Source: https://www.etikkom.no/en/our-work/about-us/the-national-committee-for-research-ethics-on-human-remains/ask-the-national-committee-for-research-ethics-on-human-remains-for-advice/guide-to-filling-in-the-form/
Timestamp: 2020-02-23 17:58:10
Document Index: 690096252

Matched Legal Cases: ['§ 6', '§ 14', '§ 7', '§ 25', '§ 25', '§ 7', '§ 24', '§ 24']

﻿ Guide to filling in the form 'Form for ethical evaluation of research on human remains' - Etikkom
Ask The National Committee for Research Ethics on Human Remains for advice
Guide to filling in the form 'Skjema for etisk vurdering ved forskning på menneskelige levninger'
When filling in the form, please have your comments on relevant ethical issues (12 below) and the relevant research proposal (13 below) available, both in electronic form.
(The project description and assessment of the ethical issues that the project raises must be uploaded as separate PDF attachments at the end.) If applicable, please also have ready the specific collection numbers of the material you wish to include (9 below).
(3) Applicant
(7) Project aim
(9) Description of the research material
(10) Explain what will happen with the material at the end of the project
(11) Approval from other relevant institutions
(12) Explain the ethical issues raised by the project
(13) Project description and time frame
The title used here must be identical with the official project title.
The person named as applicant assumes overall responsibility for the practical implementation of the research project. For student projects, the project supervisor must be listed as project leader. The project description must describe who will carry out the actual work.
The applicant must provide a brief description of the project’s aims and research questions. The description must be written in a form that can be understood by readers without the applicant’s specific academic background. It is not sufficient to refer to attachments, such as the project description.
Provide a brief description of the method(s) to be employed. Provide references to the relevant literature.
(9) Description of research material
It is a matter of importance whether the material has already been collected or has yet to be collected. Applicants who are not affiliated with any of the university museums must be aware that, if the project requires excavation of skeletal material, there are specific formal rules of procedure. Norwegian graves pre-dating 1537 and Sami graves older than 100 years are automatically protected under the Cultural Heritage Act of 1978 (kulturminneloven). Excavating such material thus requires an application to the appropriate authorities for exemption from the Cultural Heritage Act. Graves less than 40 years old are covered by the Funeral Act (gravferdsloven).
An application for exemption must be submitted to the regional administrative authority, i.e. the appropriate county or the Sami Parliament, and a copy must be sent to the relevant archaeological museum (university museum), depending on where the excavation will take place. The regional authority will forward the application to the Directorate for Cultural Heritage with its recommendation on whether or not an exemption should be granted, while the University Museum will provide the Directorate for Cultural Heritage with a professional recommendation. The actual exemption is granted by the Directorate for Cultural Heritage. Excavation may not be implemented without such an exemption.
In such cases, applicants should normally submit the project proposal to The National Committee for Ethics in Research on Human Remains and obtain the Committee's statement before the application is sent to the regional administration, the University Museum and the Directorate for Cultural Heritage. The administrative authorities will want to have all relevant information available before they submit their recommendations and make their decisions. In the absence of a statement from The National Committee for Ethics in Research on Human Remains, the application may be delayed because the administrative authorities must submit it to The National Committee for Ethics in Research on Human Remains for comment.
In principle, only archaeologists affiliated to a professional institution can undertake an excavation. Applicants should be aware that very good reasons are required for obtaining an exemption for the excavation of graves that are protected by law, and they must thus demonstrate why the project depends on the excavation.
(10) Explain what will happen with the material when the project ends
Any material taken from a collection, but not destroyed in the course of the research, must be returned to the museum or collection.
(11) Approval from other institutions
For all projects that use skeletal material
Conditions that apply to the collection and use of human skeletal material are mainly governed by laws and regulations, such as the Cultural Heritage Act and the International Council of Museums (ICOM) code of ethics (http://www.icom-norway.org/).
The Cultural Heritage Act protects all archaeological finds of graves and human remains predating the Reformation (1537) and Sami finds more than 100 years old. Burial laws and regulations protect graves and remains that are less than 40 years old. The five university museums and the University of Oslo’s Department of Anatomy have administrative responsibility for excavated human skeletal material. This means that all requests for research on excavated human skeletal material should be accompanied by written permission for their use from these institutions.
Sami skeletal material
For items of Sami skeletal material stored at the Department of Anatomy, University of Oslo, there is a separate agreement between the University and the Sami Parliament that gives the Sami Parliament decisive rights over the Sami skeletal material and all research that may be carried out on this material (see § 6 of the Lønning Commission's "Recommendation on the use and management of skeletal material at the Department of Anatomy (The Schreiner Collections)." The recommendation forms the basis for the interim guidelines, adopted by the Collegium of the University of Oslo on September 7, 1999). In matters concerning this material, applicants must request an ethical assessment by The National Committee for Ethics in Research on Human Remains and obtain the Committee's statement before an application is submitted to the Sami Parliament.
