5
Review and Consent in the Use of Residual Newborn Screening Samples

Important Points Highlighted by Speakers

  • An important distinction exists between anonymous samples that cannot be linked to an individual and de-identified samples for which linkage can be made by an outside party if research uncovers a finding of use to an individual.

  • The process of review and consent needs to become more dynamic and flexible.

  • Giving parents an option to opt out of long-term storage of samples rather than consenting for storage is less likely to jeopardize the public health newborn screening process.

  • IRBs and other oversight authorities need to have a strong community representation.

DISTINGUISHING BETWEEN ANONYMIZED AND DE-IDENTIFIED SAMPLES

Alan Fleischman drew a crucial distinction between anonymized and de-identified samples, a distinction that is usually not appreciated by the public (and sometimes not even by researchers). Making this distinction is essential, he said, because it allows different rules to be set for different types of research.



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5 Review and Consent in the Use of Residual Newborn Screening Samples Important Points Highlighted by Speakers • An important distinction exists between anonymous samples that cannot be linked to an individual and de-identified samples for which linkage can be made by an outside party if research uncovers a finding of use to an individual. • The process of review and consent needs to become more dynamic and flexible. • Giving parents an option to opt out of long-term storage of samples rather than consenting for storage is less likely to jeop- ardize the public health newborn screening process. • IRBs and other oversight authorities need to have a strong com- munity representation. DISTINGuISHING BETWEEN ANONyMIZED AND DE-IDENTIFIED SAMPLES Alan Fleischman drew a crucial distinction between anonymized and de-identified samples, a distinction that is usually not appreciated by the public (and sometimes not even by researchers). Making this distinction is essential, he said, because it allows different rules to be set for different types of research. 

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 USING RESIDUAL NEWbORN SCREENING SAMpLES Anonymous samples do not have identifiers that enable the samples to be linked with individuals. As an example, Kenneth Pass described the use of such samples in a blinded seroprevalence study for HIV in New York. The only identifiers retained with the samples were the mother’s age, the gender of the child, and the ZIP code. “Using those three pieces of informa- tion, it would be literally impossible to go back and identify an individual specimen,” he said. By the same token, however, anonymized data would, at least theoretically, make it impossible to find a subject who needs to be treated for a life-threatening disease. By contrast, de-identified samples are coded and separated from iden- tifiers. These identifiers are not held by the researchers themselves, but are instead kept by an “honest broker.” In this case, the identifier can be retrieved and linked to a sample if necessary, allowing the person who donated the sample to be re-contacted if something is discovered that could be beneficial to his or her health. Fleischman and several other speakers raised the issue of whether anonymous samples containing DNA could be linked to individuals. They acknowledged that this could occur. For example, Terry pointed out that additional data could be obtained to link the DNA in an anonymized sample to a particular person and such identification will become increas- ingly possible in the future. Fleischman observed, however, that creating such linkages would require the use of other databases. Careful data and sample access agreements with researchers can make it inappropriate and unethical for people to make such linkages. Other speakers pointed out that legal provisions can also be used to prohibit the identification of anonymized samples. A SENSE OF STEWARDSHIP Public health programs are the stewards of newborn screening samples, Kelly Edwards said, in the sense that these programs are responsible and accountable for the fair use of samples and for follow-up with the pub- lic. Stewardship implies program-level decisions about who has access to samples, for what purpose, and relative to what expenditures of resources. Stewardship is also related to accountability for fair use, ethical practices, and follow-up with dissemination where appropriate, Edwards said. More broadly, stewardship means taking responsibility for the care and well-being of something that is valued, Edwards added. It entails the science, art, and skill of responsible and accountable management of resources. A steward assumes responsibility for the donor’s intent, the man- ner in which resources are used, and the outcomes from their use. Achieving these objectives requires that stewardship be built into governance strate- gies, Edwards said.

