Higher Consent Rates Research Articles

Feasibility of including patients with migration background in a structured heart failure management programme: A prospective case-control study exemplarily on Turkish migrants.

AimsStructured management programmes deliver optimized care in heart failure patients and improve outcome. We examined the feasibility of including patients with migration background speaking little or no German in a heart failure management programme.Methods and resultsAfter adaption of script material and staff to Turkish language we aimed to recruit 300 Turkish and 300 German (control group) patients within 18 months using the operational basis of a local heart failure management programme for screening, contact and inclusion.Of 488 and 1,055 eligible Turkish and German patients identified through screening, 165 Turkish (34%) and 335 German (32%) patients consented on participation (p = 0.46). General practitioners contributed significantly more of the Turkish (84%) than of the German patients (16%, p<0.001). Contact attempts by programme staff were significantly less successful in Turkish (52%) than in German patients (60%, p = 0.005) due to significantly higher rate of missing phone numbers (36% vs 25%), invalid address data (28% vs 7%) and being unreachable by phone more frequently (39% vs 26%, all p<0.001). Consent rate was significantly higher in successfully contacted Turkish (63%) compared to German patients (50%, p<0.001).ConclusionThe inclusion of Turkish minority patients into a heart failure management programme is feasible with higher consent rate than in Germans. However, effort is high due to inherent logistic adaptions and barriers in identification and contacting of patients.Trial registrationDRKS00007780

The HIV Epidemic in Sub-Saharan Africa is Aging: Evidence from the Demographic and Health Surveys in Sub-Saharan Africa.

We use the individual-level data from all available Demographic and Health Surveys (DHS) from 27 sub-Saharan African countries conducted between 2003 and 2012 (40 population-based and nationally representative surveys in total) to calculate HIV testing consent rates and HIV prevalence for each country separately, as well as for the pooled sample. The pooled sample comprised of 427,130 individuals. In most countries HIV prevalence in adults aged 45years and above is higher than in the total population. We further show that over the past decade HIV prevalence has increased in older age groups, while it has decreased in younger ones. While the age patterns of HIV consent rates vary across the 27 countries included in our sample, analysis of the pooled sample across all countries reveals a u-shaped relationship with lowest consent rates around age 35years and higher consent rates among younger and older people. We argue that future DHS and other population-based HIV surveys should offer HIV testing to all adults without age limits.

Comprehensive clinical assessment of home‐based older persons within New Zealand: an epidemiological profile of a national cross‐section

ObjectiveSince 2012, all community care recipients in New Zealand have undergone a standardised needs assessment using the Home Care International Residential Assessment Instrument (interRAI‐HC). This study describes the national interRAI‐HC population, assesses its data quality and evaluates its ability to be matched. MethodsThe interRAI‐HC instrument elicits information on 236 questions over 20 domains; conducted by 1,800+ trained health professionals. Assessments between 1 July 2012 and 30 June 2014 are reported here. Stratified by age, demographic characteristics were compared to 2013 Census estimates and selected health profiles described. Deterministic matching to the Ministry of Health's mortality database was undertaken. ResultsOverall, 51,232 interRAI‐HC assessments were conducted, with 47,714 (93.1%) research consent from 47,236 unique individuals; including 2,675 Māori and 1,609 Pacific people. Apart from height and weight, data validity and reliability were high. A 99.8% match to mortality data was achieved. ConclusionsThe interRAI‐HC research database is large and ethnically diverse, with high consent rates. Its generally good psychometric properties and ability to be matched enhances its research utility. ImplicationsThis national database provides a remarkable opportunity for researchers to better understand older persons’ health and health care, so as to better sustain older people in their own homes.

