Romania’s clinical trials ethics committee has new members: two of nine replaced

An order that replaces a list of names looks like the smallest category of legislative act there is, but here its function is not merely administrative. The National Bioethics Committee for Medicines and Medical Devices has no legal personality and no founding act of its own, so the only document from which the public learns who carries out the ethical assessment of a clinical trial is precisely this annex. Publication in the Official Gazette of Romania does not merely confirm that people have been appointed, it is the mechanism through which a sponsor, an investigator or a patient can know who assessed their file. On that count the act does its job: it keeps the structure of 9 members and 3 alternates and changes only two positions, so continuity of assessment does not suffer.

Judged by that same function, however, the annex says less than the one it replaces. It is a list of names with academic titles and nothing else: no specialty, no institution of origin, no mention of the capacity in which each person takes part. The 2023 version carried at least one note of that kind, „medic de familie”, family doctor, against one of the names. The consequence shows up at the most sensitive requirement in the rulebook that stays unchanged, that the committee include at least one member who is not a health professional and who represents patients. From the published list, compliance with it can only be inferred, by noticing that the ninth position, Costin Radu Gănescu, is the only one without a professional title. A statutory condition that can be checked only through the absence of an abbreviation is not really checkable at all. In the same vein, the sixth position carries the abbreviation „Q.P.”, which the act nowhere explains.

What is missing altogether is the dimension of time. The order does not say when this membership starts or how long it lasts, and the 2023 one stood for three and a half years, from 18 January 2023 until now, with no act in between. The practice appears to be until the next change, which means that a reader opening the annex in two years’ time has no way of knowing whether the list is still current without hunting for a possible later order. To that is added the silence about the reason: the two replacements are made with no mention of a resignation, an expiry of term or an incompatibility, although for a body that gives opinions on trials financed by the pharmaceutical industry the way people enter and leave the committee matters as much as the list itself.

What should be changed

• The capacity, entered next to every name. The annex ought to give the specialty, the institution and the capacity in which each member takes part, including the seat reserved for the patient representative. In practice, compliance with the structure the rules require would be visible from reading the annex, rather than inferred from the absence of an academic title.
• The starting date and the length of the term. The order ought to state from when the membership takes effect and for how long. In practice, anyone opening the annex a year from now would know whether it is still in force, without searching for later acts.
• The declarations of interests, published together with the membership. The Ministry of Health could publish on its website the declarations of the members and of the alternates, updated at every change. In practice, a sponsor and a patient could check a possible conflict of interests before the file is assessed, rather than after the opinion has been given.
• A rule for the files under assessment on the date of the change. The act ought to say whether the assessment carries on with the new member or starts again. In practice, sponsors would know whether the deadlines in the opinion procedure are affected by the replacements.
• Publication of the executive board. Once the chair, the deputy chair and the secretary general have been elected, the composition of the board ought to be made public on the ministry’s website. In practice, it would be known who runs the proceedings and who signs the opinions, information that today appears nowhere.