Original Consent Research Articles

Provenance and Dynamic Consents for the Management of Medical Data.

Medical data describe patient health information, both in healthy and disease conditions. In any case, health institutions need to ask for patient consent in order to provide their services. Patients usually give consent on a one-time basis, for a specific usage. Afterwards, if medical data usage is research, original patient consent does not apply and further consents should be required. On the other hand, provenance of medical data to verify the origin of health procedures is desirable, as digital health is increasing. We propose HIPAMS modular architecture to provide both provenance and dynamic consents for medical data as described in this paper.

The curious case of the vanishing fraud

ABSTRACT This case review critiques Cohen J’s judgment in Goddard-Watts v Goddard-Watts [2022] EWHC 711 (Fam), a second rehearing of the wife’s application for financial remedies on divorce. The foundational critique is Cohen J’s minimisation of the husband’s fraudulent non-disclosure of a massive increase in the value of some shares, which had necessitated the rehearing. I argue that the judge failed to consider whether the husband’s non-disclosure had undermined the basis on which the original consent order had been made: the husband had received more than half of the capital based largely on the risk associated with the shares, which had clearly paid off. The judge also failed to consider whether the decision in the first rehearing that the increase in the value of the shares was attributable to the husband’s post-separation endeavour was undermined by his failure to disclose the size of the increase. I critique the judge for making a needs-based award to the wife, arguing that this switches focus to the wife, further obscuring the husband’s deceit. Switching to needs allows the judge to retreat to safe ground where he can avoid difficult questions about the impact of the husband’s fraud on his ability to resist sharing his wealth with the wife.

Applying a Digital Health Checklist and Readability Tools to Improve Informed Consent for Digital Health Research.

Background: As research involving human participants increasingly occurs with the aid of digital tools (e.g., mobile apps, wearable and remote pervasive sensors), the consent content and delivery process is changing. Informed consent documents to participate in research are lengthy and difficult for prospective participants to read and understand. As the consent communication will need to include concepts and procedures unique to digital health research, making that information accessible and meaningful to the prospective participant is critical for consent to be informed. This paper describes a methodology that researchers can apply when developing a consent communication for digital health research.Methods: A consent document approved by a US institutional review board was deconstructed into segments that aligned with federal requirements for informed consent. Three researchers independently revised each segment of text with a goal of achieving a readability score between a 6–8th grade level. The team then consulted with an external readability expert well-versed in revising informed consent documents into “plain language.” The resulting text was evaluated using Microsoft Word and Online-Utility accessibility software. The final step involved adding visual images and graphics to complement the text. The Digital Health Checklist consent prototype builder was then used to identify areas where the consent content could be expanded to address four key domains of Access and Usability, Privacy, Risks and Benefits, and Data Management.Results: The approved consent was evaluated at a 12.6 grade reading level, whereas the revised language by our study team received 12.4, 12, and 12.58, respectively. The final consent document synthesized the most readable of the three revised versions and was further revised to include language recommended by the software tool for improving readability, which resulted in a final revised consent readability score of a 9.2 grade level. Moreover, word count was reduced from 6,424 in the original consent to 679 in the rewritten consent form.Conclusion: Utilizing an iterative process to design an accessible informed consent document is a first step in achieving meaningful consent to participate in digital health research. This paper describes how a consent form approved by an institutional review board can be made more accessible to a prospective research participant by improving the document readability score, reducing the word count and assessing alignment with the Digital Health Checklist.

Balancing scientific interests and the rights of participants in designing a recall by genotype study

Recall by genotype (RbG) studies aim to better understand the phenotypes that correspond to genetic variants of interest, by recruiting carriers of such variants for further phenotyping. RbG approaches pose major ethical and legal challenges related to the disclosure of possibly unwanted genetic information. The Cooperative Health Research in South Tyrol (CHRIS) study is a longitudinal cohort study based in South Tyrol, Italy. Demand has grown for CHRIS study participants to be enrolled in RbG studies, thus making the design of a suitable ethical framework a pressing need. We here report upon the design of a pilot RbG study conducted with CHRIS study participants. By reviewing the literature and by consulting relevant stakeholders (CHRIS participants, clinical geneticists, ethics board, GPs), we identified key ethical issues in RbG approaches (e.g. complexity of the context, communication of genetic results, measures to further protect participants). The design of the pilot was based on a feasibility assessment, the selection of a suitable test case within the ProtectMove Research Unit on reduced penetrance of hereditary movement disorders, and the development of appropriate recruitment and communication strategies. An empirical study was embedded in the pilot study with the aim of understanding participants’ views on RbG. Our experience with the pilot study in CHRIS allowed us to contribute to the development of best practices and policies for RbG studies by drawing recommendations: addressing the possibility of RbG in the original consent, implementing tailored communication strategies, engaging stakeholders, designing embedded empirical studies, and sharing research experiences and methodology.

