Table 3.
National regulatory guidance language on collection and use of HBS by country*
| Legislation, regulations, and/or guidance re. research and/or HBS | Specific HBS language | HBS consent | HBS ownership | HBS secondary use | HBS storage | HBS Import/export |
|---|---|---|---|---|---|---|
| Angola | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| Benin | ||||||
| Loi 2005-31 Portant prevention, prise en charge et contrôle du VIH/SIDA (2006) [28] Loi No. 2010-40 portant code d'éthique et de déontologie pour la recherche en santé en République du Bénin (8 December 2010) [29]. |
Loi 2005-31 portant prevention, prise en charge et conttrolé du VIH/SIDA en Republique du Benin (2005) Loi No. 2010-40 Portant code d'éthique et de déontologie pour la recherche en santé en République du Bénin (8 December 2010). |
No language | No language | No language | No language | No language |
| Botswana | ||||||
| Botswana Statute Law: Anthropological Research Act 1967 [30] Drugs and Related Substance Act, 1992 [31] Botswana Drugs Advisory Board: Guidelines on drug registration applications in Botswana [4th edition] 2014.[32] Botswana Ministry of Health,: Standard Operating Procedures for Review of Biomedical and Bio-behavioral Research in Botswana, 2011 [33] |
Ministry of Health Standard Operating Procedures, Article 7.2 Procedures on Human Genetic Research, pages 103-108. Articles 8.1-8.5, Human Biological Materials, pages 111-114 |
Consent required unless waived by an ethics committee." (MOH SOPs, 2011, 7.2.iv) An ethics committee may sometimes waive, with or without conditions, the requirement for consent. (MOH SOPs, 2011, 7.2.v) Acquisition, storage and future use of biological materials: Informed consent process and forms separate from and in addition to informed consent for research participation. (MOH SOPs,2011, 8.2) |
Government of Botswana is normally the owner of research data. The creators of the data, the Principal Investigators and local institutions in Botswana should hold the data in trust on behalf of the Botswana government and the research participant. The host institutions or researcher has to apply to the HRDC regarding the decisions about use and sharing of their data with other researchers and institutions according to Botswana law (MOH SOPs, 2011, 8.5.Appendix 11)." | Research protocols should detail the purpose and use of research specimens Where archived specimens are required in another experiment, researchers must provide a new protocol for review and approval by HRDC. (MOH SOPs, 2011, 8.2.iii) |
Host institution in Botswana is entrusted custodianship of samples and should hold samples in trust on behalf of Botswana Government and the research participant. Research subjects have right to withdraw their samples if traceable. Health Research and Development Committee approval required for use, transfer, storage & future use according to Botswana laws. Where samples have not been obtained as part of research, the institution that collected them takes custodianship of them. Any future study on such samples is subject to review by HRDC. (MOH SOPs, 2011, 8.2) |
No transfer unless: a) the researcher and the other research group are collaborating on research that has been approved by an ethics committee; and b) the genetic material cannot be identified. Transfer of identifiable or potentially identifiable genetic material may be approved by HRDC in certain circumstances. (MOH SOPS, 2011, 7.2.vi) All exchanges and transfers (including importation) of HBS for research purposes shall require clearance from the HRDC. (MOH SOPs, 2011, 8.3) Procedures for Exchange/Transfer of HB Materials, pg. 112:(MOH SOPs, 2011, 8.3) |
| Burkina Faso | ||||||
| Law No. 23/94/ADP of 19 May 1994 on the Code of Public Health [34] Décret No. 2002-536 Established National Bioethics Committee [35] Minister of Health, the Minister of Secondary and Higher Education and Scientific Research (2004) Joint order No. 2004/147/MS/MESSRS on the organization and functioning of the Ethics Committee for Health Research in Burkina Faso. [36] (Decree contains no research ethics regulatory guidance.) A draft Code of Ethics was written in 2005 but there is no publicly available data indicating it was operationalized. |
