Ethical Integration of Research and Women Health Care

By

Prof. Wagida Abdel Rahman Anwar, MDDepartment of Community, Environmental and Occupational Medicine,

Faculty of Medicine, Ain Shams University, Cairo, Egypt

What is Ethics? It is an understanding of

the nature of conflicts arising from moral imperatives andhow best we may deal with them.

It considers how we should act best

in the light of our duties and obligations

as moral agents.

• Why research? To Improve Health Care

Health EthicsResearch Ethics

• Who?

• What?

• Where?

• How?

• How long?

• Who?• What?• Where?• How?• How long?

Health CareResearch Ethical Integration

Planning

Implementation

Monitoring and Evaluation

Women health care

1- Antenatal care 2- Screening for high risk pregnancy

Women health care

3- Nutrition4- Safe delivery and Post partum (natal % postnatal)5- Family planning services

Women health care

6- Control of reproductive health problems7- Screening for cancer

Key Messages

1. Significant reduction in the maternal mortality ratio.

2. Increase in the proportion of births attended by skilled personnel.

3. Increase in medically assisted deliveries. 4. Systematic increase in antenatal care

utilization.5. Contraceptive prevalence rate (CPR) has

increased over time

Major challenges in improving maternal health

• Marked disparities in the use of maternity care services low social status , rural areas.

• Essential Obstetric Care (EOC) program & efficient referral system needs expansion.

• Presence of skilled birth attendants is lower in rural than in urban areas.

• National funding of family planning programs.

• Cultural attitudes as: early marriage, early pregnancy, and short spacing between pregnancies.

• Perceptions regarding reproductive health issues, the need for comprehensive adoption of the reproductive health paradigm.

Major challenges in improving maternal health

How to improve women health?

building public trust

encouragehigh quality research

Good science Good ethics

Improve Women Health Care

• There is growing awareness of the ethical aspects of research.

This applies in all areas of research:

Interests of in Women health-related research

Companies - Making money(drug, biotech) - Improving women health

Scientists - Career: publish- Improving women health

Societies - Improving women health- Reduce health care cost

Communities - Improving health- Equality, justice

What is required for a good community-based study?Good science • A valid reseach topic• Testable hypothesis• Up-to-date methods• Integrity of research

Good contacts with the community• Good communication• Trust

How to protect integrity of scientific research?

Legislation Institutional, nationaland international bodies

Personal responsibility Education

Institutional regulations

International agreements Peer pressureand recommendations

Ethics review boards

Recommendations by scientific Peer review of papersSocieties and grant proposals

Ethics Issues

– The benefit and burden of the study– The effects it may have on the

research subject.

Clinical Trials:

Approvals from national competent authorities are

required.

Elements of informed consent

Respect for persons - Truth telling. - Confidentiality- Privacy

Principles

Beneficence• What Hippocrates actually said is “I will keep

(patients) from harm and injustice• Frankena arranged the components of this principle

in the following hierarchical order– I ought not to do evil or inflict harm (non-maleficence)– I ought to prevent evil or harm (beneficence)– I ought to remove evil or harm (beneficence)– I ought to do or promote good (beneficence)This ordering is not universally accepted

Justice – in the sense of what is fair and what is deserved

• Equals must be treated equally.• Ensuring that no particular group bears

excessive burden on behalf of others

To be valid, it must have the following components• Contain adequate information sufficient for a

reasonable person to take an informed decision• Design of the consent process must be

appropriate for – Type of study– Expected participants– Anticipated risks– Social, cultural etc environment in which the research

will take place

Informed consent

• The informed consent document should not be excessively long in order to avoid- Reader fatigue- Loss of interest- Inability to recall or notice pertinent information

• Unnecessary repetitions, legalisms, unexplained scientific jargons must be avoided

• Avoid truth dumping•Use the recommended format

Informed consent

• Whatever method is chosen must be approved by the institutional ethics committee before research commences

Informed consent

• Title of research• Names and affiliations of researchers• Sponsor of research, if any• Purpose of research• Procedure –how the research will be carried out and

what participants will be required to do• Approximate number of participants that will be

recruited locally and internationally where relevant• Expected amount of time that participants will need to

commit to the research• Risks

Contents of the informed consent form

• Costs to participants• Benefits –should be included after risks so that

participants have an idea of one before the other• How confidentiality will be maintained• Clear statement that participation is voluntary• Appropriate inducement –compensation for lost

daily wages, transport cost, refreshments, “care package”

Contents of the informed consent form

• Consequences of participants’ decision to withdraw from research

• Procedure for orderly termination of participation• Modality for provision of care should research related

injury occur• Post-research activities

- Dissemination of findings- Provision of “benefits”- Ancillary care responsibilities of researchers

• Statement about benefits sharing –in case of development of products with commercial benefits

Contents of the informed consent form

• Conflict of interest- Apparent- Potential

• Detailed contact information –address, telephone, fax, e-mail or any other reasonable mode of communication for the - Researcher- Institutional ethics committee chairman- Institutional ombudsman/executive

• Clear indication that participants are entitled to retain a copy of the consent form

Contents of the informed consent form

• Ethics committee may require that all or some types of consent process be witnessed

• Researchers must keep copies of all consent forms and make them available for examination by research participants, sponsors, institutional officials, ethics committees or their designee and the National Health Research Ethics Committee

• Where appropriate, ethics committees may require that researchers provide translations of the consent process appropriate to the socio-cultural characteristics of the population being studied

Contents of the informed consent form

• All research carry some element of risk to participants

• Distinguish between risks and benefits of treatments that participants would be exposed to even if they were not in the research

• Benefits of the research must outweigh the risk

Minimize risk and maximize health benefits

• The selection of participants must be based on the scientific objective of the study

• Research protocols must include inclusion and exclusion criteria

• Explanation of reason for the choice of participants and location (research sites or communities)

Fair selection of participants

• Methodology of research must be valid. It must be in accordance with established norms

• There must be a clear hypothesis or the question that the research is addressing must be clearly stated

• The study must be designed to have adequate statistical power to answer the scientific question

Scientific validity

Research should – Focus on issues that lead to improvement

in health

–Contribute to meaningful knowledge

–Contribute to capacity building

Scientific and social value

• In therapeutic research –benefits may include relief from disease, diminished suffering or provision of diagnostic information

• In non-therapeutic research participants join for altruistic reasons to benefit society

• In exchange for these benefits, participants accept some risk.

Benefits

• Avoid the unnecessary collection and use of personal data.

• Identify the source of the data, describing whether it is collected as part of the research or is previously collected data being used.

• Consider issues of informed consent for any data being used.

• Describe how personal identify of the data is protected. • Data protection issues require authorization from the

national data protection authorities.

Data protection issues