Development of a Multi-Study Repository to Support Research on Veteran Health: The VA Cooperative Studies Program Epidemiology Center-Durham (CSPEC-Durham) Data and Specimen Repository.

Federal agencies, including the Department of Veterans Affairs (VA), have prioritized improved access to scientific data and results collected through federally funded research. Our VA Cooperative Studies Program Epidemiology Center in Durham, North Carolina (CSPEC-Durham) assembled a repository of data and specimens collected through multiple studies on Veteran health issues to facilitate future research in these areas. We developed a single protocol, request process that includes scientific and ethical review of all applications, and a database architecture using metadata (common variable descriptors) to securely store and share data across diverse studies. In addition, we created a mechanism to allow data and specimens collected through older studies in which re-use was not addressed in the study protocol or consent forms to be shared if the future research is within the scope of the original consent. Our CSPEC-Durham Data and Specimen Repository currently includes research data, genomic data, and study specimens (e.g., DNA, blood) for three content areas: colorectal cancer, amyotrophic lateral sclerosis, and Gulf War research. The linking of the study specimens and research data can support additional genetic analyses and related research to improve Veterans' health.

Secondary Use of Patient Tissue in Cancer Biobanks.

As scientific techniques evolve, historical informed consent forms may inadequately address modern research proposals, leading to ethical questions regarding research with archived biospecimens. We conducted focus groups among patients with cancer recruited from Massachusetts General Hospital to explore views on medical research, biobanking, and scenarios based on real biospecimen research dilemmas. Our multidisciplinary team developed a structured focus group guide, and all groups were recorded and transcribed. Transcripts were coded for themes by two independent investigators using NVivo software. Across five focus groups with 21 participants, we found that most participants were supportive of biobanks and use of their own tissue to advance scientific knowledge. Many favor allowing research beyond the scope of the original consent to proceed if recontact is impossible. However, participants were not comfortable speaking for other patients who may oppose research beyond the original consent. This was viewed as a potential violation of participants' rights or interests. Participants were also concerned with a "slippery slope" and potential scientific abuse if research were permitted without adherence to original consent. There was strong support for recontact and reconsent when possible and for the concept of broad consent at the time of tissue collection. Our participants support use of their tissue to advance research and generally support any productive scientific approach. However, in the absence of broad initial consent, when recontact is impossible, a case-by-case decision must be made regarding a proposal's potential benefits and harms. Many participants support broad use of their tissue, but a substantial minority object to use beyond the original consent. For prospective studies collecting tissue for future research, investigators should consider seeking broad consent, to allow for evolution of research questions and methods. For studies using previously collected tissues, researchers should attempt recontact and reconsent for research aims or methods beyond the scope of the original consent. When reconsent is not possible, a case-by-case decision must be made, weighing the scientific value of the biobank, potential benefits of the proposed research, and the likelihood and nature of risks to participants and their welfare interests. This study's data suggest that many participants support broad use of their tissue and prefer science to move forward.

Central States Pension Fund: Investment Policy Decisions and Challenges Facing the Plan

Central States Pension Fund: Investment Policy Decisions and Challenges Facing the Plan

Postpartum Tubal Sterilization: Making the Case for Urgency.

The parturient who requests postpartum sterilization has given consideration to and has made decisions regarding this aspect of her medical care long before her delivery. She arrives at parturition expecting the postpartum procedure to be performed as intended. The American Congress of Obstetricians and Gynecologists has reaffirmed its opinion that postpartum sterilization is an urgent procedure, owing to the safety and superior effectiveness of tubal sterilization via minilaparotomy in the immediate postpartum period, and the adverse consequences for mothers, babies, and society when the procedure is not actualized as desired and intended. In contrast, recent practice guidelines for obstetric anesthesia address anesthetic procedural aspects and short-term safety but overlook the long-term complications and considerations associated with failure to perform postpartum sterilization as planned. In practice, procedure completion rates are strikingly low, reportedly ranging from 31% to 52%. Reasons for failure to complete abound and include inadequate resources or inavailability of necessary personnel; obstetrician reluctance due to concerns for patient regret in younger women or medical comorbidities; barriers related to provision of obstetric care in a religiously affiliated hospital, or incomplete, improperly completed, or unavailable original federal consent forms among Medicaid-insured women. The federal requirement to wait 30 days after signing informed consent, and to retain the original signed document to be physically verified at time of the procedure, serves as a significant source of health care disparity for Medicaid-dependent mothers. This article reviews these larger issues of maternal health and comprehensive maternal care to broaden the anesthesiologist's appreciation of major benefits and potential risks of postpartum sterilization, including long-term effects, to promote an evidence-based, informed, and proactive role in delivering equitable, safe, and optimal care for these patients.