Human biological materials means the organs, tissues and products that can be used for therapeutic or research purposes on human beings. They can be derived from living or cadaveric donors. (Law No. 23/94) | Consent required for human genetic research unless waived by an ethics committee. Institutions or organizations wishing to conduct research on genetic material and on information collected for non-research purposes should develop and disseminate a general policy that informs subjects that such material and information may be used for future research, following research ethics committee approval, participants in such institutions or organizations should be informed that this policy exists and that their privacy and confidentiality will be protected. (p. 105-106). Page 106 specifies information that must be contained in a consent document for a study involving human genetic research. (Joint Order No. 2004) |
No language | No language | No language | No language |
| Burundi | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| Cameroon | ||||||
| Arrêté No. 079/A/MSP/DS- Order of the Minister of Public Health, October 22, 1987: Creation and organization of an ethics committee for research involving human subjects [37] (Article 9 refers to an evaluation process relying on Declaration of Helsinki) Decision 0674/D/MSP/CIRCB, October 13, 2006: Creation and functions of an ethics committee in the Chantal International Reference Center for research on the prevention and treatment of HIV/AIDS [38] |
No language | No language | No language | No language | No language | No language |
| Cape Verde | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| Central African Republic | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| Chad | ||||||
| Part of UNESCO Bioethics project. Efforts to establish National Ethics Commission reported in meeting report, UNESCO, 2008) [23] | None found | None found | None found | None found | None found | None found |
| Comoros | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| Republic of Congo | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| Congo (DRC) | ||||||
| Ministry of Health, Politique nationale de recherché sure les systems de santé en RDC (June 2004) [39] | No language | No language | No language | No language | No language | No language |
| Côte D’ivoire | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| Djibouti | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| Equatorial Guinea | ||||||
| Presidential Decree No. 124/2014: Establishes the National Ethics Committee of Equatorial Guinea (CENGE), 2014. [40] Presidential Decree 125/2014: Constitute CENGE and appoints inaugural members, 2014 [41] |
No language | No language | No language | No language | No language | No language |
| Eritrea | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| Ethiopia | ||||||
| FDRE Ministry of Science & Technology; National Research Ethics Review Guideline [5th Ed.] Sept. 2014 [42] | National Health Research Ethics Review Guideline, Guideline 8.3.2, p. 51-52 | IC process should include info on HBS and data to be collected, data anticipated to be derived from sample as well as health and other records to be accessed, their intended uses, storage and duration of storage. Participants must be informed that specific information will not be shared with family members, and that, if shared with third parties, will be anonymized. Participant should be given option of allowing sharing of samples or not. (Guideline, 8.3.2., p. 52) Separate consent form for HBS collected for storage and/or future use. Participant may choose whether to have HBS stored for future studies. (Guideline, 9.2, p. 57) |
Host institution in Ethiopia holds HBS in trust on behalf of research participant. (Guideline, 9-2, p. 58) Where HBS have not been obtained as part of research, the institution that collected the samples takes custodianship. (Guideline 9.2, p. 58) | Any shared samples must be anonymized to the recipient, Use of HBS beyond what is stated in original protocol must have consent of research participants or their representatives. Secondary use may only be done on anonymized samples and after getting approval by the IRB. When subsequent use of HBS or data is proposed that is not consistent with original I/C, a new consent should be obtained from participant/guardian or LAR or a waiver of consent should be requested from IRB. (Guideline, 8.3.2, p. 52) | Intent to store HBS and place and duration of storage must be specified in initial consent document (Guideline, 8.3.2) Research participants reserve right to withdraw their HBS from storage if samples are linked. (Guideline, 9.2) | MTA required. It must contain details regarding purpose of transfer/export, arrangements for collaboration and benefit-sharing, a framework for accessing and sharing data, restrictions to third party transfers, and annual reports to host institution. An Ethiopian scientist must be included as a co-investigator in all future studies using the HBS. The IRB in Ethiopia must review all research studies on stored HBS. (Guideline 9.2, p. 58) |
