A biobank management model applicable to biomedical research.

Abstract:

BACKGROUND:The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. Some REBs have even rejected research projects where the use of a biobank with coded samples was an integral part of the study, the greatest fear being the lack of participant protection and uncontrolled use of biological samples or related genetic data. The risks of discrimination and stigmatization are a recurrent issue. In light of the increasing interest in biomedical research and the resulting benefits to the health of participants, it is imperative that practical solutions be found to the problems associated with the management of biobanks: namely, protecting the integrity of the research participants, as well as guaranteeing the security and confidentiality of the participant's information. METHODS:We aimed to devise a practical and efficient model for the management of biobanks in biomedical research where a medical archivist plays the pivotal role as a data-protection officer. The model had to reduce the burden placed on REBs responsible for the evaluation of genetics projects and, at the same time, maximize the protection of research participants. RESULTS:The proposed model includes the following: 1) a means of protecting the information in biobanks, 2) offers ways to provide follow-up information requested about the participants, 3) protects the participant's confidentiality and 4) adequately deals with the ethical issues at stake in biobanking. CONCLUSION:Until a governmental governance body is established in Quebec to guarantee the protection of research participants and establish harmonized guidelines for the management of biobanks in medical research, it is definitely up to REBs to find solutions that the present lack of guidelines poses. The model presented in this article offers a practical solution on a day-to-day basis for REBs, as well as researchers by promoting an archivist to a pivotal role in the process. It assures protection of all participants who altruistically donate their samples to generate and improve knowledge for better diagnosis and medical treatment.

journal_name

BMC Med Ethics

journal_title

BMC medical ethics

authors

Auray-Blais C,Patenaude J

doi

10.1186/1472-6939-7-4

subject

Has Abstract

pub_date

2006-04-06 00:00:00

pages

E4

issn

1472-6939

pii

1472-6939-7-4

journal_volume

7

pub_type

杂志文章
  • Responsible data sharing in international health research: a systematic review of principles and norms.

    abstract:BACKGROUND:Large-scale linkage of international clinical datasets could lead to unique insights into disease aetiology and facilitate treatment evaluation and drug development. Hereto, multi-stakeholder consortia are currently designing several disease-specific translational research platforms to enable international h...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-019-0359-9

    authors: Kalkman S,Mostert M,Gerlinger C,van Delden JJM,van Thiel GJMW

    更新日期:2019-03-28 00:00:00

  • Confidentiality breaches in clinical practice: what happens in hospitals?

    abstract:BACKGROUND:Respect for confidentiality is important to safeguard the well-being of patients and ensure the confidence of society in the doctor-patient relationship. The aim of our study is to examine real situations in which there has been a breach of confidentiality, by means of direct observation in clinical practice...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-016-0136-y

    authors: Beltran-Aroca CM,Girela-Lopez E,Collazo-Chao E,Montero-Pérez-Barquero M,Muñoz-Villanueva MC

    更新日期:2016-09-02 00:00:00

  • A framework for the ethical assessment of chimeric animal research involving human neural tissue.

    abstract:BACKGROUND:Animal models of human diseases are often used in biomedical research in place of human subjects. However, results obtained by animal models may fail to hold true for humans. One way of addressing this problem is to make animal models more similar to humans by placing human tissue into animal models, renderi...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-019-0345-2

    authors: Porsdam Mann S,Sun R,Hermerén G

    更新日期:2019-01-25 00:00:00

  • Policy recommendations for addressing privacy challenges associated with cell-based research and interventions.

    abstract:BACKGROUND:The increased use of human biological material for cell-based research and clinical interventions poses risks to the privacy of patients and donors, including the possibility of re-identification of individuals from anonymized cell lines and associated genetic data. These risks will increase as technologies ...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/1472-6939-15-7

    authors: Ogbogu U,Burningham S,Ollenberger A,Calder K,Du L,El Emam K,Hyde-Lay R,Isasi R,Joly Y,Kerr I,Malin B,McDonald M,Penney S,Piat G,Roy DC,Sugarman J,Vercauteren S,Verhenneman G,West L,Caulfield T

    更新日期:2014-02-03 00:00:00

  • Attitudes and behaviors of Japanese physicians concerning withholding and withdrawal of life-sustaining treatment for end-of-life patients: results from an Internet survey.

    abstract:BACKGROUND:Evidence concerning how Japanese physicians think and behave in specific clinical situations that involve withholding or withdrawal of medical interventions for end-of-life or frail elderly patients is yet insufficient. METHODS:To analyze decisions and actions concerning the withholding/withdrawal of life-s...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/1472-6939-8-7

    authors: Bito S,Asai A

    更新日期:2007-06-19 00:00:00

  • "You would not be in a hurry to go back home": patients' willingness to participate in HIV/AIDS clinical trials at a clinical and research facility in Kampala, Uganda.