Abstract 3468: High rates of informed consent for biospecimen sharing among hispanic women in a safety-net clinic

Abstract Introduction: Biospecimen sharing among low-income and undeserved individuals has been reported to low. Few data exist on participation in biospecimen sharing for research purposes and reasons for declining participation by individuals from underserved populations. To address this gap, we conducted a randomized study to compare the rate of informed consent for biospecimen collection and data sharing for research when participants were consented by their physician versus a research assistant. Methods: Eligible participants included Hispanic English or Spanish-speaking patients 18 years of age or older who underwent breast biopsy at the Breast Center in Maricopa Integrated Health Services (MIHS), a safety-net facility in Phoenix, Arizona. Consecutive patients receiving care at the center were asked to participate in the study and individually randomized to be consented by their physician or a research assistant not working in the Breast Center. Informed consent was delivered vi an electronic tablet. Biospecimen sharing for research included a saliva sample for DNA extraction and formalin fixed paraffin embedded tissue. Data collection included sociodemographic variables, health literacy using Newest Vital Sign (NVS) instrument, and a trust questionnaire based on the Biobanking Attitudes and Knowledge Survey (BANKS-SP-Trust). Rate of participation was compared between the two randomization arms and reasons for participation were assessed. Results: The study enrolled 140 women (70 to each randomization arm). Study participants had a mean + sd age of 46.7 +11.6 years and most (95%) were of Mexican descent and Spanish-speakers (85%). Mean (sd) education level was low (8.7 + 4.1) years. Eighty-five percent of the participants were found to have limited health literacy. Using a 1 to 10 Likert scale, the mean + sd range of responses to the BANKS-SP-Trust in relation to 10 different attributes was from 7.7 + 2.5 for “health insurance companies” to 9.2 + 1.5 for “doctors who do research.” Results showed very high rates of consent with no significant difference between the two randomization arms: 97.1% for the physician and 92.9% for the research assistant. Participants who were current smokers were ∼60% less likely to consent (p = 0.045) and those who were unmarried were ∼90% less likely to consents (p = 0.043). All women who refused consent had limited health literacy whereas 86% of those who consented had this limitation but this was not statistically significant (p = 0.346). No association between consent and trust was observed. Conclusions: Consent for biospecimen and data sharing among low-income Hispanic women is very high, with only current smokers and unmarried females being significantly less likely to provide consent. More efforts should be made to reach out to patients in safety-net facilities for biospecimen sharing to overcome the scarcity of representation of underserved individuals in biospecimen repositories. Citation Format: Jesse Nodora, Maria E. Martinez, Richard Schwab, Kristen Wells, Hyeon-eui Kim, Claudiu Farcas, Marcia Bouton, Ian Komenaka. High rates of informed consent for biospecimen sharing among hispanic women in a safety-net clinic. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr 3468.

Challenges in Implementation of ANISA Protocol at the Vellore Site, India.

The Aetiology of Neonatal Infection in South Asia (ANISA) study aims to determine the population-based incidence, etiology, risk factors and antibiotic resistance profiles of community-acquired young infant infections in Bangladesh, India and Pakistan using community-based surveillance and standard newer diagnostic tests. The data generated will help plan preventive and treatment strategies to reduce neonatal and infant mortality in this region. The aim of this article is to describe the site-specific characteristics, challenges and solutions in implementing the ANISA protocol at the Vellore site, India. Vellore joined the ANISA study 2 years after the sites in Bangladesh and Pakistan, and some challenges relate to the need for rapid implementation. The Vellore site differs primarily in the high rate of institutional deliveries, actively promoted by the Government of India's conditional cash transfer program. The Vellore site hospitals are regular care providers for the study population, which leads to very high rates of consent for enrollment and collection of samples. Keeping blood culture contamination rates low was a challenge the site team overcame by adhering strictly to the protocol. Issues related to incorporation of a large study into a busy clinical services laboratory were overcome by meticulously setting up algorithms related to receipt, processing and storage of samples. ANISA is a complex study, but the challenges in implementation have been largely resolved and documented.