| Gabon | ||||||
| Establishment of a National Research Ethics Committee (UNESCO 2007) [24] | No language | No language | No language | No language | No language | No language |
| The Gambia (Republic oF) | ||||||
| [No national regulatory guidance for general research although final drafts exist.] Dept. of State for Health & Welfare; National Health Research Policy[revised draft for discussion: 29/10/2009] [43] Dept. of State for Health & Welfare; National Health Research Strategic Plan 2010-2014 [final draft: 15/01/2010] [44] |
Guidelines for The Gambia National DNA Bank, 2001 [22] | Samples from children only after permission from parents or guardians No consent for reuse, but permission of Gambian government/MRC Laboratories Ethics Committee is required. Permission from donor for reuse of samples that have not been anonymized is required in principle, but committee can waive this requirement. (DNA Bank Guidelines, 2001) | DNA Collections are jointly owned by the Gambian people through their government representatives and the Medical Research Council (DNA Bank Guidelines, 2001) | Reuse permissible with approval from Joint Committee. Different levels of permissions/consents required depending on whether or not requested specimens have been anonymized, collected as part of a specific protocol or available to researchers with approval from Committee only. [DNA Bank Guidelines, 2001] | The Gambia National DNA Bank was established in 2001, the first biobank on the African continent (DNA Bank Guidelines, 2001). | Permission for export based on signed agreement between researchers and the DNA Bank, with approval of Committee. Agreement must describe analyses to be undertaken with specimens; feedback must be given to MRC Labs, results of analyses must eventually be placed in the public domain, and any manuscripts resulting from research must be submitted to Joint Committee prior to submission. (DNA Bank Guidelines, 2001) |
| Ghana | ||||||
| No research ethics regulatory guidance Public Health Act 2012 [Act 851] Good Clinical Practice Doc No FDA/SMC/CTD/GL- GCP/2013/02 Ver. 2, 18 Dec 2015 (Adopted 27 Jan 2016) [45] |
No language | No language | No language | No language | No language | No language |
| Guinea (Republic of) | ||||||
| Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (Decree No D/218). 1998. [46] Decree contains no ethics regulatory guidance language. |
No language | No language | No language | No language | No language | No language |
| Guinea-Bissau | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| Kenya | ||||||
| The Science, Technology and Innovation Act, 2013 [47] National Council for Science and Technology Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) 2004. [48] Kenya Medical Research Institute (KEMRI), National Ethics Review Committee: Guidelines and Standard Operating Procedures, 2004. [49] Ministry of Health, National Guidelines for Research and Development of HIV/AIDS Vaccines, 2005. [50] Pharmacy and Poisons Board: Guidelines for applications to conduct clinical trials in Kenya, 2011. [50] |
HBS reference limited to Guideline 15 (National Guidelines, 2004) | Guideline 15. Informed Consent for epidemiological studies- ERC to determine whether or not individual informed consent is needed for studies involving "left-over" HBS (Natl Guidelines 2004) Applications for clinical trials must include patient information leaflets and informed consent forms for any proposed archiving of biological specimens for later research or genetics research. (Pharmacy & Poisons Board Guidelines, 2011, Art. 4.12) |
No language | Guideline 15. Informed Consent for epidemiological studies- ERC to determine whether or not individual informed consent is needed for studies involving "left-over" HBS (Natl Guidelines 2004) | No language | No biological material transfer is permitted without the informed consent of the trial participants and without approval of protocol and in accordance to Ministry of Health guidelines on transfer of HBS. (Vaccine guideline 7.3, p. 44 2005) MTAs govern all transferred materials and specimens used for vaccine studies. MTAs must state that specimens will only be used for scientific, educational, non- commercial use. Any other uses require a cooperative research and development agreement (RADA). (Vaccine Guidelines, 8.3, 2005) |
| Lesotho | ||||||
