Ethical Review Process by Ethics Committees

4. Disclosure to Prospective Participants

The following are some key elements that should be disclosed to prospective participants:
  • The invitation to participate in the research.

  • Research aims and methods.

  • Identification of researchers and sponsors.

  • Sources of funding.

  • Any possible conflicts of interest, including institutions that the researcher is linked to.

  • The anticipated benefits of the research.

  • Alternatives of the research intervention that are already available (if applicable).

  • Potential risks of the research.

  • The right to abstain (withhold) from participation in the study or to withdraw consent to participate at any time without reprisal.

  • Measures taken for the respect of the privacy of participants and for the confidentiality of records in which participants are identified.

  • Kind and amount of any compensation.

  • The address of who to contact at any time for more information.

  • Access to free treatment in case of injury from research procedures and compensation of resulting impairment, disability, and handicap.

  • Access to interventions identified as beneficial in the study or access to other appropriate care or benefits.