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1.  Disclosing Individual CDKN2A Research Results to Melanoma Survivors: Interest, Impact, and Demands on Researchers 
Background
Whether to return individual research results from cancer genetics studies is widely debated, but little is known about how participants respond to results disclosure or about its time and cost burdens on investigators.
Methods
We recontacted participants at one site of a multicenter genetic epidemiologic study regarding their CDKN2A gene test results and implications for melanoma risk. Interested participants were disclosed their results by telephone and followed for 3 months.
Results
Among 39 patients approached, 27 were successfully contacted, and 19 (70% uptake) sought results, including three with mutations. Prior to disclosure, participants endorsed numerous benefits of receiving results (mean = 7.7 of 9 posed), including gaining information relevant to their children’s disease risk. Mean psychological well-being scores did not change from baseline, and no decreases to melanoma prevention behaviors were noted. Fifty-nine percent of participants reported that disclosure made participation in future research more likely. Preparation for disclosure required 40 minutes and $611 per recontact attempt. An additional 78 minutes and $68 was needed to disclose results.
Conclusion
Cancer epidemiology research participants who received their individual genetic research results showed no evidence of psychological harm or false reassurance from disclosure and expressed strong trust in the accuracy of results. Burdens to our investigators were high, but protocols may differ in their demands and disclosure may increase participants’ willingness to enroll in future studies.
Impact
Providing individual study results to cancer genetics research participants poses potential challenges for investigators, but many participants desire and respond positively to this information.
doi:10.1158/1055-9965.EPI-10-1045
PMCID: PMC3833711  PMID: 21307304
2.  When research seems like clinical care: a qualitative study of the communication of individual cancer genetic research results 
BMC Medical Ethics  2008;9:4.
Background
Research ethicists have recently declared a new ethical imperative: that researchers should communicate the results of research to participants. For some analysts, the obligation is restricted to the communication of the general findings or conclusions of the study. However, other analysts extend the obligation to the disclosure of individual research results, especially where these results are perceived to have clinical relevance. Several scholars have advanced cogent critiques of the putative obligation to disclose individual research results. They question whether ethical goals are served by disclosure or violated by non-disclosure, and whether the communication of research results respects ethically salient differences between research practices and clinical care. Empirical data on these questions are limited. Available evidence suggests, on the one hand, growing support for disclosure, and on the other, the potential for significant harm.
Methods
This paper explores the implications of the disclosure of individual research results for the relationship between research and clinical care through analysis of research-based cancer genetic testing in Ontario, Canada in the late 1990s. We analyze a set of 30 interviews with key informants involved with research-based cancer genetic testing before the publicly funded clinical service became available in 2000.
Results
We advance three insights: First, the communication of individual research results makes research practices seem like clinical services for our respondents. Second, while valuing the way in which research enables a form of clinical access, our respondents experience these quasi-clinical services as inadequate. Finally, our respondents recognize the ways in which their experience with these quasi-clinical services is influenced by research imperatives, but understand and interpret the significance and appropriateness of these influences in different ways.
Conclusion
Our findings suggest that the hybrid state created through the disclosure of research results about individuals that are perceived to be clinically relevant may produce neither sufficiently adequate clinical care nor sufficiently ethical research practices. These findings raise questions about the extent to which research can, and should, be made to serve clinical purposes, and suggest the need for further deliberation regarding any ethical obligation to communicate individual research results.
doi:10.1186/1472-6939-9-4
PMCID: PMC2267198  PMID: 18294373
3.  When Do HIV-Infected Women Disclose Their HIV Status to Their Male Partner and Why? A Study in a PMTCT Programme, Abidjan 
PLoS Medicine  2007;4(12):e342.
Background
In Africa, women tested for HIV during antenatal care are counselled to share with their partner their HIV test result and to encourage partners to undertake HIV testing. We investigate, among women tested for HIV within a prevention of mother-to-child transmission of HIV (PMTCT) programme, the key moments for disclosure of their own HIV status to their partner and the impact on partner HIV testing.
Methods and Findings
Within the Ditrame Plus PMTCT project in Abidjan, 546 HIV-positive and 393 HIV-negative women were tested during pregnancy and followed-up for two years after delivery. Circumstances, frequency, and determinants of disclosure to the male partner were estimated according to HIV status. The determinants of partner HIV testing were identified according to women's HIV status. During the two-year follow-up, disclosure to the partner was reported by 96.7% of the HIV-negative women, compared to 46.2% of HIV-positive women (χ2 = 265.2, degrees of freedom [df] = 1, p < 0.001). Among HIV-infected women, privileged circumstances for disclosure were just before delivery, during early weaning (at 4 mo to prevent HIV postnatal transmission), or upon resumption of sexual activity. Formula feeding by HIV-infected women increased the probability of disclosure (adjusted odds ratio 1.54, 95% confidence interval 1.04–2.27, Wald test = 4.649, df = 1, p = 0.031), whereas household factors such as having a co-spouse or living with family reduced the probability of disclosure. The proportion of male partners tested for HIV was 23.1% among HIV-positive women and 14.8% among HIV-negative women (χ2 = 10.04, df = 1, p = 0.002). Partners of HIV-positive women who were informed of their wife's HIV status were more likely to undertake HIV testing than those not informed (37.7% versus 10.5%, χ2 = 56.36, df = 1, p < 0.001).
Conclusions
In PMTCT programmes, specific psychosocial counselling and support should be provided to women during the key moments of disclosure of HIV status to their partners (end of pregnancy, weaning, and resumption of sexual activity). This support could contribute to improving women's adherence to the advice given to prevent postnatal and sexual HIV transmission.
In a mother-to-child HIV prevention program in Côte d'Ivoire, Annabel Desgrées-du-Loû and colleagues identify three junctures at which women tend to disclose their HIV status to partners.
Editors' Summary
Background.
Since the first reported case of AIDS (acquired immunodeficiency syndrome) in 1981, the number of people infected with the human immunodeficiency virus (HIV), which causes AIDS, has risen steadily. By the end of 2006, nearly 40 million people were infected, 25 million of them in sub-Saharan Africa. HIV is most often spread by having unprotected sex with an infected partner. In Africa, most sexual transmission of HIV is between partners in stable relationships—many such couples do not adopt measures that prevent viral transmission, such as knowing the HIV status of both partners and using condoms if one partner is HIV-positive. HIV can also pass from a mother to her baby during pregnancy, labor, or delivery, or through breastfeeding. Mother-to-child transmission (MTCT) of HIV can be reduced by giving anti-HIV drugs to the mother during pregnancy and labor and to her newborn baby, and by avoiding breastfeeding or weaning the baby early.
Why Was This Study Done?
