Describe any ethical issues that may arise in their proposal. In particular, you should explain the benefit and burden of their experiments and the effects it may have on the research subject. The following special issues should be taken into account:
- Informed consent: When describing issues relating to informed consent, it will be necessary to illustrate an appropriate level of ethical sensitivity, and consider issues of insurance, incidental findings and the consequences of leaving the study.
- Data protection issues: Avoid the unnecessary collection and use of personal data. Identify the source of the data, describing whether it is collected as part of the research or is previously collected data being used. Consider issues of informed consent for any data being used. Describe how personal identify of the data is protected.
- Use of animals: Where animals are used in research the application of the 3Rs (Replace, Reduce, Refine) must be convincingly addressed. Numbers of animals should be specified. State what happens to the animals after the research experiments.
- Human embryonic stem cells: Research proposals that will involve human embryonic stem cells (hESC) will have to address all the following specific points:
- the necessity to use hESC in order to achieve the scientific objectives set forth in the proposal.
- whether the applicants have taken into account the legislation, regulations, ethical rules and/or codes of conduct in place in the country(ies) where the research using hESC is to take place, including the procedures for obtaining informed consent;
- the source of the hESC
- the measures taken to protect personal data, including genetic data, and privacy;
- the nature of financial inducements, if any.
Identify the countries where research will be undertaken and which ethical committees and regulatory organisations will need to be approached during the life of the project.
Include the Ethical issues table below. If you indicate YES to any issue, please identify the pages in the proposal where this ethical issue is described. If you are sure that none of the issues apply to your proposal, simply tick the YES box in the last row.
(No maximum length for Section 4 – depends on the number and complexity of the ethical issues involved)