What is it? Why is it important?

The study close-out-visit marks the end of the study. The collection of Biological Material (BM) or Health-Related-Personal-Data (HrPD) is no longer possible. In order to proceed with the evaluation of the study the:

  • Collected BM is analysed
  • Data (e.g. HrPD) is exported imported into a statistical software package for the statistical analysis

 

Upon analysis (e.g. based on the study protocol) results are published in order to share findings with a broader research community (e.g. scientific journals, scientific conferences)

 

 

When publicizing research results the following aspects must be considered:

  • Data protection aspects: results are summarized and not presented based on individual donor results
  • Donor rights to information: information regarding personal results and study outcome
  • Incidental findings: the unexpected and unintended finding beyond the aim of a study

More

Incidental findings are unexpected findings that emerge during research, but are beyond the aims of the study or research project. Incidental findings can be clinically relevant to a donor. Disclosing information about incidental findings to donors may be beneficial, but it may also be harmful, and potentially unwanted.

 

Donors have the right to be informed and the right to abstain from receiving information (e.g. study results, incidental findings). These rights are documented in PIS/ICF, and the SP-INV/Site-INV is required to know and respect the wishes of a donor.

In some instances and upon EC approval this right can be sidestepped. This is especially the case, when the information is deemed crucial to a donor`s current and ongoing safety and health.

What do I need to do?

In a scientific publication:

  • Acknowledge the biobank from which BM was obtained and needed for the generation of research results
  • Ensure results are presented in a form, that prevents the identification of individual donors

 

Inform donors of research results:

  • As specified in the study protocol, and/or biobank regulations, and/or donor request.
  • Based on:
    • Study donor rights (e.g. wish to be informed, or not to be informed regarding incidental findings)
    • Defined contact person (e.g. treating physician (e.g. SP-INV/Site-INV), nurse, research associate)
    • Defined communication mean (e.g. by phone, email, letter, in person)

 

In the event a donor abstains from being informed about incidental findings, but you (e.g. SP-INV/Site-INV, researcher) deem the information to be crucial for the ongoing safety/health of the person, contact the EC to discuss grounds for sidestepping donor rights.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.

External Links

Swissethics – see in particular

  • Topics/Position papers/Incidental findings

Publications PubMed

PMID: 31462969

Jui-Chu Lin et al. Managing « incidental findings » in biobank research

Abbreviations
  • BM – Biological Material
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRO – Human Research Ordinance
  • HrPD – Health related Personal Data
  • ICF – Informed Consent Form
  • PIS – Participant Information Sheet
  • PMID – PubMed ID
  • SBP – Swiss Biobanking Platform
  • Site-INV – Site-Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor Investigator
Completion ↦ Biobanking ↦ Publication ↦ Analytical Results
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Completion ↦ Biobanking ↦ Publication ↦ Analytical Results

Please note: the Easy-GCS tool is currently under construction.