How Many Lay Members Can You Have in Your IRB?: An Overview of the Danish System

How Many Lay Members Can You Have in Your IRB?: An Overview of the Danish SystemAuthor(s): Søren HolmSource: IRB: Ethics and Human Research, Vol. 14, No. 6 (Nov. - Dec., 1992), pp. 8-9+11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3563854 .

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IRB may provide a better forum for dis- cussion during the recruitment session. Interviewers usually focus on the major points before presenting the entire consent form. The graphic version supports and reinforces the recruiter's presentation rather than competing with it.

The comments received from our nine scorers were generally very favorable and several scorers had additional suggestions as to how to improve readability and comprehension. For example, one suggested putting the name of the physician conducting the study, to whom questions could be addressed, in bold type. This could improve the likelihood that the subject would remember this important information. Various other helpful comments show that given the opportunity to be creative, almost anyone can make improvements in the consent form. These improvements most likely would not be re- vealed by a computer-based readability analysis.

In summary, we believe that informed consent documents can be

greatly improved by employing methods that are neither suggested nor detected by computer-based readability scores. The computer programs can be helpful for im- proving sentence structure. However, the easiest and greatest improve- ment in readability and comprehension may come from the use of graphics and the use of simple dec- larative summary statements as headings for each paragraph. Inves- tigators writing informed consent documents could follow this format if they were given an example and were encouraged to be creative. Digesting a complex informed consent document into several simple statements of the main ideas may require some extra thought on the part of the investigators. However, we believe the benefits to the subjects and to clinical research as a whole more than justiy the effort.

References

1. Levine, RJ: Xhics and Regulation of Clinical Resecuh, 2d ed. Baltimore: Urban and Schwarzenberg, 1986, p. 98.

2. Gibbs, RD, Gibbs, PH, and Henrich, J: Patient understanding of commonly used medical vocabulary. Journal ofFamily Practice. 1987; 25: 176-78.

3. Loverde, ME, Prochazka, AV, and Byyny, RL: Research consent forms: Continued unreadability and increasing length. Jour- nalofGeneillntemalM Medicine. 1989; 4: 410-12.

4. Davis, TC, et al.: The gap between patient reading comprehension and the readability of patient education materials. Jounal ofFanmily Prdctice. 1990; 31: 533-38.

5. Davis et al., Patient reading comprehension.

6. Meade, CD, and Wittbrot, R: Computerized readability analysis of written materials. Cornputeis in Nursing 1988; 6: 30-36.

7. Loverde, Prochazka, and Byyny, Research consent forms; Davis et al., Patient reading comprehension; and Meade and Witt- brot, Computerized readability analysis.

8. Gibbs, Gibbs, and Aenrich, Patient understanding; Loverde, Prochazka, and Byyny, Research consent forms; Davis et al., Patient reading comprehension; and Meade and Wittbrot, Computerized readability analysis.

9. Taub, HA, Baker, MT, Kline, GE, and Sturr, JF: Comprehension of informed consent information by young-old through old-old volunteers. E eimentl Aging Reseamwz 1987; 4:173-78.

How Many Lay Members Can You Have in Your IRB?-An Overview of the Danish System by Soren Holm

On the last day of the 1991-92 session the Danish parliament passed a bill finally giving explicit legal status to Danish IRBs, or as they are called in Denmark, Re- search Ethical Committees (RECs).

The first RECs were established in Denmark in the Copenhagen area in the late 1970s and by 1982 all parts of Denmark were covered. The establishment of RECs was based on an agreement between the Danish Medi- cal Association, the Danish counties (who own and operate most hospitals), and the Danish Medical Re- search Council. Right from the start this.agreement imposed a strong degree of similarity on the RECs, and Denmark therefore has not been plagued by the great diversity in scope, size, and composition of these bodies that has been endemic elsewhere.2

Professor Povl Riis, one of the co- drafters of the 1975 Revision of the Declaration of Helsinki (Helsinki II),

has been the main driving force be- hind the system. He has chaired the Central Research Ethical Committee (CREC) since its inception in 1978 and has had a major influence on the development of Danish research ethics and medical ethics in general. He has also played an important role in the formulation of the new legal basis for the system.

The Shape of the Danish System

Three main features set the Danish system of RECs apart from its Amer- ican and British counterparts:

1. Their independence of specific institutions. 2. Their small size and large proportion of lay members. 3. The establishment of a central national committee. The area of responsibility of a

Danish REC is not one specific institution (e.g. a hospital or a university). Rather, RECs are regional and eval- uate all projects carried out in health care institutions within a specific geographical area. Denmark is ad-

ministratively divided into 14 counties, and each REC covers one or more of these counties. The numbers of protocols evaluated by the individual committees in 1990 range from 135 to 711, with the largest workload falling in the university cities.3

Each committee has between 6 and 10 members and exactly half (50%) of these are lay members. The term of office is 4 years (renewable once) and the "professional" members are appointed by the Danish Medical Research Council, whereas the lay members are appointed by the politically elected county coun- cils. The lay members are not usually moral or legal experts (e.g. lawyers, clergy, or philosophers), but really lay people in the full sense of the word.