Medical or health research
If skeletal material is to be used for research with a medical or health-related purpose, the project is regulated by the Biobank Act. In such cases, a research biobank must be established, and the project must be approved by a regional committee on medical and health research ethics (REK). (See http://helseforskning.etikkom.no for more information.) It is up to the National Committee for Medical and Health Research Ethics (NEM) to decide whether projects regulated by the Biobank Act, and thereby REK’s mandate, must also be approved by The National Committee for Ethics in Research on Human Remains. Other research projects that intend to use skeletal material are not generally regulated by the Biobank Act. The Norwegian Directorate of Health implements the Biobank Act and should be contacted in cases of doubt.
If the research includes the use of personal or health information, the project must also meet the appropriate requirements for approval, authorisation, etc., as required by other regulations, such as the Personal Data Act and Health Data Filing Act.
(Upload as a separate attachment)
It is recommended that the project leader pays particular attention to this point, since it forms an essential part of the basis on which the assessment will be made. The project leader should present an evaluation of the special ethical issues raised by the project.
Respect for remains and descendants
Treatment of human remains requires an ethical approach throughout the research process. Human remains must be treated with respect. There may be differing views on what this means in practice – depending on cultural, religious or ethnic affiliation. Researchers have an obligation to familiarise themselves with and, within reason, take these views into account.
There is an ethically relevant difference between older (i.e. normally archaeological) and younger remains, and between unidentified remains and remains where identity is known. As a rule, the use of older remains raises fewer ethical issues than does the use of younger remains.
Material from recent times raises particularly difficult ethical issues because it may be possible to identify the person whose remains are the subject of study. Research on material from recent years can more easily offend the public’s sensibility with regard to the treatment of the deceased. Remains from recent years should be treated in accordance with requirements of confidentiality. Confidentiality requirements dictate that the researcher must prevent the use and dissemination of information that could harm the posthumous reputation of the individuals being researched. Research material must normally be anonymised, and there are strict requirements governing how lists of names or other information, that make it possible to identify individuals, are stored and destroyed (see Research Ethics Guidelines for Social Sciences, Humanities, Law and Theology, § 14).
In research on remains with a known identity, respect for individuals and population groups implies that requirements for informed consent are particularly relevant. One should make a considerable effort to track down any descendants or relatives who can contribute to decisions regarding research on the remains and the further disposition of the material. The researcher should, as far as possible, take into account the demands of descendants or population groups to whom the remains belong (see § 7 of the mandate of The National Committee for Ethics in Research on Human Remains). Religious and ethnic affiliation should be considered and taken into account. There may be major differences between religious and ethnic groups when it comes to how the dead are perceived.
Respect for groups
Research on remains from other cultures requires knowledge of and respect for these cultures (see the Research Ethics Guidelines for the Social Sciences, Humanities, Law and Theology, § 25). The requirement for informed consent must be combined with knowledge of and respect for regional and local traditions, as well as established relations of authority. Therefore, where research on human remains is at issue, there are stringent requirements governing the problematisation, planning, dialogue and implementation of such projects. Co-determination can potentially come into conflict with standards of quality and independence of research (see Research Ethics Guidelines for Social Sciences, Humanities, Law and Theology, § 25). Such cases require that the researcher weigh these considerations against other considerations, such as the social relevance and importance of the research.
Human remains are not value-neutral material. Scientists’ or the research community's own ideas and values about respect for human remains are context-dependent, and scientific terms and concepts are dynamic. Aims and results from research on human remains can easily and unintentionally be communicated in a way that can subject vulnerable groups (religious and lineage-based), minorities and indigenous peoples to undue burdens. In research on human remains that may stem from vulnerable populations, minorities or indigenous peoples, researchers should be particularly cautious in using classifications or designations that give rise to unfair generalizations. This applies regardless of how old the material is. The researcher must avoid contributing to the degradation of human beings from earlier periods that would provide a basis for current disparaging generalisations, and would in effect question the dignity of vulnerable people, minorities and indigenous peoples.
The material's origins
Research on human remains can be seen as particularly offensive by descendants or others who may have a particular association with the remains if these have been acquired in an unethical manner. Where there are reasonable grounds for assuming that the material may have been obtained unethically, the research must be subjected to a stricter assessment (see the mandate of the National Committee for Evaluation of Research on Human Remains, § 7). "Researchers and research institutions should exercise caution and not, in the course of carrying out research, acquire items of cultural heritage that have an unclear or disputed origin and ownership history (provenance)" (Research Ethics Guidelines for Social Sciences, Humanities, Law and Theology, § 24).
Regardless of the age and identity of the remains, it could be ethically questionable to use remains for research purposes if the research method involves the destruction of the material. Research that destroys or perhaps alters skeletal material, reduces or eliminates the possibility of future research on the material. This raises ethical questions. Consequently, safeguarding human remains must be undertaken with regard to future research (see Research Ethics Guidelines for Social Sciences, Humanities, Law and Theology, § 24). Risk of damaging the material must be weighed against the potential contribution to knowledge that the research is expected to provide.
The following questions should be raised in an ethical assessment of the destruction of skeletal material: (a) Is the proposed method the one that will result in the least possible damage to the material? If the aim of the study can be carried out with techniques that do not involve destruction of material, or cause less damage, then such an alternative should be selected, (b) Is there a reasonable chance that the project will be successful? It must be demonstrated that the study is likely to provide valuable knowledge. (c) How rare is the material? If the material is very rare, stricter requirements will apply regarding the project’s value and the fulfillment of (a) and (b).
(13) Project description with time frame