Taiwan Biobank: making cross-database convergence possible in the Big Data era.

The Taiwan Biobank (TWB) is a biomedical research database of biopsy data from 200 000 participants. Access to this database has been granted to research communities taking part in the development of precision medicines; however, this has raised issues surrounding TWB’s access to electronic medical records (EMRs). The Personal Data Protection Act of Taiwan restricts access to EMRs for purposes not covered by patients’ original consent. This commentary explores possible legal solutions to help ensure that the access TWB has to EMR abides with legal obligations, and with governance frameworks associated with ethical, legal, and social implications. We suggest utilizing “hash function” algorithms to create nonretrospective, anonymized data for the purpose of cross-transmission and/or linkage with EMR.

Defensive Harm, Consent, and Intervention

Philosophy & Public AffairsVolume 45, Issue 4 p. 356-396 Original Article Defensive Harm, Consent, and Intervention Jonathan Parry, Jonathan Parry orcid.org/0000-0002-2649-9220 Search for more papers by this author Jonathan Parry, Jonathan Parry orcid.org/0000-0002-2649-9220 Search for more papers by this author First published: 21 December 2017 https://doi.org/10.1111/papa.12099Citations: 8 For comments on, and conversations about, this article, I am extremely grateful to Jessica Begon, Joseph Bowen, Lars Christie, Matthew Coakley, Helen Frowe, Jimmy Goodrich, Richard Healey, Lisa Hecht, Jeff McMahan, Janette Myers, Daniel Ramöller, Michael Robillard, Alex Silk, Victor Tadros, Leo Townsend, Alex Voorhoeve, and, especially, Daniel Viehoff. The article benefited from discussion with audiences at the University of Birmingham, the University of Oslo, the Manchester Centre for Political Theory (MANCEPT), Stockholm University, the Oxford Moral Philosophy Seminar, the University of Nottingham, Ryerson University, the 2015 Annual Meeting of the Oxford Institute for the Ethics and Law of Armed Conflict (ELAC) hosted by the Stockholm Centre for the Ethics of War and Peace (SCEWP) at Stockholm University, and the Society for Applied Philosophy 2015 Annual Conference hosted by the University of Edinburgh. Special thanks to two anonymous Associate Editors for this journal, whose detailed and challenging comments improved the article immeasurably. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Citing Literature Volume45, Issue4Fall 2017Pages 356-396 RelatedInformation

A qualitative study of participants\u2019 views on re-consent in a longitudinal biobank

BackgroundBiomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or “biobanks” over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank.MethodsWe conducted a qualitative study involving interviews with 24 people who were participating in a longitudinal biobank. Their views were elicited using a semi-structured interview schedule and scenarios based on a hypothetical biobank. Data analysis was based on the constant comparative method.ResultsWhat participants identified as requiring new consent was not a straightforward matter predictable by algorithms about the scope of the consent, but instead was contingent. They assessed whether proposed new research implied a fundamental alteration in the underlying character of the biobank and whether specific projects were within the scope of the original consent. What mattered most to them was that the cooperative bargain into which they had entered was maintained in good faith. They saw re-consent as one important safeguard in this bargain. In determining what required re-consent, they deployed two logics. First, they used a logic of boundaries, where they sought to detect any possible rupture with their existing framework of cooperation. Second, they used a logic of risk, where they assessed proposed research for any potential threats for them personally or the research endeavour. When they judged that a need for re-consent had been activated, participants saw the process as way of re-actualising and renewing the cooperative bargain.ConclusionsParticipants’ perceptions of research as a process of mutual co-operation between volunteer and researcher were fundamental to their views on consent. Consenting arrangements for biobanks should respect the cooperative values that are important to participants, recognise the two logics used by research volunteers, and avoid rigidity. Agility may be favoured by tiered consent combined with strong oversight mechanisms; this approach requires evaluation.

