All members of a team submitting an application must agree to fully comply with high ethical standards of research. The Principal investigator must further agree to immediately report to the Program Manager any difficulties encountered in complying with these ethical standards and propose suitable corrective action or remedies. In the final report presenting the study's research findings, the Principal investigator will include a description of how the research team complied with the ethical standards specified in this Annex in carrying out the study.
The draft ethical standards of research specified in the present document are drawn from and to a large extent reproduce the standards described in IDRC-UPF's "MEMORANDUM OF GRANT CONDITIONS". If awarded a Fellowship, the agreement between UPF and Fellows must include a clause binding researchers to ethical standards and will use the conditions below as a reference.
Notice to applicants: Depending on the particular features of each study, the draft text below may need to be adjusted. Failure to take into consideration appropriate ethical standards will disqualify the study for a Fellowship or may lead to the cancellation of an award.
It is the policy of IDRC and of the Amy Mahan Fellowship Program that research work involving human subjects or animals be carried out in accordance with high ethical standards. By affixing their signature to the Application Form, all members of a Research Team submitting a proposal agree that if they are awarded a Fellowship, they will fully comply with the standards described below.
Amy Mahan Fellows must immediately report to the Program Manger any difficulties they may encounter in complying with the ethical standards described below. In the final technical report, the Principal investigator shall describe how compliance with the ethical standards in carrying out their study was achieved.
1. Information Gathering
Participating researchers agree to comply with the following principles which aim at protecting the dignity and privacy of every individual who, in the course of the Research Work carried out under the study they are proposing, will be requested to provide personal or commercially valuable information about him/herself or others (hereinafter referred to as "Subject of Research"):
a) Before an individual becomes a Subject of Research, he/she shall be notified of:
- the aims, methods, anticipated benefits and potential hazards of the research;
- his/her right to abstain from participation in the research and his/her right to terminate at any time his/her participation; and
- the confidential nature of his/her replies
b) No individual shall become a Subject of Research unless he/she is given the notice referred to in the preceding paragraph and provides a freely given consent that he/she agrees to participate. No pressure or inducement of any kind shall be applied to encourage an individual to become a Subject of Research.
c) The identity of individuals from whom information is obtained in the course of the Study shall be kept strictly confidential. At the conclusion of the Study, any information that reveals the identity of individuals who were Subjects of Research shall be destroyed unless the individual concerned has consented otherwise in writing. No information revealing the identity of any individual shall be included in the final report or in any other communication prepared in the course, or as a result, of this Study, unless the individual concerned has consented in writing to its inclusion beforehand.
d) When children are involved in the Study, it is the policy of the Amy Mahan Fellowship Program that special care be taken to ensure that their participation is undertaken in accordance with high ethical standards. Accordingly, in addition to the requirements of paragraphs A4.1(a) - A4.1(c) being complied with, children shall not be allowed to participate unless:
- their parents or guardians have been counseled with respect to the children's participation in accordance with the requirements of paragraphs 1a - 1c above; and
their parents or guardians have given their free, explicit, and informed consent to the participation of the children in the Study.
Parents or guardians shall have the right to withdraw their children from the Study at any time.
2. Studies Involving Human Subjects in Biomedical Research
Participating researchers agree to comply with the following terms and conditions in carrying out any Research Work under their Study, which involves human subjects in biomedical research:
a) Participating researchers agree to comply with the International Ethical Guidelines for Biomedical Research Involving Human Subjects developed by the Council for International Organizations of Medical Sciences and the World Health Organization.
b) In addition to the requirements of paragraphs A4.1(a) - A4.1(d) being complied with, the Participating researchers shall:
- submit the research protocol for the Study to an appropriately constituted ethics review committee in its institution or at the national level (in the country where the Research Work will be carried out); and
- provide the Amy Mahan Program Manager with a copy of the Committee's written approval of the protocol.
c) The Principal investigator shall take whatever steps may be necessary to ensure:
- that health care services that are essential to the safe conduct of research are available and accessible to Subjects of Research as necessary; and
- that effective treatment is provided to those Subjects of Research who react adversely to any aspect of the experimental procedure to which they have been subjected.
d) The Principal investigator shall take all reasonable steps to ensure:
- that Subjects of Research who are discovered to have health problems as a result of the research are referred to appropriate support and health care services consistent with national health care standards in the country in which they are resident; and
- that beneficial interventions or products developed as a result of research undertaken in the course of the Study are made available to Subjects of Research who were involved in the Study and who may benefit from them.
Studies Involving Biological Knowledge
The Amy Mahan Fellowship Program supports the objectives of the 1992 Convention on Biological Diversity, in particular that of promoting the fair and equitable sharing of the benefits arising from the use of genetic resources. Researchers involved in any project that may entail the use or dissemination of knowledge, including traditional knowledge, to which a person or group of persons may claim moral or legal rights, will not take steps that would prejudice such claims or diminish their value. In particular, participating researchers will not profit or act in such a way as to facilitate profit by third parties through the commercialization or dissemination of such knowledge without the concurrence of the Amy Mahan Fellowship Program. Where the use or dissemination of such knowledge is envisioned, participating researchers will ensure that the moral or legal rights of any potential claimants are respected, through consultation with them and compensation to them where available. This section will survive beyond the Study's Contract Termination Date.
The Amy Mahan Fellowship Program does not support Studies promoting or resulting in the promotion of medical treatments that are not sanctioned as safe and efficacious in accordance with recognized national and international standards. Participating researchers will not, during the course of this Study or through activities arising from it, recommend the use of medical treatments that do not meet these standards.
Studies Involving the Use of Animals
It is the policy of the Amy Mahan Fellowship Program that any animals used in Program-supported Studies should be treated in a humane way. Therefore, it is a condition of this Memorandum that:
- All animals are acquired according to law;
- The facilities in which the animals are kept accommodate their needs;
- The environment in which the animals are kept is reasonably comfortable and constant;
- Reasonable amounts of food and water are provided to the animals;
- Reasonable veterinary care is provided to the animals;
- No animal is subjected to pain or distress unless it is a necessary aspect of experiments that has been approved by the Amy Mahan Fellowship Program; and
- Where euthanasia is necessary, the method used rapidly produces a state of unconsciousness.