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Informed consent is a decision to participate in research, taken by a competent individual who has received the necessary information;
who has adequately understood the information; and who after considering the information has arrived at a decision (voluntarily) without been subjected to coercion, undue influence or intimidation (CIOMS, 2002)
A type of contract between an investigator and a study participant The contract is sealed by the signing of the Informed Consent Form by the participant
The form spells out the responsibilities of investigators and the rights of study participants
Informed consent is a sine qua non for ethical conduct of research (page 37)
Paper size A4
Font Times New Roman or similar Font Size 12 Spacing 1.5 Margins 2.5 cm, no gutter
1. Title of the research 2. Name (s) and affiliation (s) of the researcher (s)
14. Consequences of participants decision to withdraw from research and procedure for orderly termination of participation.
15. Modality of providing treatments and action(s) to be taken in case of injury or adverse event(s). 16. What happens to research participants and communities when the research is over? 17. Statement about sharing of benefits among researchers and whether this includes or exclude research participants. 18. Any apparent or potential conflict of interest. 19. Detailed contact information including contact address, telephone, fax, e-mail and any other contact information of researcher (s), institutional HREC and head of the institution.
5. Researcher(s) must keep all copies of consent form and make them available for examination by participant(s), sponsor(s), institution(s), HREC and NHREC. 6. Where appropriate, HREC may require researchers to provide translations of consent processes appropriate to the sociocultural characteristics of the population to be studied. 7. All consent activities must be documented.
A perception that spending sufficient time for consent is a waste of time because a) Researchers or their Assistants are under pressure to recruit as many study participants are possible in a short time
b) Study population do not know their rights anyway so why worry? c) Perception that researcher is doing study participants a favour; this may apply if health care is a component of study
Culture of not challenging medical authority (the distinction between care and research may not very clear when the physician is also researcher)
Physicians have credibility and great influence over patients because of belief that a doctor will always do good for his/her patient Patients who are potential participants may be under subtle pressure to enroll in research because of concerns that quality of care may be adversely affected if the give refuse to participate Researchers working in teaching hospitals may perceive that informed consent is not necessary since patients who come to such hospitals have given assumed consent
Gender issues In many traditional settings in Nigeria, access to women during communitybased research requires permission of husbands
In many areas Nigerian women require the permission of husbands before enrolling in studies Will women who are interested in participating in a research give consent if their husbands disapprove that they enroll? If receiving informed consent from women is evidence of respect for their dignity and autonomy why is permission of husbands required before women can give consent to participate research? Many Nigerian women are poor and have been socially conditioned to submit to authority figures including husbands, to ask no questions, and to endure pain and suffering encountered in marriage (CIOMS, 2003)
One of the essential requirements of informed consent is full disclosure of the purpose of research to enable potential research participants make informed decision
However, full disclosure is often tricky in sensitive reproductive health research such as gender-based violence because if a perpetrator knows that the focus of the research is violence it may trigger more violence Yet, women need to be fully informed about the nature of and procedures involved in a research before they decide to participate in the research
Nigerians are skeptical about all forms of documentation: Fear that information may be used for nonbeneficial purposes
Many are low literate or non-literate Previous bad experiences during colonial period Some prefer verbal consent to written consent because of belief that the former is less committal
Continuing education of the importance of consent for the public, researchers, members of ERC, and sponsors of research
Strengthening of the capacity of ERC to enable them monitor consent process of approved research ERC need to set minimum standards for development of consent forms and how to apply them in the field Promotion gender equality
Council for international organizations of Medical Sciences. International ethical Guidelines for biomedical research involving human subjects. Geneva, 2002
Getz K and Borfitz D. Informed Consent: A guide to risks and benefits of vounteering for clinical trials. Thomson/CenterWatch, 2003 National Health Research Ethics Code, 2007