What do we mean by ethics?

Ethics are principles or standards that guide behavior. Aligning research processes to ethical guidelines protects research participants’ rights and welfare, ensuring that researchers:

  • act in the best interest of participants
  • consider and weigh any possible harms
  • give full, accessible, understandable information
  • facilitate participants’ right to choose e.g., to participate, withdraw, not answer
  • exercise just and fair selection.

Thus, ethics build participants’ trust in researchers and the research process.

Ethics inside human mind, Business ethics concept. Hand flip ethics inside a head symbols in wooden cubes on dark background with copy space.

Is ethics approval needed for patient-reported outcomes research and real-world studies?

The short answer is yes; although this may depend on the type or classification of study. For instance, participants can be considered to have already provided consent for research material that is freely in the public domain, meaning that obtaining consent for use of that material in later research may not be needed.

Further to this, consideration should be given to privacy and data sharing. Ethical review provides recommendations on the best way to uphold data protection principles, and helps to guard organizations (e.g., the research organization, the sponsor, etc.) from legal, financial, and reputational repercussions of ethical violations.

What should you submit, when, and to whom?

What
• Participant-facing materials
• Protocol
• Accompanying language translations and certificates
When
• Prior to any participant-screening activities
• Prior to any participant-screening activities
• Prior to any participant-screening activities
Who
• Typically submitted to a central or local ethics committee (e.g., Research Ethics Committee (REC), Institutional Review Board (IRB), etc.)
• Typically submitted to a central or local ethics committee (e.g., Research Ethics Committee (REC), Institutional Review Board (IRB), etc.)
• Typically submitted to a central or local ethics committee (e.g., Research Ethics Committee (REC), Institutional Review Board (IRB), etc.)

 “Who” the submission is made to may not always be a clear-cut decision, and the answer often comes with time and experience. For instance, a community-recruited study taking place in the UK would be submitted to an IRB rather than the NHS REC – the fact that NHS sites would not be involved means that the study would be considered outside of the jurisdiction of the NHS. In cases where a UK-based study does not involve NHS sites, ethical approval will often be obtained from IRBs, many of which are based in the US.

How do you navigate ethical approval for multi-country studies?

There is no one-size-fits-all approach to handling the complexities of ethical approval in international studies. The study design and content; the target countries, associated languages, and cultural specificities; and the relevant ethics committees from which approval is sought will contribute to variability in the process.

Ethical approval can be staggered, meaning that studies are launched in certain countries before others. Language barriers can be handled by ensuring that experts in ethics management work closely with linguists when submitting to RECs and IRBs across the world, as is the case at Vitaccess. It is best practice to involve local representatives in the target countries, including key opinion leaders and patients, to ensure that the right questions are asked in the each country.

Vitaccess case studies

What
Study protocol and materials
Study protocol and materials
Who and when
Case study 1
• UK and Ireland
• Submitted at the same time for both countries:
• US-based IRB for UK (NHS REC deemed that the study did not require their approval)
• local REC for Ireland
• Approval and launch in UK after 2 weeks
• Approval and launch in Ireland after 8 weeks (longer wait times are typical of local RECs)
Case study 2
• US, UK, Canada, Germany, Spain, Italy, Denmark, Japan, Belgium, France
• Staggered submission to a total of 8 international IRBs/local RECs, covering 10 countries
• First launch in August 2020, most recent launch in March 2022

Take-home messages

Deciding on and implementing the correct ethical approval strategy for a study can be a complex process. At Vitaccess, our patient-centered outcomes experts have extensive experience of obtaining ethical approval for patient-centric real-world studies across the globe. To learn more about how we could help you, contact us at info@vitaccess.com.

By Sally Vincent, Sam Llewellyn, Fatemeh Amini

You can watch our webinar How to approach ethics in patient-centered real-world studies here.

Sam Llewellyn, Associate Director of Patient Centered Research, and Sally Vincent, Senior Consultant, discussed how to approach ethics requirements for patient-centered real-world studies.

Ethics in patient-centered studies text
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