Abstract A12: High rates of informed consent for biospecimen and data sharing among low-income Hispanic women: Results of a pilot randomized trial

Abstract Introduction: Few data exist on the willingness of individuals from underserved populations to provide consent for and participate in biospecimen (e.g., saliva, urine, blood, tissue, DNA, etc.) collection and related data sharing for research and even fewer data are available for Hispanic populations. Lacking in the literature are reports on actual provision of data and biospecimens for research. A pilot study was conducted to compare two methods of informed consent delivery for biospecimen collection and data sharing in a population of women receiving care at a safety net health care facility. The purpose of the randomized study was to compare the rate of informed consent for biospecimen collection and data sharing for research when potential participants were approached by a physician versus a research assistant. Methods: Eligible participants included women who underwent breast biopsy at the Breast Center in Maricopa Integrated Health Services (MIHS) in Phoenix, Arizona. Consecutive patients receiving care at the center were asked to participate in the study and individually randomized to be consented by their physician or a research assistant not working in the Breast Center. Hispanic, English or Spanish-speaking women 18 years of age or older undergoing a breast biopsy, regardless of the reason for doing so, were eligible. Exclusion criteria included: women who were not Hispanic or did not speak English or Spanish. Initially, a simple general consent asking patients if they wanted to be included in the study was provided. If women agreed to participate, they were randomized to one of the two arms. Informed consent was collected via an electronic tablet. Consent for donation of a biospecimen for research included collection of formalin fixed paraffin embedded tissue (normal or tumor) and a saliva sample for DNA extraction. Data collection included sociodemographic variables and breast cancer risk factor information. Health literacy was assessed using the Newest Vital Sign (NVS) health literacy assessment instrument. Trust in individuals and organizations associated with biomedical research was assessed using the trust scale of the Biobanking Attitudes and Knowledge Survey (BANKS-SP-Trust). Results: The study enrolled 140 women (70 to each randomization arm). Study participants had a mean (sd) age of 46.7 (11.6) years and most (95%) were of Mexican descent and Spanish-speakers (85%). Mean (sd) education and monthly household income levels were 8.7 (4.1) years and $1,040 ($700.9), respectively. Eighty-five percent of the participants were found to have limited health literacy. Using a 1 to 10 Likert scale, the mean (sd) range of responses to the BANKS-SP-Trust in relation to 10 different attributes was from 7.7 (2.5) for “health insurance companies” to 9.2 (1.5) for “doctors who do research.” Results showed very high rates of consent with no significant difference between the two randomization arms: 97.1% for the physician and 92.9% for the research assistant. All consenting women (95%) provided a saliva sample and tissue retrieval is ongoing. Conclusions: Low-income, uninsured and underinsured Hispanic women provide informed consent for biospecimen collection and related data sharing at very high rates. Participants show a high level of trust in individuals and organizations associated with biomedical research. Citation Format: Jesse Nodora, Maria Elena Martinez, Richard Schwab, Kristen Wells, Hyeon-eui Kim, Claudiu Farcas, Marcia Bouton, Ian Komenaka. High rates of informed consent for biospecimen and data sharing among low-income Hispanic women: Results of a pilot randomized trial. [abstract]. In: Proceedings of the Eighth AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 13-16, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2016;25(3 Suppl):Abstract nr A12.

Success rates for consent and collection of prenatal biological specimens in an epidemiologic survey of child health.

The National Children's Study (NCS) Vanguard Study began enrollment in January 2009 as an initial pilot study for a planned large-scale, longitudinal U.S. cohort study of the effect of environmental influences on child health and development, with biological and environmental sample collection conducted in seven locations from April 2009 to October 2010. We sought to determine rates of consent for, and success of collection of, maternal and paternal biospecimens before and during pregnancy in the NCS Vanguard Study. Samples of blood, saliva, vaginal swabs, urine, hair, and nails were collected before and during pregnancy. All specimens were sent to a central repository for processing, storage, and quality assessment. Of 780 pregnant women asked to consent to sample collection, 773 (>99%) agreed, and of 295 nonpregnant women, 292 (99%) agreed. Of 440 fathers asked to consent to sample collection, 435 (99%) agreed. Frequency of successful collection of biospecimens varied depending on sample and visit type. In descending order, the ranges over all visit types of the proportion of expected samples successfully collected from women were: urine, 92.5 to 95.7%; hair, 89.6 to 92.5%; vaginal swab, 84.2 to 88.5%; blood, 74.9 to 78.5%; 2-day saliva, 65.8 to 81.6%; and nails, 76.4 to 76.7%. For fathers, rates were highest for urine (94.9%) and lowest for hair (63.0%). High rates of consent for and collection of a wide variety of biospecimens can be achieved in prospective epidemiologic cohort studies of pregnant women. Ease of sample collection may be a primary factor influencing successful biospecimen collection.

