**Ethics approval** must be obtained for each cohort, study and sub-study according to the guidelines and rules for the institution and country. Copies of the ethics approval documents (including applications, responses from IRBs, certificates, information sheets and informed consent templates & questionnaires) should be available on request and approval numbers must be included in the publications. These documents need to be stored in a central APCC archive in order to evaluate and monitor compliance with APCC policies and guidelines.  Where data is collected without an approved protocol (for example, routinely collected health care information), APCC will work with individual data supplier to ensure that the appropriate permissions are obtained before the data is shared. These permissions will be contingent within the countries. In countries where there research regulatory systems are still developing and there are no review process for data sharing, APCC will work with in-country researchers (PIs) and may request to apply the APCC guidelines in absence of any in-country guidelines. **Consent information and options**: In addition to appropriate ethical approvals, the primacy of informed consent is central to any research conducted under the auspices of APCC. Specific guidelines and consent templates will be developed by the Ethics working group. Data and Biospecimen shared with APCC members must be accompanied by approved consent forms. The information in the consent forms must include statements that explain data and biospecimen sharing. The consent forms must explicitly seek permission from participants to share their data and biospecimen. Seval options for sharing are available; different countries ascribe to different forms of consent. APCC will work with country permissions rather than impose its own, while also building in-country capacities. Where participants refusal for data and/or sample sharing, that data cannot be shared with APCC and will be under the custodianship of the primary research/host institution. Where consent for sharing is provided, this can be in form of **broad consent** where data and biospecimens can be shared with others and for indefinite time. Other forms of consent include **dynamic consent** where participants request to be re-contacted and re-consented for any subsequent sharing. **Specific consent** is given for sharing data for a very specific question/research area, or with specific institution/individuals, or for specific time frame. APCC will be guided by in-country regulations and permissions. It will also aim to support – as far as possible – countries whose ethics guidance are still developing. #### Data anonymisation or pseudoanonymisation - All data will be de-identified and linked to a study ID - Identifiers will only be kept by the cohorts that collected the data and biospecimens and who could provide linking back to participants, should this become necessary. - Standardised guidelines will be developed to guide cohort data managers in methods for data masking, generalization of cohort data, data swapping and aggregation to promote the privacy of cohort data #### Benefit sharing - The types and forms of benefit that can arise from research conduct could vary. A critical aspect of research is to generate new knowledge. The transformation of that knowledge to sharable benefits is a long and complex process. Recognising this, however means that as far as possible, research should consider the different forms and types of benefits that can arise in research, and how those are equitably shared. - Some of the benefits from research is to inform and transform health care practices. Policy engagement and translation of research into policy decisions and actions will be a critical aspect in research conduct. APCC offers a platform in which large scale studies can be conducted efficiently and generalisability of findings can be assessed. - Benefit sharing with the cohort communities should be discussed and the results and outcomes of the individual studies should be communicated through appropriate contextually relevant channels. In all the dissemination of findings, protection of privacy and confidentiality of individual participants and of participating communities – as far as possible – should be upheld. - A key aspect of all the APCC activities is engaging communities, the public and individual participants, and strengthening transparency of the research undertaken with the data and biospecimens. Benefit sharing will seek opinions from diverse stakeholders including the community members and cohort populations. In some instances, capacity of local research teams to undertake community engagement would be necessary, APCC will consider how such initiatives can best be supported, whilst also encouraging individual researchers to seek funding support as much as possible. - For each approved request for access, APCC will check if the requestor may derive any form of commercial gains from the use of the data or biospecimens  or develop a new product or intervention. If so, APCC, in consultation with ethics committees and Intellectual Property (IP) offices, shall assess the potential benefits and risks of this activity to participants or their communities.   - The APCC would then make a decision on whether or not the agreement should be modified to include specific benefit-sharing arrangements. #### Intellectual property rights and patents - The APCC is in support of initiatives aimed at developing products and interventions that may improve health outcomes in Africa and the world. - Intellectual property will be dealt with through relevant laws related to the applicable protocol and underlying third-party agreements. - Specific IPR policies and guidelines for APCC will be developed, with involvement of legal experts, ensuring that they provide grounds for resolving that might arise in attribution and management of IPRs. - Should IP arise from the joint project, attribution will be managed according to the processes of the relevant parties taking into account the contributions from all those involved in accordance with the legal frameworks in each country. - Each Party will be mindful of the needs of the other with regard to disclosure of information that may attract IP. Should either party consider that a joint publication would disclose Joint Project IP, the other Party should be notified at least thirty days prior to publication, that Party may request a delay in publication of up to ninety days in order to secure protection of the Joint Project IP. - Any intellectual property (IP), patents or royalties arising from APCC data should be equitably divided among the originator of the data and the innovator. IP and patents will only be acceptable if they will not impede further research. - All investigators and external users have the responsibility to honour the policies of their respective institutions in the acquired IPs. **Relevant references** Deflaux N, Selvaraj MS, Condon HR, Mayo K, Haidermota S, Basford MA, Lunt C, Philippakis AA, Roden DM, Denny JC, Musick A, Collins R, Allen N, Effingham M, Glazer D, Natarajan P, Bick AG. Demonstrating paths for unlocking the value of cloud genomics through cross cohort analysis. Nat Commun. 2023 Sep 5;14(1):5419. doi: 10.1038/s41467-023-41185-x. PMID: 37669985; PMCID: PMC10480504.