Request concerning destructive and non-destructive analysis in the project entitled Osteoporosis – a Modern Lifestyle Disease? (2018/200)

Background

The PhD project Osteoporosis- a Modern Lifestyle Disease? is part of the ArchSci2020 project, which is funded by EU Horizon2020 within the framework of Marie Sklodowska Curie Actions, International Training Network. This is a shared PhD project and the doctoral candidate is therefore associated with both the University of Copenhagen and Stockholm University. There are two applications submitted from this project, each dealing with separate analyses to be undertaken at the two institutions. The following will first provide a general summary of the project and afterwards present information specific to the separate applications.

Due to the apparent increase in prevalence over recent decades, osteoporosis has come to be seen as a disease associated with the modern, sedentary lifestyle. The current project questions this, and seeks to apply a range of bioarchaeological methodologies to the investigation of the prevalence of osteoporosis and osteopenia in earlier populations. aDNA analyses will identify the presence/absence, frequency and distribution of genetic loci associated with osteoporosis/increased fracture risk. This is a destructive analytical method. Osteoarchaeological analyses will evaluate demographic as well as pathological data, with emphasis on evidence of breakages/physical evidence for osteoporosis. This is a non-destructive analytical method. This phase has already been completed. pQCT scanning (peripheral quantitative CT scanning) will provide measurements of bone mineral density. This is in principle a non-destructive analytical method, although not without risk (see below).

The analyses will be performed on select individuals from the medieval assemblage recovered from St. Olav’s kirke/Folkebibliotekets tomt, Trondheim. In both instances, van Spelde has applied to Vitenskapsmuseet, NTNU for permission to access and sample the material. It is unknown to the Committee whether or not permission has been granted yet.

aDNA analyses

For aDNA analyses, the applicant has applied for permission to sample 11 individuals from the St. Olav’s kirke assemblage. In addition to these, she intends to use data developed during previous aDNA analyses of this assemblage. aDNA analyses will identify the presence/absence, frequency and distribution of genetic loci associated with osteoporosis/increased fracture risk. Van Spelde intends to sample the petrous bone. Sampling will be performed in Trondheim at NTNU, and the samples will be transported to the Centre for Geogenetics in Copenhagen for analysis. Any unused material will be returned to Vitenskapsmuseet, NTNU.

Ethics evaluation of aDNA analyses

Van Spelde acknowledges the need to treat the remains with the utmost respect. She does not see an ethical conflict involving living descendants as relevant, given that none of the individuals in the assemblage can be identified. She acknowledges that the assemblage is unique, but also highlights that it is quite a large assemblage and that the small amount of sampling involved will neither be detrimental to the assemblage’s value overall nor hinder future researchers. Furthermore, the highly innovative design of the project will not only lead to new and valuable knowledge regarding this aspect of health in medieval Trondheim, but improve our general understanding of osteoporosis. In addition to this, the data from these samples will be made accessible to another research project “The population genomic consequences of the second plague pandemic”, maximizing its utility. In this sense, the sampling can be ethically justified.

Van Spelde has clearly thought through the sampling process in detail. She has chosen to focus on petrous bones and justifies this choice both in terms of the potential for positive aDNA results and the needs of preserving the skeletal material (i.e. there is poor dental preservation in this assemblage and she does not wish to cause further damage/loss of teeth). Furthermore, she has evaluated which individuals have disarticulated (i.e. easily accessible) petrous bones and which have articulated (i.e. part of a fused skull and less readily accessible) petrous bones, and has a plan for sampling the latter without causing destruction to the associated skull fragments. The use of data from previously sampled individuals from this assemblage will maximize her data set while minimizing loss of material.

The committee has two remarks to this part of van Spelde’s request. First of all, she does not specify whether or not she will use the entire petrous portion. The committee assumes that she does not intend to use the entire petrous portion, but this needs to be clarified. Further, van Spelde should make some considerations concerning individual SK 21. This individual is being used as a part of the MEDHEAL600 project, and has already been sampled for aDNA in collaboration with the Center for Geogenetics. It may be that the data from this sample can be used for the present project as well. In this case, it would not be necessary to sample SK 21. The applicant should contact Tom Gilbert regarding this.

pQCT scanning

For pQCT scanning, van Spelde has applied for permission to access femora from 92 individuals from the St. Olav’s kirke assemblage. pQCT scanning will generate cross-sections of the femoral necks, providing data on the bone mineral density of both the cortical and trabecular bone. pQCT scanning will require that the material be sent to Oulu University, Finland. Van Spelde wishes to send only the femora, thus disassociating them from the rest of their skeletal elements.