Genetic material should be routinely collected in clinical vaccine trials – High consent rates can be achieved across all age groups

BackgroundGenomic and transcriptomic studies underpin much investigation in biology and should be included routinely in clinical trials such as vaccine studies to provide new insight into the development of immunity and the genetic basis for adverse reactions. Interest in collecting and storing genetic material for subsequent high-throughput meta-analyses has increased substantially in recent years. Participants in clinical trials represent an important and invaluable source of clinical material and data. MethodsHere, the experience of a single center in obtaining informed consent for the collection and long-term storage of genetic material from children, adolescents and adults, involved in clinical vaccine trials is presented and discussed. ResultsIn 11 completed vaccine studies involving almost 3000 individuals, high rates of consent (in excess of 96%) for biobanking and future genetic testing were obtained. Rates were high for participants from all age groups; however, there was a significant increase toward greater uptake by older study participants. ConclusionsThese high acceptance rates demonstrate that participants (and parents of young children) in vaccine studies are willing to consent and engage in genetic research, which provides support for routinely collecting genetic material in research involving healthy participants such as clinical vaccine trials.

Preventing depression and promoting resilience: feasibility study of a school-based cognitive-behavioural intervention

The limited reach and effectiveness of psychological treatments for adolescent depression have fuelled interest in alternative approaches designed to promote resilience. Schools offer a convenient location for the widespread delivery of depression prevention programmes, although little research has evaluated the feasibility of delivering interventions in this setting. To investigate the feasibility of delivering and evaluating a universal school-based depression prevention programme for children aged 12-16 years. A three-arm pilot study was conducted in one UK secondary school (n = 834). Interventions had good reach (96%), with high rates of consent (89%) and reasonable retention (78%). The majority of intervention sessions were delivered as intended, with 85% of students attending seven or more sessions. The programme was acceptable to students and teachers, with the specific content of the active intervention being rated differently from the control programmes. Delivering and undertaking methodologically robust evaluations of universal school-based depression programmes is feasible.

Factors Influencing Participation in a Population-based Biorepository for Childhood Heart Disease

Consenting minors for genetics research and biobanking involves ethical and social challenges. We examined factors influencing participation rates in a population-based biorepository for childhood heart disease. Individuals were prospectively enrolled across 7 centers in Ontario by using a standardized consent form. Individuals were approached for consent for the donation of blood/saliva (DNA), tissue, and skin from the affected individual for future genomics and stem cell research. Consent rates were compared between pediatric and adult patients and factors affecting consent were analyzed by using multiple logistic regression analysis. From 2008 to 2011, 3637 patients were approached. A total of 2717 pediatric patients consented (90% consent rate); mean age was 8.5 ± 5.8 years (57% male; 76% white). A total of 561 adult patients consented (92% consent rate, P = .071 versus pediatric). Factors associated with lower pediatric consent rates included younger age, race, absence of complex defects, and location of consent; these were not associated with adult consent rates. Leading causes for refusal of consent were lack of interest in research (43%), overwhelmed clinically (14%), and discomfort with genetics (11%). Concerns related to privacy, insurability, indefinite storage, and ongoing access to medical records were not the leading causes for refusal. The high pediatric consent rate (90%) was comparable with that of adults. Ethical, social, or legal issues were not the leading reasons for refusal of consent.