Decisions in the committees are always by consensus and any irre- concilable disagreements must be referred to the Central Research Ethical Committee (CREC). A researcher can also appeal to the CREC if his project has been turned down at the regional level. The CREC is composed of two members from each of the regional committees, one

Soren Holm is research fellow in the Division for the Philosophy ofMedicine and Clinical Theory, University of Copenhagen, Denmark.

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November-December 1992

professional and one lay, and a chairman and vice-chairman appointed by the Medical Research Council.

Apart from its function as a second level appeal body the CREC also is- sues more general recommendations and interpretations of the Helsinki II declaration. This declaration was the moral basis of the system until the present legislative action. Over the years, the CREC has issued 16 recommendations ranging from one on the responsibilities of Danish researchers conducting research in Third World countries to recommendations about the language to be used in research protocols.

The existence of a central coordi- nating body has ensured a great degree of uniformity in the decisions made by different RECs, and the system leaves no room for a researcher to search for the "committee of least resistance."

This uniformity has made it possible to simplify the procedure for multi-center trials. Such trials are handled by the regional committee covering the originating center. This committee takes care of the evaluation and any negotiations with the researchers. After this process is concluded and the project approved, the committee corresponds with all other committees having partici- pating centers in their area. In this way the time from the receipt of a multi-center protocol to the final national approval can be kept at ap- proximately 6 weeks if the protocol contains no major ethical problems. If a new center is added in an area not covered by the initial approval, no new approval is necessary, but only formal notification to the REC covering the new center.

Since their status has been only semi-legal, the committees have not had any formal means to enforce their decisions. Malpractice litigation is very rare in Denmark, so the only incentives to comply with the committee decisions have been the problems in publishing a study not approved by an REC, the difficulties in getting funding for such a study, and the possibility of public exposure as an "unethical researcher." The com- bined effect of these three incentives has been sufficient to keep the number of studies pursued without approval very low.

The New Developments

changes. It was prepared by a work- ing party commissioned by the Danish Ministry of Health and only very few changes were made during the following political process.4

At present all committees have parity between professional and lay members, but the new rule is parity plus one-there will always be one lay member more than the number of professional members. It is further stipulated in the official commentar- ies to the law that an equal gender distribution must be maintained.

Another change is that the members of the committees, who are pre- sently unpaid, will be able to claim the same per diem and expense pay- ments as members of other official bodies. At the same time, the secretariat of the committees will re- ceive a substantial increase in funding, enabling each committee to em- ploy at least one academic and a secretary. These increases in funding are intended to facilitate the evaluation process and to enable the committees to extend their role in moni- toring ongoing research projects. This important part of the committee work has been relatively neglected, mainly because of resource con- straint, and only obviously problem- atic projects have been monitored regularly.

The committees' new, full legal status means that their decisions can now be enforced through the legal system. Failure to comply with committee decisions can be punished by fines or, in severe cases, by up to 60 days' imprisonment.

Finally, the law establishes a new moral basis for the work of the RECs. The section in the law which explains the principles that must be used in the evaluation of protocols is, however, an almost exact translation of the principles in the Helsinki II declaration, so the actual policy should not change.

Strengths and Weaknesses

1. The lack of technical exper- tise in the committees. 2. The system is only feasible in a fairly homogeneous society where the ethos of specific hospitals and other institutions are not too different from the ethos of society in general.

The new legislation will not change these strengths and weaknesses in any significant way.

Although most Danish bioethicists believe that the Danish system has many good features, it is important to realize that the second weakness outlined above severely restricts the range of countries to which the system can be exported with success. The Danish system only works because there are no "aberrant" institutions demanding special consideration for their moral beliefs. In a situation where such institutions are prevalent, the organization of RECs by a regional model cannot work, and an institutional model must be used instead. But even in a model pri- marily based on institutional RECs there is a need for a central coordi- nating body laying down the minimal requirements to ensure that researchers are not tempted to look for the "committee of least resistance." If such a central body is to have any real influence on decisionmaking it cannot content itself only with laying down basic rules. It is well known that even the best rules can be inter- preted in many strange ways. The central body must therefore also act as a forum for interpretation of the rules and it must be able to monitor and criticize the performance of regional or institutional committees.