| Ministry of Health and Social Welfare: National Health and Social Welfare Research Policy (NHSWRP), Lesotho. 2007.[51] (Established a National Health and Social Welfare Research Ethics and Clearance Committee within the National Research Institute at the MoHSW.) No research ethics regulatory guidance. |
No language | No language | No language | No language | No language | No language |
| Liberia | ||||||
| Ethics approval required from one of three REC bodies: Liberia Institute of Biomedical Research/National Health Science Research EC (LIBR/NHSREC), the University of Liberia Institutional Review Board (UL- IRB), or the newly established National Research Ethics Board (NREB). [52] University of Liberia-Pacific Institute for Research and Evaluation: Institutional Review Board (IRB) Policies and Procedures Handbook 2008 [53] Liberia Medicines and Health Products Regulatory Authority, Guideline for Application to Conduct Clinical Trials in Liberia 2014. [54] |
Research involving the collection or study of pathological specimens, or diagnostic specimens may be exempt, if those sources are publicly available or if the information is recorded by the investigator in such a manner that the subjects cannot be identified, directly or indirectly, through identifiers linked to the subjects. Archival research in which individual subjects could potentially be identified is not exempt. (University of Liberia, Policies & Procedures Handbook, 2008, Art. 5 pg. 23) |
Applications for clinical trials must include patient information leaflets and informed consent forms for any proposed archiving of biological specimens for later research or genetics research. (LMHRA Guidelines, 2014, Art. 4.12.5 p. 14) | No language | No language | No language | Materials Transfer Agreement must be provided to the Liberia Medicines and Health Products Regulatory Authority’s (LMHRA) (LMHRA Guidelines, 2014.) |
| Madagascar | ||||||
| Decree No. 5855/99-SAN (June 17, 1999) modified by Decree No. 4583/2000-SAN (May 8, 2000) (Created a National Ethical Committee for Biomedical Research.) Documents contain no research ethics regulatory guidance. [55] |
No language | No language | No language | No language | No language | No language |
| Malawi | ||||||
| National Health Sciences Research Committee: General Guidelines on Health Research (December 2007) [56] National Health Sciences Research Committee, Policy Requirements, Procedures, and Guidelines for the Conduct and Review of Human Genetic Research in Malawi (September 2012) [23] National Commission for Science and Technology (2012). National Policy measures and Requirements for the Improvement of Health Research Coordination in Malawi (Revised ed., 11/2012). [57] |
Clear explanation and justification for the collection and exporting of biological samples will have to be made. (General Guidelines, 2007, Section 6.1) HBS language contained in 2007 and 2012 documents. |
Informed consent for HBS required. Persons may only be consented for HBS collection for purposes of answering the study objectives of a presently intended study that has been clearly defined.(Policy Requirements, 2007, 10.0) | No language | All forms of studies & testing aimed at collecting and storing HBS for future unspecified genetic research/analysis, including scientific retrospective analysis is non- permissible (HBS Guidelines, 2012, 3.4.7) Plans, attempts, requests for obtaining HBS for future research non-permissible (HBS Guidelines, 2012, 3.4.8) |
Procedures for specimen storage will have to be clearly defined. (General Guidelines, 2007, Section 6.1) Not permissible to consent participants to collection, use, storage of specimens for future use, HBS may be stored for future analysis as specified in a presently intended study approved by NSTC but not for a period to exceed five years. Additional time period may be granted. (Policy Requirements, 2007, 10.0) |
Analysis of specimens should be done within Malawi by local technicians/professionals. Export permitted only in exceptional circumstances when the needed technology does not exist in Malawi nor can it be imported or when tests are needed to confirm results and/or quality control and validation are required.(Policy Requirements, 2007, 10.0) MTAs are required. Agreement must clearly specify why export is necessary, its intended use, length of time HBS will be kept, and name of local technician/professional who will be responsible for HBS testing.(Policy Requirements, 2007, 10.0) |
| Mali | ||||||