Liver transplantation in Indian Armed Forces—initial experience

BackgroundThis study retrospectively analyses the initial experience of liver transplantation (LT) in the Indian Armed Forces. MethodsFifty-three patients underwent LT at Army Hospital (R&R) Delhi Cantt. between March 2007 and March 2011. Of these 35 patients underwent deceased donor liver transplantation (DDLT) and living donor liver transplantation (LDLT) was carried out in 18 patients. The surgical techniques, complications and mortality were analysed. ResultsA high consent rate of 35.9% for organ donation was achieved by the Armed Forces Organ Retrieval and Transplantation Authority (AORTA). Biliary complications occurred in five patients (9.4%). However, most of them could be managed by endoscopic interventions. Hepatic artery thrombosis (HAT) occurred in five patients (9.4%). Of these, two DDLT grafts were revascularised following HAT, by creating extra-anatomic arterial conduits with excellent outcome. The overall mortality was 18.8% (n = 10). There was no significant difference in the overall complications or mortality in patients undergoing DDLT or LDLT. ConclusionThe overall survival and morbidity in this study is comparable to those from other centres. Urgent revascularisation of grafts following HAT should be attempted as it can salvage grafts with satisfactory outcome. There is a reduction in the incidence of biliary complications with refinements in surgical techniques.

A Randomized Controlled Trial of Short and Standard-Length Consent Forms for a Genetic Cohort Study: Is Longer Better?

BackgroundAlthough the amount of detail in informed consent documents has increased over time and the documents have therefore become very long, there is little research on whether longer informed consent documents actually result in (1) better informed research subjects or (2) higher consent rates. We therefore conducted an add-on randomized controlled trial to the Takashima Study, a prospective Japanese population-based genetic cohort study, to test the hypothesis that a shorter informed consent form would satisfy both of the above goals.MethodsStandard (10 459 words, 11 pages) and short (3602 words, 5 pages) consent forms in Japanese were developed and distributed using cluster-randomization to 293 potential cohort subjects living in 9 medico-social units and 288 subjects in 8 medico-social units, respectively.ResultsFew differences were found between the 2 groups with regard to outcome measures, including participants’ self-perceived understanding, recall of information, concerns, voluntariness, trust, satisfaction, sense of duty, and consent rates.ConclusionsA short informed consent form was no less valid than a standard form with regard to fulfilling ethical requirements and securing the scientific validity of research.

Trained Organ Donation Practitioners Lead to Higher Consent Rates

Trained Organ Donation Practitioners Lead to Higher Consent Rates

Stillbirth Collaborative Research Network: design, methods and recruitment experience

The Stillbirth Collaborative Research Network (SCRN) has conducted a multisite, population-based, case-control study, with prospective enrollment of stillbirths and livebirths at the time of delivery. This paper describes the general design, methods and recruitment experience. The SCRN attempted to enroll all stillbirths and a representative sample of livebirths occurring to residents of pre-defined geographical catchment areas delivering at 59 hospitals associated with five clinical sites. Livebirths <32 weeks gestation and women of African descent were oversampled. The recruitment hospitals were chosen to ensure access to at least 90% of all stillbirths and livebirths to residents of the catchment areas. Participants underwent a standardised protocol including maternal interview, medical record abstraction, placental pathology, biospecimen testing and, in stillbirths, post-mortem examination. Recruitment began in March 2006 and was completed in September 2008 with 663 women with a stillbirth and 1932 women with a livebirth enrolled, representing 69% and 63%, respectively, of the women identified. Additional surveillance for stillbirths continued until June 2009 and a follow-up of the case-control study participants was completed in December 2009. Among consenting women, there were high consent rates for the various study components. For the women with stillbirths, 95% agreed to a maternal interview, chart abstraction and a placental pathological examination; 91% of the women with a livebirth agreed to all of these components. Additionally, 84% of the women with stillbirths agreed to a fetal post-mortem examination. This comprehensive study is poised to systematically study a wide range of potential causes of, and risk factors for, stillbirths and to better understand the scope and incidence of the problem.

