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1.

Informed Consent

4.

Research on Animals

2.

Research on Human Embryos/Foetus

5.

Research involving Developing Countries

3.

Privacy & Data Protection

6.

Dual Use

1. INFORMED CONSENT

Originally downloaded from Cordis Website here.

a) When do researchers need to provide an inform consent?

An inform consent should be required in the following cases:

• when the research involves children or persons not able to give consent

• when the research involves healthy volunteers

• when the research uses Human Genetic Material or biological samples

• when the research involves Human data collection

b) What need to be mentioned in the inform consent?

Certain information should be provided to research subjects before they participate in a study, including:

• A statement that the study involves research subjects, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental

• A description of any reasonably foreseeable risks or discomforts to the subject

• A description of any benefits to the subject or to others which may reasonably be expected from the research

• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject

• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained

• For research involving more than minimal risk, an explanation as to whether there are any treatments or compensation if injury occurs and, if so, what they consist of, or where further information may be obtained

• An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject

• A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled

c) How to deal with informed consent in practice?

Who should consent is the first question to be asked for. As a consensus, only persons able to freely understand and question, should consent. It does exclude vulnerable persons (prisoners, mentally-deficient persons, severely-injured patients, very young children, etc.). However, to avoid any loss of opportunities for these persons, legal framework should guarantee their participation (notion of surrogate legal/ therapeutic representative).

How to inform is the critical part of the process. Numerous anthropological studies have pointed out that participants are rarely able to recall what they have agreed upon by signing an inform consent. The following strategies may be of great help:

• Participation of a linguist for preparing the inform consent

• Presentation of the research project using information technologies (video, power-point, theatre play, etc.)

• Interviews conducted among the participants to ensure that they understand the issues at stake in the research project

How to get approval is the third major issue regarding inform consent. It relates to the person autonomy and vulnerability. It depends on the cultures and the traditions of the population concerned: in some communities the notion of individuality is lacking; written agreements do not exist; women’s autonomy is unacceptable. Again, some strategies should be used:

• Presence of a community representative trained by the scientific team

• Witnessing the oral approval by the trained community representative

• Presence of a lawyer in case of incompetent patients

Research involving human beings raises two general questions that should be answered in the Inform Consent:

• How human subjects can help to contribute to science and/or public health? It is crucial to explain the impact of the research for all the society and for the individuals involved: to describe the potential and direct benefits of the research as well as the slide effects.

• How researchers will work to protect subjects and their data? Often Researchers do not explain what happens to the data, samples or animals at the end of the research period. If the data/ samples are retained for further research they need to ensure that the informed consent shows this.

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2. RESEARCH ON HUMAN EMBRYOS/FOETUS

Originally downloaded from Cordis Website here

When involving the use of hESC in their research project, researchers should take into account and specify:

• That the proposal does not include research Activities which destroys embryos including for the procurement of stem cells;

• Whether the consortium has 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

A positive opinion from a Regulatory Committee constituted by Member States’ representatives is required.

Participants in research projects must seek the approval of the relevant national or local ethics committees prior to the start of the research activities.

In conclusion, each research proposal involving the use of hESC, which is supported within FP7, is assessed by at least two independent ethical reviews: one in the country itself where the research will be carried out, and one at the EU level.* No System in the world offers a higher guarantee regarding the respect of fundamental  ethical principles.

* If the research raising ethical issues is performed in more than one country (i.e. n countries), it implies that more than two ethical reviews will be performed (i.e. in fact n+1 ethical reviews)

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3. DATA PROTECTION AND PRIVACY

Originally downloaded from Cordis Website here

a) What are the issues at stake in Data Protection and Privacy?

Data privacy refers to the evolving relationship between technology and the legal right to, or public expectation of privacy in the collection and sharing of data. Privacy problems exist wherever uniquely identifiable data relating to a person or persons are collected and stored, in digital form or otherwise. Improper or non-existent disclosure control can be the root cause for privacy issues. The most common sources of data that are affected by data privacy issues are:

• Health information.

• Criminal justice.

• Financial information.

• Genetic information.

• Location information.

The challenge in data privacy is to share data while protecting the personally identifiable information. Consider the example of health data which are collected from hospitals in a district; it is standard practice to share this only in the aggregate. The idea of sharing the data in the aggregate is to ensure that only non-identifiable data are shared.

b) How to deal with Data Protection and Privacy?