Many African countries have programs for prevention of MTCT (PMTCT) that offer pregnant women prenatal HIV counseling and testing. As a result, women are often the first member of a stable relationship to know their HIV status. PMTCT programs advise women to disclose their HIV test result to their partner and to encourage him to have an HIV test. But for many women, particularly those who are HIV-positive, talking to their partner about HIV/AIDS is hard because of fears of rejection (which could mean loss of housing and food) or accusations of infidelity. Knowing more about when women disclose their HIV status and what makes them decide to do so would help the people running PMTCT programs to support women during the difficult process of disclosure. In this study, the researchers have investigated when and why women participating in a PMTCT research project in Abidjan (Côte d'Ivoire) told their partner about their HIV status and the impact this disclosure had on their partner's uptake of HIV testing.
What Did the Researchers Do and Find?
At regular follow-up visits, the researchers asked women in the Abidjan PMTCT project whether they had told their partners their HIV status and whether they were breast-feeding or had resumed sexual activity. Nearly all the women who tested negative for HIV, but slightly fewer than half of the HIV-positive (infected) women had told their partner about their HIV status by two years after childbirth. Two-thirds of the HIV-positive women who disclosed their status did so before delivery. Other key times for disclosure were at early weaning (4 months after birth) for women who breast-fed their babies, and when sexual activity resumed. HIV-positive women who bottle fed their babies from birth were more likely to tell their partners of their status than women who breast-fed. Factors that prevented women disclosing their HIV status included living in a polygamous relationship or living separately from their partners. Finally, the researchers report that the partners of HIV-positive women who disclosed their HIV status were about three times more likely to take an HIV test than the partners of HIV-positive women who did not disclose.
What Do These Findings Mean?
These findings identify three key times when women who have had an HIV test during pregnancy are likely to disclose their HIV status to their partner. The main one is before delivery and relates, in part, to how the mother plans to feed her baby. To bottle feed in Abidjan, women need considerable support from their partners and this may be the impetus for disclosing their HIV status. Disclosure at early weaning may reflect the woman's need to enlist her partner's support for this unusual decision—the normal time for weaning in Abidjan is 17 months. Finally, disclosure when sexual activity resumes may be necessary so that the woman can explain why she wants to use condoms. Although these findings need confirmation in other settings, targeting counseling and support within PMTCT programs to these key moments might help HIV-positive women to tell their partners about their status. This, hopefully, would help to reduce sexual transmission of HIV within stable relationships in sub-Saharan Africa.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040342.
Information is available from the US National Institute of Allergy and Infectious Diseases on HIV infection and AIDS and on HIV infection in women
HIV InSite has comprehensive information on all aspects of HIV/AIDS
Women Children and HIV provides extensive information on prevention of mother-to-child transmission of HIV in developing countries
Information is available from Avert, an international AIDS charity, on HIV and AIDS in Africa and on HIV and AIDS prevention
AIDSinfo, a service of the US Department of Health and Human Services provideshealth information for HIV-positive pregnant women (in English and Spanish)
doi:10.1371/journal.pmed.0040342
PMCID: PMC2100145  PMID: 18052603
4.  Conflict of Interest Reporting by Authors Involved in Promotion of Off-Label Drug Use: An Analysis of Journal Disclosures 
PLoS Medicine  2012;9(8):e1001280.
Aaron Kesselheim and colleagues investigate conflict of interest disclosures in articles authored by physicians and scientists identified in whistleblower complaints alleging illegal off-label marketing by pharmaceutical companies.
Background
Litigation documents reveal that pharmaceutical companies have paid physicians to promote off-label uses of their products through a number of different avenues. It is unknown whether physicians and scientists who have such conflicts of interest adequately disclose such relationships in the scientific publications they author.
Methods and Findings
We collected whistleblower complaints alleging illegal off-label marketing from the US Department of Justice and other publicly available sources (date range: 1996–2010). We identified physicians and scientists described in the complaints as having financial relationships with defendant manufacturers, then searched Medline for articles they authored in the subsequent three years. We assessed disclosures made in articles related to the off-label use in question, determined the frequency of adequate disclosure statements, and analyzed characteristics of the authors (specialty, author position) and articles (type, connection to off-label use, journal impact factor, citation count/year). We identified 39 conflicted individuals in whistleblower complaints. They published 404 articles related to the drugs at issue in the whistleblower complaints, only 62 (15%) of which contained an adequate disclosure statement. Most articles had no disclosure (43%) or did not mention the pharmaceutical company (40%). Adequate disclosure rates varied significantly by article type, with commentaries less likely to have adequate disclosure compared to articles reporting original studies or trials (adjusted odds ratio [OR] = 0.10, 95%CI = 0.02–0.67, p = 0.02). Over half of the authors (22/39, 56%) made no adequate disclosures in their articles. However, four of six authors with ≥25 articles disclosed in about one-third of articles (range: 10/36–8/25 [28%–32%]).
Conclusions
One in seven authors identified in whistleblower complaints as involved in off-label marketing activities adequately disclosed their conflict of interest in subsequent journal publications. This is a much lower rate of adequate disclosure than has been identified in previous studies. The non-disclosure patterns suggest shortcomings with authors and the rigor of journal practices.
Please see later in the article for the Editors' Summary
Editor's Summary
Background
Off-label use of pharmaceuticals is the practice of prescribing a drug for a condition or age group, or in a dose or form of administration, that has not been specifically approved by a formal regulatory body, such as the US Food and Drug Administration (FDA). Off-label prescribing is common all over the world. In the US, although it is legal for doctors to prescribe drugs off-label and discuss such clinical uses with colleagues, it is illegal for pharmaceutical companies to directly promote off-label uses of any of their products. Revenue from off-label uses can be lucrative for drug companies and even surpass the income from approved uses. Therefore, many pharmaceutical companies have paid physicians and scientists to promote off-label use of their products as part of their marketing programs.
Why Was This Study Done?
Recently, a number of pharmaceutical companies have been investigated in the US for illegal marketing programs that promote off-label uses of their products and have had to pay billions of dollars in court settlements. As part of these investigations, doctors and scientists were identified who were paid by the companies to deliver lectures and conduct other activities to support off-label uses. When the same physicians and scientists also wrote articles about these drugs for medical journals, their financial relationships would have constituted clear conflicts of interest that should have been declared alongside the journal articles. So, in this study, the researchers identified such authors, examined their publications, and assessed the adequacy of conflict of interest disclosures made in these publications.
What Did the Researchers Do and Find?
The researchers used disclosed information from the US Department of Justice, media reports, and data from a non-governmental organization that tracks federal fraud actions, to find whistleblower complaints alleging illegal off-label promotion. Then they identified the doctors and scientists described in the complaints as having financial relationships with the defendant drug companies and searched Medline for articles authored by these experts in the subsequent three years. Using a four step approach, the researchers assessed the adequacy of conflict of interest disclosures made in articles relating to the off-label uses in question.
