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1.  Ethical and practical challenges to studying patients who opt out of large-scale biorepository research 
Large-scale biorepositories that couple biologic specimens with electronic health records containing documentation of phenotypic expression can accelerate scientific research and discovery. However, differences between those subjects who participate in biorepository-based research and the population from which they are drawn may influence research validity. While an opt-out approach to biorepository-based research enhances inclusiveness, empirical research evaluating voluntariness, risk, and the feasibility of an opt-out approach is sparse, and factors influencing patients’ decisions to opt out are understudied. Determining why patients choose to opt out may help to improve voluntariness, however there may be ethical and logistical challenges to studying those who opt out. In this perspective paper, the authors explore what is known about research based on the opt-out model, describe a large-scale biorepository that leverages the opt-out model, and review specific ethical and logistical challenges to bridging the research gaps that remain.
PMCID: PMC3861935  PMID: 23886923
Medical Records Systems, Computerized; Medical Informatics Computing; Informed Consent; Support, U.S. Gov’t, P.H.S.; Biorepositories; Biomedical Ethics
2.  Impact of privacy legislation on the number and characteristics of people who are recruited for research: a randomised controlled trial 
Journal of Medical Ethics  2006;32(8):473-477.
Privacy laws have recently created restrictions on how researchers can approach study participants.
In a randomised trial of 152 patients, 50–74 years old, in a family practice, 60 were randomly selected to opt‐out and 92 to opt‐in methods. Patients were sent an introductory letter by their doctor in two phases, opt‐out before and opt‐in after introduction of the new Privacy Legislation in December 2001. Opt‐out patients were contacted by researchers. Opt‐in patients were contacted if patients responded by email, free telephone number or a reply‐paid card.
Opt‐in recruited fewer patients (47%; 43/92) after invitation compared with opt‐out (67%; 40/60); (−20%; [−4% to −36%]). No proportional difference in recruitment was found between opt‐in and opt‐out groups varied by age, sex or socioeconomic status. The opt‐in group had significantly more people in active decision‐making roles (+30%; [10% to 50%]; p = 0.003). Non‐significant trends were observed towards opt‐in being less likely to include people with lower education (−11.8%; [−30% to 6.4%]; p = 0.13) and people who were not screened (−19.1%; [−40.1% to 1.9%]; p = 0.08). Opt‐in was more likely to recruit people with a family history of colorectal cancer (+12.7%; [−2.8%, 28.2%]; p = 0.12).
The number of participants required to be approached was markedly increased in opt‐in recruitment. Existing participants (eg, screening attendees) with a vested interest such as increased risk, and those preferring an active role in health decision making and with less education were likely to be recruited in opt‐in. Research costs and generalisability are affected by implementing privacy legislation.
PMCID: PMC2563378  PMID: 16877628
3.  Parental Perspectives on a Pediatric Human Non-Subjects Biobank 
AJOB primary research  2012;3(3):21-29.
Genomic biorepositories will be important tools to help unravel the effect of common genetic variants on risk for common pediatric diseases. Our objective was to explore how parents would respond to the inclusion of children in an opt-out model biobank.
We conducted semi-structured interviews with parents in hospital-based pediatric clinics. Participants responded to a description of a biorepository already collecting samples from adults. Two coders independently analyzed and coded interviews using framework analysis. Opt-out forms were later piloted in a clinic area. Parental opt-out choices were recorded electronically, with opt-out rates reported here.
Parents strongly supported medical research in general and expressed a high level of trust that Vanderbilt University would keep their child’s medical information private. Parents were more likely to allow their child’s sample to be included in the biorepository than to allow their child to participate in a hypothetical study that would not help or harm their child, but might help other children. Only a minority were able to volunteer a concern raised by the description of the biobank. The opt-out rate was initially high compared with the opt-out rate in the adult biorepository, but after the first week decreased to near the baseline in adult clinics.
Parents in our study generally support an opt-out model biobank in children. Most would allow their own child’s sample to be included. Institutions seeking to build pediatric biobanks may consider the human non-subjects model as a viable alternative to traditional human-subjects biobanks.
PMCID: PMC3501745  PMID: 23181193
pediatric research ethics; biorepository research; genomic research
4.  Inclusion of Residual Tissue in Biobanks: Opt-In or Opt-Out? 
PLoS Biology  2012;10(8):e1001373.
This paper reviews the key arguments of the two predominant methods for the inclusion of human residual tissue in biobanks: opt-in and opt-out.
Residual samples are an important source of tissue for biobanks. They refer to leftover tissue that is obtained in the course of clinical care. Residual samples can be included through an opt-in method—that is, a person explicitly expresses consent to include residual tissue—or an opt-out method—that is, the tissue is stored unless a person explicitly refuses. At the moment there is a renewed interest in the appropriate method for the inclusion of residual samples in biobanks. The expansion of biobanks and rapid developments in biomedical research underscore the need to evaluate the proper procedure. In this article we revisit the arguments in favor and against opt-in and opt-out methods for residual tissue research. We conclude firstly that an opt-out method is only justifiable when certain conditions are met: (1) awareness has to be raised, (2) sufficient information has to be provided, and (3) a genuine possibility to object has to be offered. An opt-out procedure that fulfills these conditions can be called a “thick” opt-out method. As a consequence, the dichotomy between opt-in and opt-out is less stark than usually suggested, as both methods require a certain amount of effort. Secondly, we conclude that because of the diversity of tissue and research, not every situation can be treated alike. There are at least four situations that require opt-in procedures: (1) research with higher risks or increased burdens, (2) the use of controversial or high-impact techniques, (3) research on sensitive tissue types, and (4) research involving vulnerable patients. We suggest that further interdisciplinary debate should answer the question when to opt-in or when to opt-out.