| No. 02-200/P-RM April 22, 2002- Creation of a National Ethics Committee for Health and Life Sciences [58] Minister of Health- Internal Ruling August 26, 2004- Operation and Functions of Ethics Committee for Health and Life Sciences. [59] Loi 86-11 N RM Fundamental Principles of Scientific and Technological Research [60] (Documents contain no ethics guidance for conduct of research.) Organization and functions of the National Institute of Public Health Research, including establishment of an ethics committee within Institute) [61] |
No language | No language | No language | No language | No language | No language |
| Mauritania | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| Mauritius | ||||||
| The Clinical Trials Bill (Feb 11, 2010)- calls for Ethics Committee to uphold International Ethics provisions while respecting customs and values of country. [62] Mauritius Research Council (MRC) drafted ethics guidelines for biomedical research involving human subjects in July 2003 and they remain out for public comment. No on-line evidence that final guidelines have been approved. |
No language | No language | No language | No language | No language | No language |
| Mozambique | ||||||
| Order May 21, 2002- Minister of health established National Research Ethics Committee [63] No specific laws on research involving human beings. National ERC (CNBS-Comité national de Bioética para Saude) applies international principles (Dec. of Helsinki, CIOMS, ICH-GCP.) | No language | No language | No language | No language | No language | No language |
| Namibia | ||||||
| Ministry of Health and Social Sciences has constituted a Biomedical Research Ethical Committee but it is not operational. [64] | None found | None found | None found | None found | None found | None found |
| Niger | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| Nigeria | ||||||
| National Health Research Ethics Committee of Nigeria (NHREC) National Code of Health Research Ethics 2007. [65] Policy Statement on Storage of Human Samples in Biobanks and Biorepositories in Nigeria (PS1.02013) (November 1, 2013) [66] |
Reference to HBS in connection with MTAs (Ethics Code, 2007) See Biobanks (Biobank Policy, 2013) NHREC to provide sole oversight of ethical aspects of biobanking (Biobank Policy, 2013) |
Biobanks in Nigeria must retain copies of all consent forms and these must be matched to all samples in biobanks (Section D,iii,a., Biobanks, 2013) NHREC supports Broad Consent- consent in which the type or purpose of research is defined in broad terms and for a work that is not specified by time (Section E.1, Biobanks, 2013) | No language | No language | Any samples kept more than 2 months post-analysis are considered 'banked' and covered by Biobank Policy. Copies of all participant I/C forms must be available and can be matched to samples stored in biobanks (Biobank Policy 2013) | Export permitted, subject to MTA approved by HREC. Institutional HRECs shall grant final approval for research involving international transfer of HBS. (HREC Code, 2007) |
| Rwanda | ||||||
| Rwanda Ministry of Health, National Research Ethics Committee: Standard Operating Procedures, 2009 [67] Rwanda Ministry of Health, National Health Research Committee: Operational Guidelines, 2012. [68] |
Regulations with respect to HBS (Sections 35 & 36 of Rwanda Ministry of Health Standard Operating Procedures, 2009. | HBS must be collected with free and informed consent even if tissue is obtained as part of patient care. Consent forms must indicate if HBS is being collected for current research only, how long the specimens will be kept, and when they will be destroyed. If HBS is stored longer than the current research, then a separate permission for storage must be obtained. | Under MTAs: Ownership is the "Provider of the samples." Ownership of any income resulting from commercialization must be negotiated in good faith (Rwanda SOPs, 2009, Appendix 7). | No language | No language | MTAs are required. Entities to whom HBS is transferred must provide any resultant publications, and provider must be part of the publication team. (Rwanda SOPs, 2009, Appendix 7) |
| Sao Tome & Principe | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| Senegal | ||||||
| Arrêté ministerial No. 3224 MSP- DERF-DER, March 17, 2004: Creation and organization of National Council for Health Research (CNRS) [69] Loi No. 2009-17, March 9, 2009: Code of Ethics for Health Research. [70] Règlement Intérieur du Conseil National de la Recherche en Santé [Standard Operating Procedures], March 7, 2006. [71] |
No language | No language | No language | No language | No language | No language |
| Seychelles | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| Sierra Leone | ||||||