Using these methods, the researchers examined 26 complaints alleging illegal off-label promotion and identified the 91 doctors and scientists recorded as being involved in this practice. The researchers found 39 (43%) of these 91 experts had authored 404 related publications. In the complaints, these 39 experts were alleged to have engaged in 42 relationships with the relevant drug company: the most common activity was acting as a paid speaker (n = 26, 62%) but also writing reviews or articles on behalf of the company (n = 7), acting as consultants or advisory board members (n = 3), and receiving gifts/honoraria (n = 3), research support funds (n = 2), and educational support funds (n = 1). However, the researchers found that only 62 (15%) of the 404 related articles had adequate disclosures—43% (148) had no disclosure at all, 4% had statements denying any conflicts of interest, 40% had disclosures that did not mention the drug manufacturer, and 13% had disclosures that mentioned the manufacturer but inadequately conveyed the nature of the relationship between author and drug manufacturer reported in the complaint. The researchers also found that adequate disclosure rates varied significantly by article type, with commentaries significantly less likely to have adequate disclosure compared to articles reporting studies or trials.
What Do These Findings Mean?
These findings show the substantial deficiencies in the adequacy of conflict-of-interest disclosures made by authors who had been paid by pharmaceutical manufacturers as part of off-label marketing activities: only one in seven authors fully disclosed their conflict of interest in their published articles. This low figure is troubling and suggests that approaches to controlling the effects of conflicts of interest that rely on author candidness are inadequate and furthermore, journal practices are not robust enough and need to be improved. In the meantime, readers have no option but to interpret conflict of interest disclosures, particularly in relation to off-label uses, with caution.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001280.
The US FDA provides a guide on the use of off-label drugs
The US Agency for Healthcare Research and Quality offers a patient guide to off-label drugs
ProPublica offers a web-based tool to identify physicians who have financial relationships with certain pharmaceutical companies
Wikipedia has a good description of off-label drug use (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The Institute for Medicine as a Profession maintains a list of policies regulating physicians' financial relationships that are in place at US-based academic medical centers
doi:10.1371/journal.pmed.1001280
PMCID: PMC3413710  PMID: 22899894
5.  Returning individual research results for genome sequences of pancreatic cancer 
Genome Medicine  2014;6(5):42.
Background
Disclosure of individual results to participants in genomic research is a complex and contentious issue. There are many existing commentaries and opinion pieces on the topic, but little empirical data concerning actual cases describing how individual results have been returned. Thus, the real life risks and benefits of disclosing individual research results to participants are rarely if ever presented as part of this debate.
Methods
The Australian Pancreatic Cancer Genome Initiative (APGI) is an Australian contribution to the International Cancer Genome Consortium (ICGC), that involves prospective sequencing of tumor and normal genomes of study participants with pancreatic cancer in Australia. We present three examples that illustrate different facets of how research results may arise, and how they may be returned to individuals within an ethically defensible and clinically practical framework. This framework includes the necessary elements identified by others including consent, determination of the significance of results and which to return, delineation of the responsibility for communication and the clinical pathway for managing the consequences of returning results.
Results
Of 285 recruited patients, we returned results to a total of 25 with no adverse events to date. These included four that were classified as medically actionable, nine as clinically significant and eight that were returned at the request of the treating clinician. Case studies presented depict instances where research results impacted on cancer susceptibility, current treatment and diagnosis, and illustrate key practical challenges of developing an effective framework.
Conclusions
We suggest that return of individual results is both feasible and ethically defensible but only within the context of a robust framework that involves a close relationship between researchers and clinicians.
doi:10.1186/gm558
PMCID: PMC4067993  PMID: 24963353
6.  Offering Individual Genetic Research Results: Context Matters 
Science translational medicine  2010;2(38):38cm20.
The disclosure of individual genetic research results to participants continues to be the subject of vigorous debate, centered primarily on the nature of the results: What are the criteria for the kinds of information that should, could, or should not be offered? There are widely diverging views about how to define these categories, as reasonable people can disagree about the value of various kinds of information. Data concerning participant preferences regarding receipt of results are important, but not determinative of researchers’ fundamental obligations.
We suggest that research context is a vital consideration that has not been sufficiently incorporated into the discussion. We adapt an ancillary care framework to explore what different contexts might call for with regard to offering individual genetic research results. Our analysis suggests that, beyond exceptionally rare circumstances that give rise to a duty to rescue, a “one size fits all” threshold cannot be developed for decisions about return of individual results. Instead, researchers and IRBs must consider the scope of entrustment involved in the research, the intensity and duration of interactions with participants, and the vulnerability and dependence of the study population. The strength of this approach is that research context is foreseeable at the time a study is designed. Assessments of the nature and value of the information may still be required to decide whether to offer a particular result, but perhaps will be facilitated by a more grounded understanding of researchers’ obligations in different contexts.
doi:10.1126/scitranslmed.3000952
PMCID: PMC3136874  PMID: 20592417
7.  What is a meaningful result? Disclosing the results of genomic research in autism to research participants 
Developments in genomics research have been accompanied by a controversial ethical injunction: that researchers disclose individually relevant research results to research participants. With the explosion of genomic research on complex psychiatric conditions such as autism, researchers must increasingly contend with whether – and which results – to report. We conducted a qualitative study with researchers and participants involved in autism genomics research, including 4 focus groups and 23 interviews with parents of autistic children, and 23 interviews with researchers. Respondents considered genomic research results ‘reportable' when results were perceived to explain cause, and answer the question ‘why;' that is, respondents set a standard for reporting individually relevant genetic research results to individual participants that is specific to autism, reflecting the metaphysical value that genetic information is seen to offer in this context. In addition to this standard of meaning, respondents required that results be deemed ‘true.' Here, respondents referenced standards of validity that were context nonspecific. Yet in practice, what qualified as ‘true' depended on evidentiary standards within specific research disciplines as well as fundamental, and contested, theories about how autism is ‘genetic.' For research ethics, these finding suggest that uniform and context-free obligations regarding result disclosure cannot readily be specified. For researchers, they suggest that result disclosure to individuals should be justified not only by perceived meaning but also by clarity regarding appropriate evidentiary standards, and attention to the status of epistemological debates regarding the nature and cause of disorders.
doi:10.1038/ejhg.2010.34
PMCID: PMC2987386  PMID: 20234389
research ethics; duty to disclose; genomics; research results; autism; psychiatric genetics
8.  Comparing test-specific distress of susceptibility versus deterministic genetic testing for Alzheimer’s disease 
Background
Genetic risk for Alzheimer’s disease (AD) may be conferred by the susceptibility polymorphism apolipoprotein E (APOE), where the ε4 allele increases the risk of developing late-onset Alzheimer’s disease but is not a definitive predictor of the disease, or by autosomal dominant mutations (e.g., the presenilins), which almost inevitably result in early-onset familial Alzheimer’s disease. The purpose of this study was to compare the psychological impact of using these two different types of genetic information to disclose genetic risk for AD to family members of affected patients.
