Ethical review processes

Although IRB members can and should come from a variety of backgrounds, all board members should know the basic elements of clinical research and should stay focused on their role in the ethical review process. Any board member who does not have a research background should take the time to learn the basics of the industry. Books, such as this one, can introduce the language, regulations, and ethical issues in the conduct of research with humans. 

The Policy attempts to address the responsibilities of researchers, institutions, and Research Ethics Boards (REBs) to their subjects. Ethical principles are shared across disciplines such that subjects should expect equal rights as well as benefits and risks across all fields. The Policy provides a framework of common procedures by which the ethics review process may be standardized. The Policy continues to recognize the diversity of various fields, but promotes the sharing of general ethical principles. Thus, this document can lend itself to many areas. The Policy is not intended to address specific ethical dilemmas but to provide guiding principles and standards as well as promote thought regarding areas of controversy. 

Figure 3. Ethical review process of human experiments at Port on Down, c. 1965...

Today, an ethical review is an essential part of the biomedical research process. lECs provide ethical guidance on research protocols and ensure the protection of research participants. In the United States, similar bodies called institutional review boards (IRBs) have a similar role to that undertaken by lECs in the rest of the world. 

Scientific discourse depends on critical review of manuscripts before publication. (Peer review—including ethical considerations—is discussed in greater detail in Chapter 6 of this volume.) The primary obligation of reviewers is to provide a rational, objective review of the science. This requires a careful reading of the manuscript and a careful preparation of the review. The review process is anonymous for most journals, but this does not mean that the reviewer has free rein to criticize. Any criticism must be logically and objectively delineated, and it should never be directed at the authors personally. Reviewers also should place the work within the context of the field is it a major contribution, minor contri-... 

Finally, the results in a manuscript under review cannot be quoted or incorporated into a reviewer s own research program. After the work is published, a reviewer may use the ideas and data presented (with proper attribution), but the reviewer should not do so based on the review process. Such behavior is akin to insider trading in the purchase of stocks. Although a prison term is unlikely for this breach of conduct, the ethical principle is quite clear. 

When a member of the REB has a personal interest in the project he or she cannot be present during the decision-making process, although disclosure of conflict and opportunity to rebut are allowed. All ongoing research must have a follow-up review proportionate to the level of risk. Such review often consists of evaluating the submission at an annual update. Ethics review must be performed by the appropriate REB of all involved institutions or jurisdictions. Ethics review must be per-... 

In practice, the scientific process is not quite so linear. Many related experiments may also be explored to test the hypothesis. Once a body of scientific evidence has been collected and checked, the scientist submits a paper reporting the new work to a peer-reviewed journal. An impartial editor will send the work to at least two reviewers ( referees ) who are experts in that particular field, and they will recommend to the editor whether the paper should be accepted, modified, or rejected. Since expert reviewers are sometimes the author s competitors, high ethical standards and confidentiality must be the rule during the review process. 

Some of the best work to date on the nature and ethics of authorship has been done by the International Committee of Medical Journal Editors (ICMJE). The most current version of its work is contained in a 2013 document Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Joimials. Recommendations are made on five authorship-related topics the nature of authorship, responsibilities of authors (including matters related to conflicts of interest), responsibilities of authors and referees in the submission and peer-review processes, responsibilities of journal owners, and the protection of research participants. ... 

In a sense, the direct mail product described under the facts is not unlike mail order certifications offered by so-called diploma mills whereby individuals self-certify their competency based upon a perfunctory review process that rarely involves comprehensive study, examination, or practice. By ordering and using the CD-ROM, Engineer A in a sense was self-certifying his competency to perform facilities design and construction services without obtaining the substantive education, experience, and qualifications to perform those services in a competent and professional manner. The Board considers such activities completely contrary to the basic ethical principles established in the Code of Ethics. 

The conduct of clinical trials is regulated in all the countries, except Cypms. In Cypms, the policy of the Ministry of Health is not to permit clinical trials for experimental medical products. Multicountry clinical trials for products licensed in developed countries are undertaken in some institutions and regulated by ethics committees (Table 8.5). In these countries, approval of clinical trials is carried out either by the DRA, as in Estonia, Malaysia, Tunisia, Venezuela and Zimbabwe, or by ethics committees. When the DRA itself is responsible for control, information about the trials is processed centrally. In Tunisia, clinical trials form part of the registration process. Trials are requested, when deemed necessary, by the specialized committee charged with reviewing the new dmg. The trial proposal is then evaluated by the technical committee, and forwarded to the Health Minister for final approval. Cuba has a National Centre for the Coordination of... 

Perhaps this is the way it should be - in essence, a zero defect policy for all research proposals. On the other hand, perhaps the process has become so laborious and frustrating that researchers postpone or abandon useful experiments. Ethics is not a simple subject. Today it is a new profession. Practitioners, called ethicists , have increasing power to judge whether certain kinds of experiments are permissible. Their opinions, although not always binding, strongly influence both investigators and review committees. 

The basic ethical questions raised by clinical research should never be underestimated. The pharmaceutical physician will need to be aware that failure, intentionally or because of misguided enthusiasm, to protect the health and well-being of each study subject can have very serious consequences. In an age where the medical profession is constantly under scrutiny, the drug industry is heavily criticised and the communication industry extremely active, mistakes in clinical trials are pimished. Therefore, before a study is commenced, a review should be made that the scientific approach is current, the motivation is clear, the processes are imambiguous, and there should be sufficient data to judge the safety and effectiveness of the interventions proposed. 

Institutional Review Board/ Independent Ethics Committee and Informed Consent Protecting Subjects Throughout the Clinical Research Process... 

Guarino, R.A. Institutional review board/independent ethics committee and informed consent. Protecting subjects throughout the clinical research process. In New Drug Approval Process, 3rd Ed. Marcel Dekker, Inc. New York, 2000 100, 271. 

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