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 REVIEW AND CONSENT In the case of residual newborn screening samples, it is not enough to rely on bare minimum safety standards. What is needed is a standard of excellence that goes well beyond the minimum standards. For example, Edwards said, when genomic samples are identifiable, they should be trace- able so that research participants can learn who has their samples and how they are being used. Similarly, the research loop needs to be closed so that people know how their samples contributed to a published paper or to changes in research or health care. “Those are very simple things to keep track of,” she said, “and we are at risk if we cannot let people know how we are using their information.” MAINTAINING PuBLIC TRuST Trustworthy practices will be key to the long-term success of newborn screening programs and research, said Kelly Edwards, but current regula- tory systems and practices may not be sufficient to sustain the trust of the public. The current system relies largely on upfront review and consent. Review traditionally consists of an IRB or a department of health review- ing a proposal for the use of residual newborn screening samples. Consent traditionally consists of telling people up front what will happen to them and to their sample and asking for their permission. “As long as we tell you everything up front and you sign that piece of paper, we are ethically in the clear,” Edwards said. These processes place a very heavy burden on review and consent. They offer little or no opportunity for ongoing follow-up, for checking on how samples were used, or for determining what outcomes happened as a result of a project. Traditional forms of consent can be especially problematic. People can- not easily absorb such large amounts of information at once. They often do not completely understand what they are consenting to, much less the detailed risks and benefits relevant to the decision. Furthermore, while consent focuses on individual privacy and autonomy, there are also harms to groups that can result from research. Alternatives such as anonymiza- tion that reduce reliance on consent can reduce the amount of regulatory review, but the resulting lack of identifiers may cause researchers to forgo richer research results, forfeit valuable connections with research subjects, and have less control over ethical issues. Furthermore, one-time consents do not allow appropriate responses and modifications that reflect the rapidly changing nature of research and of society. The use of residual newborn screening samples in research raises special considerations. Newborn samples are collected for a public health purpose, which places an even greater onus on the people who collect and use these samples, Edwards said. If plans change about how a sample will be used,

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4 USING RESIDUAL NEWbORN SCREENING SAMpLES that information needs to be communicated to the public. These are man- datory programs, which means that the bar needs to be set especially high when engaging people about their participation and about secondary uses of their materials. Consent should not be abandoned, Edwards said. The challenge is to build a responsive system that would be more dynamic and flexible as circumstances change over time. The result could be a transformation of research practices and oversight that brings benefits to both researchers and research subjects. NEW WAyS OF THINkING ABOuT CONSENT Consent is sometimes confused with the idea that people must have control over their own data, Edwards said. But the more important issue is conveying respect. Researchers must have enough respect for members of the public to have a conversation with them about what is happening. Consent conveys respect by asking questions and inviting participation. It permits the expression of diverse beliefs, values, and preferences. And it provides an opportunity for education and outreach (which are discussed in Chapter 6). “The consent process is a perfect place for education to hap- pen,” Edwards said. A range of consent options needs to be available for use with residual newborn screening samples. Some states and research repositories use a community consent model in which town hall meetings are held to let people know about research using their samples. Blanket consent at birth releases a sample for any and all research purposes in the future. Tiered consent at birth gives individuals some choices about how a sample is man- aged. A waiver of consent may be used with identified, de-identified, or anonymized samples. Potential research subjects can be notified that work is being planned and be given an opportunity to opt out or to withdraw a sample if they do not wish to participate. Finally, each individual can be reconsented for each new use of a sample. Edwards argued that two of these options satisfy the goals of main- taining public trust and keeping the community engaged in the research enterprise: recontacting and reconsenting. Recontacting and reconsenting have many advantages in the review and consent process, Edwards said. They can help create partnerships, rela- tionships, and opportunities for public education. They keep participants engaged and informed about research activities. They can contribute to sci- ence literacy and create good will toward public programs and the research enterprise. “You are enlisting people into the excitement of the work that you’re doing, [letting them know] why you think this is a good idea, and getting them on board with you,” she said. “This is a real opportunity.”