Methods
Data were compared from two separate protocols. The Risk Evaluation and Education for Alzheimer’s Disease (REVEAL) Study is a randomized, multi-site clinical trial that evaluated the impact of susceptibility testing for Alzheimer’s disease with APOE in 101 adult children of Alzheimer’s disease patients. A separate study, conducted at the University of Washington, assessed the impact of deterministic genetic testing by disclosing presenilin-1, presenilin-2, or TAU genotype to 22 individuals at risk for familial Alzheimer’s disease or frontotemporal dementia. In both protocols, participants received genetic counseling and completed the Impact of Event Scale (IES), a measure of test-specific distress. Scores were analyzed at the time point closest to one year post-disclosure at which IES data were available. The role of genetic test result (positive vs. negative) and type of genetic testing (deterministic vs. susceptibility) in predicting log-transformed IES scores was assessed with linear regression, controlling for age, gender, and time from disclosure.
Results
Subjects from the REVEAL Study who learned that they were positive for the susceptibility gene APOE ε4+ experienced similar, low levels of test-specific distress compared to those who received positive results of deterministic testing in the University of Washington study (p= 0.78). APOE ε4+ individuals in the susceptibility protocol experienced more test-specific distress than those who tested ε4− in the same study (p= 0.04); however, among those receiving deterministic test disclosure, the subjects who received positive results did not experience significantly higher levels of distress when compared to those who received negative results (p= 0.88).
Conclusions
The findings of this preliminary study, with limited sample size, suggest that the test-related distress experienced by those receiving positive results for a deterministic mutation is similar to the distress experienced by those receiving positive results from genetic susceptibility testing, and that the majority of participants receiving genotype disclosure do not experience clinically significant distress as indicated by IES scores one year after learning of their test results.
doi:10.1016/j.jalz.2008.04.007
PMCID: PMC2610442  PMID: 19012865
genetic susceptibility testing; deterministic testing; Alzheimer’s disease; APOE; genetic counseling
9.  Disclosure of Individualized Research Results: A Precautionary Approach 
Accountability in research  2011;18(6):382-397.
Assessing and managing risks to participants is a central point of contention in the debate about disclosing individualized research results. Those who favor disclosure of only clinically significant results think that disclosing clinically insignificant results is risky and costly, and that harm prevention should take precedence over other ethical considerations. Those who favor giving participants the option of full disclosure regard these risks as insubstantial, and think that obligations to benefit participants and promote their autonomy and right to know outweigh the obligation to prevent harm or financial considerations. The risks of disclosing clinically insignificant research results are currently not quantifiable, due to lack of empirical data. The precautionary principle provides some insight into this debate because it applies to decision-making concerning risks that are plausible but not quantifiable. A precautionary approach would favor full disclosure of individualized results with appropriate safeguards to prevent, minimize, or mitigate risks to participants, such as: validating testing methods; informing participants about their options for receiving tests results and the potential benefits and risks related to receiving results; assessing participants' comfort with handling uncertainty; providing counseling and advice to participants; following-up with individuals who receive tests results; and forming community advisory boards to help investigators deal with issues related to disclosure.
doi:10.1080/08989621.2011.622172
PMCID: PMC3953618  PMID: 22011068
autonomy; beneficence; disclosing research results; precautionary principle; risk
10.  HIV serostatus disclosure among people living with HIV/AIDS in Mwanza, Tanzania 
Background
Disclosing HIV serostatus is important for HIV prevention and maintenance of health for people living with HIV their spouses and the community, it plays a role in the social relation which is critical in reducing HIV transmission. The process may have positive and negative effects to the HIV infected people who disclose their status. The present study was undertaken to describe HIV serostatus disclosure among HIV infected people attending care and treatment clinic at Sekou-Toure hospital in Mwanza, Tanzania.
Methods
A cross-sectional study was carried out on 270 HIV infected adults attending Care and Treatment Clinic (CTC) at Sekou-Toure hospital between September and October, 2010. A Swahili questionnaire was used to obtain demographic and HIV disclosure information.
Results
Hundred and ninety five (72.5%) of all recruited participants were females, 88.1% (238/270) were aged above 30 years and 44.1% (119/270) were married. The prevalence of serostatus disclosure was 93.3% (252/270) with participants aged above 30 years having significantly higher proportion of serostatus disclosure compared to those aged below 30 years (94.5% vs. 84.4%, p < 0.05). Among the participants who disclosed their status, 69.3% reported closeness to the disclosed person as the reason for disclosure while 25.8% (65/252) disclosed because they needed help. Two hundred (79.4%) reported to have received emotional support following disclosure while 25.8% and 29.7% received financial support and freedom to use their anti-retroviral drugs around the person they disclosed their status respectively. Thirty four participants reported to have been discriminated following disclosure and 12 participants reported to have been divorced.
Conclusions
Rate of disclosure of HIV serostatus was noted to be high in this study. Delayed disclosure was also noted in small proportion of participants. Negative outcomes following disclosure of serostatus were reported by participants. Efforts need to be increased to promote disclosure of HIV serostatus in Tanzania through health education and awareness for both HIV infected individuals and the community.
doi:10.1186/1742-6405-11-5
PMCID: PMC3900936  PMID: 24450933
11.  Using AD biomarker research results for clinical care 
Neurology  2013;81(13):1114-1121.
Objective:
To inform whether the Alzheimer's Disease Neuroimaging Initiative (ADNI) should change its policy of not returning research results to ADNI participants, we surveyed investigators and research staff about disclosing ADNI biomarker information to research participants, with particular emphasis on amyloid imaging results.
Methods:
In April 2012, just before Food and Drug Administration approval of the amyloid-binding radiotracer, florbetapir, all ADNI investigators and personnel were recruited to complete an anonymous online survey that contained fixed choice and free-text questions.
Results:
Although ADNI participants often requested amyloid imaging results (the proportions of investigators who reported requests from more than half of their participants with normal cognition or mild cognitive impairment were 20% and 22%, respectively), across all diagnostic groups, the majority of ADNI investigators (approximately 90%) did not return amyloid imaging results to ADNI participants. However, the majority of investigators reported that, if the Food and Drug Administration approved florbetapir, they would support the return of amyloid imaging results to participants with mild cognitive impairment and normal cognition, but they emphasized the need for guidance on how to provide these results to participants and for research to assess the value of returning results as well as how returning results will affect study validity and participant well-being.