PMCID: PMC3415320  PMID: 22899893
5.  Costs and Consequences of the US Centers for Disease Control and Prevention's Recommendations for Opt-Out HIV Testing 
PLoS Medicine  2007;4(6):e194.
The United States Centers for Disease Control and Prevention (CDC) recently recommended opt-out HIV testing (testing without the need for risk assessment and counseling) in all health care encounters in the US for persons 13–64 years old. However, the overall costs and consequences of these recommendations have not been estimated before. In this paper, I estimate the costs and public health impact of opt-out HIV testing relative to testing accompanied by client-centered counseling, and relative to a more targeted counseling and testing strategy.
Methods and Findings
Basic methods of scenario and cost-effectiveness analysis were used, from a payer's perspective over a one-year time horizon. I found that for the same programmatic cost of US$864,207,288, targeted counseling and testing services (at a 1% HIV seropositivity rate) would be preferred to opt-out testing: targeted services would newly diagnose more HIV infections (188,170 versus 56,940), prevent more HIV infections (14,553 versus 3,644), and do so at a lower gross cost per infection averted (US$59,383 versus US$237,149). While the study is limited by uncertainty in some input parameter values, the findings were robust across a variety of assumptions about these parameter values (including the estimated HIV seropositivity rate in the targeted counseling and testing scenario).
While opt-out testing may be able to newly diagnose over 56,000 persons living with HIV in one year, abandoning client-centered counseling has real public health consequences in terms of HIV infections that could have been averted. Further, my analyses indicate that even when HIV seropositivity rates are as low as 0.3%, targeted counseling and testing performs better than opt-out testing on several key outcome variables. These analytic findings should be kept in mind as HIV counseling and testing policies are debated in the US.
Scenario and cost-effectiveness analyses found that for the same programmatic cost, targeted counseling and testing would diagnose more people living with HIV and prevent more HIV infections than opt-out testing.
Editors' Summary
About a quarter of a million people in the United States do not realize they are infected with HIV. Because they are unaware of their infection, they don't get the medicines they need to stay healthy, and they may also be transmitting HIV, the virus that causes AIDS, to others unwittingly. How can public health professionals best reach such people to offer them an HIV test? There are a number of different schools of thought, the two most common of which are studied in this paper.
The first is that the best way to reach them is by simply offering every single patient in every health care setting an HIV test, but giving them the option to decline. This approach is known as “opt-out testing” (because everyone gets tested unless they choose to opt out); it has recently been recommended by the leading US government agency responsible for promoting the US public's health, an agency called the Centers for Disease Control and Prevention (CDC). The CDC says that there is no need for patients to give specific written permission for the HIV test to be done and that there is no need for health professionals to offer counseling of what the consequences of a positive test might mean for them before the test.
The second school of thought is that public health professionals should instead target their efforts towards those who are at increased risk of being HIV positive, such as those who inject drugs or who have had high-risk sex. Persons at risk of infection or transmission are offered counseling before the test, to assess their actual risk of HIV and to discuss what would happen in the event that the HIV test comes back positive. During counseling, people are also given advice on steps they can take to stay HIV negative if their test comes back negative, and to prevent infecting others if their test comes back positive. This approach to HIV testing is called “targeted counseling and testing.” While targeting can be done according to levels of risk behavior, counseling and testing services can also be targeted by focusing on geographic areas (e.g., cities) with high levels of HIV infection, or focusing on different types of clinics that serve persons at high risk of HIV infection and/or with little routine access to health care (such as sexually transmitted disease or drug treatment clinics, emergency rooms, or medical clinics in prison settings).
Why Was This Study Done?
The researcher, David Holtgrave, wanted to know which of these two different approaches would be better at reaching people with undiagnosed HIV infection over the course of a one-year period. He also wanted to know the costs of each approach, and which might be better at curbing the spread of HIV.
What Did the Researcher Do and Find?
He used two research techniques. One is called “scenario analysis,” which involves trying to forecast the consequences of several different possible scenarios. The other is called “cost-effectiveness analysis,” which involves comparing the costs and effects of two or more different courses of action.
According to Dr. Holtgrave's analysis, opt-out testing might reach 23% of those people who are currently unaware that they are HIV positive. The program might also prevent 9% of the 40,000 new HIV infections that occur each year in the US. The cost of averting one new infection would be US$237,149. In contrast, targeted counseling and testing might identify about 75% of people in the US now unaware they are living with HIV infection, and prevent about 36% of the new HIV infections. The cost of averting one new infection would be US$59,383. Even when the author changed several assumptions in his analysis (e.g., assumptions about levels of HIV infection or the effectiveness of counseling), he found that targeted counseling and testing still performed better (so the results are “robust” across a variety of such assumptions).