    abstract:BACKGROUND:Few studies have examined factors associated with willingness of people living with HIV (PLHIV) to participate in HIV treatment clinical trials in Sub-Saharan Africa. We assessed the factors associated with participation of PLHIV in HIV treatment clinical trials research at a large urban clinical and researc...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-020-00516-z

    authors: Sebatta DE,Siu G,Nabeta HW,Anguzu G,Walimbwa S,Lamorde M,Bukenya B,Kambugu A

    更新日期:2020-08-24 00:00:00

  • A principled ethical approach to intersex paediatric surgeries.

    abstract:BACKGROUND:Surgery for intersex infants should be delayed until individuals are able to decide for themselves, except where it is a medical necessity. In an ideal world, this single principle would suffice and such surgeries could be totally prohibited. Unfortunately, the world is not perfect, and, in some places, inte...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-020-00550-x

    authors: Behrens KG

    更新日期:2020-10-29 00:00:00

  • Ethics of neuroimaging after serious brain injury.

    abstract:BACKGROUND:Patient outcome after serious brain injury is highly variable. Following a period of coma, some patients recover while others progress into a vegetative state (unresponsive wakefulness syndrome) or minimally conscious state. In both cases, assessment is difficult and misdiagnosis may be as high as 43%. Recen...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/1472-6939-15-41

    authors: Weijer C,Peterson A,Webster F,Graham M,Cruse D,Fernández-Espejo D,Gofton T,Gonzalez-Lara LE,Lazosky A,Naci L,Norton L,Speechley K,Young B,Owen AM

    更新日期:2014-05-20 00:00:00

  • Viewpoint discrimination and contestation of ideas on its merits, leadership and organizational ethics: expanding the African bioethics agenda.

    abstract::The 3rd Pan-African Ethics Human Rights and Medical Law (3rd EHRML) conference was held in Johannesburg on July 7, 2013, as part of the Africa Health Congress. The conference brought together bioethicists, researchers and scholars from South Africa, Zimbabwe, Kenya and Nigeria working in the field of bioethics as well...

    journal_title:BMC medical ethics

    pub_type:

    doi:10.1186/1472-6939-14-S1-S1

    authors: Chima SC,Mduluza T,Kipkemboi J

    更新日期:2013-01-01 00:00:00

  • Co-design and implementation research: challenges and solutions for ethics committees.

    abstract:BACKGROUND:Implementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-015-0072-2

    authors: Goodyear-Smith F,Jackson C,Greenhalgh T

    更新日期:2015-11-16 00:00:00

  • The Picture Talk Project: Starting a Conversation with Community Leaders on Research with Remote Aboriginal Communities of Australia.

    abstract:BACKGROUND:Researchers are required to seek consent from Indigenous communities prior to conducting research but there is inadequate information about how Indigenous people understand and become fully engaged with this consent process. Few studies evaluate the preference or understanding of the consent process for rese...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-017-0191-z

    authors: Fitzpatrick EFM,Macdonald G,Martiniuk ALC,D'Antoine H,Oscar J,Carter M,Lawford T,Elliott EJ

    更新日期:2017-05-11 00:00:00

  • Patients as consumers of health care in South Africa: the ethical and legal implications.

    abstract:BACKGROUND:South Africa currently has a pluralistic health care system with separate public and private sectors. It is, however, moving towards a socialised model with the introduction of National Health Insurance. The South African legislative environment has changed recently with the promulgation of the Consumer Prot...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/1472-6939-14-15

    authors: Rowe K,Moodley K

    更新日期:2013-03-21 00:00:00

  • Effect of written outcome information on attitude of perinatal healthcare professionals at the limit of viability: a randomized study.

    abstract:BACKGROUND:Differences in perception and potential disagreements between parents and professionals regarding the attitude for resuscitation at the limit of viability are common. This study evaluated in healthcare professionals whether the decision to resuscitate at the limit of viability (intensive care versus comfort ...

    journal_title:BMC medical ethics

    pub_type: 杂志文章,随机对照试验

    doi:10.1186/s12910-019-0413-7

    authors: Papadimitriou V,Tosello B,Pfister R

    更新日期:2019-10-22 00:00:00

  • Obtaining subjects' consent to publish identifying personal information: current practices and identifying potential issues.