Conclusions:
A majority of ADNI investigators support returning amyloid imaging results to ADNI participants. The findings that they want guidance on how to do this and research on the impact of disclosure suggest how to develop and monitor a disclosure process.
doi:10.1212/WNL.0b013e3182a55f4a
PMCID: PMC3795601  PMID: 23966249
12.  The role of disclosure in relation to assent to participate in HIV-related research among HIV-infected youth: a formative study 
Background
The objective of this study was to develop a culturally appropriate approach for obtaining assent from children aged eight to 17 years to participate in paediatric HIV-related operational research in Kinshasa, Democratic Republic of Congo (DRC). Included within this objective was to determine whether or not HIV disclosure should be included as part of the assent process prior to research participation, a component of research participation, or not incorporated in any aspect of the child's involvement in the research. Factors that influence parents' and caregivers' decisions to disclose HIV status to children in non-research contexts were also explored.
Methods
A qualitative formative study was conducted. Semi-structured interviews were conducted with 19 youth living with HIV, 36 parents and caregivers of youth living with HIV, and 17 health professionals who provide care and support to youth living with HIV and their families. Participants were purposefully selected from three HIV care, treatment and/or psychosocial support programmes in Kinshasa, DRC.
Results
Most youth interviewed believed minors participating in HIV-related research should be informed of their HIV-positive status. Parents and caregivers and health professionals had varied perspectives on if and when HIV status should be disclosed to minors during research participation. The age of the youth influenced parents and caregivers' responses, and disclosure to adolescents was more frequently supported than disclosure to children.
Several parents and caregivers, as well as some health professionals, suggested that minors should never be told their HIV-positive status when participating in HIV-related research, regardless of their age. Within the context of treatment programmes, disclosure of HIV status to minors was supported by youth, parents and caregivers, and health professionals as a means to improve adherence to medication.
Conclusion
In settings where most minors are unaware of their HIV infection, researchers should consider excluding the term, "HIV", when explaining HIV-related research to minors, and omitting it from assent forms or informational sheets related to research participation. However, an individualized disclosure plan should be initiated with parents and caregivers at the time of enrolment in HIV-related research, particularly in research that involves treatment.
doi:10.1186/1758-2652-12-17
PMCID: PMC2753623  PMID: 19712468
13.  Disclosing intimate partner violence to health care clinicians - What a difference the setting makes: A qualitative study 
BMC Public Health  2008;8:229.
Background
Despite endorsement by national organizations, the impact of screening for intimate partner violence (IPV) is understudied, particularly as it occurs in different clinical settings. We analyzed interviews of IPV survivors to understand the risks and benefits of disclosing IPV to clinicians across specialties.
Methods
Participants were English-speaking female IPV survivors recruited through IPV programs in Massachusetts. In-depth interviews describing medical encounters related to abuse were analyzed for common themes using Grounded Theory qualitative research methods. Encounters with health care clinicians were categorized by outcome (IPV disclosure by patient, discovery evidenced by discussion of IPV by clinician without patient disclosure, or non-disclosure), attribute (beneficial, unhelpful, harmful), and specialty (emergency department (ED), primary care (PC), obstetrics/gynecology (OB/GYN)).
Results
Of 27 participants aged 18–56, 5 were white, 10 Latina, and 12 black. Of 59 relevant health care encounters, 23 were in ED, 17 in OB/GYN, and 19 in PC. Seven of 9 ED disclosures were characterized as unhelpful; the majority of disclosures in PC and OB/GYN were characterized as beneficial. There were no harmful disclosures in any setting. Unhelpful disclosures resulted in emotional distress and alienation from health care. Regardless of whether disclosure occurred, beneficial encounters were characterized by familiarity with the clinician, acknowledgement of the abuse, respect and relevant referrals.
Conclusion
While no harms resulted from IPV disclosure, survivor satisfaction with disclosure is shaped by the setting of the encounter. Clinicians should aim to build a therapeutic relationship with IPV survivors that empowers and educates patients and does not demand disclosure.
doi:10.1186/1471-2458-8-229
PMCID: PMC2474863  PMID: 18601725
14.  Disclosure of HIV status to children in resource-limited settings: a systematic review 
Introduction
Informing children of their own HIV status is an important aspect of long-term disease management, yet there is little evidence of how and when this type of disclosure takes place in resource-limited settings and its impact.
Methods
MEDLINE, EMBASE and Cochrane Databases were searched for the terms hiv AND disclos* AND (child* OR adolesc*). We reviewed 934 article citations and the references of relevant articles to find articles describing disclosure to children and adolescents in resource-limited settings. Data were extracted regarding prevalence of disclosure, factors influencing disclosure, process of disclosure and impact of disclosure on children and caregivers.
Results
Thirty-two articles met the inclusion criteria, with 16 reporting prevalence of disclosure. Of these 16 studies, proportions of disclosed children ranged from 0 to 69.2%. Important factors influencing disclosure included the child's age and perceived ability to understand the meaning of HIV infection and factors related to caregivers, such as education level, openness about their own HIV status and beliefs about children's capacities. Common barriers to disclosure were fear that the child would disclose HIV status to others, fear of stigma and concerns for children's emotional or physical health. Disclosure was mostly led by caregivers and conceptualized as a one-time event, while others described it as a gradual process. Few studies measured the impact of disclosure on children. Findings suggested adherence to antiretroviral therapy (ART) improved post-disclosure but the emotional and psychological effects of disclosure were variable.
Conclusions
Most studies show that a minority of HIV-infected children in resource-limited settings know his/her HIV status. While caregivers identify many factors that influence disclosure, studies suggest both positive and negative effects for children. More research is needed to implement age- and culture-appropriate disclosure in resource-limited settings.
doi:10.7448/IAS.16.1.18466
PMCID: PMC3665848  PMID: 23714198
HIV; disclosure; children; resource-limited settings; systematic review
15.  DISCLOSURE TO PHYSICIANS OF CAM USE BY BREAST CANCER PATIENTS: FINDINGS FROM THE WOMEN’S HEALTHY EATING AND LIVING STUDY 
Integrative cancer therapies  2008;7(3):122-129.
Background
Physician awareness of their patients’ use of complementary and alternative medicine (CAM) is crucial, particularly in the setting of a potentially life-threatening disease such as cancer. The potential for harmful treatment interactions may be greatest when a patient sees a CAM practitioner – perceived as a physician-like authority figure – but does not disclose this to their physician. We therefore investigated the extent of nondisclosure in a large cohort of cancer patients.