What Do These Findings Mean?
These findings suggest that targeted counseling and testing would be better than opt-out testing for reaching people with undiagnosed HIV infection and for helping to stop the spread of the virus. Opt-out testing, says the author, might even make some people increase their risky behavior. For example, if someone is injecting drugs, is given an opt-out HIV test, but is never questioned about substance use or counseled, and gets an HIV-negative result, they could easily conclude that their drug injecting is not putting them at risk of becoming HIV positive.
However, it is important to note that this study has a major limitation in that it tried to predict what might happen in the future—it did not study the actual impact of the two different types of testing on a group of people. Studies such as this one, which try to predict the future, are always based on a number of assumptions and these assumptions may turn out not to be true. So we should always be cautious in interpreting the results of a “scenario analysis.” In addition, because of the assumptions made in this study, these results are only directly applicable to the US population and hence the implications for other countries are not clear.
Additional Information.
Please access these Web sites via the online version of this summary at
In a related Perspective on this article, Ronald Valdiserri discusses the public health implications of the study
The CDC has a Web site with information on national HIV testing resources
In addition, the CDC has published its “Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings,” which lay out its proposal for opt-out testing
The international AIDS charity AVERT has a comprehensive page on HIV testing, including information on the reasons to have a test and what the test involves
Johns Hopkins University is host to a site that provides extensive information on HIV care and treatment
The University of California at San Francisco maintains HIV InSite, an authoritative Web site covering topics such as HIV prevention, care, and policy
PMCID: PMC1891318  PMID: 17564488
6.  Evaluation of a HIV Voluntary Opt-Out Screening Program in a Singapore Hospital 
PLoS ONE  2015;10(1):e0116987.
Early diagnosis of human immunodeficiency virus (HIV) allows for appropriately timed interventions with improved outcomes, but HIV screening among asymptomatic persons and the general population in Singapore remains low. In 2008, Singapore’s Ministry of Health implemented HIV voluntary opt-out screening (VOS) for hospitalised adults. We evaluated the outcome of VOS and surveyed reasons for its low uptake in our institution.
We assessed the outcomes of the VOS programme from January 2010 to December 2013 at National University Hospital, a 1081-bed tertiary hospital in Singapore. We also examined reasons for opting-in and opting-out using an interviewer–administered structured questionnaire in a representative sample in January 2013.
107,523 patients fulfilled VOS criteria and were offered HIV screening, of which 5215 (4.9%) agreed to testing. 4850 (93.1%) of those who opted-in had an HIV test done. Three (0.06%) tested positive for HIV. 238 patients (14.2%) were surveyed regarding reasons for opting-in or out of VOS. 21 (8.8%) had opted-in. Patients who opted-in were likely to be younger, more educated and reported having more regular sexual partners. Type of housing, number of casual sexual partners, sexual orientation, intravenous drug use, condom use and previous sexually transmitted infection were not associated with deciding to opt-in/out. Patients’ most common reasons for opting-out were: belief that they were at low risk (50.2%), belief that they were too old (26.8%), cost (6.9%) and aversion to venepuncture (6.5%). The most common reason for opting-in was desire to know their HIV status (47.6%).
The success of an HIV-VOS program is largely determined by test uptake. Our study showed that the majority of eligible VOS patients opted-out of HIV screening. Given the considerable cost and low yield of this programme, more needs to be done to better equip patients in self-risk assessment and opting in to testing.
PMCID: PMC4303265  PMID: 25611741
7.  Recruiting patients to medical research: double blind randomised trial of “opt-in” versus “opt-out” strategies 
BMJ : British Medical Journal  2005;331(7522):940.
Objective To evaluate the effect of opt-in compared with opt-out recruitment strategies on response rate and selection bias.
Design Double blind randomised controlled trial.
Setting Two general practices in England.
Participants 510 patients with angina.
Intervention Patients were randomly allocated to an opt-in (asked to actively signal willingness to participate in research) or opt-out (contacted repeatedly unless they signalled unwillingness to participate) approach for recruitment to an observational prognostic study of patients with angina.
Main outcome measures Recruitment rate and clinical characteristics of patients.
Results The recruitment rate, defined by clinic attendance, was 38% (96/252) in the opt-in arm and 50% (128/258) in the opt-out arm (P = 0.014). Once an appointment had been made, non-attendance at the clinic was similar (20% opt-in arm v 17% opt-out arm; P = 0.86). Patients in the opt-in arm had fewer risk factors (44% v 60%; P = 0.053), less treatment for angina (69% v 82%; P = 0.010), and less functional impairment (9% v 20%; P = 0.023) than patients in the opt-out arm.
Conclusions The opt-in approach to participant recruitment, increasingly required by ethics committees, resulted in lower response rates and a biased sample. We propose that the opt-out approach should be the default recruitment strategy for studies with low risk to participants.
PMCID: PMC1261191  PMID: 16157604
8.  A Comparison of Patient Satisfaction with Emergency Department Opt-In and Opt-Out Rapid HIV Screening 
AIDS Research and Treatment  2012;2012:904916.