| Pharmacy Board of Sierra Leone: Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone (Version 02) (G-SLClinTrial). 2014. [72] Pharmacy Board of Sierra Leone: Guideline for Good Clinical Practice (GCP) in Sierra Leone (Version 01) (SL-GCPs). 2014 [73 73] Ministry of Health & Sanitation, Office of the Sierra Leone Ethics and Scientific Review Committee: Sierra Leone Ethics and Scientific Review Committee –Guidelines. n.d.[74] |
Section 3.9 Biological specimens/samples (Guidelines for conducting clinical trials, 2014, p. 20-21) Definition of HBS: a biological specimen or a biological sample is defined as material derived from various animal and human sources (e.g., blood, tissues, and cells) used to treat and prevent diseases. (Guidelines for GCP, 2014) |
Separate consent for use of HBS (Guidelines, 2014, Sec. 3.9.1) HBS taken in course of clinical care may be used for research without consent subject to ethics committee review. Patients have right to know their HBS is being used for research. Patient refusal to such use does not warrant waiver of consent. Refusals to be honored except in case of public health emergency. (Guidelines, 2014, Sec. 3.9.2) |
No language | Secondary use of HBS is constrained by conditions specified in initial consent. Therefore, initial consent should specify whether or not there will be secondary use; conditions under which subjects must be re-contacted; plans, if any, for de-identification; and subject rights. (Guidelines, 2014, Sec. 3.9.3) | No language | Materials Transfer Agreement is required. (NIAID Communication with the Pharmacy Board of Sierra Leone (PBSL) (October 2014–January 2015) |
| Somalia | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| South Africa | ||||||
| Act 61 of 2003 National Health Act [75] Regulations Relating to the Use of Human Biological Material, March 2012 [76] |
Chapter 8, Sections 53-68. (National Health Act, 2003) Regulations Relating to the Use of HBS (2012) | Written informed consent of individual with provisions for consent from subjects who are minors or mentally ill (Regulations, 2012, 3.1) Written informed consent by users/donors for release of stored information and for long-term storage of genetic material, stem cells, or research findings (Regulations, 2012, 13.d & f). |
No language | HBS information used for purposes for which it was originally intended. (Regulations, 2012, 13.e). | Written informed consent of the user or donor for long term storage of genetic material, stem cells, or research findings. HBS information treated confidentially. Users' written informed consent prior to release of stored information. (Regulations 2012, 13e & f). |
Export permit is required. No export unless it is established that sample was donated under terms of Act and will be used in accordance with terms of Act. (Act, 2003, 8.68.1(g)) |
| South Sudan | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| SUDAN | ||||||
| National Guidelines for Ethical Conduct of Research Involving Human Subjects (2008) [77] | Guidelines, 2008, Secs. 5.2, 5.10, & 5.11). | Investigator must provide subjects: policy to use results of genetic tests and familial genetic information and precautions to prevent disclosure to others (Guidelines, 2008, 5.2.16); possible research sites, direct or secondary use of HBS taken in course of clinical care (5.2.18); disposal, storage, future use of HBS (5.2.19); any commercial products from HBS and distribution of any revenues (Guidelines, 2008, 5.2.20) Consent forms must have separate sections requesting use of HBS for research purposes (Guidelines, 2008, 5.10) HBS taken in course of clinical care may be used w/o consent subject to approval of ethics committee (Guidelines, 2008, 5.11). |
No language | Constrained by conditions specified in original consent (Guidelines, 2008, 5.12) | No language | No language |
| Swaziland | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| TANZANIA | ||||||
| National Institute for Medical Research Act, 1979 [78] Guidelines of Ethics for Health Research in Tanzania, 2nd ed., 2009. [24] The Human DNA Regulations Act, 2009 [79] Standard Operating Procedures for the National Health Research Ethics Review Committee, 2007 [80] |
Part V Human DNA Research Activities, Medical Research & Treatment (Act, 2009). | Consent for intended study only. New protocol required for reuse (Guidelines, 2009, 8.8) No collection of a sample without the consent of the sample source (DNA Act, 2009, 38-41). |
Samples of Human DNA are the property of the sample source. (DNA Act, 2009, 28.2.b) Where the research results from an individual or an institute are new or unique, the researcher or the institute shall have the intellectual property rights (DNA Act, 2009, 5.3.7). |