Mortality outcomes after busulfan-containing conditioning treatment and haemopoietic cell transplantation in patients with Gilbert's syndrome: a retrospective cohort study

Gilbert's syndrome is a common inherited disorder of bilirubin metabolism, characterised by mild, unconjugated hyperbilirubinaemia. However, the effect of Gilbert's syndrome on the disposition of some drugs can lead to unexpected toxicity. We tested the hypothesis that patients undergoing myeloablative conditioning and haemopoietic cell transplantation would have different mortality outcomes depending on whether or not they had laboratory evidence of Gilbert's syndrome. In this retrospective cohort study, we used clinical and laboratory data of patients who had haemopoietic cell transplantation from Jan 1, 1991, to Dec 31, 2011. Patients were included if they had received high-dose conditioning regimens of cyclophosphamide plus total body irradiation (CY/TBI), busulfan plus cyclophosphamide (BU/CY), busulfan plus melphalan plus thioTEPA (BUMELTT), or melphalan before transplant. Patients were excluded if their original consent forms to report transplant outcomes were not signed, if consent was withdrawn, or if they were a prisoner. Patients with Gilbert's syndrome were defined as having laboratory values before the start of conditioning therapy for unconjugated serum bilirubin concentrations of at least 17·1 μmol/L (≥1 mg/dL), normal conjugated serum bilirubin, and no evidence of hepatitis, cholestasis, or haemolysis. We assessed the association of Gilbert's syndrome with overall mortality and non-relapse mortality using adjusted Cox regression models at day 200 after transplantation. Our study cohort was 3379 patients-1855 (55%) allograft and 1524 (45%) autograft recipients. 211 (6%) patients had Gilbert's syndrome and 3168 (94%) did not have this condition. Most patients were adults (median age 45·8 years [IQR 33·2-55·5]) with haematological malignancies. For overall mortality 664 (20%) patients had died by day 200 after transplant (47 [22%] of 211 who had Gilbert's syndrome vs 617 [19%] of 3168 who did not have Gilbert's syndrome), and for non-relapse mortality 499 (92%) patients had died before relapse was recorded (38 [18%] who had Gilbert's syndrome vs 461 [15%] who did not have Gilbert's syndrome). The effect of Gilbert's syndrome on the risk of overall mortality and non-relapse mortality by transplant day 200 varied between the conditioning regimens and donor groups. In patients conditioned with a myeloablative regimen that contained busulfan (n=1131), those with Gilbert's syndrome (n=60) were at a significantly increased risk of death and non-relapse mortality by day 200 compared with those without Gilbert's syndrome (n=1071; hazard ratio [HR] 2·30, 95% CI 1·47-3·61, p=0·00030; and 2·77, 1·71-4·49, p<0·0001). In patients who received CY/TBI or melphalan conditioning regimens, those with Gilbert's syndrome had similar outcomes to those without Gilbert's syndrome (overall mortality at day 200 HR 0·90, 95% CI 0·60-1·34, p=0·60; non-relapse mortality at day 200: 0·90, 0·56-1·45, p=0·65). Analyses of causes of death and busulfan disposition provided no mechanistic explanation for the differences in mortality. Overall mortality and non-relapse mortality at day 200 after transplant were significantly worse in patients with Gilbert's syndrome who received busulfan-containing myeloablative conditioning regimens, compared with non-Gilbert's syndrome patients. Patients with Gilbert's syndrome should receive busulfan-containing myeloablative conditioning regimens with caution. US National Institutes of Health.

Identification of ‘at risk’ students using learning analytics: the ethical dilemmas of intervention strategies in a higher education institution

Learning analytics is an emerging field in which sophisticated analytic tools are used to inform and improve learning and teaching. Researchers within a regional university in Australia identified an association between interaction and student success in online courses and subsequently developed a learning analytics system aimed at informing learning and teaching practices. Contemporary literature draws attention to ethical considerations and moral tensions in the implementation of learning analytics. This paper presents a case study of the ethical implications of a learning analytics implementation at CQUniversity, a regional Australian university. There was an institutional assumption that student data, consensually gathered at enrollment could be analyzed beyond the scope of the original consent. Further, academics were using the data in a manner not intended by the designers of the learning analytic system, and academics interpreted the student’s individualized data to label students based on their estimate of success. The learning analytics system is still being used and the ethical findings from this paper have implications for CQUniversity, academics and students. In order to resolve the ethical dilemmas the university could increase transparency of the process to students and obtain consent at multiple levels throughout the student journey.

Return of individual genomic research results: what do consent forms tell participants?