Study objective. To compare patient satisfaction with emergency department (ED) opt-in and opt-out HIV screening. Methods. We conducted a survey in an urban ED that provided rapid HIV screening using opt-in (February 1, 2007–July 31, 2007) and opt-out (August 1, 2007–January 31, 2008) approaches. We surveyed a convenience sample of patients that completed screening in each phase. The primary outcome was patient satisfaction with HIV screening. Results. There were 207 and 188 completed surveys during the opt-in and opt-out phases, respectively. The majority of patients were satisfied with both opt-in screening (95%, 95% confidence interval [CI] = 92–98) and opt-out screening (94%, 95% CI = 89–97). Satisfaction ratings were similar between opt-in and opt-out phases even after adjusting for age, gender, race/ethnicity, and test result (adjusted odds ratio 1.3, 95% CI = 0.5–3.1). Conclusions. Emergency department patient satisfaction with opt-in and opt-out HIV screening is similarly high.
PMCID: PMC3286895  PMID: 22400107
9.  Architecture of a consent management suite and integration into IHE-based regional health information networks 
The University Hospital Heidelberg is implementing a Regional Health Information Network (RHIN) in the Rhine-Neckar-Region in order to establish a shared-care environment, which is based on established Health IT standards and in particular Integrating the Healthcare Enterprise (IHE). Similar to all other Electronic Health Record (EHR) and Personal Health Record (PHR) approaches the chosen Personal Electronic Health Record (PEHR) architecture relies on the patient's consent in order to share documents and medical data with other care delivery organizations, with the additional requirement that the German legislation explicitly demands a patients' opt-in and does not allow opt-out solutions. This creates two issues: firstly the current IHE consent profile does not address this approach properly and secondly none of the employed intra- and inter-institutional information systems, like almost all systems on the market, offers consent management solutions at all. Hence, the objective of our work is to develop and introduce an extensible architecture for creating, managing and querying patient consents in an IHE-based environment.
Based on the features offered by the IHE profile Basic Patient Privacy Consent (BPPC) and literature, the functionalities and components to meet the requirements of a centralized opt-in consent management solution compliant with German legislation have been analyzed. Two services have been developed and integrated into the Heidelberg PEHR.
The standard-based Consent Management Suite consists of two services. The Consent Management Service is able to receive and store consent documents. It can receive queries concerning a dedicated patient consent, process it and return an answer. It represents a centralized policy enforcement point. The Consent Creator Service allows patients to create their consents electronically. Interfaces to a Master Patient Index (MPI) and a provider index allow to dynamically generate XACML-based policies which are stored in a CDA document to be transferred to the first service. Three workflows have to be considered to integrate the suite into the PEHR: recording the consent, publishing documents and viewing documents.
Our approach solves the consent issue when using IHE profiles for regional health information networks. It is highly interoperable due to the use of international standards and can hence be used in any other region to leverage consent issues and substantially promote the use of IHE for regional health information networks in general.
PMCID: PMC3200153  PMID: 21970788
10.  Opt-out as an acceptable method of obtaining consent in medical research: a short report 
A prospective cohort study was set up to investigate a possible association between antibiotic prescribing and antibiotic resistance of E. coli urinary tract infection in the community. Participation of patients with urinary tract infection was obtained through an opt-out methodology. This short paper reports on the acceptability of the opt-out recruitment approach.
Participating practices (22) were requested to send a urine sample from all patients presenting with symptoms of urinary tract infection. Upon receipt of the sample in the laboratory, a letter explaining the study, an opt-out form and a freepost envelope were sent to all adult patients. A website with additional information and including an 'opt-out' button was set up for the study.
A total of 1362 urine samples were submitted by the 22 participating practices representing 1178 adult patients of whom 193 actively responded to the letter: 142 opted out by letter, 15 through the website, 2 by phone and 12 sent the letter back without indication, making a total of 171 patients or 14.5% opt-out; the remaining 22 patients (1.9%) explicitly opted in. The total group consisted of 80% women and the mean age was 50.9 years (sd 20.8). No significant differences were found between patients who participated and those who opted out in terms of age, gender or whether the urine sample was positive or not.
Overall the opt-out method was well received and participation in the study reached 85.5%. The low number of complaints (2) indicates that this is a generally acceptable method of patient recruitment. The 14.5% opt-out shows that it effectively empowers patients to decline participation. The similarity between patients opting out and the rest of the patients is reassuring for extrapolation of the results of the study.
PMCID: PMC3079702  PMID: 21470399
11.  The Effect of Including an Opt-Out Option in Discrete Choice Experiments 
PLoS ONE  2014;9(11):e111805.
to determine to what extent the inclusion of an opt-out option in a DCE may have an effect on choice behaviour and therefore might influence the attribute level estimates, the relative importance of the attributes and calculated trade-offs.
781 Dutch Type 2 Diabetes Mellitus patients completed a questionnaire containing nine choice tasks with an opt-out option and nice forced choice tasks. Mixed-logit models were used to estimate the relative importance of the five lifestyle program related attributes that were included. Willingness to pay (WTP) values were calculated and it was tested whether results differed between respondents who answered the choice tasks with an opt-out option in the first or second part of the questionnaire.