The regional structure of the Danish system makes the committees independent of institutional interests. The professional members are not representing their institution, nor lay members their county coun- cils. They cannot in any way be con- strued as protecting the interests of one specific institution, neither by allowing prestigious but ethically questionable projects, nor by prohib- iting projects thought to raise awkward questions.

Another important feature of the Danish system which is probably also exportable-if someone just had the courage to try-is the large lay representation. The Danish committees have worked without major problems for more than 10 years, and this cannot be attributed to some special Danish psychological trait

Continued on page 11

The Danish system has five main strengths:

1. It ensures a great degree of uniformity in the decisions. 2. It simplifies the approval procedure for multi-center trials. 3. It has a large lay representation. 4. It reduces the influence of the medical profession. 5. It incorporates a straight- forward appeals procedure.

Its main weaknesses are:

The new Danish law that comes into force on 1 October 1992 pre- serves most parts of the present system, but there are some important

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November-December 1992

Continued from page 9

making Danish lay people more knowledgeable and peaceful than lay people elsewhere. Outside observers at committee meetings have found that the most valuable contributions are often made by lay members, who seem better able to spot the equivoca- tions in a consent from or an inap- propriate trade-off between risks and benefits. There are as yet no studies published on this subject, so it is impossible to say whether this impression will withstand more detailed investigation. The impression is, however, reinforced by the observa- tion that the provisions in the new law mandating a majority of lay members has not been the target of any protests from the medical profession.

The relatively small size of the individual committees gives rise to one of the largest problems, i.e., the lack of a sufficient range of medical exper- tise on the committee. This is partly remedied by ad hoc consultations with experts, and partly, as far as nursing research is concerned, by the permanent attachment of a special advisor in this field who par- ticipates in all evaluations of nursing research. There is an obvious trade- off between large committees with a broad coverage of the entire field of medicine and thereby the ability to spot details in the research design, and small committees that overlook such details but are instead more efficient and able to process the ap- plications faster. There is probably not one specific, optimal trade-off, but it is clear that the Danish system is leaning toward efficiency as the important consideration.

References

1. L59 Lov om et videnskabsetisk komit6sy- stem og behandling af biomedicinske fors- kningsprojekter (19/6-1992). (Law on a scientific-ethical committee system and on the management of biomedical research projects.)

2. Neuberger, J: Ethics and Health Care: The Rde of ResearchEthics Committees in the United Kingdom. London: King's Fund In- stitute, 1992; McNeil, PM: Research ethics review in Australia, Europe, and North America. JRB 1989; 11(3): 4-7.

3. Central Scientific-Ethical Committee of Denmark: Report for 1990 (With an Eng- lish Summary). Copenhagen: Undervisn- ing-og Forsknnming isteriet, 1991.

4. Research Involving Human Subjects. Co- penhagen: Ministry of Health, 1989.

ANNOTATIONS

British Paediatric Association's Ethics Advisory Committee. "Guidelines for the Ethical Con- duct of Medical Research Involv- ing Children." Bulletin of Medical Ethics no. 80 (July/August 1992): 13-20.

The committee's original 1980 guidelines have been revised to in- clude recent developments in the regulation of research, the understanding of children's interests, and legal requirements. The guidelines address six concerns: 1) the value of ethical research with children; 2) children's unique interests; 3) in- junctions to use children in research only when adults cannot be subjects; 4) requirements that research directly benefit children; 5) the man- date that all proposals be reviewed by a local research ethics committee; and 6) the need to obtain consent-- from the child, parent, or guardian as appropriate.

Committee on Science, En- gineering, and Public Policy, Panel on Scientific Responsibility and the Conduct of Research. Re- sponsible Science: Ensuring the Integ- rity of the Research Process. Vol. 1.

Washington, DC: National Aca- demy Press, 1992.

This book is the result of a two-year study conducted by a panel of experts convened by the National Academy of Sciences to examine misconduct in science and review institutional and governmental efforts to address problems of misconduct. The committee discusses the present research environment and explains how institutions can encourage re- sponsible and ethical research prac- tices.

Markman, Maurie. "Ethical Diffi- culties with Randomized Clinical Trials Involving Cancer Patients: Examples from the Field of Gyne- cologic Oncology." Journal of Clinical Ethics 3, no.3 (Fall, 1992): 193-234. [M. Markman, MD, Direc- tor , Cleveland Clinic Cancer Cen- ter, Chairman, Dept of Hematol- ogy/Oncology, Cleveland Clinic Foundation, Cleveland, OH]

Markman presents the debate on the ethics of and the need for randomized clinical trials. He argues that the physician's responsibility to protect the best interests of the individual patient must supercede the

Continued on page 12

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How Many Lay Members Can You Have in Your IRB?: An Overview of the Danish System