more patients to get human leukocyte agent matched transplants. As a result of this adopted pro-life view which is ethically derived NIH funds have been channelled to a narrowed down line of support where only hESC lines approved by NIH are under hESC research. The federally funded program does not support the acquisition of new embryo stem cell lines or any working on non-approved stem cell lines. These ethically based restrictions have hindered progress on hESC research. Fortunately, the prohibition does not extend to privately funded research, but only serves to restrict public NIH funding. As a result, some states have taken up funding responsibilities and made possible non-federal funding, which has facilitated a number of stem cell research programs and derivation of new stem cell lines. As an example, the state of California has set aside $3 billion dollars over a 10-year period to support stem cell research. Under the Obama regime it is anticipated that more federal funding will be provided for hESC research on lines that are not on the NIH approved list (Lo & Lindsay 208). The funding is also expected to support the derivation of new hESC lines, which will be acquired from frozen embryos, which are donated for research once the couples using in vitro have stated that they no longer need the embryos for reproductive purposes. However, it has to be noted that federal funding may not be expressly provided for embryonic stem cell lines expressly derived for research purposes from embryos created purposefully for research. Frozen embryos providing for new embryonic stem cell lines Couples or women that undergo infertility treatment always have frozen embryos that are left over after the completion of the treatment. The couples or women often choose to donate the remaining embryos for research rather than have the embryos destroyed on given to another couple. During the donation of frozen embryos a number of ethical issues come into play including consent from the gamete donors, consent from the donating couple or women and confidentiality of the involved donors (Lo & Lindsay 206). Informed Consent for hESC donation for research The inception of the Nuremburg Code has ensured that the acquisition of informed consent is a basic requirement for research where human subjects are involved. As such, consent is also important in research involving human embryos (Lyerly & Faden 46). Potential embryo donors and the public hold diverse and strong opinions on the research matter with some considering hESC research to be wrong; whereas others only support only some forms of the research. For example, one may consider research on infertility as an acceptable thing whereas, objecting to aimed at deriving hESC or research which may eventually lead to commercial products or patents. The process of obtaining consent for use of donated embryo material has respect for all these diverse views. In addition, people often have special moral and emotional significance in relation to their reproductive material when compared to other non-reproductive tissues. Waiver of Consent In the U. S there is a waiver of informed consent by the federal regulations when dealing with deidentified biological material, which has no link to the original donors. Therefore, it is logistically possible to conduct hESC research on deidentified material without acquiring consent. For example, in in vitro fertilization (IVF) embryos which do not develop or oocytes that do not fertilize are discarded because they cannot be implanted successfully. Such material can be deidentified and then offered for research purposes. Furthermore, any remaining frozen embryos after completion of treatment are often stored at the discretion of the infertility patient. As a routine the IVF program often contacts the infertility patients seeking to know whether they would like to pay for storage or donate the embryos to another infertile couple or have them discarded (Lo & Lindsay 210). If the owner chooses to have them discarded, then identifiers could be removed and the embryos used for hESC research. Another possible source of hESC research material requiring no consent is patients that fail to respond to requests on how their frozen embryos should be handled. IVF practices have a policy that recommends that such embryos should be discarded if the patient does not respond when contacted about the disposition. Infertility patients are often informed about the policy when they get into the IVF procedure (Lo & Lindsay 210). Instead of discarding such embryos it is possible to deidentify them and put them up for hESC research without the consent of the infertility patient concerned. The ethical justifications behind the use of deidentified material without the owners’ consent do not however; always hold for hESC research. One reason behind the use of deidentified material is that the ethical risks are low because the confidentiality of the owner cannot be breached-breach of confidentiality is the main concern in such hESC research. The second reason is that most people may not object to having the material used if they were formally requested. However, the assumptions behind these reasons do not necessarily hold in the case of hESC research. According to a study conducted in 2007, 49% of women that held frozen embryos would be ready to offer then for research purposes (Lyerly & Faden 47). However, such donors may get offended if they were to find that their material had been used for hESC research without their consent. Therefore, deidentification