Human biological samples are a valuable source of information that may aid in the generation of new knowledge. However, the use of human biological samples for research poses various ethical, legal and social issues (ELSI). We performed a scoping review to identify the ethical issues surrounding the use of human biological samples for research. We developed a search string strategy to identify literature in PubMed, Scopus, Web of Science, and Google Scholar. Out of 4067 identified articles, 61 articles were included for final analysis. The findings of this study revealed multiple ethical issues stemming from the knowledge and awareness of different stakeholders involved in research, the factors affecting donors’ study participation, the consent process, and the governance and structures of these human biological samples. This study will provide guidance for researchers, IRB members, and other stakeholders involved in the ethical consideration of using human biological samples for secondary research.
AbdelhafizA. S.AhramM.IbrahimM. E.ElgamriA.GamelE.LabibR.SilvermanH. (2022). Biobanks in the low-and middle-income countries of the arab Middle East region: Challenges, ethical issues, and governance arrangements—a qualitative study involving biobank managers. BMC Medical Ethics, 23(1), 1–16. https://doi.org/10.1186/s12910-022-00822-8
2.
Abou-ZeidA.SilvermanH.ShehataM.ShamsM.ElshabrawyM.HifnawyT.RahmanS. A.GalalB.SleemH.MikhailN.MoharramN. (2010). Collection, storage and use of blood samples for future research: Views of Egyptian patients expressed in a cross-sectional survey. Journal of Medical Ethics, 36(9), 539–547. https://doi.org/10.1136/jme.2009.033100
3.
AhramM.AbdelgawadF.ElHafeezS. A.AbdelhafizA. S.IbrahimM. E.ElgamriA.MohammedZ.El-RhaziK.ElsebaieE.GamelE. (2022). Perceptions, attitudes, and willingness of the public in low-and middle-income countries of the Arab region to participate in biobank research. BMC Medical Ethics, 23(1), 1–18. https://doi.org/10.1186/s12910-022-00855-z
4.
Al-EbbiniL. M. K.KhabourO. F.AlzoubiK. H.AlkarakiA. K. (2021). Ethical issues in bio-sample sharing among the public in Jordan [article]. Heliyon, 7(2), Article e06316. https://doi.org/10.1016/j.heliyon.2021.e06316
5.
AlkarakiA. K.KhabourO. F.AlzoubiK. H.Al-EbbiniL. M. K.AltaanyZ. (2022). Sharing, reuse, and storage of biosamples among biomedical researchers in Jordan: Practice and concerns [article]. PLoS One, 17(4), Article e0267552. https://doi.org/10.1371/journal.pone.0267552
6.
Al-QadireM. M.HammamiM. M.AbdulhameedH. M.Al GaaiE. A. (2010). Saudi Views on consenting for research on medical records and leftover tissue samples [article]. BMC Medical Ethics, 11, Article 18. https://doi.org/10.1186/1472-6939-11-18
7.
AlrabadiN.MakhloufH.KhabourO. F.AlzoubiK. H. (2019). Jordanians’ perspectives on open consent in biomedical research. Risk Management and Healthcare Policy, 12, 265–273. https://doi.org/10.2147/rmhp.S217209
8.
AngellE.TarrantC.Dixon-WoodsM. (2009). Research involving storage and use of human tissue: How did the Human Tissue Act 2004 affect decisions by research ethics committees?Journal of Clinical Pathology, 62(9), 825–829. https://doi.org/10.1136/jcp.2008.060699
9.
ArkseyH.O'MalleyL. (2005). Scoping studies: Towards a methodological framework. International Journal of Social Research Methodology, 8(1), 19–32. https://doi.org/10.1080/1364557032000119616
10.
AsaiA.OhnishiM.NishigakiE.SekimotoM.FukuharaS.FukuiT. (2002). Attitudes of the Japanese public and doctors towards use of archived information and samples without informed consent: Preliminary findings based on focus group interviews. BMC Medical Ethics, 3, E1. https://doi.org/10.1186/1472-6939-3-1
11.
BallantyneA.MooreA. (2018). Data and tissue research without patient consent: A qualitative study of the views of research ethics committees in New Zealand. Ajob Empirical Bioethics, 9(3), 143–153. https://doi.org/10.1080/23294515.2018.1518938
12.
BallantyneA.MooreA.BartholomewK.AagaardN. (2020). Points of contention: Qualitative research identifying where researchers and research ethics committees disagree about consent waivers for secondary research with tissue and data. PLoS One, 15(8), e0235618. https://doi.org/10.1371/journal.pone.0235618
13.