Methods
We investigated CAM use in participants of the UCSD Women’s Healthy Eating and Living (WHEL) Study, a multicenter study of the effect of diet and lifestyle on disease-free and overall survival in women ages 18–70 who had completed treatment for invasive breast cancer between 1995 and 2000. Data regarding CAM use and disclosure was collected via a telephone-administered questionnaire in 2003–2004. This questionnaire asked about different CAM modalities including those requiring a “skilled CAM practitioner” (acupuncturist, chiropractor, homeopath, or naturopath) for administration. Demographic data was obtained at the WHEL baseline clinic interview. Modality-specific disclosure rates were determined and a comparison of demographic variables of disclosers versus nondisclosers was conducted using Chi-squared tests for categorical variables, and t-tests for continuous variables.
Results
Of 3088 total WHEL participants, 2527 completed the CAM questionnaire. Of these, 2017 reported using some form of CAM. Of these, 300 received treatment from an acupuncturist, chiropractor, homeopath, or naturopath and also provided information on whether or not they disclosed this care to their conventional physician. The highest disclosure rate was for naturopathy (85%), followed by homeopathy (74%), acupuncture (71%), and chiropractic (47%). Among demographic characteristics, only education (p = 0.047) and study site (p=0.039) were associated with disclosure. College graduates and postgraduates, in particular, were more likely to disclose CAM use to their physicians than those with lesser education.
Conclusion
Overall, we observed moderately high rates of physician disclosure of CAM use for all modalities except chiropractic. Education and study site associations suggest that disclosure may be greater when CAM use is more prevalent and possibly more socially accepted. These findings underscore the importance of open, destigmatized patient-physician communication regarding CAM use.
PMCID: PMC2763208  PMID: 18956493
Breast cancer; CAM; complementary and alternative medicine; acupuncture; naturopathy; chiropractic; health communication; disclosure
16.  Appropriate disclosure of a diagnosis of dementia: identifying the key behaviours of 'best practice' 
Background
Despite growing evidence that many people with dementia want to know their diagnosis, there is wide variation in attitudes of professionals towards disclosure. The disclosure of the diagnosis of dementia is increasingly recognised as being a process rather than a one-off behaviour. However, the different behaviours that contribute to this process have not been comprehensively defined. No intervention studies to improve diagnostic disclosure in dementia have been reported to date. As part of a larger study to develop an intervention to promote appropriate disclosure, we sought to identify important disclosure behaviours and explore whether supplementing a literature review with other methods would result in the identification of new behaviours.
Methods
To identify a comprehensive list of behaviours in disclosure we conducted a literature review, interviewed people with dementia and informal carers, and used a consensus process involving health and social care professionals. Content analysis of the full list of behaviours was carried out.
Results
Interviews were conducted with four people with dementia and six informal carers. Eight health and social care professionals took part in the consensus panel. From the interviews, consensus panel and literature review 220 behaviours were elicited, with 109 behaviours over-lapping. The interviews and consensus panel elicited 27 behaviours supplementary to the review. Those from the interviews appeared to be self-evident but highlighted deficiencies in current practice and from the panel focused largely on balancing the needs of people with dementia and family members. Behaviours were grouped into eight categories: preparing for disclosure; integrating family members; exploring the patient's perspective; disclosing the diagnosis; responding to patient reactions; focusing on quality of life and well-being; planning for the future; and communicating effectively.
Conclusion
This exercise has highlighted the complexity of the process of disclosing a diagnosis of dementia in an appropriate manner. It confirms that many of the behaviours identified in the literature (often based on professional opinion rather than empirical evidence) also resonate with people with dementia and informal carers. The presence of contradictory behaviours emphasises the need to tailor the process of disclosure to individual patients and carers. Our combined methods may be relevant to other efforts to identify and define complex clinical practices for further study.
doi:10.1186/1472-6963-8-95
PMCID: PMC2408568  PMID: 18452594
17.  Biobank Participants’ Preferences for Disclosure of Genetic Research Results: Perspectives From the OurGenes, OurHealth, OurCommunity Project 
Mayo Clinic proceedings  2014;89(6):738-746.
Objective
To assess biobank participants’ preferences for disclosure of genetic research results. Patients and Methods: We conducted a cross-sectional survey of participants in the OurGenes, OurHealth, OurCommunity biobank. Respondents were surveyed about preferences for disclosure, importance of disclosure, communication of results with practitioners, and sharing of results after respondents’ death. Multivariate regression analysis was used to assess independent sociodemographic and clinical predictors of disclosure preferences. Data collection occurred from June 6, 2011, to June 25, 2012.
Results
Among 1154 biobank participants, 555 (48%) responded. Most thought that research result disclosure was important (90%). Preference for disclosure varied, depending on availability of disease treatment (90% vs. 64%, P<.001), high vs. low disease risk (79% vs. 66%, P<.001), and serious vs. mild disease (83% vs. 68%, P<.001). More than half of respondents (57%) preferred disclosure even when there is uncertainty about the results’ meaning, and 87% preferred disclosure if the disease is highly heritable. Older age was positively associated with interest in disclosure, whereas female sex, nonwhite race, diabetes mellitus, and depression and/or anxiety were negatively associated with disclosure. More than half of respondents (52%) would want their results returned to their nearest biological relative after death.
Conclusions
OurGenes biobank participants report strong preferences for disclosure of research results, and most would designate a relative to receive results after death. Participant preferences for serious vs. mild disease, high vs. low disease risk, and availability of disease treatment differed significantly. Future research should consider family members’ preferences for receiving research results from enrolled research participants.
doi:10.1016/j.mayocp.2014.03.015
PMCID: PMC4148696  PMID: 24943692
18.  Handling ethical, legal and social issues in birth cohort studies involving genetic research: responses from studies in six countries 
BMC Medical Ethics  2010;11:4.
Background
Research involving minors has been the subject of much ethical debate. The growing number of longitudinal, pediatric studies that involve genetic research present even more complex challenges to ensure appropriate protection of children and families as research participants. Long-term studies with a genetic component involve collection, retention and use of biological samples and personal information over many years. Cohort studies may be established to study specific conditions (e.g. autism, asthma) or may have a broad aim to research a range of factors that influence the health and development of children. Studies are increasingly intended to serve as research platforms by providing access to data and biological samples to researchers over many years.
This study examines how six birth cohort studies in North America and Europe that involve genetic research handle key ethical, legal and social (ELS) issues: recruitment, especially parental authority to include a child in research; initial parental consent and subsequent assent and/or consent from the maturing child; withdrawal; confidentiality and sample/data protection; handling sensitive information; and disclosure of results.
Methods
Semi-structured telephone interviews were carried out in 2008/09 with investigators involved in six birth cohort studies in Canada, Denmark, England, France, the Netherlands and the United States. Interviewees self-identified as being knowledgeable about ELS aspects of the study. Interviews were conducted in English.