Advances in genomic technology make possible the large-scale collection of genomic data for research purposes. Many international initiatives seek to collect genomic data on large populations, often relying on existing collections to populate their databases. As these efforts progress, the debate over whether or not to return individual genetic research results to study participants remains an area of much contention. Some recommend returning results to participants only if the issue was addressed in the original study consent form. Much of the data being used in current studies, however, may have been derived from biospecimens collected years ago with consent documents that did not anticipate the possibility of returning individual level genomic results. We conducted an analysis of informed consent documents from published genome-wide association studies (GWAS) (n=40) to explore whether future research use of biospecimens or data is anticipated, and if return of results is addressed and how it is described to better understand participants' expectations for future disclosure. The majority (70%) of the GWAS consent documents we analyzed either stated explicitly that individual genomic results would not be returned or were silent on the issue. This has implications for how researchers and members of Research Ethics Committees manage the return of results from sequencing studies using legacy samples and data.

Consent Issues in Genetic Research: Views of Research Participants

Background: With the arrival of large-scale population-based genomic research studies, such as the Precision Medicine Initiative (PMI), the question of how to best consent participants is significant, and in an era of patient-centered research, few studies have evaluated participants' preferences about re-consent and broad consent. Using quantitative methods, this study evaluates participants' views regarding the acceptability of re-consent and broad consent in subjects from the Participant Issues Project. Methods: A total of 450 participants were recruited from a cancer genetics registry, including cancer patients, their relatives, and controls. Participants completed a secure online survey. Results: Most participants endorsed re-consent when investigating an unrelated health condition or sharing their de-identified data with an investigator at a different institution. Notification rather than re-consent was preferred when studying a different gene but the same disease. Over 80% of respondents endorsed re-consent when parents of a child gave the original consent and the child has now reached adulthood. Preferences for some scenarios varied by history of cancer at baseline, gender, stage of cancer, or case versus control group. The large majority of participants preferred the option to select broad consent categories of research. Conclusion: Understanding research participants' preferences, including their views on the need for re-consent, are critical to the success of the PMI.

The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol.

REVIEW QUESTION / OBJECTIVE The aim of this systematic review is to establish the best available evidence of the effectiveness of health literacy interventions on the informed consent process for health care users. The specific review question is: What is the effectiveness of health literacy interventions on health care users' informed consent to health procedures processes? INCLUSION CRITERIA Types of participants This review will consider all studies that include adults (18 years or over) receiving care or adults who are proxies of incompetent health care users or of children (parents or guardians) who have been actively involved in an informed consent process regarding health care procedures. Participants may be healthy or may have any kind of physical disability, be recruited in any type of health care environment, including acute (hospital), primary care, psychiatric and aged care, in any health specialty, including medicine, dentistry and pharmacy. Studies whose participants have cognitive impairment will be excluded. Studies on informed consent processes for research participants will be also excluded. Types of intervention(s) The interventions, methods, and strategies will be included if: - they aim to improve the informed consent process related to health issues among health care users or their proxies, - they are designed taking into consideration health literacy as a main concept, and - the intervention is provided by any health care provider. Such interventions my focus on either the material provided (e.g. readability, processability), or the supportive procedure of informed consent (e.g. video) in order to decrease the health literacy TRUNCATED AT 250 WORDS

A written consent form dating back to 1524 in Bursa Şer’iye (Sharia Court) records and a proposal of a new start date for consent forms

BACKGROUND AND OBJECTIVESQadi registers are important documents for Ottoman medical history research. “Sharia Court Records (Ser’iyye Sicilleri)” are notebooks that include the records that qadis kept with regard to their decisions and deeds. These registers are the only authentic sources from which to acquire information on rural life, away from the center of the town, and to understand the daily practices of the Ottoman society. The objective of this study is to provide evidence for the fact that the concept of informed consent on medical interventions, and hence the written consent documents arranged between patients and physicians, dates back to older times in our history when compared to the Western world.DESIGN AND SETTINGA large number of Ser’iyye (Sharia Court) record originals have been surveyed. The consent form registered as A-40. 221a in Ser’iyye (Sharia Court) Records found in Bursa has been presented here as the earliest consent document found by the authors. Transcription of the original document has been performed and analyzed. The aforementioned consent form dates back to 26/Dhu al-Qi’dah/933 (August 24, 1524).METHODSThe original version of the referenced consent document is the earliest consent document presented so far to the best of the authors’ knowledge; it was found in Bursa Ser’iyye Records and evaluated accordingly.RESULTSBased on the document, it is argued that the history of consent forms dates back about 500 years.CONCLUSIONObtaining consent in scientific research from human beings was considered to have originated from the Nuremberg Code (1949). However, with this study, it has been shown that the concept of informed consent was already present in the Ottoman Period, during the 16th century, and that the original consent document dates back to 1524, pertaining to a surgical intervention.