BarchiF.MatlhagelaK.JonesN.KebaabetsweP. M.MerzJ. F. (2015). The keeping is the problem": A qualitative study of IRB-member perspectives in Botswana on the collection, use, and storage of human biological samples for research. BMC Medical Ethics, 16, 54. https://doi.org/10.1186/s12910-015-0047-3
14.
BombardY.MillerF. A.HayeemsR. Z.CarrollJ. C.AvardD.WilsonB. J.LittleJ.BytautasJ. P.AllansonJ.AxlerR.GiguereY.ChakrabortyP. (2012). Citizens’ values regarding research with stored samples from newborn screening in Canada [article]. Pediatrics, 129(2), 239–247. https://doi.org/10.1542/peds.2011-2572
15.
BraunK. L.TsarkJ. U.PowersA.CroomK.KimR.GachupinF. C.MorrisP. (2014). Cancer patient perceptions about biobanking and preferred timing of consent. Biopreservation and Biobanking, 12(2), 106–112. https://doi.org/10.1089/bio.2013.0083
16.
BrownK. M.DrakeB. F.GehlertS.WolfL. E.DuBoisJ.SeoJ.WoodwardK.PerkinsH.GoodmanM. S.KaphingstK. A. (2016). Differences in preferences for models of consent for biobanks between black and white women [article]. Journal of Community Genetics, 7(1), 41–49. https://doi.org/10.1007/s12687-015-0248-y
17.
CaulfieldT.RachulC.NelsonE. (2012). Biobanking, consent, and control: A survey of Albertans on key research ethics issues. Biopreservation and Biobanking, 10(5), 433–438. https://doi.org/10.1089/bio.2012.0029
18.
ChenY.SangC.BianZ.ZhangY.JiangE.ZhouX.ChenT.TangH.WangC. (2020). The Scale, Collections, and Biospecimen Distribution of Grade A Tertiary Hospital Biobanks in China: A National Survey. Front Med (Lausanne), 7, 560600. https://doi.org/10.3389/fmed.2020.560600
19.
ClarkG.LipworthW.BokeyL.LittleM.KerridgeI. (2006). An empirical study of tissue banking in Australia: Navigating regulatory and ethical challenges.
20.
ColledgeF.De MassougnesS.ElgerB. (2018). Consent requirements for research with human tissue: Swiss ethics committee members disagree. BMC Medical Ethics, 19, 1–8. https://doi.org/10.1186/s12910-018-0331-0
21.
ColledgeF.PerssonK.ElgerB.ShawD. (2014). Sample and data sharing barriers in biobanking: Consent, committees, and compromises. Annals of Diagnostic Pathology, 18(2), 78–81. https://doi.org/10.1016/j.anndiagpath.2013.12.002
22.
Council for International Organizations of MedicalS.World HealthO. (2016). International ethical guidelines for health-related research involving humans. CIOMS.
23.
DissanayakeV. H.SumathipalaD. S.KariyawasamU. G.JayamanneJ. M.NisansalaP. K.LieR. (2015). A survey of scientist and policy Makers’ attitudes toward research on stored human biological materials in Sri Lanka. Developing World Bioethics, 15(3), 226–232. https://doi.org/10.1111/dewb.12065
24.
Dixon-WoodsM.KocmanD.BrewsterL.WillarsJ.LaurieG.TarrantC. (2017). A qualitative study of participants’ views on re-consent in a longitudinal biobank. BMC Medical Ethics, 18(1), 22. https://doi.org/10.1186/s12910-017-0182-0
25.
EdwardsT.CadiganR. J.EvansJ. P.HendersonG. E. (2014). Biobanks containing clinical specimens: Defining characteristics, policies, and practices. Clinical Biochemistry, 47(4-5), 245–251. https://doi.org/10.1016/j.clinbiochem.2013.11.023
26.
EikemoH.RotenL. T.VaalerA. E. (2022). Research based on existing clinical data and biospecimens: A systematic study of patients’ opinions. BMC Medical Ethics, 23(1), 1–8. https://doi.org/10.1186/s12910-022-00799-4
27.
EU. (2016). Regulation (EU) 2016/679 of the European Parliament and of the Council on the Protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), (2016).
28.
FDA, U. (2006). Guidance on informed consent for In Vitro diagnostic device studies using leftover human specimens that are not individually identifiable: Guidance for sponsors, Institutional Review Boards, and Food and Drug Administration Staff. Retrieved from https://www.fda.gov/media/122648/download.
29.
FongM.BraunK. L.ChangR. M. (2004). Native Hawaiian preferences for informed consent and disclosure of results from research using stored biological specimens. Pacific Health Dialog, 11(2), 154–159.