Results
The studies vary in breadth of initial consent, but none adopt a blanket consent for future use of samples/data. Ethics review of new studies is a common requirement. Studies that follow children past early childhood recognise a need to seek assent/consent as the child matures. All studies limit access to identifiable data and advise participants of the right to withdraw. The clearest differences among studies concern handling of sensitive information and return of results. In all studies, signs of child abuse require reports to authorities, but this disclosure duty is not always stated in consent materials. Studies vary in whether they will return to participants results of routine tests/measures, but none inform participants about findings with unknown clinical significance.
Conclusions
Analysis of how cohort studies in various jurisdictions handle key ELS issues provides informative data for comparison and contrast. Consideration of these and other examples and further scholarly exploration of ELS issues provides insight on how best to address these aspects in ways that respect the well-being of participants, especially children who become research subjects at the start of their lives.
doi:10.1186/1472-6939-11-4
PMCID: PMC2859353  PMID: 20331891
19.  A Case of Error Disclosure: A Communication Privacy Management Analysis 
To better understand the process of disclosing medical errors to patients, this research offers a case analysis using Petronios’s theoretical frame of Communication Privacy Management (CPM). Given the resistance clinicians often feel about error disclosure, insights into the way choices are made by the clinicians in telling patients about the mistake has the potential to address reasons for resistance. Applying the evidenced-based CPM theory, developed over the last 35 years and dedicated to studying disclosure phenomenon, to disclosing medical mistakes potentially has the ability to reshape thinking about the error disclosure process. Using a composite case representing a surgical mistake, analysis based on CPM theory is offered to gain insights into conversational routines and disclosure management choices of revealing a medical error. The results of this analysis show that an underlying assumption of health information ownership by the patient and family can be at odds with the way the clinician tends to control disclosure about the error. In addition, the case analysis illustrates that there are embedded patterns of disclosure that emerge out of conversations the clinician has with the patient and the patient’s family members. These patterns unfold privacy management decisions on the part of the clinician that impact how the patient is told about the error and the way that patients interpret the meaning of the disclosure. These findings suggest the need for a better understanding of how patients manage their private health information in relationship to their expectations for the way they see the clinician caring for or controlling their health information about errors.
Significance for public healthMuch of the mission central to public health sits squarely on the ability to communicate effectively. This case analysis offers an in-depth assessment of how error disclosure is complicated by misunderstandings, assuming ownership and control over information, unwittingly following conversational scripts that convey misleading messages, and the difficulty in regulating privacy boundaries in the stressful circumstances that occur with error disclosures. As a consequence, the potential contribution to public health is the ability to more clearly see the significance of the disclosure process that has implications for many public health issues.
doi:10.4081/jphr.2013.e30
PMCID: PMC4147749  PMID: 25170501
disclosure; medical errors; communication privacy management theory; privacy boundaries
20.  Consulting communities on feedback of genetic findings in international health research: sharing sickle cell disease and carrier information in coastal Kenya 
BMC Medical Ethics  2013;14:41.
Background
International health research in malaria-endemic settings may include screening for sickle cell disease, given the relationship between this important genetic condition and resistance to malaria, generating questions about whether and how findings should be disclosed. The literature on disclosing genetic findings in the context of research highlights the role of community consultation in understanding and balancing ethically important issues from participants’ perspectives, including social forms of benefit and harm, and the influence of access to care. To inform research practice locally, and contribute to policy more widely, this study aimed to explore the views of local residents in Kilifi County in coastal Kenya on how researchers should manage study-generated information on sickle cell disease and carrier status.
Methods
Between June 2010 and July 2011, we consulted 62 purposively selected Kilifi residents on how researchers should manage study-generated sickle cell disease findings. Methods drew on a series of deliberative informed small group discussions. Data were analysed thematically, using charts, to describe participants’ perceptions of the importance of disclosing findings, including reasoning, difference and underlying values. Themes were derived from the underlying research questions and from issues emerging from discussions. Data interpretation drew on relevant areas of social science and bioethics literature.
Results
Perceived health and social benefits generated strong support for disclosing findings on sickle cell disease, but the balance of social benefits and harms was less clear for sickle cell trait. Many forms of health and social benefits and harms of information-sharing were identified, with important underlying values related to family interests and the importance of openness. The influence of micro and macro level contextual features and prioritization of values led to marked diversity of opinion.
Conclusions
The approach demonstrates a high ethical importance in many malaria endemic low-to-middle income country settings of disclosing sickle cell disease findings generated during research, alongside provision of effective care and locally-informed counselling. Since these services are central to the benefits of disclosure, health researchers whose studies include screening for sickle cell disease should actively promote the development of health policy and services for this condition in situations of unmet need, including through the prior development of collaborative partnerships with government health managers and providers. Community consultation can importantly enrich ethical debate on research practice where in-depth exploration of informed views and the potential for difference are taken into account.
doi:10.1186/1472-6939-14-41
PMCID: PMC4016314  PMID: 24125465
Kenya; Africa; Sickle cell disease; Community consultation; Genetic findings; Genetic and genomics research; Deliberative methods; Empirical ethics
21.  Researcher Perspectives on Disclosure of Incidental Findings in Genetic Research 
Genetic research can produce information that is beyond the aims of the research study yet may be of clinical or personal interest to study participants. We conducted semi-structured interviews with 44 researchers who were asked to describe how they would respond to a hypothetical vignette regarding the disclosure of findings with unanticipated clinical significance to research study participants. Interviews were transcribed and analyzed using content and thematic analyses. Researchers’ decision-making processes about whether to disclose incidental findings were governed by potentially conflicting duties in three primary domains: information quality, adherence to rules, and participant welfare. There are several actions researchers can take to prepare for incidental findings, including: adding specific language in informed consent documents to state clearly how investigators will handle disclosure; exploring how prepared participants might be during the consent process to make decisions about how they would like to be approached in the event of incidental findings; developing procedures for appropriately communicating individual results and providing follow-up support based on participant preferences; and, in genetic research, having an awareness of the range of traits expressed by the genes under study.
doi:10.1525/jer.2010.5.3.31
PMCID: PMC3413406  PMID: 20831419
incidental findings; genetic studies; decision-making processes; communication of results; disclosure; qualitative research; vignette study
22.  What Do Physicians Tell Patients About Themselves? 
OBJECTIVE
Physician self-disclosure (PSD) has been alternatively described as a boundary violation or a means to foster trust and rapport with patients. We analyzed a series of physician self-disclosure statements to inform the current controversy.
DESIGN
Qualitative analysis of all PSD statements identified using the Roter Interaction Analysis System (RIAS) during 1,265 audiotaped office visits.
SETTING AND PARTICIPANTS
One hundred twenty-four physicians and 1,265 of their patients.