Researchers should describe the procedure for obtaining inform consent of persons to whom the information relates and describe the arrangements for protecting the confidentiality of personal data of the individuals concerned. If the data are retained for further research they need to ensure that the inform consent form mentions it. Applicants should describe the measures taken to encode or anonymise banked biomaterial (including traceability measures). Even where only anonymised data are used, adequate security for storage and handling of such data must be shown.

Eight enforceable principles of good practice - Data must be:

1. Fairly and lawfully processed

2. Processed for limited purposes

3. Adequate, relevant and not excessive

4. Accurate

5. Not kept longer than necessary

6. Processed in accordance with the data subject's rights

7. Secure

8. Not transferred to countries without adequate protection

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4. RESEARCH ON ANIMALS

Originally downloaded from Cordis Website here

Researchers should provide details of the species (and strains where appropriate) of animals to be used and explain why they have been chosen. They should explain why the anticipated benefits justify the use of animals and why methods avoiding the use of living animals cannot be used. They should also give details and justify the numbers of animals proposed with reference to statistical advice if applicable.

They have to indicate what steps have been taken to comply with the principles of the 3 Rs: reduction, refinement and replacement. In particular, they should describe these procedures adopted to ensure that the amount of suffering to the animals is minimised and that their welfare is protected as far as possible (e.g. improvements in technique, application of human end-points, environmental enrichment).

The "three Rs" are guiding principles for the use of animals in research in many countries:

Reduction refers to methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals.

Replacement refers to the preferred use of non-animal methods over animal methods whenever it is possible to achieve the same scientific aim.

Refinement refers to methods that alleviate or minimize potential pain, suffering or distress, and enhance animal welfare for the animals still used.

IN SUMMARY

 ■ Convincing Application of the 3Rs

             Reduction, Replacement, Refinement

 ■ To describe and justify:

             Species and Numbers

             Humane End Points and Pain Suffering

 ■ To Check for alternatives (cf. the following websites):

            http://www.nc3rs.org.uk/category.asp?catID=3

   http://www.vet.uu.nl/nca/links/databases_of_3r_models

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5. RESEARCH INVOLVING DEVELOPING COUNTRIES & DOUBLE STANDARDS

Originally downloaded from Cordis Website here

a) What are the issues at stake in research involving developing countries?

When the source of, and justification for, universal ethical standards remain the subject of complex debates, it is generally accepted that there is a need for universal ethical standards for research on humans, and considerable effort has been made towards achieving this goal. Achieving universality in ethical standards requires reflection such as: (1) what constitutes the best interest of subjects – with insightful recognition that individual and cultural preferences, and what can be achieved in any particular context, may differ significantly; (2) what distinguishes the truly universal from imperialistic notions; and (3) the relevance of contextual issues that can be taken into consideration on moral grounds without resorting to ethical relativism.

Food for thoughts

b) How to deal with research involving developing countries?

The categories of issues requiring special attention include:

• A disproportionately heavy burden of diseases (particularly infectious diseases); the breadth and depth of poverty; and high levels of illiteracy

• Wide disparities in health systems and in access to health care; and imbalance between the often-ample resources available for research and the meagre resources available for even basic health care

• Inadequate scientific and ethics infrastructures for the required reviewing process

• The extent of disempowerment of the poor in their personal and communal lives

• Knowledge of the ways in which people of other cultures traditionally view themselves as individuals embedded in communities with respect to the changing boundaries between perceptions of the self that differ from the classical western notion

• The need to understand what it means to be ill in contexts very different from those known to researchers and what can be expected from those one consult for help under those circumstances

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6. DUAL USE

Originally downloaded from Cordis Website here

a) What to be considered as potential dual use?

Dual-use is a term often used in politics and diplomacy to refer to technology which can be used for both peaceful and military aims, usually in regard to the proliferation of nuclear weapons.

More generally speaking, dual-use can also refer to any technology which can satisfy more than one goal at any given time. Thus, expensive technologies which would otherwise only serve military purposes can also be utilized to benefit civilian commercial interests when not otherwise engaged.

b) How to deal with potential dual use?

Regarding implications for the use of and misuse of the research and products, the following measures and strategies should be applied:

• The setting up of an advisory board to support the research consortium in examining the societal, political and legal aspects of the study applications

• The exploitation strategy of the study results should be reviewed by the advisory board

• The dissemination and communication strategy of the study results to a wider audience should be controlled by the advisory board (organisation of wider stakeholder discussions)

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