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 REVIEW AND CONSENT Edwards cited Washington State as an example of a state that has sought to maintain public trust through a stewardship model using recon- sent. Data are released to researchers with written informed consent from parents and IRB approval from the Department of Health and Department of Social and Health Services. Anonymous samples may be released if the department determines that the intended use has significant potential health benefits and that each of the following criteria has been met1: • The investigation design is adequate to ensure anonymity. • All newborn screening tests have been completed. • At least one fully adequate spot will remain after the anonymous sample has been taken. • Sufficient resources, including personnel, are available for sampling. • The Department of Health/Department of Social and Health Ser- vices human subjects research review board has reviewed and approved the investigation. Residual newborn screening samples have been used in Washington State to study type 1 diabetes, hearing loss, maternal smoking, H1N1 infec- tion, and lysosomal storage diseases. Participation rates for reconsented studies have been as high as 90 percent. (For example, in the type 1 diabetes study, approximately 104,000 of the 116,000 people contacted agreed to be in the study.) Since 2004, out of 450,000 births, there have been fewer than 10 requests for destruction of blood spots. “People are worried about privacy, yes, but they are willing to take those risks if the payoff is worth it,” Edwards said. “So the onus comes back to us to say, ‘What kind of research is going on? Is it worthwhile research from the health benefit point of view? And is this something that we can keep the public excited about?’” THE uSE OF TECHNOLOGy IN CONSENT Edwards pointed out that technology-based ways of managing consent can provide people with a dynamic interface with which to make choices and, in particular, smart informatics tools can help cope with diverse beliefs. “We are not going to be smart enough to anticipate all of the harms and how they might be perceived by others,” she said. “We are going to need informatics help to make this feasible.” Sharon Terry elaborated on the ways in which technology can con- tribute to thinking about consent in new ways. Social networking sites 1Criteria available at www.doh.wa.gov/ehsphl/phl/newborn/privacy.htm (accessed August 23, 2010).

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 USING RESIDUAL NEWbORN SCREENING SAMpLES and other new applications of information technologies, though not yet prominent in medicine or biomedical research, can yield very strong privacy protections. People in all socioeconomic classes can interact with the health- care system through such means as cell phones and computers in libraries or other public places. But different people need to be reached in different ways, so reliance on a single system is not optimal. One new technology cited by Terry is a system called PrivateAccess (pri- vateaccess.com). It provides parents with “dynamic consent,” allowing them to provide different kinds of consent at the time of pregnancy, at the time of the birth, and later as well as giving them the option of changing their pref- erences through an online system. The preferences can be very specific. For example, a parent could give permission for a blood spot to be used for qual- ity control for the newborn screening lab but not for behavioral research. In addition, new technologies can generate audit trails of requests for informa- tion, so that the uses of information can be monitored and controlled. New- born screening would make an excellent test case for such a system because of how it would let parents change their consent declarations over time. The issues associated with newborn screening are exciting because they are going to push the system, Terry said. If states decide, as Texas did, to destroy their samples, a great public treasure will be lost. Parents will lose the opportunity to have choices about how their child’s blood spot is used. Terry expressed confidence that a poll of parents in Texas would have led to a different result. “The case was decided by a few parents and their representatives,” she said. ISSuES WITH ExPANDED CONSENT The issues associated with consent generated the longest and most detailed discussions of the workshop. In particular, several speakers and participants raised questions about whether the consent process should dif- fer in form or substance from what is typical today. Ann Waldo pointed to a study by the University of Michigan establishing that roughly three-fourths of people would be willing to have their children’s residual newborn screen- ing samples stored and used in research if a consent mechanism existed. If there is no consent mechanism, roughly three-fourths say no. Terry pointed out that not asking for consent for the use of residual newborn screening samples can open the door to lawsuits. “So consent really does matter,” said Waldo. Requiring retention of residual dried blood spots would necessitate making storage as compulsory as the census or newborn screening accord- ing to Terry. These are programs that have been implemented on a national scale and require mandatory participation. Terry expressed doubt that every

