Table 1.
Basic characteristics of documents included in the analysis
| Title | Year of publication | Level of organization | Publishing institution | Countries | Level of authority |
|---|---|---|---|---|---|
| Exclusively addresses genetics and genomics research | |||||
| HUGO Statement on The Principled Conduct of Genetics Research | 1996 | International | HUGO | International | Statement or Declaration |
| UNESCO Universal Declaration on the Human Genome and Human Rights Sect. 17 | 1997 | International | UNESCO | International | Statement or Declaration |
| HUGO Statement on DNA Sampling Control and Access | 1998 | International | HUGO | International | Statement or Declaration |
| HUGO Statement on Gene Therapy Research | 2001 | International | HUGO | International | Statement or Declaration |
| Guidelines of the National DNA bank, The Gambia | 2001 | National | Government of The Gambia | Gambia | Guideline or Policy |
| HUGO Statement on Human Genomic Databases | 2002 | International | HUGO | International | Statement or Declaration |
| MRC Guidelines on Ethics for Medical Research, Reproductive Biology, and Genetic Research | 2002 | National | Medical Research Council of South Africa | South Africa | Guideline or Policy |
| Procedures and Guidelines for Access and Collection of Genetic Resources in Malawi | 2002 | National | National Research Council of Malawi | Malawi | Guideline or Policy |
| The Human DNA Regulation Act | 2009 | National | Government of Tanzania | Tanzania | Law or Act |
| Policy Requirements, Procedures and Guidelines for Conduct and Review of Human Genetic Research in Malawi | 2012 | National | National Health Sciences Research Committee | Malawi | Guideline or Policy |
| H3Africa Data and Biospecimen Access Committee Guidelines | 2017 | International | H3Africa | Africa | Guideline or Policy |
| H3Africa Decision Tree for Feedback of Individual Genetic Results | 2017 | International | H3Africa | Africa | Guideline or Policy |
| H3Africa Ethics and Governance Framework for Best Practice in Genomic Research and Biobanking in Africa | 2017 | International | H3Africa | Africa | Guideline or Policy |
| H3Africa Guidelines for Community Engagement | 2017 | International | H3Africa | Africa | Guideline or Policy |
| H3Africa Guidelines for the Return of Individual Genetic Research Findings | 2017 | International | H3Africa | Africa | Guideline or Policy |
| H3Africa Guideline for Informed Consent | 2018 | International | H3Africa | Africa | Guideline or Policy |
| Human Genetics and Genomics in South Africa: Ethical, Legal and Social Implications Consensus Study | 2018 | National | Academy of Science of South Africa | South Africa | Guideline or Policy |
| Mentions genetics/genomics research | |||||
| National Health Act | 2004 | National | Government of South Africa | South Africa | Law or Act |
| ISSCR Guidelines for the Conduct of Human Embryonic Stem Cell Research | 2006 | International | ISSCR | International | Guideline or Policy |
| National Biotechnology Authority Act | 2006 | National | Government of Zimbabwe | Zimbabwe | Law or Act |
| Guideline for Obtaining Informed Consent For the Procurement and Use of Human Tissues, Cells and Fluids in Research | 2007 | International | WHO | International | Guideline or Policy |
| National Code of Heath Research Ethics | 2007 | National | Ministry of Health | Nigeria | Law or Act |
| Guidelines for Ethical Conduct of Research Involving Human Subjects | 2008 | National | Ministry of Health | Sudan | Guideline or Policy |
| National Guidelines for Ethical Conduct of Research Involving Human Subjects | 2008 | National | Ministry of Health | Kenya | Guideline or Policy |
| Good Clinical Practice Regulations | 2009 | National | National Agency for Food and Drug Administration and Control | Nigeria | Law or Act |
| Rwanda Ministry of Health, National Research Ethics Committee Standard Operating Procedures | 2009 | National | Ministry of Health | Rwanda | Guideline or Policy |
| National policy for Science, Technology and Innovation | 2011 | National | Ministry of Higher Education, Science, and Technology | Angola | Guideline or Policy |
| Regulations Relating to Artificial Fertilisation of Persons (Regulations added to the National Health Act of 2003) | 2012 | National | Ministry of Health | South Africa | Law or Act |
| Policy Statement on Storage of Human Samples in Biobanks and Biorepositories in Nigeria | 2013 | National | National Health Research Ethics Committee of Nigeria (NHREC) | Nigeria | Guideline or Policy |
| The National Health Research Act | 2013 | National | Government of Zambia | Zambia | Law or Act |
| Guideline for Application to Conduct of Clinical Trials in Liberia | 2014 | National | Liberia Medicines and Health Products Regulatory Authority (LMHRA) | Liberia | Guideline or Policy |
| National Guidelines for Research Involving Humans as Research Participants | 2014 | National | Uganda National Council for Science and Technology (UNCST) | Uganda | Guideline or Policy |
| National Research Ethics Review Guideline | 2014 | National | FDRE Ministry of Science and Technology | Ethiopia | Guideline or Policy |
| Ethics in Health Research Principles, Processes and Structures | 2015 | National | Ministry of Health | South Africa | Guideline or Policy |
| WMA Declaration of Taipei on Ethical Considerations Regarding Health Databases and Biobanks | 2016 | International | WMA | International | Statement or Declaration |
| Research Registration and Clearance Policy and Guidelines | 2016 | National | Uganda National Council for Science and Technology | Uganda | Guideline or Policy |