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Abstract

Research ethics committees have become a permanent ﬁxture when it comes to ethics of research. They are essential part of quality control of research protocol, and their existence and work are thoroughly described in all important international documents dealing with research ethics issues. In this contribution history, development and different types of research ethics committees are discussed. The functions, structure, and locale of research ethics committees are also addressed. The global dimension of the work of research ethics committees is also discussed.

Introduction

Today one cannot imagine doing a research of any kind on human subjects or on animals without having to undergo a thorough review by a research ethics committee. They are there to ensure that all the ethical issues raised by a research are properly addressed. Research ethics committees monitor the research in progress and are mandated by law in almost all national legislation around the world dealing with research on human subjects or animals. However, their existence is not something that came about with the advent of human research. It took many years for them to become permanent ﬁxture. This contribution will present the story about their beginnings and their everyday work as well as highlight some future challenges that lay ahead. In this contribution history, development and the different types of research ethics committees are discussed. The functions, structure, and locale of research ethics committees are also addressed. The global dimension of the work of research ethics committees is also discussed.

History And Development

The natural sciences were progressing in the nineteenth century, and the experimental method became very important. However, the scientists dealing with research on humans and animals often paid a little attention to the issues that later became extremely important (protection of research participants, waging risks versus beneﬁts of their potential research subjects, their informed consent to participate in research), and sometimes they did not pay attention also to the quality and the scientiﬁc merit of the research protocol. In their opinion any research that has some potential to beneﬁt mankind was deemed acceptable, and the issues that later prompted the development of the ﬁeld are called research ethics. It was after the Second World War and the creation of Nuremberg Code in 1947 that the importance of adequate ethical approach to human experimentation became very important. For the ﬁrst time the issues of informed consent of the participant, absence of any coercion, waging risk and beneﬁts, and protection of research participants became very important in the texts that will follow after Nurnberg Code. However, although Nurnberg Code and later Helsinki declaration created in 1964 by World Medical Association were in place, unethical research was still happening and there was a need for creation of a quality assurance system. Therefore, an idea of an independent body that performs a review of a research protocol-research ethics committee came into existence (Jonsen et al. 1998).

The ﬁrst requirement of committee review can be found in 1953 US Federal Document entitled “Group Consideration for Clinical Research Procedures Deviating from Accepted Medical Practice or Involving Unusual Hazard.” This guideline applied only to the research that was to be conducted at the newly opened National Institutes of Health Clinical Center. In 1966 the surgeon general of the US Public Health Services issued the ﬁrst federal public statement requiring research institutions to establish research ethics committees (RECs) (Jonsen et al. 1998; Levine 2004). In 1975 in the Tokyo revision of the Declaration of Helsinki, the following is stated under the point number 2:

The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted to a specially appointed independent committee for consideration, comment and guidance.

Form this point on the review of the research protocol by an independent expert body became an obligatory requirement worldwide. Nowadays research ethics committees are mandated by many international documents and national legal provisions all around the world.

Soon after that the review of the research protocol by the research ethics committee became obligatory in may international documents that C followed.

The International Ethical Guidelines for Biomedical Research Involving Human Subjects by Council of International Organizations of medical Sciences (CIOMS) from 1993 are stating the following:

Guideline 2: Ethical review committees

All proposals to conduct research involving human subjects must be submitted for review of their scientiﬁc merit and ethical acceptability to one or more scientiﬁc review and ethical review committees. The review committees must be independent of the research team, and any direct ﬁnancial or other material beneﬁt they may derive from the research should not be contingent on the outcome of their review. The investigator must obtain their approval or clearance before undertaking the research. The ethical review committee should conduct further reviews as necessary in the course of the research, including monitoring of the progress of the study.

The World Health Organization Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products from 1995 at point 3.2 are also emphasizing the importance of research ethics review, as well as 200 Operational Guidelines for Ethics Committees that review Biomedical Research.

