Environmental and Biosafety Research Ethics Committees: Guidelines and Principles for Ethics Reviewers in the South African Context

Date
2021-12
Journal Title
Journal ISSN
Volume Title
Publisher
Stellenbosch : Stellenbosch University
Abstract
ENGLISH ABSTRACT: Over the last two decades, there was an upsurge of research and innovation in biotechnology and related fields, leading to exciting new discoveries in areas such as the engineering of biological processes, gene editing, stem cell research, CRISPR-Cas9 technology, Synthetic Biology, recombinant DNA, LMOs and GMOs, to mention only a few. At the same time, these advances generated concerns about biosafety, biosecurity and adverse impacts on biodiversity and the environment, leading to the establishment of Research Ethics Committees (RECs) at Higher Education and Research Institutions dedicated to reviewing research with implications for biosafety and the environment. These Biosafety and Environment Research Ethics Committees, referred to as EBRECs, are in the early stages of their establishment and formalisation, and there is much uncertainty about their composition, scope, procedures of decision-making and the principles that should guide their deliberations and assessments. In many respects, EBRECs are venturing into uncharted territory, facing a very wide range of complex research fields, far-reaching research practices and deep concerns new to Review Boards, raising the question to what extent EBRECs can fall back on the fairly well-established principles and procedures of RECs focusing on Human, Health or Animal research, and to what extent they need new or adapted principles and procedures. Against this background, I set out to answer the following three main research questions in this thesis: 1. What is the current state of ethical principles for ethics reviews in the field of environmental and biosafety research ethics? Which principles are currently used in this context, and how? 2. What are the shortcomings of the current principles used by EBRECs and how can they be overcome? 3. What ethical principles must be adopted by environmental and biosafety research ethics committees and guide them in their decision-making? In order to prepare the ground and set the scene for my discussion of these questions, I also formulated four supporting research questions: i. What is environmental research ethics in action? ii. What is biosafety research ethics in action? ii. How are environmental and biosafety ethics related to one another? iv. How should the guidelines and ethical principles related to these two overlapping fields be implemented in the ethics review process? Following my introduction and problem statement in Chapter 1, I devoted Chapters 2 and 3 to an overview of my supporting questions to set the scene for Environmental and Biosafety Research Ethics. In Chapter 4, I turned to my main research question with a discussion of national and international declarations, frameworks and legislation and an investigation of principles in the different research areas to get a picture of applicable principles that can guide EBRECs. The main finding of my thesis is that due to the complexity of EBR, different categories of principles could be the solution for EBRECs. I elaborate on this in Chapter 5, my concluding chapter, in which I also propose a list of core principles that can serve as an accessible and easy-to-use guide for EBRECs in their decision-making. In this proposal, I cluster different kinds of principles in terms of four categories: 1. Principles as a Moral Concept 2. Principles as a Social Concept 3. Principles as a Legal Concept 4. Principles as a Safety Concept
AFRIKAANSE OPSOMMING: Die afgelope twee dekades was daar 'n toename in navorsing en nuutheid op biotegnologie en verwante terreine, wat lei tot opwindende nuwe ontdekkings op gebiede soos die ontwerp van biologiese prosesse, geenbewerking, stamselnavorsing, CRISPR-Cas9-tegnologie, sintetiese biologie, rekombinante DNA, LMO's en GMO's, om maar net ’n paar te noem. Terselfdertyd het hierdie vordering kommer veroorsaak oor bioveiligheid, biosekuriteit en nadelige gevolge vir die biodiversiteit en die omgewing, wat gelei het tot die stigting van Navorsingsetiekkomitees (RECs) by hoëronderwys- en navorsingsinstellings wat toegewy is aan die hersiening van navorsing met implikasies vir bioveiligheid en die omgewing. Hierdie etiekkomitees vir bioveiligheid en omgewing, waarna verwys word as EBRECs, is in die vroeë stadiums van hul stigting en formalisering en daar is baie onsekerheid oor die samestelling, omvang, prosedures van besluitneming en die beginsels wat hul beraadslagings en assesserings moet rig. In baie opsigte waag EBRECs op ’n onbekende gebied, met ’n baie wye reeks ingewikkelde navorsingsvelde, verreikende navorsingspraktyke en diep bekommernisse wat nuut is by beoordelingsrade en laat die vraag ontstaan in watter mate EBRECs kan terugval op die redelik gevestigde beginsels en prosedures van RECs wat fokus op navorsing oor mense, gesondheid of diere, en in watter mate hulle nuwe of aangepaste beginsels en prosedures benodig. Met hierdie agtergrond in gedagte het ek die volgende drie hoofnavorsingsvrae in hierdie tesis probeer beantwoord: 1. Wat is die huidige stand van etiese beginsels vir etiese resensies op die gebied van omgewings- en bioveiligheidsnavorsingsetiek? Watter beginsels word tans in hierdie konteks gebruik, en hoe? 2. Wat is die tekortkominge van die huidige beginsels wat EBRECs gebruik en hoe kan dit oorkom word? 3. Watter etiese beginsels moet deur die etiekkomitees vir omgewings- en bioveiligheidsnavorsing aanvaar word en hulle lei in hul besluitneming? Ter voorbereiding vir my bespreking van hierdie vrae, het ek ook vier ondersteunende navorsingsvrae geformuleer: I. Wat is omgewingsnavorsingsetiek in werking? II. Wat is navorsingsetiek vir bioveiligheid in werking? III. Hoe hou omgewings- en bioveiligheidsetiek met mekaar verband? IV. Hoe moet die riglyne en etiese beginsels wat verband hou met hierdie twee oorvleuelende velde in die etiek-hersieningsproses geïmplementeer word? Na my inleiding en probleemstelling in hoofstuk 1, het ek hoofstukke 2 en 3 gewy aan 'n oorsig van my ondersteunende vrae om die toneel te stel vir omgewings- en bioveiligheidsnavorsingsetiek. In Hoofstuk 4 het ek my hoofnavorsingsvraag gewend met 'n bespreking van nasionale en internasionale verklarings, raamwerke en wetgewing en 'n ondersoek na beginsels in die verskillende navorsingsgebiede om 'n beeld te kry van toepaslike beginsels wat EBRECs kan lei. Die belangrikste bevinding van my proefskrif is dat as gevolg van die kompleksiteit van EBR, verskillende kategorieë beginsels die oplossing vir EBRECs kan wees. Ek brei hieroor uit in hoofstuk 5, my slothoofstuk, waarin ek ook 'n lys van kernbeginsels voorstel wat kan dien as 'n toeganklike en maklik om te gebruik gids vir EBRECs in hul besluitneming. In hierdie voorstel groepeer ek verskillende soorte beginsels in terme van vier kategorieë: 1. Beginsels as 'n morele konsep 2. Beginsels as 'n sosiale konsep 3. Beginsels as 'n regskonsep 4. Beginsels as 'n veiligheidskonsep
Description
Thesis (MPhil)--Stellenbosch University, 2021.
Keywords
Ethics Principles, UCTD, Research Ethics, Environmental ethics, Ethics -- Reviews
Citation