30.
FrunzăA.SanduA. (2017). Ethical acceptability of using generic consent for secondary use of data and biological samples in medical research [article]. Acta Bioethica, 23(2), 289–299. https://doi.org/10.4067/S1726-569X2017000200289
31.
GaoH.JiangJ.FengB.GuoA.HongH.LiuS. (2018). Parental attitudes and willingness to donate children's biospecimens for congenital heart disease research: A cross-sectional study in Shanghai, China [article]. BMJ Open, 8(10), Article e022290. https://doi.org/10.1136/bmjopen-2018-022290
32.
GoisaufM.MartinG.BentzenH. B.Budin-LjøsneI.UrsinL.DurnováA.LeitsaluL.SmithK.CasatiS.LavitranoM.MascalzoniD.BoeckhoutM.MayrhoferM. T. (2019). Data in question: A survey of European biobank professionals on ethical, legal and societal challenges of biobank research. PLoS One, 14(9), e0221496. https://doi.org/10.1371/journal.pone.0221496
33.
GordonD. R.Radecki BreitkopfC.RobinsonM.PetersenW. O.EggintonJ. S.ChaffeeK. G.PetersenG. M.WolfS. M.KoenigB. A. (2019). Should researchers offer results to family members of cancer biobank participants? A mixed-methods study of proband and family preferences. Ajob Empirical Bioethics, 10(1), 1–22. https://doi.org/10.1080/23294515.2018.1546241
34.
HensK.DierickxK. (2010). Human tissue samples for research. A focus group study in adults and teenagers in Flanders. Genetic Counseling, 21(2), 157–168. https://www.ncbi.nlm.nih.gov/pubmed/20681216
35.
HensK.NysH.CassimanJ. J.DierickxK. (2010). The use of diagnostic collections of DNA for research: Interviews at the eight Belgian centers for human genetics. European Journal of Medical Genetics, 53(5), 274–279. https://doi.org/10.1016/j.ejmg.2010.07.003
36.
HuiL. L.NelsonE. A. S.DengH.LeungT. Y.HoC.ChongJ. S. C.FungG. P. G.HuiJ.LamH. S. (2022). The view of Hong Kong parents on secondary use of dried blood spots in newborn screening program. BMC Medical Ethics, 23(1), 105. https://doi.org/10.1186/s12910-022-00839-z
37.
HullS. C.SharpR. R.BotkinJ. R.BrownM.HughesM.SugarmanJ.SchwinnD.SankarP.Bolcic-JankovicD.ClarridgeB. R.WilfondB. S. (2008). Patients’ views on identifiability of samples and informed consent for genetic research. American Journal of Bioethics, 8(10), 62–70. https://doi.org/10.1080/15265160802478404
38.
IbrahimM. E.AdarmouchL.ElgamriA.Abd ElHafeezS.MohammedZ.AbdelgawadF.ElsebaieE. H.AbdelhafizA. S.GamelE.El RhaziK. (2023). Researchers’ Perspectives Regarding Ethical Issues of Biobank Research in the Arab Region. Biopreservation and Biobanking, 22(2), 98–109. https://doi.org/10.1089/bio.2022.0112
39.
International Ethical Guidelines for Health-related Research Involving Humans. (2016).
40.
JansenM. E.van den BoschL. J. M.HendriksM. J.SchefferM. M. J.HeijnenM. L.DouglasC. M. W.van ElC. G. (2019). Parental perspectives on retention and secondary use of neonatal dried bloodspots: A Dutch mixed methods study. BMC Pediatrics, 19(1), 230. https://doi.org/10.1186/s12887-019-1590-8
41.
JolyY.DalpéG.SoD.BirkoS. (2015). Fair shares and sharing fairly: A survey of public views on open science, informed consent and participatory research in biobanking. PLoS One, 10(7), e0129893. https://doi.org/10.1371/journal.pone.0129893
42.
KasperbauerT.HalversonC.GarciaA.SchwartzP. H. (2022). Biobank participants’ attitudes toward data sharing and privacy: The role of trust in reducing perceived risks. Journal of Empirical Research on Human Research Ethics, 17(1-2), 167–176. https://doi.org/10.1177/15562646211055282
43.
LeeS. S.ChoM. K.KraftS. A.VarsavaN.GillespieK.OrmondK. E.WilfondB. S.MagnusD. (2019). I don't want to be henrietta lacks": Diverse patient perspectives on donating biospecimens for precision medicine research. Genetics in Medicine, 21(1), 107–113. https://doi.org/10.1038/s41436-018-0032-6
MakhloufH.AlrabadiN.KhabourO. F.AlzoubiK. H.Al-DelaimyW. (2019). Population's perspectives toward biobanks in scientific research: A study from Jordan [article]. Pharmacogenomics & Personalized Medicine, 12, 23–32. https://doi.org/10.2147/pgpm.S187657
46.