Council of Ministers of the European Union adopted a Directive on clinical trials Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 which in article 2 points the following under point j:

“‘ethics committee’: an independent body in a Member State, consisting of healthcare professionals and nonmedical members, whose responsibility it is to protect the rights, safety and wellbeing of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, expressing an opinion on the trial protocol, the suitability of the investigators and the adequacy of facilities, and on the methods and documents to be used to inform trial subjects and obtain their informed consent.”

Council of Europe’s Oviedo Convention in chapter V on Scientiﬁc research under article 16 states the following

iii. the research project has been approved by the competent body after independent examination of its scientiﬁc merit, including assessment of the importance of the aim of the research, and multidisciplinary review of its ethical acceptability.

Additional Protocol to the Oviedo Convention concerning biomedical research gives the following explanation concerning the work of research ethics committees:

CHAPTER III – Ethics committee

Article 9 – Independent examination by an ethics committee

Every research project shall be submitted for independent examination of its ethical acceptability to an ethics committee. Such projects shall be submitted to independent examination in each State in which any research activity is to take place.
The purpose of the multidisciplinary examination of the ethical acceptability of the research project shall be to protect the dignity, rights, safety and well-being of research participants. The assessment of the ethical acceptability shall draw on an appropriate range of expertise and experience adequately reﬂecting professional and lay views.
The ethics committee shall produce an opinion containing reasons for its conclusion.

Article 10 – Independence of the ethics committee

Parties to this Protocol shall take measures to assure the independence of the ethics committee. That body shall not be subject to undue external inﬂuences.
Members of the ethics committee shall declare all circumstances that might lead to a conﬂict of interest. Should such conﬂicts arise, those involved shall not participate in that review.

Article 11 – Information for the ethics committee

All information which is necessary for the ethical assessment of the research project shall be given in written form to the ethics committee.
In particular, information on items contained in the appendix to this Protocol shall be provided, in so far as it is relevant for the research project. The appendix may be amended by the

Committee set up by Article 32 of the Convention by a two-thirds majority of the votes cast.

Article 12 – Undue inﬂuence

The ethics committee must be satisﬁed that no undue inﬂuence, including that of a ﬁnancial nature, will be exerted on persons to participate in research. In this respect, particular attention must be given to vulnerable or dependent persons.

The UNESCO Universal Declaration on Bioethics and Human Rights states the following in article 19 about research ethics committees:

Independent, multidisciplinary and pluralist ethics committees should be established, promoted and supported at the appropriate level in order to:

(a) assess the relevant ethical, legal, scientiﬁc and social issues related to research projects involving human beings.

Research Ethics Committee: Definition, Names Used, And Legal Foundations

Research ethics committee is one of the three types of ethics committees that can be found. A research ethics committee is an independent, multidisciplinary body that performs the review of the research protocol. Throughout its development it was called differently, and these differences still remain in different countries in the world. In the United States, research ethics committees are usually called institutional review boards or IRBs since from the beginning, they were placed at those institutions that were performing research. Since they were mainly dealing with the research on human subjects, they were also called human investigation committee by some institutions in the United States. Since they also dealt with the protection of human subjects, they were also called committees for the protection of human subjects. Today in all other parts of the world, the term research ethics committee is one most often used, and in Canada, they are called research ethics boards. Research ethics committees are, in majority of the cases, mandated by different national laws and bylaws, and their work and decisions have legal consequences (Levine 2004).

