Guidelines for Research on Deceased Persons

Health science research on deceased individuals is governed by the Committee Act § 8. This guidance aims to provide clarity on the current rules and practices for notifying and securing approval for research involving biological material taken from deceased individuals. The guidance is designed for both researchers and regional scientific ethics committees. For specific protocol design requirements concerning research on the deceased, refer to the  Guidelines for Research on Deceased Persons.

The Committee Act § 8 is viewed as comprehensively regulating research on tissue or other biological material sourced from the deceased. For tissue sourced from living test subjects and patients, reference is made to the Guidance on the Use of Biological Material in Health Science Research Projects.

Research on the deceased must be reported to a scientific ethics committee, unless it pertains to entirely anonymized material (§ 14, para. 3).

2.1 Medical Autopsies

Health science research projects can be conducted with tissue and other biological material from deceased individuals taken during an autopsy as per the Health Act chapter 56 (Committee Act § 8, para. 1).

The material in question must be taken during a medical autopsy in accordance with the rules of the Health Act § 187. It is the consent rules of the Health Act for autopsies that dictate when tissue and other biological material can be extracted (and researched) in connection with medical autopsies (Health Act § 187). See the Danish Ministry of Health's  Guidance on Consent to Medical Autopsies etc. (hospital autopsies). The baseline is that autopsies must not be conducted against the wishes of the deceased or their relatives.

If the research is conducted in conjunction with a medical autopsy, the Health Act's rules for consent and the procedure for obtaining consent from the relatives for the autopsy itself must be followed. The scientific ethics committee must then solely address the research project itself (scientific standards, etc., per Committee Act § 18, see section 2.5.1 below). In these cases, the committees should not receive any consent declarations or participant information.

If the autopsies are conducted under earlier legislations (Act no. 246 of June 9, 1967 on the extraction of human tissue etc. and Act no. 402 of June 13, 1990 on post-mortem examinations, autopsies, and transplantation etc.), emphasis is placed on whether the extraction of the material during the medical autopsies was conducted in line with the rules for such at the time of the autopsy.

2.2 Forensic Autopsies

Health science research projects can be conducted with tissue and other biological material taken during forensic autopsies, as stipulated in the Health Act § 184 (Committee Act § 8, para. 1).

For material extracted after January 1, 2012, to conduct health science research on material taken during forensic autopsies, there is a requirement to follow similar procedures for information dissemination and consent collection as those set out in the Health Act § 187 concerning medical autopsies. Refer to the Guidance no. 9267 of June 13, 2013 (for the country's forensic medical institutes) on consent for research in tissue and other biological material taken during forensic autopsy.

The Health Act's rules for consent and the procedure for obtaining consent for research use from the relatives, etc., must be followed, and the scientific ethics committee should solely address the research project itself (scientific standards, etc., as per Committee Act § 18, see section 2.5.1). In these cases, the committees should not receive any consent declarations or participant information.

For material extracted during forensic autopsies before January 1, 2012, there is no requirement for consent (neither under the Health Act nor the Committee Act, cf. Committee Act § 8, para. 1, 2nd sentence). This is a very special exception from the main rule of consent according to the Health Act or the Committee Act.

In these cases, committees should only consider the research project itself (scientific standards, etc., as per Committee Act § 18, see section 2.5.1), and they should not receive any consent declarations or participant information.

2.3 Body Donation to Science

Health science research can be conducted using tissue and biological material obtained from deceased individuals who have donated their bodies to science under Section 188 of the Danish Health Act (Committee Act Section 8, Subsection 1). This is in accordance with a letter from the Ministry of Health and Elderly Affairs dated December 21, 2016, stating that Section 8, Subsection 1 is a continuation of the legal situation in the previous Committee Act Section 18, Subsection 1. This continuation allows research in connection with transplantation (Chapter 12 of the Health Act, cf. Section 55) and other interventions in connection with autopsies beyond those mentioned in Chapter 56, cf. Section 188. Further details are provided in Annex I.
 
It is assumed that the deceased, after reaching the age of 18, has made written provisions for this, and the other requirements of Section 188 of the Health Act are met.
 
Thus, it is Section 188 of the Health Act that regulates the consent requirement, and the ethical committee only needs to address the project itself (scientific standards, etc., according to Committee Act Section 18). In this case, the committees do not need to receive a consent declaration or participant information. See Section 2.5.1.