MasterZ.ClaudioJ. O.RachulC.WangJ. C.MindenM. D.CaulfieldT. (2013). Cancer patient perceptions on the ethical and legal issues related to biobanking. Bmc Medical Genomics, 6, 8. https://doi.org/10.1186/1755-8794-6-8
47.
MatandikaL.NgóngólaR. T.MitaK.Manda-TaylorL.GoodingK.MwaleD.MasiyeF.Mfutso-BengoJ. (2020). A qualitative study exploring stakeholder perspectives on the use of biological samples for future unspecified research in Malawi. BMC Medical Ethics, 21(1), 61. https://doi.org/10.1186/s12910-020-00503-4
48.
MathewsD. J. H.RabinJ. T.QuainK.CampbellE.CollyarD.HlubockyF. J.IsakoffS.PeppercornJ. (2019). Secondary use of patient tissue in cancer biobanks. The Oncologist, 24(12), 1577–1583. https://doi.org/10.1634/theoncologist.2018-0376
49.
MerdadL.AldakhilL.GadiR.AssidiM.SaddickS. Y.AbuzenadahA.VaughtJ.BuhmeidaA.Al-QahtaniM. H. (2017). Assessment of knowledge about biobanking among healthcare students and their willingness to donate biospecimens. BMC Medical Ethics, 18(1), 32. https://doi.org/10.1186/s12910-017-0195-8
50.
MoodleyK.SibandaN.FebruaryK.RossouwT. (2014). It's my blood": Ethical complexities in the use, storage and export of biological samples: Perspectives from South African research participants. BMC Medical Ethics, 15, 4. https://doi.org/10.1186/1472-6939-15-4
51.
MoodleyK.SinghS. (2016). “It's all about trust": Reflections of researchers on the complexity and controversy surrounding biobanking in South Africa. BMC Medical Ethics, 17(1), 57. https://doi.org/10.1186/s12910-016-0140-2
52.
MunnZ.PetersM. D. J.SternC.TufanaruC.McArthurA.AromatarisE. (2018). Systematic review or scoping review? Guidance for authors when choosing between a systematic or scoping review approach. BMC Medical Research Methodology, 18(1), 143. https://doi.org/10.1186/s12874-018-0611-x
53.
MuradA. M.MyersM. F.ThompsonS. D.FisherR.AntommariaA. H. (2017). A qualitative study of adolescents’ understanding of biobanks and their attitudes toward participation, re-contact, and data sharing. American Journal of Medical Genetics. Part A, 173(4), 930–937. https://doi.org/10.1002/ajmg.a.38114
54.
MwakaE.HornL. (2019). Researchers’ perspectives on informed consent and ethical review of biobank research in South Africa: A cross-sectional study. Journal of Empirical Research on Human Research Ethics, 14(4), 307–317. https://doi.org/10.1177/1556264619866991
55.
NagarajC. B.RothwellE.HartK.LatimerS.SchiffmanJ. D.BotkinJ. R. (2014). Attitudes of parents of children with serious health conditions regarding residual bloodspot use. Public Health Genomics, 17(3), 141–148. https://doi.org/10.1159/000360251
56.
PageM. J.McKenzieJ. E.BossuytP. M.BoutronI.HoffmannT. C.MulrowC. D.ShamseerL.TetzlaffJ. M.AklE. A.BrennanS. E.ChouR.GlanvilleJ.GrimshawJ. M.HrobjartssonA.LaluM. M.LiT.LoderE. W.Mayo-WilsonE.McDonaldS.MoherD. (2021). The PRISMA 2020 statement: An updated guideline for reporting systematic reviews. BMJ, 372, n71. https://doi.org/10.1136/bmj.n71
57.
PageS. A.ManhasK. P.MuruveD. A. (2016). A survey of patient perspectives on the research use of health information and biospecimens. BMC Medical Ethics, 17(1), 48. https://doi.org/10.1186/s12910-016-0130-4
58.
PentzR. D.BillotL.WendlerD. (2006). Research on stored biological samples: Views of African American and white American cancer patients. American Journal of Medical Genetics. Part A, 140(7), 733–739. https://doi.org/10.1002/ajmg.a.31154
59.