Types

In general we have three types of ethics committees worldwide. The ﬁrst one is research ethics committees which deal with review of the research protocols and which are thoroughly discussed in this contribution. Another type of ethics committee which emerged in the Unites States during the1970s is the healthcare ethics committee (HEC) or clinical ethics committee or hospital ethics committee. Healthcare ethics committees, unlike research ethics, are usually not required, but their development was rather a result of the democratic notion that a variety of individuals from different backgrounds with different professional perspectives and experiences can come together and openly discuss problematic issues involving conﬂicting values. The emphasis in the HEC development is on discussing and exchanging ideas with morally justiﬁed decision-making emerging from this process of deliberation. They have a multidisciplinary membership structure aimed at thorough discussion and debate among representatives of different perspectives. In general, healthcare ethics committees have three functions: education, case review, and recommendation or formation of policies and guidelines. Another type of ethics committee has also existed from the beginning – the national bioethics committee. Its predecessors in the 1970s were different presidential commissions in the United States focusing on regulatory frameworks and policies on the national level regarding, for example, research on human beings and brain death criteria. National bioethics committees are governmental bodies usually formed by the governments according to speciﬁc legal requirements. Their main function is to issue recommendations and opinions on speciﬁc ethical issues, to participate in the drafting of legal provisions, and to encourage and participate in public debate on current bioethical issues. Their recommendations are usually not binding, but rather of a consolatory nature. National bioethics committees are especially well developed in Europe, where the Standing Committee on Bioethics of the Council of Europe (CDBI) is constituted of the representatives of the national ethics committees from all member countries. The CDBI has been responsible for drafting a number of important documents, of which the European Convention on Human Rights and Biomedicine represents a legal cornerstone (Glasa 2000; ten Have 2005; Huriet 2009).

However, in reality all the combinations of ethics committees can be found. We have ethics committees that are both research ethics committees and healthcare ethics committees. We have also national bioethics committees who are also research ethics committees performing the review of the research project etc.

Duties

The purpose of the research ethics committee is to ensure that the research is designed in conformity to relevant ethical standards. They were primarily focused on safeguarding the rights and welfare of individual research subjects concentrating on the plans of the informed consent and the assessment of risks and anticipated beneﬁts. Later there was a debate whether research ethics committee should also concentrate on scientiﬁc design of the study because there is often a second committee who does scientiﬁc review of a research protocol. However, nowadays it is accepted that one cannot separate the two. One cannot determine if the risks to subjects are reasonable in relation to anticipated beneﬁts if one cannot prove that they are based on adequate scientiﬁc design. This can be well observed from the work of research ethics committees in different regulatory agencies that deal with clinical research all around the world. Usually those committees do both in their review. They evaluate at the same time scientiﬁc soundness and validity of the research and the ethical standards upheld in the research protocol.

At the beginning of their work, research ethics committees were exclusively oriented towards review of the research on humans. Nowadays they are also oriented on the protection of animals and animal welfare when it comes to research.

Some research ethics committees can be specialized only in animal research. Moreover, works of ethics committees were focused more on medical research especially the research done in clinical settings and clinical trials. Behavioral and social scientists did not feel that ethics review is needed for their research protocols. Nowadays the ethical review is done for all types of research including social research. It is clear that data protection and privacy issues and the research on vulnerable persons and marginal social groups deserve a special attention and concern of a research ethics committee (Bouëssau et al. 2009).

Structure

Research ethics committees have a multidisciplinary structure of their membership. The number of members may vary from 5 to 20. The membership should possess the competencies necessary to perform the review of the research protocol. The membership structure should include experts from many ﬁelds of research, lawyers, ethicists, lay people, and members of the clergy. This membership structure points out that the ethics committee unlike other types of ethics committees should have a high level of expertise when it comes to performing a review. They should perform interdisciplinary professional review. However, the presence of people who are not experts in the committee creates a dialog between the experts and the public making a committee also a place of exchange of different points of view. Their work can be done on voluntary basis or they can receive money for it since sometimes a certain fee is paid by the investigator for administrative costs (Glasa 2000; Borovecki et al. 2009).

Issues Addressed

Research ethics committee looks at several important issues when performing a review of research protocol. In reviewing a research protocol, an ethics committee should consider suitability of investigator, meaning his/her qualiﬁcations and ethical acceptability. Suitability of the protocol should be also considered including the ethical and scientiﬁc acceptability of research, its feasibility at the institution where it will take place, as well as all the necessary guarantees of the research completion (funding, manpower, material resources, etc.). The review should also address the adequacy and completeness of the information to be given to subjects or other as appropriate. It should look at the appropriateness of the means of the initial recruitment of subjects and how the full information will be provided to subjects as well as how the informed consent will be obtained. Moreover, it should also address the provision of compensation/treatment of subjects in the case of injury, insurance, and indemnity cover of the liability of the investigator and sponsor. Furthermore, it should take into account the extent to which investigators and subjects will be rewarded and compensated for the participation in research. Finally, it should address possible emerging conﬂicts of interest in research. For a research on vulnerable populations (e.g., people not able to consent, children, psychiatric patients), the committee should address whether special safeguard mechanisms are in place for their additional protection. Special attention should also be paid to data protection and privacy issues and transfer of data and biological samples between different institutions and countries involved in research. If research on animals is reviewed, special attention should be paid to 3 Rs: reﬁnement, reduction, and replacement.