MAIN RESULTS
Some form of PSD occurred in 195/1,265 (15.4%) of routine office visits. In some visits, disclosure occurred more than once; thus, there were 242 PSD statements available for analysis. PSD statements fell into the following categories: reassurance (n = 71), counseling (n = 60), rapport building (n = 55), casual (n = 31), intimate (n = 14), and extended narratives (n = 11). Reassurance disclosures indicated the physician had the same experience as the patient (“I've used quite a bit of that medicine myself”). Counseling disclosures seemed intended to guide action (“I just got my flu shot”). Rapport-building disclosures were either humorous anecdotes or statements of empathy (“I know I'd be nervous, too”). Casual disclosures were short statements that had little obvious connection to the patient's condition (“I wish I could sleep sitting up”). Intimate disclosures refer to private revelations (“I cried a lot with my divorce, too”) and extended narratives were extremely long and had no relation to the patient's condition.
CONCLUSIONS
Physician self-disclosure encompasses complex and varied communication behaviors. Self-disclosing statements that are self-preoccupied or intimate are rare. When debating whether physicians ought to reveal their personal experiences to patients, it is important for researchers to be more specific about the types of statements physicians should or should not make.
doi:10.1111/j.1525-1497.2004.30604.x
PMCID: PMC1492523  PMID: 15333054
patient-physician communication; physician self-disclosure; patient-physician relationship; professionalism; qualitative analysis
23.  Improving the use of research evidence in guideline development: 4. Managing conflicts of interests 
Background
The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the fourth of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this.
Objectives
We reviewed the literature on conflicts of interest to answer the following questions:
1. What is the best way to obtain complete and accurate disclosures on financial ties and other competing interests?
2. How to determine when a disclosed financial tie or other competing interest constitutes a conflict of interest?
3. When a conflict of interest is identified, how should the conflict be managed?
4. How could conflict of interest policies be enforced?
Methods
We searched PubMed, the Cochrane Methodology Register and selectively searched for the published policies of several organizations, We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments.
Key questions and answers
What is the best way to obtain complete and accurate disclosures on financial ties and other competing interests?
• Although there is little empirical evidence to guide the development of disclosure forms, minimal or open-ended formats are likely to be uninformative. We recommend the development of specific, detailed, structured forms that solicit as much information as possible about the nature and extent of the competing interests.
How to determine when a disclosed financial tie or other competing interest constitutes a conflict of interest?
• There is no empirical evidence to suggest that explicit criteria are preferable to ad hoc committee decisions when deciding if a disclosed financial tie is a conflict of interest. However, explicit criteria may make decision-making easier.
When a conflict of interest is identified, how should the conflict be managed?
• Descriptive studies suggest that appropriate management strategies are best determined on a case-by-case basis. Thus, WHO should use a wide range of management strategies to address disclosed conflicts of interest, with public disclosure of conflicts associated with each meeting as a minimum and recusal of conflicted individuals as the other extreme.
How could conflict of interest policies be enforced?
• Although there are no empirical studies of the enforcement of conflict if interest policies, descriptive studies of other organizations and institutions suggest that WHO convene a standing committee to review all financial disclosure statements prior to the commencement of committee meetings/hearings and to make management recommendations when necessary. A standard policy requiring all financial ties to be made public (i.e., recorded into the meeting minutes) should reduce the number of problematic cases. In instances where the conflicts seem intractable, a recommendation of recusal may be necessary to protect the greater interests of WHO and its constituents.
doi:10.1186/1478-4505-4-16
PMCID: PMC1693552  PMID: 17140441
24.  Finding Fault? Exploring Legal Duties to Return Incidental Findings in Genomic Research 
The Georgetown law journal  2014;102:795-843.
The use of whole-genome sequencing in biomedical research is expected to produce dramatic advances in human health. The increasing use of this powerful, data-rich new technology in research, however, will inevitably give rise to incidental findings (IFs)—findings with individual health or reproductive significance that are beyond the aims of the particular research—and the related questions of whether and to what extent researchers have an ethical obligation to return IFs. Many have concluded that researchers have an ethical obligation to return some findings in some circumstances but have provided vague or context-dependent approaches to determining which IFs must be returned and when. As a result, researchers have started returning IFs inconsistently, giving rise to concerns about legal liability in circumstances in which notification could have potentially prevented injury. Although it is clear that ethical guidance should not be automatically codified as law and that crafting ethical obligations around legal duties can be inappropriate, the ethical debate should not proceed unaware of the potential legal ramifications of advancing and implementing an ethical obligation to return IFs.
This Article assesses the legal claims that could be brought for a researcher’s failure to return IFs. The potential for researchers to be held liable in tort is still uncertain and turns largely on a number of factors—including customary practice and guidance documents—that are still in flux. Unlike medical care, which has a well-defined duty into which evolving scientific knowledge about genetics and genomics can readily be incorporated, a researcher’s duty to return IFs is less well defined, making it difficult to determine at the outset whether and when legal liability will attach.
This Article advocates for a clearer, ethically sound standard of requiring that researchers disclose in the informed consent document which approach to offering IFs will be taken. This approach enables participants to know at the outset which findings, if any, will be returned, allows researchers to ascertain when their failure to appropriately return incidental findings will give rise to liability, and enables courts to make determinations that will produce more consistent legal guidance.
PMCID: PMC4207216  PMID: 25346543
25.  “In Sickness and in Health”? Disclosures of Genetic Risks in Dating 
Journal of genetic counseling  2010;20(1):98-112.
Individuals who have, or are at risk for, various genetic disorders face many challenges concerning disclosures of genetic information in dating situations. We conducted a qualitative interview study of 64 individuals confronting Huntington’s disease, breast cancer, or Alpha-1 antitrypsin deficiency, examining what issues these individuals encountered, and how they viewed and addressed these—including issues of understandings, privacy, and disclosures of genetic information to various groups (e.g., family members). Incidental to the primary research questions addressed, participants also often described a series of dilemmas in dating situations that they and/or family members, friends, and fellow patients faced of whether to date, and if so, whether, what, how, why, and when to disclose their genetic risk or illness. At times, these individuals feared and experienced rejection, and hence delayed, avoided, or opposed disclosure, or disclosed indirectly or inadvertently. These data are reported in this paper and highlight the importance of patients, their loved ones, genetic counselors, and other health care providers being aware of these issues, and appreciating the complex factors involved, which can affect patients’ coping and social support. This paper, the first to explore several key aspects of disclosures of genetic information in dating, thus suggests needs for public and professional education, and future research in this area.
doi:10.1007/s10897-010-9331-z
PMCID: PMC3152490  PMID: 20890722
Risk communication; Decision-making; Health behaviors; Confidentiality; Ethics; Family relationships; Reproductive choices; Reproductive decisions; Qualitative research

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