21.4% of the respondents always opted out. Respondents who were given the opt-out option in the first part of the questionnaire as well as lower educated respondents significantly more often opted out. For both the forced and unforced choice model, different attributes showed significant estimates, the relative importance of the attributes was equal. However, due to differences in relative importance weights, the WTP values for the PA schedule differed significantly between both datasets.
Results show differences in opting out based on the location of the opt-out option and respondents' educational level; this resulted in small differences between the forced and unforced choice model. Since respondents seem to learn from answering forced choice tasks, a dual response design might result in higher data quality compared to offering a direct opt-out option. Future research should empirically explore how choice sets should be presented to make them as easy and less complex as possible in order to reduce the proportion of respondents that opts-out due to choice task complexity. Moreover, future research should debrief respondents to examine the reasons for choosing the opt-out alternative.
PMCID: PMC4218820  PMID: 25365169
12.  Prenatal Screening for HIV in Nova Scotia: Survey of Postpartum Women and Audit of Current Prenatal Screening Practices 
Current guidelines for screening for HIV infections in Nova Scotia recommend an opt-in approach in which patients are counselled and consent to testing. The objectives of the present study were to measure adherence to these recommendations, to explore women’s knowledge, attitudes, beliefs and behaviours concerning HIV screening, and to compare these results with prenatal screening practices for rubella, hepatitis B and group B streptococcus.
All women who gave birth consecutively during a seven-week period were recruited. Study participants were interviewed to determine their knowledge, attitudes and beliefs concerning prenatal screening. Hospital and laboratory records were reviewed for information concerning prenatal screening and perinatal treatment to audit screening practices.
A total of 279 patients were enrolled in the study, representing 58% of those eligible. The HIV screening rate was 72%, compared with 95% for rubella, 89% for hepatitis B and 24% for group B streptococcus. Of the participants tested for HIV, 80% were aware of being tested. Of all the study participants, 17% indicated having received pretest counselling about HIV, 56% volunteered to be tested for HIV, 78% received the test results, and 3.8% received post-test counselling. More participants preferred an opt-out approach to HIV screening (50%), where testing is routinely performed on everyone, rather than the opt-in approach (43%). Participants displayed a similar preference for screening for the other infections.
HIV prenatal testing rates in Nova Scotia are comparable with those of other provinces that recommend an opt-in approach, but are lower than testing rates for opt-out programs. Most study participants were not screened using the recommended opt-in approach.
PMCID: PMC2095076  PMID: 18382632
HIV antibodies; Mass screening; Pregnancy; Prenatal screening; Survey
13.  Projected Survival Gains from Revising State Laws Requiring Written Opt-in Consent for HIV Testing 
Although the Centers for Disease Control and Prevention recommends HIV testing in all settings unless patients refuse (opt-out consent), many state laws require written opt-in consent.
To quantify potential survival gains from passing state laws streamlining HIV testing consent.
We retrieved surveillance data to estimate the current annual HIV diagnosis rate in states with laws requiring written opt-in consent (19.3%). Published data informed the effect of removing that requirement on diagnosis rate (48.5% increase). These parameters then served as input for a model-driven projection of survival based on consent method. Other inputs included undiagnosed HIV prevalence (0.101%); and annual HIV incidence (0.023%).
Hypothetical cohort of adults (>13 years) living in written opt-in states.
Life years gained (LYG).
In the base-case, of the 53,036,383 adult persons living in written opt-in states, 0.66% (350,040) will be infected with HIV. Due to earlier diagnosis, revised consent laws yield 1.5 LYG per HIV-infected person, corresponding to 537,399 LYG among this population. Sensitivity analyses demonstrate that diagnosis rate increases of 24.8-72.3% result in 304,765–724,195 LYG. Net survival gains vanish if the proportion of HIV-infected persons refusing all testing in response to revised laws exceeds 18.2%.
The potential survival gains of increased testing are substantial, suggesting that state laws requiring opt-in HIV testing should be revised.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-011-1637-5) contains supplementary material, which is available to authorized users.
PMCID: PMC3101973  PMID: 21286837
HIV; AIDS; screening; modeling; survival analysis
14.  Alternatives to project-specific consent for access to personal information for health research: Insights from a public dialogue 
BMC Medical Ethics  2008;9:18.
The role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues.
We conducted seven day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly.
Broad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research.
Because no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for example, through a web-based patient portal to their electronic health record. Researchers and policy makers should continue to engage the public to promote greater public understanding of the research process and to look for feasible alternatives to existing approaches to project-specific consent for observational research.
PMCID: PMC2601042  PMID: 19019239
15.  Do children with optic pathway tumors have an increased frequency of other central nervous system tumors? 
Neuro-Oncology  2003;5(2):116-120.