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 REVIEW AND CONSENT state would be able to mandate storage, since the public in at least some states would not agree to such a provision. Asking for consent to store residual dried blood spots may also pose a risk if parents interpret such a request as consent to be screened. If parents in large numbers began to refuse screening, an extremely valuable program could be destroyed. For this reason, Alan Fleischman argued that parents should be offered the choice to opt out of long-term storage of samples for research unrelated to the newborn screening program, but only after the blood samples have been obtained and screened. Offering the choice of opt- ing out of storage is less likely to jeopardize the public health program than asking for full and informed consent for storage, Fleischman said. This is a consequentialist argument based on believing that the processes of com- mittee review ought to be able to reassure families that opting out is a suf- ficient protection for their families’ interests. Although research involving identified subjects requires an appropriate and informed consent process, the vast majority of research now being done with specimens requires only that families be asked whether they want to opt out after their babies have been screened, Fleischman said. In the best of all possible worlds, families would be engaged in a comprehensive consent process, he added, “but opting out after full informing seems to me to be a very reasonable process for most of the research we’re talking about, until we reach those types of research that require identified subjects.” Families need to understand that they may benefit from having their specimens stored in case something happens with the family, Fleischman said. They also need to understand that the research to which they are being asked to consent will not have identifiers. They should also be reassured that if any identifiable research is done with individuals in the family, per- mission will be asked. “We should support those models and study them, and then we ought to develop some practices across the country that will emulate the best practice models,” he said. Anne-Marie Comeau objected to giving families a choice to opt out of storage, however, because half of the population could say that they do not want their specimens stored. “Consenting to storage is possibly throwing away the national resource that we are all trying to protect for individual and societal benefits,” she said. Families should be reassured about the use of their samples by storing and treating specimens responsibly and appro- priately. Edwards added that a research repository governance system needs to have built-in accountability mechanisms that track the research uses of repository samples and data, that incorporate plans for risk management, and that establish recourse or consequences if breaches occur. “It is not satisfying to the public to say, ‘Well, they won’t get to use the data again if somebody violates this agreement.’ That is not good enough.” Transpar- ency about accountability systems will help build trust, she added.

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 USING RESIDUAL NEWbORN SCREENING SAMpLES Wylie Burke pointed out that an important distinction exists between the storage necessary for maintaining a high-quality newborn screening program and storage for research unrelated to the newborn screening pro- gram. Even if the storage process is the same, the distinction is material to parents. Programs should be able to label certain samples that have been stored as not available for secondary research. Laboratorians would then determine how long samples should be stored for purposes related to the public health program and storage for that length of time ought to be part of the mandatory public health program. If half of parents still opted out of de-identified or anonymized research, more deliberation would be needed, Burke said. But a distinction needs to be made between maintaining a good public health program and supporting secondary research uses. Fleischman expressed the opinion that with the proper public education very few families would choose to opt out. He pointed to the experience in states like South Carolina and Michigan where people are not opting out and are accepting anonymized research. Conversations should be held with the small number of families that do choose to opt out so that the families understand the consequences of their decision. “If they continue to believe that that is best for their family, then they have opted out,” he said, “and I think you have to destroy the sample after the testing and the public health program.” In states where the samples have already been gathered without a consent process, he said, there should be a dialogue with the public in order to decide on the appropriate policies. Fleischman also argued that it is important to make distinctions between different kinds of research. In fact, he argued that the word “research” should not be used as an overarching concept for how the samples are used because it can sometimes be seen as a pejorative term. Comeau agreed that consenting to different kinds of research is acceptable, but she maintained that consenting to storage should not be an option. Edwards emphasized that people should always have the right to say that they do not want their samples to be in a study. So far, the newborn screening program in Washington State has used anonymized samples only for test development. The samples have not been used for epidemiological research. “The Washington State newborn screening program directors are taking their job as stewards of this public health program very seriously,” Edwards said. They have chosen to maintain high standards to meet public expectations and have insisted on proactive consent if research samples are identifiable. If people in Washington State were told that samples would be retained for future research, a review process would be carried out to determine if people need to be re-consented, Edwards said. The usual IRB reviews would then come into play. What she would advocate is an ongoing com- munications strategy that would inform people what is being done with

