Research Ethics

1. Introduction- 

Ethics review and publishing:

Ethics review is also essential if researchers intend to publish the results of their investigations as most reputable medical journals will not publish research results that have not been approved by a research ethics committee.

• Ethics in research and publication (Elsevier)

http://www.ethics.elsevier.com/index.asp

• PLoS editorial and publishing guidelines on the web

http://www.plosone.org/static/policies.action#animal

• Publication Ethics Policies for Medical Journals (WAME)

http://www.wame.org/about/recommendations-on-publication-ethics-policie

Ethical Guidance for research

"Ethics guidance for research involving human participants has been developed and disseminated by numerous organizations and agencies at international [...], regional, and national levels over the past 50 years. Adherence to these guidelines helps to promote the ethical conduct of research and enhances and protects the rights and well-being of research participants and communities. A core component of all contemporary research ethics guidelines is that research should be subject to prior ethical review by a competent REC. Such review is intended to ensure that the ethical principles and practices put forward in the guidelines will be followed in the proposed research." From: WHO. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva. World Health Organization (2011). Pp. xi

International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS) (Guidelines 2 & 3)

International Ethical Guidelines for Epidemiological Studies (CIOMS) (Guidelines 2 & 3)

Declaration of Helsinki (World Medical Association (Guidance Point 15)

WHO. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva, World Health Organization (2011): https://extranet.who.int/eauthoring/GetImageFile.aspx?id=4586

More information on what a research protocol contains can be found here: Recommended format for a Research Protocol. WHO.

The importance of research ethics oversight

Research with human beings is absolutelyvital for improvements in health and those engaged in research are largely motivated by the desire to do good - accepting that prestige and profit are motivating factors for some as well. Despite the best of intentions, however, research carries varying degrees of risk to research participants and their communities. For example, when we test a vaccine, we place the research participant at risk of harm with no necessary benefit to that individual. Because it is unknown whether the vaccine will work or not, participants may experience harms such as pain from the needle stick, nausea, or even a serious reaction to the test drug without any corresponding benefit. There is, after all, no guarantee that the test vaccine/drug will provide any benefit at all and may, in fact, be harmful.

That said, it is also important to be aware that participants may believe that the vaccine will be beneficial and that it is in their personal best interest to accept the vaccine. In research this is called the ‘therapeutic misconception’ and shows a misunderstanding of the research process and purpose.

Likewise, if we ask sensitive questions in a survey concerning domestic assault (WHO has developed a set of ethical and safety recommendations for research on domestic violence against women titled "Putting Women First"  (http://www.who.int/gender/violence/womenfirtseng.pdf), the knowledge gained might provide important information for in-country policy changes, but might place individual respondents at risk from their intimate partners, or even from other family or community members.

Types of research receiving ethical review

Ethics review committees review different types of research studies, including, but not limited to, the following types of research:

• Clinical trials - Clinical development (Phase 1 through to registration) of meningococcal A conjugate vaccine for use in developing countries

• Epidemiological research - Malaria incidence and transmission in different regions of the world

• Social science research - Improving quality of services for reproductive health of adolescents and young adults

• Research on medical records or other personal information - Comparison of medical records review and incidence reporting for assessment of hospital-based adverse event reporting.

• Research on stored samples - Development of rapid diagnostic tests for malaria using stored samples

• Health systems research - Effectiveness and cost effectiveness of scaling-up improvements in maternal and new-born care in primary health facilities.

• Implementation research - Implementation strategies for managing visceral leishmaniasis in 3 countries in South Asia.

Documents required for review

In this section, we have reviewed the rationale for research ethics oversight and have described in broad strokes your primary responsibilities regarding ethical oversight. You should also become familiar with what a protocol should typically contain.

1. Brief background and justification

1. Objective of study and brief statement as to why the research question(s) is relevant.

1. Methodology / procedures / analysis plan

1. Sampling methodology and sample size calculations

1. Study instruments and data collection forms

1. Limitations / delimitations

1. Ethical considerations including assessment of predictable risks and burdens to individuals and communities compared to foreseeable benefits

1. Description of the recruitment process and the consent process, including informed consent documentation

1. Budget and timelines

1. References

1. Curriculum Vitae or biography of Principal Investigator and co-investigators

1. Previous review by other ethical or scientific board or committee

For an expanded list see: WHO. Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants. Geneva. World Health Organization (2011) p. 34-5.https://extranet.who.int/eauthoring/GetImageFile.aspx?id=4586

You may also have institutional and national policies on materials required for review (seehttp://globalhealthreviewers.tghn.org/resources/guidance-and-regulation/ for links to a wide range of guidance and regulation on research ethics).