Consent for genetic research in the Framingham Heart Study

Extensive efforts have been aimed at understanding the genetic underpinnings of complex diseases that affect humans. Numerous genome-wide association studies have assessed the association of genes with human disease, including the Framingham Heart Study (FHS), which genotyped 550,000 SNPs in 9,000 participants. The success of such efforts requires high rates of consent by participants, which is dependent on ethical oversight, communications, and trust between research participants and investigators. To study this we calculated percentages of participants who consented to collection of DNA and to various uses of their genetic information in two FHS cohorts between 2002 and 2009. The data included rates of consent for providing a DNA sample, creating an immortalized cell line, conducting research on various genetic conditions including those that might be considered sensitive, and for notifying participants of clinically significant genetic findings were above 95%. Only with regard to granting permission to share DNA or genetic findings with for-profit companies was the consent rate below 95%. We concluded that the FHS has maintained high rates of retention and consent for genetic research that has provided the scientific freedom to establish collaborations and address a broad range of research questions. We speculate that our high rates of consent have been achieved by establishing frequent and open communications with participants that highlight extensive oversight procedures. Our approach to maintaining high consent rates via ethical oversight of genetic research and communication with study participants is summarized in this report and should be of help to other studies engaged in similar types of research. Published 2010 Wiley-Liss, Inc.

Pediatric organ donation: A national survey examining consent rates and characteristics of donor hospitals*

To characterize the eligible pediatric donor pool in the United States by age, consent rate, location, and cause of donor loss. Survey. Organ procurement organizations in the United States. Pediatric patients who suffered brain death in the United States in 2005 and who were medically suitable for organ donation. None. We determined the number of patients, age < or =17 yrs, who were eligible for organ donation and the consent rate by age. Each hospital in which donation occurred was characterized by the presence of a pediatric intensive care unit (PICU), a pediatric critical care medicine (PCCM) fellowship, solid organ transplant programs, and level I trauma programs. Additional information was obtained on the number of donation after cardiac death donors and eligible donors lost due to medical examiner refusals and deterioration before organ recovery. The number of reported eligible pediatric donors in 2005 was 1330. The consent rate was 69.2% with higher consent rates in eligible donors 12 yrs of age and older. Eligible donors were spread across a large number of hospitals with few having ten or more eligible donors. Variability exists among hospitals in consent rate and number of donors per 100 PICU beds. The presence of a level I trauma program and/or a PCCM fellowship was associated with higher numbers of donors per 100 PICU beds. Ninety-four eligible donors were lost before recovery of organs due to medical examiner denials or cardiac arrest. Donation after cardiac death accounted for 37 donors. Overall pediatric consent rates were 69.2% but varied by age. Eligible donors were found most often in hospitals with level I trauma programs or PCCM fellowship programs. Few hospitals had >10 eligible donors in a 12-month period. This study is the first to describe in detail the U.S. pediatric donor population.

Feasibility and cost of obtaining informed consent for essential review of medical records in large-scale health services research

To evaluate the effectiveness and cost of obtaining consent for review of medical records within the passively observed non-intervention arm of a cluster randomized controlled trial, 'Comparison Arm for ProtecT'. Two hundred and thirty men, who had been notified to the trial by cancer registries as having prostate cancer, were sent a consent form from their general practitioner or secondary care clinician. The consent rate of participants to the review of their medical records and the estimated costs of the process were evaluated. One hundred and seventy-nine men (84%: 95% CI = 78%, 89%) consented to have their medical notes reviewed at an estimated cost of pound123 (euro172, $248) per person. A high consent rate for review of medical notes is achievable but at a cost. There needs to be renewed debate about the automatic need for consent to review medical records where the chance of personal harm is negligible and the purpose of the review is to provide robust evidence to save lives, prevent needless suffering, and improve the effectiveness and efficiency of health care delivery.