Spanish regulatory approach for biobanking.

The Spanish regulatory framework for storage of samples for research responds to most issues raised by both researchers and society regarding biobanking. The Spanish regulation currently foresees three possible ways in which these samples are to be handled: (a) gathering for use in a specific project, (b) storage in a collection, and (c) storage in a Biobank. Samples incorporated into a 'collection' can only be used by the investigator who requested them and cannot be transferred to third parties or used in research projects outside the particular research line foreseen in the original consent. On the other hand, the legal entity 'Biobank' refers not only to a set of physical facilities but to the management of the samples stored under that label, and particularly to the requirements for their cession. An approach based on putting most of the regulatory weight on the biobank side has been chosen in order to guaranty the rights of the donors as well as to ease the task of the researchers. A Biobank requires both to be authorized and to be registered in a public Registry. The requirements are quite stringent, allowing for the consent to be given as 'broad' in scope without implying being 'blank.' In this regard, for Biobanks to justify the taking on of some of the donors' rights, a key requirement is to have an external ethics committee supervising the adequacy of samples cession and use, notwithstanding the need for a previous bioethical supervision of the target protocol.

RHETORIC OR REALITY: WHAT IS THE LEGAL STATUS OF THE CONSENT FORM IN HEALTH-RELATED RESEARCH?

This article addresses the unresolved conundrum of the legal status of consent forms used in research involving tissue samples or personal data. It identifies which rights participants might have by virtue of any consent form they have signed and which legal remedies might be available to them should the research depart from the terms of the original consent. The paper demonstrates that, although the legal status of consent forms is not clear in the UK, the landscape is evolving. We suggest that the growing legal protection afforded to autonomy and judicial recognition of individual property rights in tissues may offer opportunities for remedies in law where the regulatory regimes controlling uses of human tissue and personal data do not. However, we argue that in the governance of research relationships—which depend crucially on trust—resort to legal remedy may be undesirable. We suggest that treating consent as a one-off event that can be effectively captured in a written document—as the law tends to do—is an inappropriate and counter-productive approach. The aims of ethical research governance will be better served by seeing consent as continuing relational process, requiring on-going mutual respect, opportunity for communication, and accommodation of changing circumstances. The consent form is merely a framing instrument and only the starting point for a partnership that will evolve over time. Crucially, the limits of consent must be recognised in the design and governance of modern research practices. The article concludes with recommendations to reconceive consent in these terms.

"It's for a good cause, isn't it?" - Exploring views of South African TB research participants on sample storage and re-use

BackgroundThe banking of biological samples raises a number of ethical issues in relation to the storage, export and re-use of samples. Whilst there is a growing body of literature exploring participant perspectives in North America and Europe, hardly any studies have been reported in Africa. This is problematic in particular in light of the growing amount of research taking place in Africa, and with the rise of biobanking practices also on the African continent. In order to investigate the perspectives of African research participants, we conducted a study with research participants in a TB study in the Western Cape, South Africa.MethodsSemi-structured interviews were conducted using an interview guide which drew on the most prominent themes expressed in current literature on sample storage, re-use and exportation. Interviews were conducted in Afrikaans and subsequently translated into English by the same interviewer. Interviews were transcribed verbatim and analysed qualitatively.ResultsThe results of our study indicate that the majority of participants were supportive of giving one-time consent to the storage and re-use of their samples. The concept of research being for a “good cause” was a central prerequisite. Additionally, a significant minority requested that they be re-contacted if a future use was not stipulated on the original consent. There was also considerable variation in how participants understood the concept of a ‘good cause’, with participants describing three distinct categories of research, of which two were generally thought to constitute ‘good cause’ research. Research that was for-profit was considered to fall outside the spectrum of ‘good cause’ research. Participants displayed confidence in the abilities of the researchers to make future decisions regarding sample use, but seemed unaware of the role of ethics committees in either this process or more generally.ConclusionsParticipants expressed a wide and complex range of views about issues of sample storage and re-use, and they showed a great deal of trust in researchers. Participants’ willingness to have their samples stored and re-used is consistent with findings from existing studies. However, in contrast to existing literature, participants were generally not in favour of for-profit research. Further research needs to be done to explore these ideas in other communities, both in South Africa and other countries.