By Ademola J. Ajuwon, MPH, PhD Department of Health Promotion and Education, College of Medicine, University of Ibadan Email: ajajuwon@yahoo.

com

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)

Understanding and voluntary decision are essential components

of the informed consent process Understood Consent and Informed Dissent are two sides a coin

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

Is an ongoing process and more than mere ritual of signing a paper

Adequate time and resources must be set aside for the process to be meaningful Investigators and those involved in taking consent must be available to answer questions before and every time during the research (CIOMS, 2002)

Informed consent is a sine qua non for ethical conduct of research (page 37)

Adequate information must be provided in a language that the participant understands

(the language must not be higher than that of individuals with at most 9 years of education in Nigeria page 37) Consent forms must not be longer than 8 pages in order to ensure comprehensibility and enhance recall of pertinent information Unnecessary jargons and technical and legalistic terms must be avoided

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)

3. Sponsor (s) of research

4. Purpose (s) of research 5. Procedure of the research, what shall be required of each participant and approximate total number of participants that would be involved in the research. 6. Expected duration of research and of participant (s) involvement. 7. Risk (s) 8. Costs to the participants, if any, of joining the research 9. Benefit (s) 10. Confidentiality 11. Voluntariness

12. Alternatives to participation 13. Incentive (inducement) to participants

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.

1. Research participants are entitled to retain a copy of the consent form.

2. Where appropriate, researcher (s) may be required to undertake a re-consenting process during the course of research as determined by the HREC. 3. In situations where participant (s) are unable to provide written consent, researcher (s) must propose a process of consent that adequately records participants informed decision such as witnessed thumb-printing or witnessed audio recording. 4. HREC may require that all or some types of consent process be witnessed.

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

Tension between community assent and individual consent

Is obtaining permission from a community leader, chief or another designated authority in a community sufficient to serve as individual consent? What happens when a gate-keeper do not give approval for a research that will potentially be of benefit to some members of the community? Possible reasons: corruption, previous bad experience, lack of trust of investigators

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