Pediatric organ donation: What factors most influence parents??? donation decisions?*

To identify factors that influence parents' decisions when asked to donate a deceased child's organs. Cross-sectional design with data collection via structured telephone interviews. One organ procurement organization in the Southeastern United States. Seventy-four parents (49 donors, 25 nondonors) of donor-eligible deceased children who were previously approached by coordinators from one organ procurement organization in the southeastern United States. None. Multivariate analyses showed that organ donation was more likely when the parent was a registered organ donor (odds ratio [OR] = 1.4, confidence interval [CI] = 1.1, 2.7), the parent had favorable organ donation beliefs (OR = 5.5, CI = 2.7, 12.3), the parent was exposed to organ donation information before the child's death (OR = 2.6, CI = 1.7, 10.3), a member of the child's healthcare team first mentioned organ donation (OR = 1.4, CI = 1.2, 3.7), the requestor was perceived as sensitive to the family's needs (OR = 0.4, CI = 0.2, 0.7), the family had sufficient time to discuss donation (OR = 5.2, CI = 1.4, 11.6), and family members were in agreement about donation (OR = 2.8, CI = 1.3, 5.2). This study identifies several modifiable variables that influence the donation decision-making process for parents. Strategies to facilitate targeted organ donation education and higher consent rates are discussed.

Achieving high rates of consent for genetic testing among African American smokers

Genetic factors play an important role in smoking behavior. Although African Americans are at disproportionately increased risk for tobacco-related morbidity and mortality, limited attention has been given to genetic investigation of tobacco use in this population. The present study examined consent for genetic testing among African American smokers enrolled in a smoking cessation clinical trial. African American light smokers (</=10 cigarettes/day) enrolled in a smoking cessation study met with study counselors to review consent forms for an adjunct study and responded to a request for genetic analysis related to smoking. Participants completed assessment of demographic, psychosocial, and tobacco-related variables. Of 755 clinical trial participants, 745 (99%) responded to the genetic consent form. Of participants who responded, 620 (83%) provided consent for blood collection for genetic analysis. No significant differences were identified between individuals who consented to genetic analysis and those who denied consent. This study demonstrated the feasibility of obtaining consent for genetic analysis for smoking-related investigation among African American smokers. Findings support the inclusion of African Americans within genetic investigation of tobacco use and treatment.

Record linkage research and informed consent: who consents?

BackgroundLinking computerized health insurance records with routinely collected survey data is becoming increasingly popular in health services research. However, if consent is not universal, the requirement of written informed consent may introduce a number of research biases. The participants of a national health survey in Taiwan were asked to have their questionnaire results linked to their national health insurance records. This study compares those who consented with those who refused.MethodsA national representative sample (n = 14,611 adults) of the general adult population aged 20 years or older who participated in the Taiwan National Health Interview Survey (NHIS) and who provided complete survey information were used in this study. At the end of the survey, the respondents were asked if they would give permission to access their National Health Insurance records. Information given by the interviewees in the survey was used to analyze who was more likely to consent to linkage and who wasn't.ResultsOf the 14,611 NHIS participants, 12,911 (88%) gave consent, and 1,700 (12%) denied consent. The elderly, the illiterate, those with a lower income, and the suburban area residents were significantly more likely to deny consent. The aborigines were significantly less likely to refuse. No discrepancy in gender and self-reported health was found between individuals who consented and those who refused.ConclusionThis study is the first population-based study in assessing the consent pattern in a general Asian population. Consistent with people in Western societies, in Taiwan, a typical Asian society, a high percentage of adults gave consent for their health insurance records and questionnaire results to be linked. Consenters differed significantly from non-consenters in important aspects such as age, ethnicity, and educational background. Consequently, having a high consent rate (88%) may not fully eliminate the possibility of selection bias. Researchers should take this source of bias into consideration in their study design and investigate any potential impact of this source of bias on their results.