    abstract:BACKGROUND:In studies publishing identifying personal information, obtaining consent is regarded as necessary, as it is impossible to ensure complete anonymity. However, current journal practices around specific points to consider when obtaining consent, the contents of consent forms and how consent forms are managed h...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/1472-6939-14-47

    authors: Yoshida A,Dowa Y,Murakami H,Kosugi S

    更新日期:2013-11-25 00:00:00

  • A risk screening tool for ethical appraisal of evidence-generating initiatives.

    abstract:BACKGROUND:The boundaries between health-related research and practice have become blurred as initiatives traditionally considered to be practice (e.g., quality improvement, program evaluation) increasingly use the same methodology as research. Further, the application of different ethical requirements based on this di...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-015-0039-3

    authors: Ondrusek NK,Willison DJ,Haroun V,Bell JA,Bornbaum CC

    更新日期:2015-07-07 00:00:00

  • Challenges and opportunities for ELSI early career researchers.

    abstract:BACKGROUND:Over the past 25 years, there has been growing recognition of the importance of studying the Ethical, Legal and Social Implications (ELSI) of genetic and genomic research. A large investment into ELSI research from the National Institutes of Health (NIH) Human Genomic Project budget in 1990 stimulated the gr...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-016-0121-5

    authors: Bell J,Ancillotti M,Coathup V,Coy S,Rigter T,Tatum T,Grewal J,Akcesme FB,Brkić J,Causevic-Ramosevac A,Milovanovic G,Nobile M,Pavlidis C,Finlay T,Kaye J,ELSI2.0.

    更新日期:2016-07-08 00:00:00

  • Lessons learned from implementing a responsive quality assessment of clinical ethics support.

    abstract:BACKGROUND:Various forms of Clinical Ethics Support (CES) have been developed in health care organizations. Over the past years, increasing attention has been paid to the question of how to foster the quality of ethics support. In the Netherlands, a CES quality assessment project based on a responsive evaluation design...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-019-0418-2

    authors: Van Baarle EM,Potma MC,van Hoek MEC,Hartman LA,Molewijk BAC,van Gurp JLP

    更新日期:2019-11-01 00:00:00

  • Ethical competence in DNR decisions -a qualitative study of Swedish physicians and nurses working in hematology and oncology care.

    abstract:BACKGROUND:DNR decisions are frequently made in oncology and hematology care and physicians and nurses may face related ethical dilemmas. Ethics is considered a basic competence in health care and can be understood as a capacity to handle a task that involves an ethical dilemma in an adequate, ethically responsible man...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-018-0300-7

    authors: Pettersson M,Hedström M,Höglund AT

    更新日期:2018-06-19 00:00:00

  • Documentation of best interest by intensivists: a retrospective study in an Ontario critical care unit.

    abstract:BACKGROUND:Intensive care physicians often must rely on substitute decision makers to address all dimensions of the construct of "best interest" for incapable, critically ill patients. This task involves identifying prior wishes and to facilitate the substitute decision maker's understanding of the incapable patient's ...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/1472-6939-11-1

    authors: Ratnapalan M,Cooper AB,Scales DC,Pinto R

    更新日期:2010-02-10 00:00:00

  • Personalized assent for pediatric biobanks.

    abstract::Pediatric biobanking is considered important for generating biomedical knowledge and improving (pediatric) health care. However, the inclusion of children's samples in biobanks involves specific ethical issues. One of the main concerns is how to appropriately engage children in the consent procedure. We suggest that c...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-016-0142-0

    authors: Giesbertz NA,Melham K,Kaye J,van Delden JJ,Bredenoord AL

    更新日期:2016-10-12 00:00:00

  • Patients' perceived purpose of clinical informed consent: Mill's individual autonomy model is preferred.

    abstract:BACKGROUND:Although informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients' perceived purpose of informed consent, which may include administrative routine/courtesy g...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/1472-6939-15-2

    authors: Hammami MM,Al-Gaai EA,Al-Jawarneh Y,Amer H,Hammami MB,Eissa A,Qadire MA

    更新日期:2014-01-10 00:00:00

  • The use of empirical research in bioethics: a survey of researchers in twelve European countries.

    abstract:BACKGROUND:The use of empirical research methods in bioethics has been increasing in the last decades. It has resulted in discussions about the 'empirical turn of bioethics' and raised questions related to the value of empirical work for this field, methodological questions about its quality and rigor, and how this int...

    journal_title:BMC medical ethics

    pub_type: 杂志文章,多中心研究

    doi:10.1186/s12910-017-0239-0

    authors: Wangmo T,Provoost V

    更新日期:2017-12-22 00:00:00

  • "Media, politics and science policy: MS and evidence from the CCSVI Trenches".