alone does not address their ethical concerns. Gamete donors consent Frozen embryos for hESC research may be created from oocytes and sperms from donors who do not take part anymore in assisted reproduction. Some argue that in such cases there is no consent necessary from the gamete donors because they have given up their rights to direct further use of the gametes to the patients. However, it should be noted that donors willing to donate their gametes may object to their use in hESC research. For example, in a certain study, 25% of oocyte donors for infertility treatment were against the use of the resultant embryos for hESC research (Kalfoglou & Geller 664). This percentage is expected because people attach a lot of significance to reproductive material and most people in the US oppose hESC research. There are significant differences between seeking consent for embryo research from sperm and oocyte donors. Clinics can easily discuss research donations with oocyte donors when they visit for oocyte retrieval and stimulation. However, all clinics obtain their sperm from sperm banks, and as such, they have no direct contact with the sperm donors. Furthermore, sperm donations occur under strict confidentiality and anonymity. As a matter of giving respect the donors’ wishes should be determined regarding stem cell derivation and be respected. Donors of gametes may be willing to help infertile couples, but may be unwilling to have their genetic material used in hESC research. The National Academy of Sciences recommends that consent should be sought from both oocyte and gamete donors. This has already been adopted by the “California Institute of Regenerative Medicine” (CIRM)-a California state agency funding stem cell research. Donor Information Confidentiality Confidentiality should always be upheld in hESC research because any breach in confidentiality may cause harassment and negative publicity for the donors among opponents of hESC. However, it is necessary to retain donor information for audit purposes by the Food and Drug Administration during the process of approving new therapies. However, it should be noted that concerns on confidentiality may prevent some donors from accepting to be reached. In recent times confidentiality of records has been breached through deliberate violations by staff members that either hack into systems or break in to access data. Similarly theft or loss of laptop computers has led to unwanted access to confidential information. In view of this, there is a need to heighten security when protecting files of individuals whose embryos or gametes have been used to derive hESC lines for research (Lo et al. 1457). Computers holding such information should be securely locked in rooms with controlled access and regular audits on access periods. The computers should also be password protected and access limited to a few people that should be granted access on a need to know basis. Entry into rooms housing such computers should be accessed via card keys or any other systems with a capability to record access time and people that access the room and computers so as to ensure the highest levels of confidentiality are maintained. Regular monitoring should also be conducted to ensure that there is no inappropriate access. There is also a need to have the files encrypted and copy-protected to ensure that people who access the system do not copy the information for malicious purposes (Lo & Lindsay 212). Additionally, computers storing such information should be network-protected and if possible they should not be connected to the internet to avoid hackers from reaching into the system via the network connections. It would also be recommendable that the person in charge of maintaining the database and contacting the donors should not be part of the team in charge of research. Such personnel should also receive appropriate training on how to maintain the database and if possible a background check should be conducted on them to ensure their befit the job (Lo & Lindsay 209). Oocyte donation for research and ethical concerns There are greater concerns on oocyte donation for research particularly after the Hwang scandal witnessed in South Korea. In the Hwang scandal there were widespread claims that the derivation of somatic cell nuclear transfer (SCNT) lines was fabricated. In addition to the scientific fraud experienced, the Hwang scandal also involved poor payment to the donors and there was a clearly deficient process in the search for informed consent. Additionally, there was undue influence on junior scientists and staff that were influenced to take up donor roles and a significantly high rate of complications, which resulted from the oocyte donation process. In the state of California part of the public and legislators have charged that clinics concerned with oocyte donation downplay the risk involved in oocyte donation (Lomax, Hall & Lo, 114). As a result CIRM has set up protections that can safeguard women donating oocytes in all state-funded hESC research. Oocyte retrieval medical risks According to the National Research Council and Institute of Medicine there are various medical risks which may affect oocyte retrieval and these include anaesthesia complications, infections, bleeding and hyper-stimulation syndrome. As a matter of ethical consideration, fertility clinics should seek to reduce the levels of risks involved in oocyte donation. The first step towards eliminating such risks should entail the exclusion of donors at a high risk of developing complications such