QuinnG. P.KoskanA.SehovicI.PalT.MeadeC.GwedeC. K. (2014). Contrasting the ethical perspectives of biospecimen research among individuals with familial risk for hereditary cancer and biomedical researchers: Implications for researcher training. Genetic Testing and Molecular Biomarkers, 18(7), 467–473. https://doi.org/10.1089/gtmb.2013.0461
60.
RothwellE.AndersonR.BotkinJ. (2010). Policy issues and stakeholder concerns regarding the storage and use of residual newborn dried blood samples for research. Policy, Politics & Nursing Practice, 11(1), 5–12. https://doi.org/10.1177/1527154410365563
61.
RothwellE.AndersonR.GoldenbergA.LewisM. H.StarkL.BurbankM.WongB.BotkinJ. R. (2012). Assessing public attitudes on the retention and use of residual newborn screening blood samples: A focus group study. Social Science & Medicine (1982), 74(8), 1305–1309. https://doi.org/10.1016/j.socscimed.2011.12.047
62.
Sexton-OatesA.DodgshunA.MacGregorD.LudlowL. E.SullivanM.SafferyR. (2016). Evidence of broad-based family support for the use of archival childhood tumour samples in future research. Journal of Medical Ethics, 42(7), 460–465. https://doi.org/10.1136/medethics-2015-103141
63.
ThielD. B.PlattT.PlattJ.KingS. B.KardiaS. L. (2014). Community perspectives on public health biobanking: An analysis of community meetings on the Michigan BioTrust for health. Journal of Community Genetics, 5(2), 125–138. https://doi.org/10.1007/s12687-013-0162-0
64.
TindanaP.MolyneuxC. S.BullS.ParkerM. (2014). Ethical issues in the export, storage and reuse of human biological samples in biomedical research: Perspectives of key stakeholders in Ghana and Kenya. BMC Medical Ethics, 15, 76. https://doi.org/10.1186/1472-6939-15-76
65.
TriccoA. C.LillieE.ZarinW.O'BrienK.ColquhounH.KastnerM.LevacD.NgC.SharpeJ. P.WilsonK.KennyM.WarrenR.WilsonC.StelfoxH. T.StrausS. E. (2016). A scoping review on the conduct and reporting of scoping reviews. BMC Medical Research Methodology, 16, 15. https://doi.org/10.1186/s12874-016-0116-4
66.
UNESCO. (2005). Universal Draft Declaration on Bioethics and Human Rights. United Nations Educational, Scientific and Cultural Organization. Unesco.
van TeeffelenS. R.DouglasC. M.van ElC. G.WeinreichS. S.HennemanL.RadstakeM.CornelM. C. (2016). Mothers’ views on Longer storage of neonatal dried blood spots for specific secondary uses. Public Health Genomics, 19(1), 25–33. https://doi.org/10.1159/000441516
69.
VaughtJ. B.HendersonM. K. (2011). Biological sample collection, processing, storage and information management. IARC Scientific Publications, 163, 23–42. https://www.ncbi.nlm.nih.gov/pubmed/22997855
70.
VazM.VazM. (2018). The views of ethics committee members and medical researchers on the return of individual research results and incidental findings, ownership issues and benefit sharing in biobanking research in a South Indian city. Developing World Bioethics, 18(4), 321–330. https://doi.org/10.1111/dewb.12143
71.
VermeulenE.SchmidtM. K.AaronsonN. K.KuenenM.van LeeuwenF. E. (2009). Obtaining ‘fresh’consent for genetic research with biological samples archived 10 years ago. European Journal of Cancer, 45(7), 1168–1174. https://doi.org/10.1016/j.ejca.2008.11.022
72.
WhitleyE. A.KanellopoulouN.KayeJ. (2012). Consent and research governance in biobanks: Evidence from focus groups with medical researchers. Public Health Genomics, 15(5), 232–242. https://doi.org/10.1159/000336544
73.
WHO. (2000). Guidelines for the collection of clinical specimens during field investigation of outbreaks. World Health Organization. https://apps.who.int/iris/handle/10665/66348
74.
WMA. (2013). WMA Declaration of Helsinki - Ethical principles for medical research involving human subjects. In W. M. Association (Ed.). Fortaleza, Brazil.
75.
WMA. (2016). WMA Declaration of Taipei on Ethical Considerations Regarding Health Databases and Biobanks. In.
76.
ZhangX.MatsuiK.KrohmalB.ZeidA. A.MuthuswamyV.KooY. M.KitaY.LieR. K. (2010). Attitudes towards transfers of human tissue samples across borders: An international survey of researchers and policy makers in five countries. BMC Medical Ethics, 11, 16. https://doi.org/10.1186/1472-6939-11-16
Supplementary Material
Please find the following supplemental material available below.
For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.
For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.