    abstract:BACKGROUND:In 2009, Dr. Paolo Zamboni proposed chronic cerebrospinal venous insufficiency (CCSVI) as a possible cause of multiple sclerosis (MS). Although his theory and the associated treatment ("liberation therapy") received little more than passing interest in the international scientific and medical communities, hi...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/1472-6939-14-6

    authors: Pullman D,Zarzeczny A,Picard A

    更新日期:2013-02-12 00:00:00

  • Developing an ethics support tool for dealing with dilemmas around client autonomy based on moral case deliberations.

    abstract:BACKGROUND:Moral Case Deliberations (MCDs) are reflective dialogues with a group of participants on their own moral dilemmas. Although MCD is successful as clinical ethics support (CES), it also has limitations. 1. Lessons learned from individual MCDs are not shared in order to be used in other contexts 2. Moral learni...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-018-0335-9

    authors: Hartman LA,Metselaar S,Molewijk AC,Edelbroek HM,Widdershoven GAM

    更新日期:2018-12-22 00:00:00

  • Convergent ethical issues in HIV/AIDS, tuberculosis and malaria vaccine trials in Africa: Report from the WHO/UNAIDS African AIDS Vaccine Programme's Ethics, Law and Human Rights Collaborating Centre consultation, 10-11 February 2009, Durban, South Africa

    abstract:BACKGROUND:Africa continues to bear a disproportionate share of the global HIV/AIDS, tuberculosis (TB) and malaria burden. The development and distribution of safe, effective and affordable vaccines is critical to reduce these epidemics. However, conducting HIV/AIDS, TB, and/or malaria vaccine trials simultaneously in ...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/1472-6939-11-3

    authors: Mamotte N,Wassenaar D,Koen J,Essack Z

    更新日期:2010-03-09 00:00:00

  • Public responses to the sharing and linkage of health data for research purposes: a systematic review and thematic synthesis of qualitative studies.

    abstract:BACKGROUND:The past 10 years have witnessed a significant growth in sharing of health data for secondary uses. Alongside this there has been growing interest in the public acceptability of data sharing and data linkage practices. Public acceptance is recognised as crucial for ensuring the legitimacy of current practice...

    journal_title:BMC medical ethics

    pub_type: 杂志文章,评审

    doi:10.1186/s12910-016-0153-x

    authors: Aitken M,de St Jorre J,Pagliari C,Jepson R,Cunningham-Burley S

    更新日期:2016-11-10 00:00:00

  • Experiences of community members and researchers on community engagement in an Ecohealth project in South Africa and Zimbabwe.

    abstract:BACKGROUND:Community engagement (CE) models have provided much needed guidance for researchers to conceptualise and design engagement strategies for research projects. Most of the published strategies, however, still show very limited contribution of the community to the engagement process. One way of achieving this is...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-017-0236-3

    authors: Musesengwa R,Chimbari MJ

    更新日期:2017-12-13 00:00:00

  • Microbicides development programme: engaging the community in the standard of care debate in a vaginal microbicide trial in Mwanza, Tanzania.

    abstract:BACKGROUND:HIV prevention research in resource-limited countries is associated with a variety of ethical dilemmas. Key amongst these is the question of what constitutes an appropriate standard of health care (SoC) for participants in HIV prevention trials. This paper describes a community-focused approach to develop a ...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/1472-6939-10-17

    authors: Vallely A,Shagi C,Lees S,Shapiro K,Masanja J,Nikolau L,Kazimoto J,Soteli S,Moffat C,Changalucha J,McCormack S,Hayes RJ

    更新日期:2009-10-09 00:00:00

  • An interprofessional cohort analysis of student interest in medical ethics education: a survey-based quantitative study.

    abstract:BACKGROUND:There is continued need for enhanced medical ethics education across the United States. In an effort to guide medical ethics education reform, we report the first interprofessional survey of a cohort of graduate medical, nursing and allied health professional students that examined perceived student need for...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-020-00468-4

    authors: DeFoor MT,Chung Y,Zadinsky JK,Dowling J,Sams RW 2nd

    更新日期:2020-04-08 00:00:00

  • The emergence of ethical issues in the provision of online sexual health outreach for gay, bisexual, two-spirit and other men who have sex with men: perspectives of online outreach workers.

    abstract:BACKGROUND:Mobile applications and socio-sexual networking websites are used by outreach workers to respond synchronously to questions and provide information, resources, and referrals on sexual health and STI/HIV prevention, testing, and care to gay, bisexual and other men who have sex with men (GB2M). This explorator...

    journal_title:BMC medical ethics

    pub_type: 杂志文章

    doi:10.1186/s12910-017-0216-7

    authors: Fantus S,Souleymanov R,Lachowsky NJ,Brennan DJ

    更新日期:2017-11-03 00:00:00