In 2010 the Executive Committee of CIOMS decided to revise the CIOMS Ethical Guidelines for Biomedical Research. The document was last revised in 2002 and since then, several developments have taken place, both in the field of biomedical research itself and in the field of research ethics. Among the latter developments is the recent revision of the Declaration of Helsinki in 2013.
In 2011, the CIOMS Executive Committee meeting decided to set up a Working Group to revise the CIOMS guidelines. The Working Group consists of 10 members, one chair (President of CIOMS), four advisers (from WHO, UNESCO, COHRED and WMA) and one professional secretary. The composition of the Working Group ensures that different cultural perspectives are present, members vary in age and expertise, and a gender balance is reached. A member representing the patient perspective is also present. The group aims to meet three times a year until 2015.
In September 2012 the Working Group met for the first time. During that meeting the Group considered which guidelines needed major and minor revisions. Guidelines that require major revision include the guideline on risks and benefits (Guideline 8), choice of control (Guideline 11) and women (Guideline 16). The Group also discussed which guidelines could be merged (for instance, Guidelines 4 and 6 which are both on informed consent). Furthermore, the Group decided to merge the Green Book (the CIOMS Guidelines for Biomedical Research) with the Blue Book (the CIOMS Guidelines for Epidemiological Research). In 2012 the Group also considered that the addition of glossaries and appendices with a list of obligations for specific stakeholders would be useful. At present, the Working Group has met four times. Most of the guidelines have been discussed in plenary within the Working Group, and proposals for revisions have been discussed internally. At the World Congress of the International Association of Bioethics in Mexico City in June 2014, the Working Group hopes to present first drafts of the revised guidelines.
The revised CIOMS guidelines will be published as a book and as a pdf document on the internet. As of 2012, it has been CIOMS policy to make ethical guidelines available free of charge on its website, as the guidelines will be mainly used in low- and middle- income countries. The content of the revised guidelines will be discussed in international journals interested in research ethics.
At the last CIOMS Executive Committee meeting on 20 November 2013, a resolution was adopted for the CIOMS Working Group on the Revision of the 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjectsto disclose the following information on the CIOMS website:
|1.||membership selection process and expertise of the members|
|3.||a brief biography of each member mentioning any potential conflicts of interest|
The following document describes the membership selection process and working procedures of this Working Group:
Revising the 2002 CIOMS ethical guidelines for biomedical research
JJM van Delden
During its annual meeting in 2009 the executive board of CIOMS considered the desirability of a revision of the CIOMS ethical guidelines for biomedical research. The last revision of that document dates from 2002 and since then several developments have taken place, both in the field of biomedical research itself and in the field of research ethics. Among the latter developments is the revision of the Declaration of Helsinki in 2008, which at the moment is revised as well. The executive board therefore decided to first explore the desirability of such a revision.
In its 2010 meeting the report on the desirability, drafted by Prof JJM van Delden, was discussed. The CIOMS guidelines for biomedical research are mostly viewed and presented as detailed rules of application of the principles listed in the various guidelines for research with humans, including the Declaration of Helsinki. As such the CIOMS guidelines are unique in offering a practical approach and working tool for all actors involved in biomedical research involving human subjects. Therefore most experts consulted found the CIOMS guidelines had an additional value. All experts consulted, for various reasons, were of the opinion that a revision of the 2002 CIOMS guidelines for biomedical research was indeed desirable. The board therefore decided to start preparations for the revision process.
In one of the preparatory meetings with WHO, the relation between CIOMS and WHO with respect to this guideline was discussed. The 2002 version of the guideline, on the second page, states that the guideline has been developed “in collaboration” with WHO. At that time no specific regulations applied that governed the possibility for including such a statement. At the present time however, WHO has clear guidelines that shape the process of drafting a guideline. Any document that contains the phrase that it was written ‘’in collaboration with WHO” needs the upfront approval of the Guidelines Review Committee. One of their conditions is a description of the process of drafting the guideline. The present document will therefore describe the process that is envisaged or the revision of the 2002 CIOMS ethical guidelines for biomedical research.
The working group will start its work by identifying the guidelines that should be revised. If one member of the WG has reason to believe a particular guideline should be revised, the WG shall discuss that proposal. The WG shall decide in favour of revision if at least half of the members present during the meeting so desire.
All decisions by the working group will be reasoned decisions. This means that positions will need to be based on reasons. Where possible, these should be evidence-based. For this, literature searches will be performed for all major topics. Evidence can concern different types of data (see below).
The WG shall discuss all proposals for revision of particular text during its meetings. Members of the WG will deliberate until they have reached a well-argued position. If no such position can be reached, the old text of the 2002 version of the guidelines will remain in place.
After reaching reasoned positions on the revised guidelines, the draft document will be sent out for review. There will be several sources of feedback:
- From the member organizations of CIOMS
- From users through the Regional Offices of WHO, from the WHO network of Collaborating Centres for Bioethics and from a workshop with ERCs at WHO
- From stakeholders during an international invitational meeting, to be held in conjunction with the 12th World Congress of Bioethics in June 2014 in Mexico City. Co-organizing with members of NECs participating in the Global Summit of NECs will be considered. This group will function as an external review group.