Ethics evaluation of pQCT scanning

The ethics evaluation provided with this request is in many respects, identical to the one submitted with the aDNA application. Previous comments regarding the treatment of remains with respect and the uniqueness of the assemblage also apply here. In addition to these, van Spelde acknowledges the risk involved in the transport of material. She also highlights that while pQCT scanning is, in principle, a non-destructive analytical method, it does involve low-level radiation, which has the potential of damaging any DNA present in the measured area of the femur.

This too is a well thought out request. The methodology will compliment the other aspects of the project, providing a robust data set. The applicant understands the dangers involved in the transport of material and has demonstrated experience in dealing with these. She seems to have a good plan in place for undertaking the analyses and will be present at all times to insure the safety of the material.

There are a few points which need to be addressed. Van Spelde refers to “femora” from 92 individuals.  It is unclear to the committee whether she intends to transport and analyze one femur from each individual or both femora from each individual (presumably the former). While she acknowledges the risks associated with transporting the material, she does not discuss (in the ethical evaluation) the risks associated with disassociating the femora from the rest of their skeletal elements. Special care needs to be taken to ensure that these disassociated femora do not lose their contextual information. In many cases the elements will have their skeleton number written on them, and care for contextual information is as basic as it gets when talking about the handling of archaeological material, but it is a point worth mentioning. Two unmarked femora can be very easily mixed up if one is not paying attention, or working rapidly in a laboratory environment. Finally, 21 of the 92 individuals van Spelde wishes to use are currently on loan (through December, 2018) to Arkeologisk Museum, UiS, in association with the MEDHEAL600 project. If van Spelde wishes to undertake this phase of analysis prior to December, 2018, she needs to coordinate this between VM/NTNU and AM/UiS. Even if she intends to undertake this phase in 2019, it may be wiser to have the femora shipped directly from Stavanger to Oulu, minimizing the number of times they have to undergo transport. This decision should be taken between van Spelde and VM/NTNU.

The committee’s evaluation

In the evaluation of the project, the committee takes its Guidelines for research ethics on human remains (https://www.forskningsetikk.no/en/guidelines/social-sciences-humanities-law-and-theology/guidelines-for-research-ethics-on-human-remains/) as a starting point. Guidelines for research ethics in the social sciences, humanities, law and theology (https://www.forskningsetikk.no/en/guidelines/social-sciences-humanities-law-and-theology/guidelines-for-research-ethics-in-the-social-sciences-humanities-law-and-theology/) forms the general framework for the committees’ specialised guidelines.

It is the committee’s opinion that van Spelde’s request is very well thought through. The project will generate several different, unique data sets which not only will help address the topic of osteoporosis, but will also be available for future researchers. The topic being investigated has relevance not only to our understanding of health in medieval Trondheim but to our general understanding of osteoporosis. Van Spelde has, throughout both requests, demonstrated a strong understanding of the logistical and ethical problems associated with the proposed analyses, and has described methods for dealing with these.

Regarding the specific points laid out in the committee’s guidelines, the committee sees no significant conflicts that have not been addressed by the applicant. These remains cannot be tied to living descendants. The “ownership” of the material is clear. The project is feasible, in the sense that it uses well established methodologies, and involves minimal destruction. Transported material will be immediately returned after use, and will not involve full skeletons, limiting impact on other researchers. The assemblage’s context was taken into account in the planning stage (in fact it is the time depth of the population as well as the rich history of research on the material which made it ideal for the project). Van Spelde has yet to obtain permission from the relevant VM/NTNU committees, regarding either destructive sampling or transport of material (these are separate committees). Dissemination plans were not discussed, but given that this is a doctoral project it is clear that they will be published in one form or another.

Of the five points of concern the committee has raised, two of these are matters of coordinating the use of material with the MEDHEAL600 project and are easily resolved. The three others seem rather obvious on the surface, but do need clarification. The first is whether or not van Spelde will use the entire petrous portion. The second, whether or not she intends to transport both femora (when present) from each individual to Finland for analysis, or just one. The third involves some acknowledgement of the risks of disassociating single skeletal elements from the rest of their skeletons, and a plan for avoiding any confusion or mixing of material. As stated above, in most situations this will not be a problem, as the femora will have their skeleton numbers written on them, but there may be situations in which this was not done.

Some criticism may be levelled at van Spelde in that the osteological analyses have already been undertaken (and were thus not subject to prior review by the committee). But this was more a matter of practicality; since the applicant would be travelling to Trondheim to visually assess the material’s suitability for inclusion in her study, it was obviously sensible to collect all the data in one visit.

Conclusion

Assuming that the committee’s comments regarding coordinating the use of material with MEDHEAL600, clarifications on the petrous material, the transport of femora to Finland and the risks of disassociating skeletal elements are followed, the committee recommends van Spelde’s aDNA-analyses and pQCT scanning of human skeletal remains from St. Olav’s kirke/Folkebibliotekets tomt, Trondheim.