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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

The concept of ‘vulnerability’ in research ethics: an in-depth analysis of policies and guidelines (Dearbhail Bracken-Roche, et al | April 2017)0

Posted by Admin in on February 27, 2018
 

Abstract

Background
The concept of vulnerability has held a central place in research ethics guidance since its introduction in the United States Belmont Report in 1979. It signals mindfulness for researchers and research ethics boards to the possibility that some participants may be at higher risk of harm or wrong. Despite its important intended purpose and widespread use, there is considerable disagreement in the scholarly literature about the meaning and delineation of vulnerability, stemming from a perceived lack of guidance within research ethics standards. The aim of this study was to assess the concept of vulnerability as it is employed in major national and international research ethics policies and guidelines.

Methods
We conducted an in-depth analysis of 11 (five national and six international) research ethics policies and guidelines, exploring their discussions of the definition, application, normative justification and implications of vulnerability.

Results
Few policies and guidelines explicitly defined vulnerability, instead relying on implicit assumptions and the delineation of vulnerable groups and sources of vulnerability. On the whole, we found considerable richness in the content on vulnerability across policies, but note that this relies heavily on the structure imposed on the data through our analysis.

Conclusions
Our results underscore a need for policymakers to revisit the guidance on vulnerability in research ethics, and we propose that a process of stakeholder engagement would well-support this effort.

Keywords: Research ethics, Vulnerable populations, Vulnerability, Research policy, Ethics policy, Research oversight

Bracken-Roche, D., Bell, E., Macdonald, M. E., & Racine, E. (2017). The concept of “vulnerability” in research ethics: an in-depth analysis of policies and guidelines. Health Research Policy and Systems15, 8. http://doi.org/10.1186/s12961-016-0164-6
Publisher (Open Access): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297186/

 

Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond (Papers: Go Yoshizawa, et al | 2017)0

Posted by Admin in on February 11, 2018
 

Abstract
The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia – the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More than simply tools to gain consent from research participants, ICFs function rather as a device of social communication between research communities and civic communities in liaison with intermediary agents like ethics committees, genetic counselors, and public biobanks and databases.

Keywords: medical genomics, consent documents, group consent, family consent, community engagement

Yoshizawa G, Sasongko TH, Ho C-H and Kato K (2017) Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond. Frontiers in Genetics. 8:99. doi: 10.3389/fgene.2017.00099
Publisher (Open Access): http://www.ea.sinica.edu.tw/UploadFile/files/Social%20and%20Communicativ….

Consent for data on consent (Mollie Gerver | 2015)0

Posted by Admin in on February 8, 2018
 

Mollie Gerver wanted to look at the transcript of interviews between an NGO and refugees in Israel who had apparently agreed to return to Sudan and South Sudan.

The NGO had responsibility for screening the refugees to make sure they had given informed consent to return. The NGO was happy to hand over the transcripts if Gerber contacted the returnees and gained their consent…

“Unfortunately, I could not contact all of those who returned. Many were killed, and others displaced, possibly contrary to what HIAS had promised. Others were living in extremely rural areas, unable to access telecommunications or safe and reliable roads, also living in conditions that were possibly different to what they expected prior to repatriating. Paradoxically, the reason many could not give their informed consent to disclose their data, meant to determine if they gave informed consent to repatriate, was precisely because they repatriated to a country without giving their informed consent.”

Let that sink in for a moment…

There are instances where the provider of an intervention, such as surgery, has failed to obtain necessary informed consent from the recipient of the intervention. Perhaps a surgeon has failed to warn the patient that she may go into a coma, or even be killed, from the surgery. Sometimes, as a result of this intervention, the recipient cannot give informed consent to researchers for the release of their personal data precisely because of the intervention. If they are in a coma, they cannot be reached. Sometimes, this personal data itself can prove that the provider of the intervention failed to obtain informed consent for the intervention. For example, a personal file may include a consent form that does not include warnings about the risk of falling into a coma from the surgery. Paradoxically, those who cannot give informed consent for the disclosure of their personal data on an intervention may have been especially ill-informed about the repercussions of the intervention. In such instances, should researchers ever use the data and disclose the data in their research? In an attempt to demonstrate when this dilemma may be relevant, and how it may be solved, I will present a real-world case of this dilemma in my own empirical research on refugees who agreed to repatriate to their countries of origin from Israel. I will consider what theories on consent, if any, can help us resolve this dilemma

Gerver, Mollie (2015) Consent for data on consent. Ethical Theory and Moral Practice, 18 (4). pp. 799-816.
Publisher: http://eprints.lse.ac.uk/64012/1/__lse.ac.uk_storage…

(University of the South Pacific) HUMAN RESEARCH ETHICS: A Handbook for USP Researchers (Guidance | Updated 2013)0

Posted by Admin in on February 6, 2018
 

“This Handbook explains the values and principles that guide processes and practices of research involving human participants at the University of the South Pacific.

We believe this handbook provides some useful guidance about responsibility to the region

The ethical values and principles described here apply to all University activities, to all its staff and student researchers including those visiting for short periods, and to any research agreements or partnerships that the University establishes.
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The University’s human ethics will be compliant with the laws of individual University member states, particularly in relation to privacy, confidentiality, ownership, intellectual property requirements, research permit requirements and human rights.”
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CONTENTS

  1. Introduction
  2. Ethical principles
  3. The University Research Ethics Committee (UREC)
  4. Ethical responsibilities of researchers at the University
  5. Procedures for applying for ethical approval of proposed research

Appendix 1. Screening Questionnaire for Human Ethics (sample)

Appendix 2. Application for Human Ethics Approval (sample)

Appendix 3. Information Sheet (model)

Appendix 4. Participant Consent Form (model)

Appendix 5.Confidentiality Agreement (model)

Access the handbook

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