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Ethical implications and legal requirements of the management of biological samples in research

Andrés C. García Montero, Banco Nacional de ADN Carlos III, Universidad de Salamanca.

Monday, July 31.

Research vs diagnosis

Biomedical research is not directed towards improving the participants' health.

Actors

  • Study subjects.

  • Researchers.

  • Sample repositories (biobanks).

  • Collectors (clinics).

  • Ethics committees.

    "Primum non nocere"

To access a biobank a project with scientific quality and ethics is needed.

Informed consent

  • Understanding capacity (the information).
  • Decision capacity (the consent).
  1. Conscious: finality, benefits / disadvantages.
  2. Participation acceptance.
  3. Revocation right --> there must be a way to cancel an informed consent.

Consent:

  1. Informed
  2. Written
  3. Revokable

Previous information:

  • Finality.

  • Expected benefits.

  • Possible inconveniences.

  • Investigation responsible identity.

  • Analysis location and destination.

  • Right to know the results of the studies.

  • Confidentiality guarantee.

  • Revocation right and effects (the sample is returned, destroyed, anonymized, ...).

  • Health implications.

  • Family implications.

  • Possibility of future contact.

Informed consent types

  • Informed consent for a research project (only for a specific project).
  • Informed consent for a research line (for different projects within a specific area).
  • Informed consent for a biobank (for a lot of study types of different projects.

Clinical history access must be always justified.

Idea: Dynamic digital informed consent: the patient can manage his informed consents from a web application and gets alerts to participate in new studies.

Data disassociation

  • Anonymize (irreversible):
  • Advantages:
  • Total patient privacy guarantee.
  • Absence of risks for the researcher.
  • Disadvantages:
  • Unable to revoke informed consent.
  • Unable to return information.
  • Codify (reversible).