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Protocol Development: Benefits and risks

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Introduction

Research can and has delivered enormous benefits to society; however a degree of risk is inherent in every research study.  In order to fully develop your research protocol / proposal, you should define the nature and extent of any benefits likely to be achieved whilst ensuring the following risks are minimised;

  • The safety of potential participants
  • The rights and dignity of participants
  • The environment and wider community
  • The successful completion of the study
  • The credibility of the data collected
  • The safety and wellbeing of the research team

The assessment of potential risk should be based on published data and your own experience.  Early consideration of risk will facilitate your application for ethics committee and Research and Development permission.

Identified risks can be minimised by implementing appropriate management and monitoring strategies.  Determining what is an acceptable level of risk is a subjective judgement.  In general risks should not outweigh benefits (Declaration of Helsinki). Research that is unlikely to offer participants direct, personal benefit should expose them to minimal risk of harm.  Minimal risk of harm is a consensus judgement, informed by guidelines, the experience of Investigators and their peers, participants themselves and research ethics committees.  If it is possible to obtain similar information by a different and less risky methodology, the alternative approach must always be considered.

Consultation with Research Ethics Committees, Research and Development offices and other regulators will determine whether your protocol / proposal is appropriate, or whether you should consider using a different, less risky approach to address your research question.

Resources

  • 1. AMS Report ‘Microbial Challenge Studies of Human Volunteers’

    An Academy for Medical Sciences (AMS) report that addresses the risks, benefits and conduct of microbial challenge studies of human volunteers, with particular emphasis on vaccine development. Although directed specifically at best practise in microbial challenge studies, most of the findings can be applied more generally to experimental medicine studies.

    Good Practice for em studies specifically Date added: 29 October 2008
  • 2. RSS: Report of the Working Party on Statistical Issues in First-in-man studies

    Royal Statistical Society report on statistical issues in first-in-man studies: directly applicable to early phase clinical trials of investigational medicinal products (CTIMPs), as well as relevant for many other small scale studies.

    Good Practice for some em studies (not applicable for all) Date added: 29 October 2008
  • 3. Nuffield Council on Bioethics

    The Nuffield Council on Bioethics examines ethical issues raised by new developments in biology and medicine. Reports are available on the ethics of xenotransplantion, stem cell research and genetic screening etc.

    Good Practice for some em studies (not applicable for all) Date added: 29 October 2008
  • 4. Declaration of Helsinki (0KB)

    The World Medical Association (WMA) Declaration of Helsinki (current version 2013)

    Good Practice for all research Date added: 25 November 2008
  • 5. MRC EM Risk Assessment Tool (0KB)

    A risk assessment tool for experimental medicine studies

    Good Practice for em studies specifically Date added: 6 October 2009