2.4 Access to Autopsy Reports and Police Reports

An autopsy report is not considered part of a patient's medical record, as it doesn't pertain to the patient's treatment records. The same applies to police reports.

Regarding the use of autopsy reports and potentially police reports for research purposes, it is up to the researcher to clarify this with the holder of the report, as this is a matter outside the committee system. The committee system only has the authority to address the use of information from the patient's medical record in connection with the approval of the health science research project (§ 46, para. 1 of the Health Act).

2.5 Ethical Considerations in Research Related to Autopsies

2.5.1 About the Committee's General Assessment

Unlike research on living humans, where there may be a physical intervention, the committee, when researching the deceased, does not need to assess specific risks associated with conducting the project.

Instead, the committee will focus on whether:

there is a potential benefit to public health or the healthcare system,
the scientific standard is sufficiently high, and new knowledge is expected,
there is a reason to conduct the project, and the hypothesis is justified.

2.5.2 On Genetic Investigations

When conducting genetic testing on the deceased, it should be considered whether this might result in health-related findings. Based on considerations of ethical dilemmas and emergency considerations, it might be necessary for researchers, who are also authorized healthcare professionals, to inform relatives. This is especially relevant when extensive mapping of the deceased's genetic makeup is performed.

Decisions regarding feedback to potential relatives in cases where the test subject does not wish to receive information about their health status or is deceased must be determined based on a medical judgment. This judgment is grounded in several criteria regarding the severity of diseases, the certainty of the findings, and the possibilities for prevention or treatment.

Since the biological material is not taken from patients for a traditional biobank, the rules in the tissue use registry probably do not apply. This means there is no option for individuals to "opt out" of research in the same manner as if the material was taken during treatment.

Furthermore, it should be noted that in the field of autopsies, and especially in forensic medicine, the biological material is extracted following the specific rules of the Health Act's Chapter 56 (in some cases, unexplained causes of early death). Thus, it might be distressing for relatives to be contacted many years after the death.

Health science research can be conducted using tissue and biological material extracted in association with transplantation, as per Chapter 12 of the Health Act, see Health Act § 55 (Committee Act § 8, subsection 1)3.

A prerequisite is that the deceased, after reaching the age of 18, has made a written decision regarding this, as per Health Act § 55, and all other requirements in § 55 are met.

Thus, it is the Health Act's § 55 that regulates the requirement for consent, and the scientific ethics committee only has to address the actual project (scientific standards, etc., following Committee Act § 18). In this case, the committees do not need to submit a consent form or participant information.

4.1 General Requirements

As stipulated by the Health Act § 55, subsection 2, research may only be conducted on the deceased once irreversible cessation of breathing and heart function has occurred. This means that research on brain-dead individuals and their organs is generally not permitted.

However, if the research pertains to a scientific health research project conducted on a brain-dead individual in relation to the transplantation of their organs, the Health Act § 54a provides a possibility under certain conditions:

• The research project should aim to improve transplantation outcomes (§ 54a, subsection 1). This means that the research project is expected to either enhance the specific organ recipient's health or generally improve transplantation outcomes for future transplantation patients.
• The brain-dead individual should not be subjected to extensive interventions that wouldn't typically occur as part of a transplantation, including its preparation. This implies that only research processes that a brain-dead individual would ordinarily undergo as part of a transplantation will be permitted.
• The research project should not be expected to impede the recipient's ability to optimally utilize the donated organ.

4.2. Consent for Research on Brain-Dead Individuals

4.2.1. Consent from the Deceased

The basic principle is that the deceased individual should have given consent (§ 54a, subsection 2). After reaching the age of 15, the deceased should have indicated, either in writing (e.g., in the Donor Register) or verbally, their wish to participate in transplantation-related research in the event of a transplantation.

The deceased can choose to make the permission conditional upon the acceptance of their closest relatives. If the deceased has indicated full permission for transplantation-related research, the relatives do not need to be consulted and thus cannot object to the deceased's wish. However, if the deceased has not yet turned 18 but has granted full permission after the age of 15, the holder of parental rights must also give consent and can thus object to the child's wish.

4.2.2. Consent from the Deceased's Relatives

If the deceased did not express their stance on transplantation-related research before their death, it is entirely up to the relatives to give consent. The same applies if the deceased was under the age of 15 and therefore did not have the opportunity to express their views before their death.