bleeding. Secondly, there should be careful monitoring of the follicles developing. Thirdly, the dosage of chorionic gonadotropin used to induce the ovulation process should be well monitored and adjusted (National Research Council and Institute of Medicine). More often than not severe hyperovulation syndrome may need surgery or hospitalization. As such, women donating oocytes for hESC research should have protection against the expenses that may result from the complications of oocyte retrieval and hormonal stimulation (Lomax et al. 114). The US offers no universal health cover. Therefore, in order to be fair, women undergoing invasive procedures to benefit research efforts and who are not getting pay beyond expenses should not have to bear any expenses for treating any complications, which may arise during the procedure. As such, free medical care for complications that arise out of oocyte donation should be made feasible. In California, for example, hESC research institutions ensure free treatment for donors for proximate and direct complications that arise from oocyte retrieval in all state-funded hESC research cases. The protection of reproductive rights of women in infertility treatment When women in infertility clinics share their oocytes with researchers, their prospects in reproductive success could get compromised because few oocytes will be available for reproductive purposes. In such cases, the physician conducting the retrieval of oocytes should prioritize the reproductive needs of the patient in in vitro fertilization. The oocytes with the best quality should be used for reproductive purposes (Lo & Lindsay 212). As earlier discussed some oocytes may fail to develop sufficiently or may fail to fertilize, and such material could offered for hESC research purposes. However, in this process there should be various safeguards in place to protect the reproductive rights and interests of the donating parties. For example, in the donation of fresh embryos for hESC research the embryologist should be able to determine that the embryos are not suitable for implantation before they can be declared usable in research (Lo & Lindsay 212). To prevent a conflict of interest and a breach of ethical standards it is appropriate that the embryologist should not know whether the donor has consented to research donation. Additionally, the embryologist should not receive any funding from the grants of the research. Furthermore, the physicians treating infertility should not know whether or not the donors have agreed to make donations of the reproductive material for research. Oocyte donors’ payment Different jurisdictions have differing policies on payment to donors. Paying donors for out-of-pocket costs has no ethical problem because donors get no financial gains from participation in research. However, paying donors in excess of reasonable expenses incurred is controversial, and different regions have a conflict of policies, which may internally be inconsistent (Spar, 1290). A number of sensible arguments can be made for and against payment of donors in excess of their expenses (Hyun 630). However, others object that such payments may induce women to take excess risk especially for poorly educated women that have limited employment options, as witnessed in the Hwang scandal. These concerns about undue influence could, however, be dealt with without totally banning payments. For example, participants could be interviewed to determine whether they understand important features of the study and whether they felt free to participate in the study (Lomax 114). Further objections also often arise regarding payment of women that provide oocytes for research. The payment seems to undermine human dignity because biological material is devalued if it can be bought and sold like some commercial commodities (Radin 217). On the other hand, some people contend that it is unfair to ban paying donors for donating oocytes yet infertile women pay thousands of dollars to undergo a process in which they are provided by the same oocytes for infertility treatment (Hyun 630). Moreover, healthy men and women get payment before they can undergo invasive research procedures such as liver biopsy. Furthermore, the ban of pay for oocyte donors has been labelled paternalistic because it denies women authority to make decisions for them (Steinbock 258). However, on a pragmatic level, it is very difficult to conduct recruitments for oocyte donors without payment for such research activities. Oocyte donation and informed consent Several state bodies including California’s CIRM have put in place significant requirements for informed consent in oocyte donation research and hESC research (Lomax & Hall 114). The CIRM regulations go beyond the need for observing disclosure standards with regard to information given to oocyte donors (Lomax & Hall 114). The main ethical issue is whether the oocyte donors appreciate important information on donation and not simply whether disclosure of the information has been made or not. As earlier reviewed, some participants fail to comprehend the consent information as it is on the consent forms (Appelbaum & Lidz 637). Therefore, according to CIRM’s reasoning, disclosure may be necessary, but it is not sufficient to guarantee informed consent. As such, in addition to disclosure it is recommended that participants be asked questions to ensure that understand the important features of hESC research. Works Cited Alanso-Zaldivar, R. & Kaplan, K. 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