We questioned whether children with optic pathway tumors (OPTs) have an increased frequency of other CNS tumors on the basis of experience with a number of such children treated at our institution. The medical records of all patients with OPTs treated at Golisano Children's Hospital at Strong at the University of Rochester from 1957 to 2000 were reviewed to determine the incidence of additional CNS tumors in these children and whether the occurrence of these other CNS tumors is associated with any risk factors. Twenty-six children had OPTs. Twelve of the 26 children had biopsy-proved tumors; the remaining 14 were diagnosed on the basis of CT or MRI scans. Eight of the 26 patients (31%) had a total of 11 additional CNS tumors. (One child had 2 additional CNS neoplasms, and a second child had 3.) Nine were biopsy proved (3 glioblastoma, 3 anaplastic astrocytoma, 3 low-grade astrocytoma), and 2 were diagnosed by imaging studies alone (acoustic neuromas). Eight of the 11 tumors occurred at a median of 5 years (0.8-25 years) subsequent to the diagnosis of the OPTs; 3 were diagnosed simultaneously with the OPT. Of the 17 children with neurofibromatosis (NF) and OPTs, 8 (47%) had additional CNS tumors, while none of the 9 children (0%) without NF had other CNS tumors (P = 0.023). There was no association between radiation treatment of the primary OPT and subsequent development of other CNS tumors in the group as a whole, or when the analysis was confined to children with NF. Despite this lack of statistical association, all 7 CNS tumors that occurred following radiation arose in irradiated areas. The risk of simultaneous or subsequent CNS tumors in children with NF and OPTs is high. These children should be closely monitored for the simultaneous or subsequent occurrence of other CNS tumors.
PMCID: PMC1920670  PMID: 12672283
16.  An international comparison of deceased and living organ donation/transplant rates in opt-in and opt-out systems: a panel study 
BMC Medicine  2014;12(1):131.
Policy decisions about opt-in and opt-out consent for organ donation are based on limited evidence. To fill this gap we investigated the difference between deceased and living organ donation rates in opt-in and opt-out consent systems across a 13 year period. We controlled for extensive covariates and estimated the causal effect of consent with instrumental variables analysis.
This panel study used secondary data analysis to compare organ donor and transplant rates in 48 countries that had either opt-in or opt-out consent. Organ donation data were obtained over a 13-year period between 2000 and 2012. The main outcome measures were the number of donors, number of transplants per organ and total number (deceased plus living) of kidneys and livers transplanted. The role of consent on donor and transplant rates was assessed using multilevel modeling and the causal effect estimated with instrumental variables analysis.
Deceased donor rates (per-million population) were higher in opt-out (M = 14.24) than opt-in consent countries (M = 9.98; Β = −4.27, 95% confidence interval (CI) = −8.08, −0.45, P = .029). However, the number of living donors was higher in opt-in (M = 9.36) than opt-out countries (M = 5.49; B = 3.86, 95% CI = 1.16, 6.56, P = .006). Importantly, the total number of kidneys transplanted (deceased plus living) was higher in opt-out (M = 28.32) than opt-in countries (M = 22.43; B = −5.89, 95% CI = −11.60, −0.17, P = .044). Similarly, the total number of livers transplanted was higher in opt-out (M = 11.26) than opt-in countries (M = 7.53; B = −3.73, 95% CI = −7.47, 0.01, P = .051). Instrumental variables analysis suggested that the effect of opt-in versus opt-out consent on the difference between deceased and living donor rates is causal.
While the number of deceased donors is higher than the number of living donors, opt-out consent leads to a relative increase in the total number of livers and kidneys transplanted.
PMCID: PMC4175622  PMID: 25285666
Opt-in consent; Opt-out consent; Deceased organ donation; Living organ donation
17.  Preference for physician vs. nurse initiated opt-out screening on HIV test acceptance 
AIDS care  2013;25(11):10.1080/09540121.2013.772283.
Provider initiated opt-out HIV screening suggests that providers should routinely order HIV tests unless a patient declines. However, data on how providers will respond to this new screening model is scarce. Documented concerns from the providers’ perspectives have included time constraints of a typical patient encounter, and discomfort with discussing sexual history and risk behavior with patients. To address these potential barriers, nurse-initiated screening has been proposed as an approach to increasing screening rates in general medical and urgent care settings. This study compares patient acceptability of provider-initiated opt-out HIV screening with nurse-initiated opt-out HIV screening among 220 patients between the ages of 18–64 from two publically funded “safety-net” outpatient clinics in Los Angeles County. Our study found that 77% of patients agreed to HIV testing using opt-out screening, and that HIV test acceptance was higher with the physician initiated opt-out model compared with the nurse initiated opt-out model (Adjusted odds ratios[AOR]=2.92; 95% CI=1.37–6.22). These findings indicate that adding opt-out screening to primary care providers responsibilities may be an acceptable and effective strategy for addressing the perennially low HIV testing rates, particularly among low income, traditionally underserved patient populations among whom the epidemic is expanding most rapidly.
PMCID: PMC3679256  PMID: 23425325
HIV/AIDS; Opt-out screening; test acceptance; health care providers
18.  Time for Oncologists to Opt-In for Routine Opt-Out HIV testing? 
Human immunodeficiency virus (HIV) infected individuals are at high risk for malignancies. However, it is not currently standard of care to test routinely all cancer patients for HIV. In 2006, the Centers for Disease Control (CDC) recommended HIV testing in all healthcare settings, calling for standard non-targeted “opt-out” HIV screening. For a variety of reasons, routine opt-out HIV testing is still not widely utilized in the United States. Although many barriers to routine opt-out HIV testing have been addressed, such opt-out HIV testing continues to be conducted primarily in venues which target specific patient populations such as pregnant women. Although opt-out testing has been piloted in emergency departments, less emphasis has been placed on opt-out HIV testing in other clinical settings. We describe the background, rationale, and evidence for supporting opt-out HIV testing as routine care for cancer patients, and discuss evidence for its potential to improve clinical outcomes by facilitating appropriate HIV management during cancer treatment for those individuals who are found to be HIV positive.
