The Awareness and Perception About The Ethical Concerns Related to The Biobanks Among Medical and Dental Practitioners: A Questionnaire Based Study

Background: The term “Biobank” has been used in different ways but one way is to define it as “an organized collection of human biological material and associated information stored for one or more research purposes”. By definition, “Biobank” is a long-term storage and conservation facility for biological specimens, to support future scientific investigation. The aim of this study is to assess the awareness and perception of Biobanks, their existence, aims and objectives and the ethical concerns related to them, among the clinicians pertaining to both medical and dental specialties. Methods: A questionnaire comprising of 31 questions of which few are purely awareness and rest are perception based is framed. The questions which were framed for the questionnaire, have few of them given direct responses as YES, NO, DON’T KNOW and the remaining of them have been graded into LIKERT’S SCALE, ranging from 1 to 5. Statistical analysis: After obtaining the response, the answers were plotted in MS-Excel sheet and analysed statistically for the Percentages, Frequencies, Chi-square and degree of Association (p>0.05= No Association) between the two fraternities responses by using SPSS 22.0 version software. The p value was set at 0.05 Result: There was found a level of association between both the groups for certain sensitive questions relating to privacy of information and ownership claims. Conclusion: It can be concluded that the willingness to participate in sample donation, motivation for sample donation are in agreement with each other, which is worth being further investigated.


Introduction
The term "Biobank" has been used in different ways but one way is to define it as "an organized collection of human biological material and associated information stored for one or more research purposes". Collections of plant, animal, microbe, and other nonhuman materials may also be described as Biobanks but in some discussions the term is reserved for human specimens only. 1 By definition, "Biobank" is a long-term storage and conservation facility for biological specimens, to support future scientific investigation. 2 Biobanks consist of two different parts: 1) The biologic material that is collected, processed, and long-time stored.
2) The database, including information about demographic and clinical data for each sample. Thus the scientific research has escalated its performance since the inception of these Biobanks which are heavily supported by government as the research results are highly beneficial to the society. In recent years there has been a great ramification in the practices and policymaking of these Biobanks as there is been an increasing diversity in the set of research purposes and types as well as source of research samples. 3 For instance, Biobanks could comprise the collections of human bodily substances of all kinds, such as cells, tissues, blood, or DNA. They range in capacity from small collections of samples to large-scale national repositories. The collected samples could be populationbased or disease-specific, originating from diverse profile http://www.pacificejournals.com/aabs History of Biobank Governance: In 1998 the Icelandic Parliament passed the act on Health Sector Database which allowed for the creation of a national Biobank in that country. In 1999 the United States National Bioethics Advisory Commission issued a report containing policy recommendations about handling human biological specimens. 6 In 2005 the United States National Cancer Institute founded the Office of Biorepositories and biospecimen Research so that it could have a division to establish a common database and standard operating procedures for its partner organizations with biospecimen collections. In 2006 the Council of the European Union adopted a policy on human biological specimens which was novel for discussing issues unique to Biobanks. 6 The aim of this study is to assess the awareness and perception of Biobanks, their existence, aims and objectives and the ethical concerns related to them, among the clinicians pertaining to both medical and dental specialties.

Objectives of the study
 To assess the level of awareness among the clinicians of both medical and dental field about the existence and goals of Biobanks  To assess their perception variations about the different issues related to Biobanks like their areas of interests, aims and objectives  To assess their perception variations about the ethical issues which are being faced by these Biobanks and the ownership claims chaos involved with them.