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 REVIEW AND CONSENT de-identified samples. Fleischman suggested that governors annually spon- sor a public forum to discuss what has happened with the newborn screen- ing program during the past year, although several workshop participants thought that such a forum could become a venue for expressing skepticism and particular viewpoints. Even if it is not possible to recontact and reconsent everyone involved in a given research study, Edwards said, there should be an ongoing review or oversight process that would help build trust in the process. For instance, a community advisory board could help researchers make decisions about the use of samples in a biorepository. Such a board could also help deter- mine when it is necessary to recontact potential research participants and enhance transparency—for example, by keeping a running database of what has been done and what results have emerged. Consent can be problematic when it is taken to either extreme, Waldo said. If the claim is made that the government can do virtually anything with IRB approval, “my autonomy buzzer ... is going to go off.” On the other hand, requiring consent for each and every use of residual dried blood spots, even if the research does not involve personal identifiers and has very little risk, is excessive and would severely constrain this kind of research. Waldo suggested that thresholds of risk could be established beyond which consent would be necessary. New technologies could be a game changer for such an approach. If dynamic consent forms could be accessed through cell phones or an e-mail account and people could be in regular communication with the holder of their preferences, then granting consent could be done quickly and efficiently. On the other hand, altering consent preferences or adding new consent options could lead to a significant resource constraint for state programs. The director of one state public health laboratory stated that a law or regu- lation to track consent or dissent in the use of existing residual dried blood spots would be impossible to adhere to with current budgets. States have enough trouble tracking their citizens for more immediate purposes; track- ing them for consent to research would be much harder. Alissa Johnson agreed that in her discussions with state newborn screening programs, the issue of resources came up repeatedly. A few states allow the program to charge researchers for the preparation of specimens, but that clearly does not cover the expense of tracking consents and the extra burden which is put on these public health agencies. The cost of obtaining consent need not be borne fully by the depart- ments of health. Edwards suggested, for instance, that departments should issue a notice to researchers saying that they should set aside extra resources for the recruitment and consent process and for health department staff to prepare and deliver samples. Isn’t the investment in open communications worth the ability to keep using this resource?, asked Edwards. However,

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40 USING RESIDUAL NEWbORN SCREENING SAMpLES academic researchers at the workshop suggested that they would not be able to do their research if they had to contact the thousands of people who are involved in their studies and ask for consent. Confounding this issue is the potential for adding bias into the results by only evaluating samples from consenting individuals. Terry disagreed and said that dynamic consent need not be expensive and could eventually become as practical as online banking or the use of credit cards. As a system becomes more familiar to people and is more widely used, she noted, it becomes less expensive. Furthermore, there is a business incentive because pharmaceutical companies are interested in enlisting research subjects with dynamic forms of consent. People can decide whether to consent just for quality control experiments, for all dis- ease research, or even for forensic research. And they could change their minds. If a friend or acquaintance gets a disease, a person could update his or her consent to participate in a study that would help that person. Research would be participatory. In addition, Ellen Wright Clayton pointed out that money tends to fol- low good ideas. Partnerships with federal and state agencies, communities, disease advocacy groups, or philanthropies can bring in resources. Given the prospect of future uses, residual newborn screening samples should not be destroyed, Clayton and several other workshop participants urged. Nor is it necessary to enroll research participants retrospectively. “We can enroll more than 4 million a year in the country,” she said, “so it would be much better to be prospective about all of this.” Having a diverse set of state policies, said Fleischman, could be useful because the experiences of different states will reveal valuable lessons. At the same time, however, Waldo urged the federal government to generate guidelines and standards that states can use in developing policies. THE ROLE OF REVIEW BOARDS Several speakers emphasized that the involvement of review boards is very important in building and maintaining public trust. These boards can assure compliance with laws and regulations and can identify and explore issues that may not be immediately apparent. Comeau recommended that approvals from review boards be project- specific. “The idea of a general consent for general access to newborn screening specimens is only going to cause problems,” especially in the area of public trust, she said. Just because a project has been funded does not necessarily mean that it has been completely thought through. If review boards are appropriately educated to understand the pros and cons of such research, review can produce benefits for everyone involved in a project.