PMCID: PMC3160789  PMID: 20639567
19.  Development of a Large-Scale De-Identified DNA Biobank to Enable Personalized Medicine 
Our objective was to develop a DNA biobank linked to phenotypic data derived from an electronic medical record (EMR) system. An “opt-out” model was implemented after significant review and revision. The plan included (i) development and maintenance of a de-identified mirror image of the EMR, namely, the “synthetic derivative” (SD) and (ii) DNA extracted from discarded blood samples and linked to the SD. Surveys of patients indicated general acceptance of the concept, with only a minority (~5%) opposing it. As a result, mechanisms to facilitate opt-out included publicity and revision of a standard “consent to treatment” form. Algorithms for sample handling and procedures for de-identification were developed and validated in order to ensure acceptable error rates (<0.3 and <0.1%, respectively). The rate of sample accrual is 700–900 samples/week. The advantages of this approach are the rate of sample acquisition and the diversity of phenotypes based on EMRs.
PMCID: PMC3763939  PMID: 18500243
20.  Opt-Out Testing for Stigmatized Diseases: A Social Psychological Approach to Understanding the Potential Effect of Recommendations for Routine HIV Testing 
Little research has studied experimentally whether an opt-out policy will increase testing rates or whether this strategy is especially effective in the case of stigmatized diseases such as HIV.
Design and Main Outcome Measures
In Study 1, a 2 × 2 factorial design asked participants to make moral judgments about a person’s decision to test for stigmatized diseases under an opt-in versus an opt-out policy. In Study 2, a 2 × 2 factorial design measuring testing rates explored whether opt-out methods reduce stigma and increase testing for stigmatized diseases.
Study 1 results suggest that getting tested draws suspicion regarding moral conduct in an opt-in system, whereas not getting tested draws suspicion in an opt-out system. Study 2 results suggest that an opt-out policy may increase testing rates for stigmatized diseases and lessen the effects of stigma in people’s reluctance to test.
A social psychological approach to health services can be used to show how testing policies can influence both the stigmatization associated with testing and participation rates. An understanding of how testing policies may affect patient decision making and behavior is imperative for creating effective testing policies.
PMCID: PMC2965185  PMID: 19916635
stigma; opt-out testing; infectious disease; HIV testing; CDC policy
21.  Survival in Patients with Non-Small Cell Lung Cancer Who Opted out of Cancer-Specific Therapy 
In Malaysia, many patients opted out of cancer-specific treatment for various reasons. This study was undertaken to investigate the survival rate of patients with stages I to III non-small cell lung cancer (NSCLC) who opted out of treatment, compared with those who accepted treatment. Case records of 119 patients diagnosed with NSCLC between 1996 and 2003 in two urban-based hospitals were retrospectively examined. Survival status was ascertained from follow-up medical clinic records or telephone contact with patients or their next-of-kin. Median (25–75% IQR) survival rate for 79 patients who accepted and 22 patients who opted out of treatment, were 8.6 (16.0-3.7) and 2.2 (3.5-0.8) months respectively [log rank p< 0.001, Kaplan-Meier survival analysis]. Except for proportionately more patients with large cell carcinoma who declined treatment, there was no significant difference between the two groups in relation with age, gender, ethnicity, tumour stage, and time delays between symptom onset and treatment or decision-to-treat. We concluded that there was a small but significant survival benefit in accepting cancer-specific treatment. The findings imply that there is no effective alternative therapy to cancer-specific treatment in improving survival. However, overall prognosis for patients with NSCLC remains dismal.
PMCID: PMC3349481  PMID: 22589601
non-small cell lung cancer; survival; cancer-specific treatment; Malaysia
22.  Consent for use of personal information for health research: Do people with potentially stigmatizing health conditions and the general public differ in their opinions? 
BMC Medical Ethics  2009;10:10.
Stigma refers to a distinguishing personal trait that is perceived as or actually is physically, socially, or psychologically disadvantageous. Little is known about the opinion of those who have more or less stigmatizing health conditions regarding the need for consent for use of their personal information for health research.
We surveyed the opinions of people 18 years and older with seven health conditions. Participants were drawn from: physicians' offices and clinics in southern Ontario; and from a cross-Canada marketing panel of individuals with the target health conditions. For each of five research scenarios presented, respondents chose one of five consent choices: (1) no need for me to know; (2) notice with opt-out; (3) broad opt-in; (4) project-specific permission; and (5) this information should not be used. Consent choices were regressed onto: demographics; health condition; and attitude measures of privacy, disclosure concern, and the benefits of health research. We conducted focus groups to discuss possible reasons for observed consent choices.
We observed substantial variation in the control that people wish to have over use of their personal information for research. However, consent choice profiles were similar across health conditions, possibly due to sampling bias. Research involving profit or requiring linkage of health information with income, education, or occupation were associated with more restrictive consent choices. People were more willing to link their health information with biological samples than with information about their income, occupation, or education.