Materials and Methods:
A questionnaire comprising of 31 questions of which few are purely awareness and rest are perception based is framed and analyzed by the subject experts and also approved by the Ethical society of YENEPOYA UNIVERSITY. The questions which were framed for the questionnaire, have few of them given direct responses as YES, NO, DON'T KNOW and the remaining of them have been graded into LIKERT'S SCALE, wherein a range of 1 to 5 numbers have been given which have the interpretation as : Strongly agree (1), Agree (2), Don't know (3), Disagree (4), and Strongly disagree (5).
The sample size was decided to be 50 for each medical and dental specialties comprising to a total of 100 sample size which was decided to be appropriate to judge the level of awareness and variations in perceptions. The questionnaire was distributed among the registered medical and dental practitioners preferably practicing in and around the Mangalore city located in the southern part of Karnataka, India, After obtaining the informed consent.
Statistical Analysis: After obtaining the response, the answers were plotted in MS-Excel sheet and analysed statistically for the Percentages, Frequencies, Chi-square and degree of Association (p>0.05= No Association) between the two fraternities responses by using SPSS 22.0 version software. The p value was set at 0.05.
The sensitivity of the awareness and perception was assessed by taking Four questions from the questionnaire pertaining to awareness  About the type of volunteers to be encrolled in the Biobanks,  Information sharing by the Biobanks( confidentiality issues) ,  Ownership claims faced by them  Their willingness to participate and the type of sample donation they prefer.
( family members and relatives as well as disagreement was shown for publishing the data by both the groups. There was also found a level of ASSOCIATION between both the groups when their perception was assessed about the sharing of the research data with the researcher and the same Biobank. When the Ownership issues were assessed, both the groups have consented for sharing of the data with the donor only in majority followed by donor and Biobank was the perception for medical practitioners but it was donor and researcher by the dental practitioners. When their willingness to participate and donate different parts was assessed, most of the dental practitioners have agreed for blood only and disagreed for all the organs donation, whereas most of medical practitioners have agreed for blood only and strongly disagreed for ova/ sperm followed by all the organs donation.

Dental practitioners (Response in Likerts scale)
Level of Association

Discussion
Our results illustrated a general public agreement to participate in Biobanking and emphasize the need to establish awareness campaigns to promote public involvement in biomedical research, which correlate with increased level of participation in biobanking. 7 Speaking about the consent issues in Biobanking, Hoeyer K. 2012 8 has reported that Biobanks usually collect sample and data for multiple future research and it is not feasible to obtain specific consent for any single research. It has been discussed that one-off consent or a broad consent for various research purposes may not suffice ethical and legal requirements.
Speaking about the children and incompetent adults participation in biobanking , Hens K et al. in 2009 9 stated that the majority of Biobanks do not involve children because of special ethical problems and concerns that are not easily addressable, and also because the increased sensitivity of the public and the media toward this segment of the population sometimes makes it an unnecessary risk that many Biobanks are not willing to take. However, this could lead medical research on children to lag behind the research on adults. From the ethical point of view, in that way children will eventually suffer relatively more than adults. So, nearly all authors support the idea of involving children in Biobanks, but they also agree that the risk for them should be actively minimized.
When perception was assessed about the sharing of research data, the level of perception was found to be in accordance to what has been reported in other cultures where a high level of concern about protection of privacy was measured. i.e, limiting to oneself and not disclosing to others. [10][11][12][13][14] These findings were in agreement with the study done by Kaufman DJ 2009 andHansson MG in 2011 15,16 which stated that the fundamental concern about privacy is usually also the main concern of the participants when they are deciding whether to donate their samples to Biobanks. Their study showed that up to 90% of people were concerned about their privacy Thus, concluded that consequences of breaking privacy could substantially affect public's willingness to participate and substantially delay the research. Therefore, Biobanks must always guarantee a maximal level of protection of participants. Another study by Cambon-Thomsen A. in 2011 17 reported about the privacy and identifiability of the samples and stated that there is a widespread concern that insurance companies and employers could access personal information. They usually have great interest in personal information and Biobanks must guarantee adequate protection of personal data. Further, results of research can also harm not only individuals, but the whole groups could feel stigmatized because of their genetic predisposition or other relevant information. Biobanks that perform research on a specific ethnic or other group of people must consider this and be very careful when publishing the results.
The level of awareness about the Biobanks and its working protocols as well as the ethical concerns were found to be closely matching between these groups. It was also found that the willingness to participate and organ donation was also nearly the same.

Conclusion
This questionnaire based survey has given information about comprehension and motivation of both medical and dental practitioners towards Biobanking and its aims, objectives, research obligations as well as the ethical issues about consent, sharing of research information, willingness to participate in sample donation, motivation for sample donation and ownership claims , which is worth being further investigated. As the level of understanding of aims and methods of a specific research project seems to vary in relation to modalities of approaching research, most of the participants are seemingly motivated by a "pragmatic"or a "selfless attitude" to contribute to research.
This study also suggests that people may have a "responsibility or an obligation" to participate in research are not new, especially where risks are considered low for participants; even if the "dilemma or quandary" between respect of autonomy and respect of solidarity cannot be completely overcoming, a balance can still be continuously pursued.