Locale

Research ethics committees can be established in the institution where research will be conducted. Therefore, the review will be done locally. They are predominately organized in this way in the United States, hence their name institutional review committee or institutional review board (IRB).

This can be easier for investigators and the board since they know the person who is doing the research and one can know the quality of the facilities where the research will be performed. However, in such approach to research protocol review, it is often difﬁcult to avoid possible conﬂicts of interests. A better approach will be regional distribution of research ethics committees. For the smaller countries, one research ethics committee on national level can be a useful solution. Regional or highly centralized approach to review on national level is also proposed in the International Ethical Guidelines for Biomedical Research Involving Human Subjects by Council of International Organizations of medical Sciences (CIOMS) (Glasa 2000).

Today, especially in the United States, we ﬁnd noninstitutional review boards (NRBs). They emerged after1981 when FDA changed the regulation requiring research ethics review of all regulated research regardless where it was done, creating a problem for many physicians who were conducting investigations in private ofﬁces. The existences of such research ethics committees which are normally owned by private corporations are many (Levine 2004). One can ask oneself whether such committees which review are ﬁnancially remunerated and which ﬁnance themselves from these funds really have incentives to say no to any type of research? Can we have for proﬁt research ethics committees? Nowadays, such research committees are bought by speculative hedge funds who also own stocks in pharmaceutical companies. Can they then in such circumstances operate in a transparent way without conﬂict of interests?

Global Dimension

These days another issue is raised: that of research done in the developing countries by developed countries. Except for other issues, one which is often raised is whether a review of the proposed research should be done in a developing country which sometimes lacks capacities of a good research ethics committee. Nufﬁeld Council on Bioethics prepared in 2003 a report on research related to healthcare in developing countries. In this report the following is stated about research ethics committee review:

All developing countries should have a properly functioning system for the independent ethical review of research. If an independent national REC is the most appropriate way to review externally-sponsored research, we recommend that the Government should be responsible for establishing and funding the committee.

It is important that both the country in which the research is to be conducted and the sponsor providing funding should be satisﬁed about the ethical acceptability of research. We therefore recommend that externally-sponsored research projects should be reviewed both in the local country(ies) and in the sponsor’s country(ies).

There should be mechanisms in place to allow the committees to negotiate if there is disagreement between them.

Many RECs in developing countries have very limited ﬁnancial and administrative support. Some may receive funding from government, while others levy fees for reviewing protocols.

It is crucial that RECs are independent. There is a need for creative approaches for providing support for RECs, without compromising their independence. Sponsors should be responsible for meeting the costs of reviewing externally sponsored research in an appropriate manner.

From this document it is clear that there is a need for help to establish these local research ethics committees by international sponsors of research. However, their work should not be some sort of window dressing in order to satisfy requirements set by international research. The real emphasis should be placed on adequate membership selection and education and creation of truly independent, well staffed research ethics committees whose work will continue in the future and improve the countries’ capacities when it comes to research ethics issues.

Moreover, when doing international research, the opinions of local research ethics committees should especially be taken into account, and the requests, for example, for post-trial provision of healthcare or other issues raised should be addressed (Bouëssau et al. 2009).

Conclusion

Research ethics committees have come a long way since the beginning of their development. There are still many challenges ahead when it comes to their work. However, today one cannot imagine any research being done without thorough and proper review by an independent, multidisciplinary, well-staffed research ethics committee.

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