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4 REVIEW AND CONSENT In universities and departments of health, IRB review is necessary but not sufficient, Fleischman said. Once an IRB review is complete, there should be a secondary review by a group more oriented toward stewardship and with a stronger community influence. Review by groups with multiple people who represent the community from which samples have come can make sure that the interests of all stakeholders are represented. A number of states, such as Michigan and South Carolina, have already taken initial steps to involve communities in the review process in more substantive ways, Fleischman said. “In South Carolina, in a brochure, par- ents are told what happens to [their] baby’s blood sample after the lab test and they are told they can decide. Similarly, in Michigan, they can make a [choice].” Community-oriented review boards may also be able to help make some of the tough decisions involving prioritization of research projects with residual newborn screening samples. Blood spots are finite resources, and newborn screening programs will not reduce the sample to zero, accord- ing to Ken Pass, because they are saving a certain part for the family. He continued by saying that research results are not foreseeable, and it is not known what future scientific advances will make possible. “We have to make decisions and set priorities about how those resources are going to get used,” said Kelly Edwards. TRANSPARENCy IN SCREENING PROGRAMS AND RESEARCH Review boards offer one way to increase transparency in the uses of residual newborn screening samples, but other steps are necessary as well. Clayton asked that departments of health be more specific and open about what they are claiming and what they are not claiming. If states want to claim the royalties from intellectual property developed with residual newborn screening samples, she said, they should state that explicitly. States also need to be proactive in making information available about the options for parents. In Minnesota, for example, an opt-out provision was established that enables parents to control the use of their children’s screening samples for research, but, said one workshop participant, the state and hospitals did not do an adequate job of making parents aware of the provision. Burke read a letter to the workshop from Logan Spector, chair of the Epidemiology Steering Committee of the Children’s Oncology Group, who wrote, “While the scientific value of residual newborn screening samples is unquestionable, their long-term storage creates an undeniable tension between public health research and personal autonomy. It is our position that this tension can be alleviated through proper research protocols which include transparency and explicit declaration of the possible future uses of

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4 USING RESIDUAL NEWbORN SCREENING SAMpLES the samples.” He also wrote that “to allay concerns about the potential misuse of samples held by states, we support a strong firewall between legitimate research uses and their use for law enforcement, litigation, com- mercial, or insurance purposes.” Transparency may in some cases extend to the data generated from samples. Sharon Kardia, for example, observed that the procedures used and the data generated in research need to be transparent to the public. When researchers can see the data but the public cannot, that situation creates mistrust. Participants at the workshop also discussed the Personal Genome Project, in which participants who enroll must be willing to share their genome sequences and personal health information with the scientific community and the general public. According to Waldo, the people who are participating in the project are told, “We have no idea what will hap- pen to your data and we offer you nothing in terms of protections, and if you want to do it anyway, go ahead.” Yet a large number of people are agreeing to those terms. Waldo drew a parallel between transparency and the concept of mate- riality in consumer protection laws. Advertisements are required to make clear and conspicuous disclosures of everything that a reasonable person would find material to the transaction. Following this consumer protection principle, the transaction of collecting a blood spot would include a disclo- sure of what kinds of research the sample might be used for and what sorts of protection would be applied. If the subject objected, an opt-out mecha- nism would be available. Where consent is required, “you need to make sure [parents] know how [a sample] is going to be used and saved and give them some sense of the risks,” Waldo said. “I think that is only fair.” People also have a reasonable expectation of privacy, Waldo said. This can boil down to a judgment call—and legal arguments—about what is reasonable and what is not. But this expectation can lead to greater trans- parency by encouraging the disclosure of which information will and will not be confidential and secure. Waldo also urged that samples not be destroyed, pointing out that the process in Texas that led to the destruction of samples was far from trans- parent. The decision to destroy the samples was made behind closed doors without legislative hearings or public input, which in turn raised objections from members of the public. At a recent hearing in Texas, Waldo said, a father came forward to say, “My child’s blood was destroyed and I’m really unhappy about that. My child died of a rare disease and I wanted that blood made available so that other children wouldn’t go through what my child went through.” A large amount of valuable epidemiologic research goes on without patient or parental consent, Clayton said, and this is generally appropriate.

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4 REVIEW AND CONSENT Transparency can make possible the oversight and accountability needed for this research to proceed. BuILDING RELATIONSHIPS Review and consent are not necessarily ends in themselves, several speakers noted. They should instead be part of the process of building relationships. Consent is not just about risk disclosure. It is more about the shared expectations that everyone will be on the same page and that public communication will be incorporated into the research process. If the reasons for retaining samples have changed—because, for example, they are going to be used in new forms of research—then people need to be informed. This new information may be passed along in the form of a written consent process or via a public information campaign, but the public needs to be brought along, Edwards said. Relationships are based in part on trust. For that reason consent and review need to be more inclusive. “Consent is actually a symbol for some- thing else,” said Kardia. The consent and review process is equally about assurance and building relationships over time. Trust involves concern for others. The use of a residual blood spot for research is, in essence, the first altruistic gift that an individual makes to society, Fleischman said. It is an optional gift, but it is made in the interests of future children whose health will be better than if that gift were never made.

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