Abstract
Biobanks regulation has gradually developed following scientific and normative needs, which has led to the coexistence of a heterogeneous set of rules. Several regulations are applicable depending on the context of how the following were collected: elements of the human body and associated personal data, their conditions of conservation, and the purpose of their use. Thus, tumor banks must combine the provisions of bioethics law, public health laws with those of the data protection Act, and with that of research involving human individuals. The accumulation of rules can mean hindrance and difficulties for those concerned. The availability of biological samples to researchers, and so their scientific development, can thus be hampered by a too complex legislation which is difficult to access for its recipients. Therefore, the question that arises is the following: do biobank regulations, consisting of scattered legal rules, constitute a brake on the valorization of these activities, and do they promote the development of the biological sample collections?
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Notes
- 1.
Law No. 94-653 of 29th July 1994 relating to the respect of the human body and law No. 94-654 on the donation and use of elements and products of the human body.
- 2.
From Article 16 of the Civil Code.
- 3.
Law No. 94-548 of 1st July 1994 related to the processing of personal data for research purposes in the field of health and amending law No. 78-17 of 6th January 1978 “Informatique, Fichiers et Libertés”, French Data Protection Act.
- 4.
This system notably includes the lifting of medical secrecy necessary for the transfer of data for health research purposes, as well as that of no objection (implicit consent) to the processing of such data for research purposes in the field of health.
- 5.
Law no. 96-452 of 28th May 1996 on various health, social and statutory measures; Law no. 98-535 of July 1st, 1998 strengthening the health monitoring and control of products for human safety; Law No. 2004-800 of 6th August 2004 relating to bioethics and its successive reviews.
- 6.
Article L. 1243-3 and L. 1243-4 of CSP.
- 7.
In reference to the objectives set by Article L.111-1 of the Research Code:
the national policy of research and technological development aims to:
-
(1)
increase knowledge;
-
(2)
share scientific, technical and industrial culture;
-
(3)
develop the results of research to serve society[...]
-
(1)
- 8.
Article L. 1211-2 of the Public Health Code.
- 9.
Article L. 1211-2 of the Public Health Code.
- 10.
Article l; 1211-2 of the Public Health Code: “ (…) It is possible to bypass the duty to provide information when it is impossible to find the person concerned, or if one of the Advisory Committees for the protection of persons referred to in article l. 1123-1, consulted by the research leader, does not consider this information to be necessary (...)”.
- 11.
“Article 57 of the Data Protection Act:” II. -When personal data has been initially collected for a reason other than research, study or assessment, it can be derogated, subject to III, from the information obligation defined in I:
-
(1)
for the process required for the conservation of this data for historical, statistical or scientific purposes, under the conditions provided for in book II of the Heritage Code;
-
(2)
when individual information does not enable to find individuals.
(11 cont.) The requests for exemptions to the obligation to inform individuals of the use of their data for research, study or assessment purposes are justified in the approval file sent to the National Commission for ICT and freedoms, which will make a final decision.
-
(1)
- 12.
Institut National du Cancer, Scientific report 2015/2016, 2016, p. 93.
- 13.
NF S96-900 September 2011, Quality of biological resources centers (CRB)—Management System of a CRB and quality of biological resources. At an international scale: Normes ISO 9001.
- 14.
French Data Protection Act: Law no. 78-17 of 6th January 1978 (“ Informatique, Fichiers et Libertés”).
- 15.
Law no. 2012-300 of 5th March 2012 relating to research involving human individuals.
- 16.
OECD, Guidelines for Human Biobanks and Genetic Research Databases, October 22nd 2009.
- 17.
The French term “valorisation” (here, “development” in English) can mean assessing the value of an object or increasing its value.
- 18.
Valorization may however include an economic dimension being subject to other contributions—see, in particular, Carole Haritchabalet and Catherine Bobtcheff -, we shall focus on developing scientific collections. That being said, we must reiterate that development is conducted here on behalf of the public service for research, and on that basis, it must contribute to satisfy general interest. Thus, economic development cannot have other purposes than the maintenance and improvement of the public service for research, its goal being to meet the needs of the population in terms of health.
- 19.
A number of activities must respect various regulations.
- 20.
See on this point: Assemblée Nationale, Presentation of reasons for the Bill on research on the human person, recorded at the Presidency of Assemblée Nationale on January 6th, 2009, presented by Mr. Jardé.
- 21.
Law passed in 2012, finally applied 4 years later after the publication of Decree No. 2016 - 1537 of November 16th, 2016 relating to Research involving the human person.
- 22.
Assemblée Nationale, Report no. 1377, on behalf of the Cultural, Family and Social Affairs Committee, on Mr. Olivier Jardé’s bill (no. 1372) relating to research on the human person, January 13th, 2009.
- 23.
Article l. 1243-3 of the Public Health Code: “(...) The organizations mentioned in paragraph 1 submit their draft statement to the prior notice of a committee, as defined in chapter III of title II of book I in this part, the mission of which is to assess the quality of the information given to participants, the terms of consent and ethical and scientific relevance of the project. The statement is addressed to the Minister in charge of research and, where applicable, to the relevant Director general of the regional health agency, concomitantly to the submission for opinion to the Committee. The latter’s view is given to them without delay (...).”