Consent for intended study only New protocol required for reuse (8.8, Guidelines, 2009) Sample destroyed on completion of analysis unless sample source's representative has previously directed otherwise in writing (DNA Act, 2009, 28.2.e) After completion of original research, investigators must (a) within one month notify of their intent to reuse and secure the permission of sample source or (b) destroy samples within three months (38.44, DNA Act, 2009, 38.44) |
No language | Materials transfer agreement is required. |
| Togo | ||||||
| None found | None found | None found | None found | None found | None found | None found |
| Uganda | ||||||
| Uganda Ministry of Health, National Health Policy, 1999 [81] Uganda National Council for Science and Technology (NCST), National Guidelines for Research Involving Humans as Research Participants, July 2014. [82] |
See Guidelines 2014, Sec. 10., pp. 28-31. | Consent must include explanation of how HBS will be managed at end of study. If stored, separate consent must be obtained, with purpose of study, quantities stored, location, measures to ensure confidentiality, future governance, risks and potential benefits. (Guideline, 2014, 5.3.h) | Sample sources own the samples If samples are identified, source may withdraw them at any time. Samples to be held in trust by duly authorized Uganda organization. Trustee organization has authority to decide use, transfer, storage and future use of HBS in its care, taking into account rights and welfare of research participants (Guidelines, 2014, 10.3) If MTA doesn't specify ownership of future products, they are automatically owned by provider organization. (Guidelines 2014, 10.5) |
A Ugandan scientist must be included on all future studies. Separate informed consent document required for each reuse (See HBS, I/C). All future studies subject to REC review. If samples collected initially for purposes other than research, sample sources must be traced and consent for research use secured. (Guidelines,2014, 10.2) | See HBS I/C | MTA required. Future use of HBS subject to review and approval by an REC in provider's country. (Guideline, 2014, 10.4) Applicant for transfer must be a legal resident of Uganda and affiliated with a locally registered and recognized Uganda organization. (Guidelines, 2014, 10.5)To export, requesting entity must demonstrate lack of in-country capacity to perform tasks. Sample may be transferred for quality assurance and laboratory reference purposes. All exchanges and transfers require approval of NCST except exchanges within country. Capacity-building by requesting organization encouraged. (Guidelines, 2014, 10.4) |
| Zambia | ||||||
| The National Health Research Act 2013 [83] | May only be collected for purposes stated in research protocol (Act, Part VI) Minister of Health may designate specific sites as biobanks |
No HBS removed from living person for health research purposes without written consent of donor in accordance with provisions of the Act. Act, Art. 47 (1) | Ownership specified in MTA as determined by Minister of health in consult with Health Authority. Act, Art. 51 (1)(a) | A person shall not withdraw HBS from a living person for any unspecified future health research activity of unspecified storage. Act, Art. 47 (2) | A person shall not withdraw HBS from a living person for any unspecified future health research activity or unspecified storage. Act, Art. 47 (2) Storage not to exceed 10 years without special approval of longer period from Health Authority Act, Art. 51 (2) (b) |
Only with written approval of the National Health Research Authority Act, Art. 50 (1) and if terms of MTA are met Art. 50 (2) MTA is required. Minister, in consultation with Authority, decides on requirements. |
| Zimbabwe | ||||||
| Scientific Technological Research Act (Research Act) (Ch. 10:22), 1986 (Replaced Research Act 1959) [84] Medical Research Council of Zimbabwe: Ethics Guidelines for Health Research Involving Human participants in Zimbabwe, Version 1.4, September 30, 2011 [85] Research Council of Zimbabwe (RCZ): Specimens Transfer Agreement (STA) (online as of 1/3/15) [86] |
Discussion of HBS not included in MRCZ guidelines. | No language | No language | No language | Extraterritorial storage of biospecimens beyond Research Council of Zimbabwe approval period is illegal. RCZ STA, 2015) Note: All international studies must be registered with RCZ. |
Export for specified research purposes only. No third party transfers. Approval of REC required. Specimens Transfer Agreement (STA) is required. |
* Guidance language cited verbatim where possible.