If the deceased has no relatives, research on the deceased cannot be conducted.

4.2.3. Specifics about the Obtained Consent

The consent rules for transplantation-related research from brain-dead individuals differ from the consent rules for research on tissue and material taken in contexts like autopsy, as discussed in the previous sections. Whereas consent for an autopsy implicitly also covers research on the autopsy material, transplantation-related research on brain-dead individuals requires a specific consent for the research component. A consent to the donation does not automatically translate into a consent for transplantation-related research.

The requirements for the consent do not follow the Committee Act's general rules on informed consent for a specific research project. Given that the deceased will often not be aware of the specific project at the time they provide their consent before death, obtaining informed consent for that specific project isn't feasible. Instead, the deceased can provide a general consent for transplantation-related research projects prior to their death.

The same applies concerning the consent of the relatives. For them too, agreeing to the transplantation is not enough; a separate consent for transplantation-related research is required from them.

The detailed rules on the information that relatives should receive when giving their consent are governed by the Ministry of Health's Guidance on Consent for Transplantation from Deceased Persons and for Transplantation-Related Research.

4.3. Specific Requirements for the Principal Investigator and Hospital

It is a prerequisite that the physician who removes the organ in connection with a transplantation-related study has obtained permission from the Patient Safety Authority in accordance with the transplantation rules in Section 54 of the Health Act.

The principal investigator is responsible for ensuring that consent for participation in transplantation-related research has been obtained (although in practice this can take place, for example, in the department that performs the transplantation procedure). The principal investigator is typically also responsible for the transplantation procedure and may obtain consent from the relatives for both the organ donation and research components if the deceased did not give their own consent. However, in practice, this can also be done in the department that conducts the transplantation procedure. Neither the principal investigator nor the person who carries out the transplantation procedure should be the physician who treated the deceased during their final illness or who confirmed the person's death.

A research project involving the brain-dead individual must be conducted at the same hospital where the brain-dead person is admitted. Research projects on the organs themselves can take place at the country's transplantation centers.

Research can be conducted on biological material from deceased individuals where the extraction is not covered by Chapter 56 of the Health Act on autopsies (as per Section 189(2) of the Health Act), Section 188 on donation, or Chapter 12 on transplantation (as per Section 56(2) of the Health Act), if the procedures are considered minor (as per Section 8(3) of the Committee Act).

Minor procedures can include the extraction of blood, removal of small skin portions, and other procedures that can be equated to such actions (e.g., removal of ear bones or cartilage from the nasal septum). This does not cover the removal of corneas or other major or minor organs.

Since there's generally no consent requirement for the removal of such material from individuals after their death, it is mandatory to obtain informed consent from the relatives if one wishes to use the material for research purposes (as per Section 8(3) of the Committee Act).

This involves obtaining informed consent for the specific medical research project.

In these cases, the committee system must approve the written and oral information provided to the relatives (as per Section 8(3) of the Committee Act).

Following a specific decision established after discussions with the former Ministry of the Interior and Health, The Ethical Council, and the former Central Scientific Ethics Committee on February 22, 2006, the Brain Collection at Aarhus University Hospital, Risskov, is considered a biobank. Research on material from this collection can proceed by applying for an exemption (analogous interpretation of Section 10 of the Committee Act).

A research project involving imported personally identifiable biological material must be reported to the committee system. The decisive factor is that the research activity takes place in Denmark.

The starting point in such situations is that Danish regulations will be applied. This means that, when the scientific ethics committee assesses a research project involving material from the deceased originating from abroad, it will use the frameworks or prohibitions set out in the Danish committee law or special law (e.g., the rules of the Health Act), possibly in an analogous manner.

Furthermore, the committee must ensure that the collection does not violate fundamental ethical principles, as outlined in documents like the Bioethics Convention and the Helsinki Declaration, and that the material has been obtained legally according to the regulations of the country from which it originates.

7.1 Requirements for the Research Project

The person responsible for the experiment must ensure that it can be documented to the committee that the imported material has been obtained in an ethically responsible manner.

The application should therefore be accompanied by:

• Information about which country the material originates from.
• An explanation that the material has been legally obtained and collected according to the rules of the country from which it originates (for example, from the issuing company or institution).
• An explanation that the material has been legally exported from the country from which it originates.