This ethics checklist addresses key ethical issues that may arise in research. It provides guidance to research applicants on compliance related to informed consent, research involving human embryos/fetus, privacy concerns, research on animals, developing countries, and dual use risks. The checklist consists of questions about these topics to help identify any ethical issues and ensure they are properly addressed.

1. Document Type Checklist
Document Name Ethics Checklist
Date Created 24.06.2011
Revision No. 2
Ethics & Security Check List
The checklist addresses the main ethical dilemmas that arise in research and indicates providing research
applicants with guidance when dealing with specific ethical & security issues that can arise to ensure
compliance.
Proposal Name
Submitted By Affiliate
Acronym Submission Date
Proposal Number Evaluation Deadline
Yes No NA
Informed Consent
Does the proposal involve children?
Does the proposal involve patients or persons not able to give consent?
Does the proposal involve adult healthy volunteers?
Does the proposal involve Human Genetic Material?
Does the proposal involve Human biological samples?
Does the proposal involve Human data collection?
If you answered YES for any of the above, explain how it doesn’t breach any ethical misconduct.
Research on Human embryos/foetus
Does the proposal involve Human Embryos?
Does the proposal involve Human Foetal Tissue/Cells?
Does the proposal involve Human Embryonic Stem Cells (hESC)?
If you had to use hESC in your research, indicate 1) the source 2) The measures taken to protect personal
data, including genetic data, and privacy.
Privacy
Does the proposal involve processing of genetic information or personal data (eg. health,
sexual lifestyle, ethnicity, political opinion, religious or philosophical convinction)?
Does the proposal involve tracking the location or observation of people?
If the one or both of the previous are Yes indicate
What kind of human participants/data are involved within the research?
categories of human participants
 Patients
 Healthy volunteers (related to health research)
Ethics Checklist - Rev.2 1/2

2. Document Type Checklist
Document Name Ethics Checklist
Date Created 24.06.2011
Revision No. 2
 Volunteers (for surveys, etc…)
 Workers’ (e.g.: research lab personnel…)
 Participating researchers’ list
 Children
 Vulnerable adults
 Others…..special population groups? Developing countries? etc.
categories of data used
 Previously collected data (their sources and usage history)
Do the applicants have the necessary legal permission to obtain and process the data?
How will the collected personal data be securely accessed?
How will the data be securely stored: data structure and format?
How will the data be securely stored: location & hardware?
Research on Animals
Does the proposal involve research on animals?
Are those animals transgenic small laboratory animals?
Are those animals transgenic farm animals?
Are those animals cloning farm animals?
Are those animals non-human primates?
Research Involving Developing Countries
Use of local resources (genetic, animal, plant, etc.)?
Benefit to local community (capacity building i.e. access to healthcare, education, etc. )
Does any of the research data come from a developing or under economic transition
country?
Will any of the research outcomes to be implemented within the project include a
developing country and the deployment of any kind of personal data?
Do any of the resources the project is planning to use come from a developing country?
If this is the case, have the necessary measures for protecting and controlling data and –
if needed – privacy been designed?
Will any data gathered be transferred to a non EC Member State?
What are the data privacy standards in the country where the data are obtained? How
could the project apply best practices for data storage and processing in that country?
Which type of data is being transferred?
Have the research participants been informed that their data may be transferred to
another country where data protection is not as rigorous as the EU?
Dual Use
Research having potential military/terrorist application
Ethical issues of dual use might arise in cases where:-
- Classified information, materials or techniques are used in research
- Dangerous or restricted materials e.g. explosives are used in research
- The specific results of the research could present a danger to participants, or to
society as a whole, if they were improperly disseminated
Ethics Checklist - Rev.2 2/2