This external review group is composed of people with an interest in the subject of the
guidelines. Members can be asked to review in different stages of the development
process. They will also be asked to review the guidelines document when recommendations have been finalized. This group will be geographically and gender-balanced and include stakeholders and content experts.
The WG will study all suggestions for revision of the draft and will decide on changes.
The final authorisation of the revised guidelines is undertaken by the Executive Committee of CIOMS. It will also be responsible for the publication of the guidelines.
Composition of the Working Group involved in the revision
The CIOMS Executive Committee in its 2011 meeting decided to set up a Working Group to revise the International Ethical Guidelines for Biomedical Research involving Human Subjects. This Working Group is to seek the advice of a relatively large advisory group, in which the most relevant perspectives will be present.
The Working Group consists of 10 members, one chair (President of CIOMS), four advisers (from WHO, UNESCO, COHRED and WMA) and one professional secretary, who will be the writer. The members have one (or more) of the following backgrounds:
- clinical researcher
- medical ethicist
- expert in international health law
- young scientist or physician
The composition of the WG is such that different cultural perspectives are present and a gender balance is reached. A person taking the patient perspective is also present. In particular, adding a WMA advisor will ensure close collaboration between CIOMS and WMA. Currently, the WMA is revising its Declaration of Helsinki. The close collaboration should prevent inconsistencies between the two documents.
Managing conflicts of interests
In order to manage and report conflicts of interest, declarations are collected and reviewed before appointments are made and any changes need to be reported to the secretariat. This is standard CIOMS policy. At the meeting, each participant should verbally report potential conflicts of interests. Any changes to a member’s declaration of interests should be recorded in the minutes of the meeting.
Evidence retrieval and synthesis
It is nowadays common to require that evidence underlies the positions taken in guidelines. We speak of evidence-based medicine, evidence-based education, and evidence-based guidelines. It is considered to be a requirement of good guideline-making practice to use the available evidence. There is no reason to think that this does not pertain to ethics. In order to do ethics, you also have to know the facts. Many claims in ethics are of an empirical nature. Consider this line of argument: if we do X then Y will be the result and since Y is desirable, we should do X. Whether Y will indeed be the result is a matter for empirical examination, irrespective of the nature of Y. A relevant example concerns informed consent for research. It is claimed that detailed information to the participant will result in an improved understanding (which is desirable). Whether this is actually the case is a matter for empirical investigation.
However, at least some of the facts relevant in ethics differ in nature from the facts of bioscience. Here is a list of some of the data relevant for research ethics, which is the special domain we are dealing with while revising the guidelines:
- data about effects and side effects of drugs
- data about the number of people with a certain disease
- data about the difficulties encountered in real life with the evaluation of research protocols
- data about opinions of stakeholders
- reasoned positions in the academic literature
During the revision process, all of these data will be used. The results of systematic literature studies will be used when data from categories 1 and 2 are required. These studies will be referenced. The evidence that has been retrieved and synthesized in a systematic review will be assessed for quality. Quality of evidence is defined as the “extent to which one can be confident that an estimate is correct". Where relevant, the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach will be used to assess the quality.
We will set up an evaluation study to collect data about the difficulties encountered in real life with the evaluation of research protocols (category 3). Since the CIOMS guidelines are especially directed at Low and Middle Income Countries (LMICs), we will collect information through the WHO Regional Offices. We will try to publish that study, although response rates are difficult to predict (and to ascertain) and, therefore, so are publication chances.
In ethics numbers do not count in the same way as in democracy. The justifiability of a certain action is not determined by the number of proponents or opponents. Therefore there is no need to be aware of the exact numbers of proponents or opponents. This does not mean that data about the opinions of stakeholders (category 4) is irrelevant. A moral discussion is enriched when all perspectives are taken on board. For the revision process there are two mechanisms to reach this goal. One is to have actual input from many angles. This is effectuated by all the mechanisms described under deliberation process. The other is to take the perspective of all stakeholders while reasoning. This is part of what ethicists are used to do. Authoritative declarations such as the WMA Declaration of Helsinki will have a prominent role in these discussions.
Finally, for each ethical issue addressed, a literature review will be performed in order to describe the relevant positions in the academic literature (category 5). If possible, these reviews will be published separately in the academic literature. By doing so, they will undergo academic peer review. These reviews will be referenced in the guidelines as well.
The revised CIOMS guidelines will be published as a book and as a pdf document on the internet. As of 2012, it is CIOMS policy to make ethical guidelines available for free through the website, as the guidelines will be mainly used in LMICs. The content of the revised guidelines will be discussed in international journals interested in research ethics.
Below is a list of the members of the Working Group, together with their respective photo, short biography, CIOMS Code of Conduct form, and Declaration of Interests form:
CIOMS Working Group on Revision of 2002 International Guidelines for Biomedical Research Involving Human Subjects
|Hans van Delden, President of CIOMS||click here for details|
|Rieke van der Graaf||click here for details|
Abha Saxena, WHO
Dafna Feinholz, UNESCO
Urban Wiesing, WMA
Hans-Joerg Ehni (Alternate), WMA
Carel IJsselmuiden, COHRED