HREC Genomics Training Course
Reviewing a Genomics Application

Reviewing a Genomics Application

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Reviewing Applications

Now that you are more knowledgeable about genomics and the ethical considerations, we are going to break it down according to the components of a gneomics ethics application.

Participant Information and Consent Form (PICF)

I always begin by reviewing the PICF – a wise person once told me that you should be able to understand the purpose, nature, risks and benefits of a study from the PICF.

    • Type – blood/saliva/tumour

    • From whom - participant only or family members also?

    • What technology will be used?

    • How will the data be analysed?

      • What are the risks and benefits?

    • Privacy and secure storage of the data

    • Future plans for data/samples

    • What type?

    • By whom?

    • What are the possible health and psychological impacts of these results?

    • Details of team and any prior review of research – this section is similar to all other application types.

    • Specifies that research involves biospecimens, humans and genomic research.

    • Risks and Benefits of the research – e.g., privacy and secure storage of data, potential for reidentification, risks for incidental findings, risks of genetic discrimination, and implications for family members given the shared nature of genomic information.

  • Note each sub-section within this section has a follow up question regarding ethical considerations and risk mitigation strategies:

    • Personal, sensitive, health – storage and sharing

    • Activities planned for/with Data – as per the genomic technologies section, consider whether study will identify common or rare variants, and how the data will be analysed.

    • Incidental and Secondary findings – what is the risk of incidental findings and will the analytical approach mitigate this risk? Will there be purposeful interrogation of the data for variants in potentially actionable genes?

    • Dissemination of outcomes – will results be returned to participants? Will their family members also be receiving results and how will researchers keep each individual’s results private? Will results be published? If so, will there be any risk that participants could be re-identified based on the rarity of their condition/gene etc.?

    • Future use – have researchers been clear about the potential use of the data and samples in the future? Will they seek additional consent and/or ethics approval for other related projects in the future?

Human Research Ethics Application (HREA)

Protocol

  • All the PICF and HREA points

  • Background/Rationale, Aims, hypotheses etc.

  • Additional details regarding:

    • Recruitment – approach participant +/- family members

    • Methods including analytical approach – risk mitigation strategies

    • Rationale for deciding what types of results should be communicated and result validation etc.

    • How the study will be conducted? Is the study approach and scope clear?

Additional Documents

  • CVs – do staff members have the necessary qualifications for their roles in the team? This would be particularly relevant if team members are consenting participants, determining whether results should be returned and communicating results to participants.

  • Questionnaires/interview guides etc. – are they potentially emotive? If so, are the questions worded sensitively? Will participants be offered support if distressed?

  • Letters of support from relevant organisations/groups – this is particularly salient if recruiting from specific ancestral/cultural groups.

Checklist

Click the button below to download our checklist for reviewing applications, which we hope will facilitate the process.