- 24.
Law no. 96-452 of 28th May 1996 on various health, social and statutory measures.
- 25.
Law no. 98-535 of July 1st, 1998 on strengthening the health monitoring and control of the safety of products intended for humans.
- 26.
Assemblée Nationale, Report no. 1377.
- 27.
Assemblée Nationale, Report no. 1377.
- 28.
Article L. 1243-3 of the Public Health Code.
- 29.
The government’s research department monitors respect for safety, the conditions in which no objection can take place and the subjects of the preserved collections.
- 30.
Law no. 2012-300 of 5th March 2012 on research involving the human person.
- 31.
The first category includes interventional research and corresponds to current biomedical research, for which the regime remains unchanged. A second category includes “Interventional research which does not involve drugs, with minimal constraints and risks, the list of which is decided by order of the Minister of health, on the advice of the Director general of the national agency for medicine and healthcare products”. This new category is close to (33 cont.) the former category of “research to assess routine care”, except that its scope is wider since this category includes interventions without risk. Finally, the third category, one in which all acts are performed and products are used in the usual way, without any additional or unusual diagnosis, treatment or monitoring procedure, corresponds to the former category of non-interventional research. A new feature requires the opinion of the CPP for any research.
- 32.
This number is used to identify all research carried out in France.
- 33.
It will only be complemented with a new notice from the Research Ethics Committee if the built-up sample collection is used for a new research project, different from that for which it was originally built-up. “Therefore, there will not be two separate processes anymore, one to perform and report on research, the other to build up the biological collection”.
- 34.
Article L. 1221-8 of the Public Health Code, as amended by order No. 2016-1406 October 20th, 2016 which removes the reference to biological sample collections.
- 35.
Decree of May 3rd, 2017, giving the list of the research referred to at 2 ° of Article l. 1121-1 of the Public Health Code.
- 36.
The proponent gives a copy of the notice of the CPP and a summary of the research to the competent authority.
- 37.
Articles L. 1123-7 and L. 1123-9 of the Public Health Code and R. 1123-22 of the Public Health Code.
- 38.
Collection managers should endeavor to collect maximum information from patients and increase links between sample data and the patients at the origin of these samples. See on this point: Institute National du Cancer, Scientific Report 2015/2016, 2016, p. 93.
- 39.
Article 4, § 15 of the regulation on the protection of personal data: “health data, personal data relating to physical or mental health of an individual, including the provision of healthcare services which reveals information on the health of this person”.
- 40.
Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27th, 2016, relating to the protection of natural persons with respect to the processing of personal data and the free movement of such data, and repealing directive 95/46/EC (general regulation on data protection).
- 41.
Article 56 al. 1 of the Data Protection Act.
- 42.
Chapter IV of the Data Protection Act.
- 43.
Article 54 of the Data Protection Act.
- 44.
Article 54 of the Data Protection Act.
- 45.
Deliberation No. 2016-262 July 21, 2016, amending the referring methodology of the processing of personal data used in biomedical research (MR-001).
- 46.
Deliberation No. 2016-263 July 21st, 2016, which approves of a referring methodology relative to the processing of personal data implemented as part of research in the field of health, which does not require explicit or written consent from the person concerned (MR-003).
- 47.
Nowadays, a part of the activity of tumor banks is to create clinico-biological databases (referred to as “BCB” in French), the funding of which is on the increase. These are “tools of collection and data management relating to individuals, patients and subjects involved in research protocols. Data associates clinical information, scientific and medical tests performed on biological samples, the epidemiological information and administrative information collected from surveys or questionnaires”. The research carried out using these tools focuses on data and must be authorized by the CNIL after being assessed by the CEREES.
- 48.
In this respect, one can wonder about the relevance of the creation of a Committee that has more or less the same missions as the former CCTIRS. Article 54 of the LIL states that the latter “issues, within a period of 1 month from referral, advice on methodology, on the need for the use of personal data, on its relevance regarding the purpose of such processing and, if it is necessary, on the scientific quality of the project.” The same applies to its composition which is almost identical.
- 49.
National Assembly, report No. 2302, Bill relating to health, presented by Ms. Marisol Touraine, Minister of Social Affairs, health and women’s rights, in the name of Mr. Manuel Valls, Prime Minister October 15th, 2014.
- 50.
Chapter IX of the Data Protection Act.
- 51.
Article 20 of Decree No. 2016-1872 of December 26th, 2016, amending Decree No. 2005-1309 of 20th October 2005 taken for the application of law No. 78-17 of 6th January 1978 relative to information technology, files and freedoms.
- 52.
Article 54 of the LIL.
- 53.
CCTIRS consisted in “competent people in health research, epidemiology, genetics and biostatistics” and had to deliver their opinion on “the research methodology in the light of the provisions of this law, the need for the use of personal data and the relevance of these compared to the research objective”.
- 54.
Depending on that opinion, the CNIL may or may not pronounce on the need to waive professional secrecy that protects personal health data and allows the proposed data processing.
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Pigeon, A. (2018). Does Tumor Bank Regulation Promote the Valorization of Tumor Collections?. In: Bioy, X. (eds) Public Regulation of Tumor Banks. Springer, Cham. https://doi.org/10.1007/978-3-319-90563-1_6
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