The database, called the Icelandic Health Sector Database (IHD), is intended to contain medical records, including genetic information, of the country’s entire population, living and deceased. Under the terms of the license, deCODE may also cross-reference the IHD with the company’s genotypic and genealogical data on Icelanders.

The legislation authorizing the IHD and the collection and use of human biological samples has drawn considerable attention outside Iceland and is controversial for a number of reasons.

At the heart of one facet of the controversy over ethics are two terms: “informed consent” and “assumed consent” (also called “presumed consent”).

“Informed Consent” and “Assumed Consent” — Definitions

The concept “informed consent” is addressed in detail by the World Medical Association Declaration of Helsinki of 1964. The core of the 2000 version of the Declaration with respect to informed consent is its Article 22:

“In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subject’s freely-given informed consent, preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed.”

Under “assumed consent,” consent is deemed to exist unless there is an explicit opt-out. The ethics of “assumed consent” are the subject of intense debate worldwide.

Health Sector Database Act and Regulations

The 1998 Health Sector Database Act (Lög um gagnagrunn á heilbrigðissviði), which authorized the creation of the IHD by a licensee, does not mention informed or assumed consent.

The word “consent” appears only once in the English-language translation of the Act (likewise, the Icelandic equivalent of the word “consent,” “samþykki,” appears only once in the original Act). That sole appearance is in Article 7, Access to Data from Health Records, which states: “With the consent of health institutions or self-employed health workers, the licensee may be provided with data derived from medical records for entry onto a health sector database.” (The English-language translation of this Article 7 and all other translations into English appearing below have been drawn from the Web site of the Icelandic Ministry of Health and Social Security.)

Thus, under the Health Sector Database Act, the IHD licensee — currently deCODE genetics — is permitted to collect and use sensitive data without informed consent. According to the Act’s sponsors, the IHD could not be created if informed consent were required. Consequently, the concept “assumed consent” has been introduced to explain the Act’s silence on informed consent. In fact, it has been claimed that one of the effects of the Act was to legalize assumed consent, even though the term was not used.

Indeed, opt-out, a common corollary of assumed consent, is allowed in the Health Sector Database Act and in the 2000 Health Sector Database Regulations (Reglugerð um gagnagrunn á heilbrigðissviði), although the term “opt-out” is not used in either document. Article 12, Patients’ Rights, in the Regulations states: “A patient may at any time request that information concerning him is not transferred to the Health Sector Database. A patient’s request may involve all information already available on the patient in medical records or which may be recorded, or further specified information. Such a request from a patient shall also be observed after his death.”

Biobank Act and Regulations

The terms “informed consent” and “assumed consent” appear in the 2000 Biobank Act (Lög um lífsýnasöfn). As repositories of “permanently preserved” human biological samples, biobanks are essential sources of data for the IHD.

Article 3, Definitions, provides:

“Free, informed consent (‘upplýst, óþvingað samþykki,’ in which ‘upplýst’ means ‘informed’ and ‘óþvingað’ is equivalent to ‘free’): Consent granted in writing of the person’s own free will, after the donor of a biological sample has been informed of the purpose of taking the biological sample, its usefulness, risks attendant upon the process, and that the biological sample will be permanently preserved in a biobank for use under the terms of art. 9.” [emphasis added]

“Assumed consent: Consent that consists of the donor of a biological sample not expressing any unwillingness for a biological sample taken from him/her for a clinical test to be permanently preserved in a biobank for use under the terms of art. 9, information in writing on this possibility having been available to him/her.” [emphasis added] (Assumed consent, ætlað samþykki, is a term previously not used in Iceland.)

Thus, the Biobank Act mandates informed consent, as defined in the Act, for samples collected as part of a scientific study and permits assumed consent for samples collected as part of healthcare treatment. However, in either case, the sample is permanently preserved in a biobank. The reference to Article 9 is significant because paragraph 4 of that Article allows a sample to be used for purposes other than those originally understood by a sample donor, independent of any further consent:

“The board of the biobank may, if approved by the Data Protection Authority and the National Bioethics Committee, authorize the use of biological samples for purposes other than those for which the samples were originally collected, provided that important interests are at stake, and that the potential benefit outweighs any potential inconvenience to the donor of a biological sample or other parties.”

As to withdrawal of consent, Article 7, Consent of Donor of a Biological Sample and Withdrawal of Consent, states:

“A donor of a biological sample can at any time withdraw his/her [informed] consent under the terms of para. 1, and the biological sample shall then be destroyed. Material that has been produced from a biological sample by performance of a study or the results of studies already carried out shall, however, not be destroyed.” [emphasis added]

“A donor of a biological sample may at any time withdraw his/her assumed consent for his/her biological sample to be stored in a biobank for use as provided in art. 9, in which case it shall thereafter only be used in the interests of the donor of a biological sample or by his/her specific permission, but see also para. 4, art. 9. The request of a donor of a biological sample may apply to all biological samples which have been taken or may be taken from him/her. Such a request must be complied with.” [emphasis added]

These two provisions contain loopholes regarding donor control: in the case of samples collected for scientific study, the material produced from a sample or the results of studies based on the sample are not destroyed after consent is withdrawn; in the case of samples collected for healthcare, the sample may be used in accordance with paragraph 4 of Article 9 — in spite of a donor’s withdrawal of assumed consent, also called “opt-out” (“úrsögn,” an existing word meaning “withdrawal” called into action to signify this new concept in Iceland).

The 2001 Regulations on the Keeping and Utilization of Biological Samples in Biobanks (Reglugerð um vörslu og nýtingu lífsýna í lífsýnasöfnum) add some detail to the provisions contained in the Biobank Act on informed and assumed consent:

As to destruction of samples after withdrawal of informed consent, Article 7 of the Regulations states that some results of studies (which, as specified in the Biobank Act, are not destroyed after withdrawal of consent), such as text, measurements, or molecules on glass slides, may not be used for further research. However, this restriction apparently does not apply to “the results of studies originating in biological samples, such as tissue cultures, gene sequences, isolated genes or isolated molecules, original or mutated. ...”

As to use of samples after withdrawal of assumed consent, Article 9 of the Regulations retains the possibility that samples may be used after withdrawal, but has narrowed the language regarding that possibility in relation to similar wording in the Biobank Act:

“A biobank board may, in exceptional circumstances, with the permission of the Data Protection Authority and the National Bioethics Committee, authorize use of biological samples for purposes other than that for which they were taken, provided that important interests are at stake and that the benefit outweighs possible inconvenience to the donor of a biological sample, or other parties.”

An added restriction appears in Article 11, Obligations of Biobank Board, which states: “Before access to a biobank is granted under the terms of art. 9 of the Biobank Act No. 110/2000, a research protocol shall exist... In the case of a genetic study, the informed consent of the person in question shall normally be sought if he/she is alive, and always if the data can be traced back to a certain individual, and this shall be subject to the judgment of the Bioethics Committee and the Data Protection Authority.”

Controversy

Supporters of the Health Sector Database and Biobank Acts argue: Leveraging the country’s rich genealogical records and relative isolation over centuries — two factors facilitating identification of the genetic causes of disease — Iceland has embarked on research significant to the healthcare of its population and, ultimately, of the world, without sacrificing ethical principles.

Opponents argue that those laws have compromised ethical principles, because, among other reasons:

• Informed consent is not mandated under the Health Sector Database Act;
• Informed consent, even when mandated, as in the Biobank Act, falls short of the standard set by the World Medical Association;
• Withdrawal of consent provisions fall short of the standard set by the World Medical Association.