The heterogeneity in consent choices suggests individuals should be offered some choice in use of their information for different types of health research, even if limited to selectively opting-out. Some of the implementation challenges could be designed into the interoperable electronic health record. However, many questions remain, including how best to capture the opinions of those who are more privacy sensitive.
PMCID: PMC2724473  PMID: 19630941
23.  A trial of consent procedures for future research with clinically derived biological samples 
British Journal of Cancer  2009;101(9):1505-1512.
The aims of this study were to determine which consent procedure patients prefer for use of stored tissue for research purposes and what the effects of consent procedures on actual consenting behaviour are.
We offered 264 cancer patients three different consent procedures: ‘one-time general consent' (asked written informed consent), ‘opt-out plus' (had the opportunity to opt out by a form), or the standard hospital procedure (control group). The two intervention groups received a specific leaflet about research with residual tissue and verbal information. The control group only received a general hospital leaflet including opt-out information, which is the procedure currently in use. Subsequently, all patients received a questionnaire to examine their preferences for consent procedures.
In all, 99% of patients consented to research with their residual tissue. In the ‘one-time consent' group 85% sent back their consent form. Patients preferred ‘opt-out plus' (43%) above ‘one-time consent' (34%) or ‘opt-out' (16%), whereas 8% indicated that they did not need to receive information about research with residual tissues or be given the opportunity to make a choice.
The ‘opt-out plus' procedure, which places fewer demands on administrative resources than ‘one-time consent', can also address the information needs of patients.
PMCID: PMC2778511  PMID: 19861997
residual tissue; scientific research; consent procedure; ownership
24.  Routine Opt-Out HIV Testing in an Urban Community Health Center 
AIDS Patient Care and STDs  2009;23(8):619-623.
Undiagnosed HIV infection remains a significant public health problem. To address this, the Centers for Disease Control and Prevention revised testing recommendations, calling for routine opt-out HIV screening among adults in health care settings. However, these recommendations have not been widely implemented in primary care settings. We examined acceptability of opt-out HIV testing in an urban community health center and factors associated with accepting testing. From July 2007 to March 2008, physicians or a designated HIV tester approached patients presenting for primary care visits during 52 clinical sessions at an urban community health center. Patients were told they “would be tested for HIV unless they declined testing.” Enzyme-linked immunosorbent assays, which required venipuncture, were used to test for HIV infection. We extracted demographic, clinical, and visit characteristics from medical records and examined associations between these characteristics and accepting HIV testing using logistic regression. Of 300 patients, 35% agreed to HIV testing, with no new HIV infections detected. Common reasons for declining testing were perceived low risk (54.4%) and self-reported HIV testing previously (45.1%). Younger age (adjusted odds ratio [AOR] = 0.97, 95% confidence interval [CI] = 0.96–0.99), Hispanic ethnicity (AOR = 1.78, 95% CI = 1.01–3.14), and having another blood test during the visit (AOR = 6.36, 95% CI = 3.58–11.28) were independently associated with accepting HIV testing. This study questions whether expanding HIV testing by conducting routine opt-out HIV testing in primary care settings is an acceptable strategy. It is important to understand how various testing strategies may affect HIV testing rates. In addition, further exploration of patients' reasons for declining HIV testing in these settings is warranted.
PMCID: PMC2832648  PMID: 19591606
25.  Impact of VV optimization in relation to left ventricular lead position: an acute haemodynamic study 
Europace  2011;13(6):845-852.
Left ventricular (LV) lead placement to the most delayed segment offers the greatest potential benefit to cardiac resynchronization therapy (CRT). We assessed the impact of interventricular (VV) optimization on acute changes in cardiac output (CO) in patients with and without LV pacing of the most delayed segment.
Methods and results
In 124 patients, the most delayed segment was defined by speckle tracking radial strain and the LV lead position by biplane fluoroscopy. Patients were classified as either a concordant (LV lead at latest site), adjacent (within one segment), or remote (two or more segments away) LV lead. Atrioventricular (AV) and VV delays were optimized by echocardiography. Cardiac output was measured non-invasively and a >20% increase in CO from baseline (intrinsic) defined acute response. Changes in CO in patients with concordant, adjacent, or remote LV leads were recorded following atrioventricular optimization alone (AV OPT) and after combined AV and VV optimization (AV/VV OPT). Compared with AV OPT pacing, AV/VV OPT produced a greater rise in CO (5.45 ± 1.1 vs. 5.76 ± 1.2 L/min, P< 0.001) and higher acute response rates (48.4 vs. 61.3%, P= 0.041). In adjacent patients, compared with AV OPT pacing, AV/VV OPT settings increased the response rate from 36.4 to 63.6% (P= 0.037). VV optimization had no effect on acute response rates in patients with remote (26.7 vs. 33.3%, P = 0.581) or concordant LV leads (65.6 vs. 72.1%, P = 0.438).
VV optimization overcomes some but not all of the deleterious effects of a suboptimal LV lead position.
PMCID: PMC3101849  PMID: 21427090
CRT; VV delay; LV lead; Cardiac output

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