HSRC Integrated Annual Report 2018/2019

Between 1 April 2018 and 31 March 2019, the REC met 10 times via video- and tele-conference, as scheduled. A total of 110 new applications were considered, of which 60 were internal to the HSRC and 50 were external. There were no applications submitted that made request for exemption. There were 25 requests for amendments, extensions, and additions to approved studies. Such requests are mainly triggered by a change or extension in the scope of work and coverage area. There were 17 applications for renewal of protocols. The rate of annual ethics renewal remains low and the HSRC and the REC will continue to address this factor in the coming year. Members of the REC and HSRC researchers are encouraged to participate in relevant training opportunities to ensure basic awareness and continuous professional development in the field of research ethics. All members of the REC have submitted certificates of successful completion of required modules of the on-line Training and Resources in Research Ethics Evaluation 3 (TRREE) Programme. Applications for ethics review must be accompanied by proof of successful completion (by at least the principal investigator) of the South African module of the TRREE Programme. Apart from the above-mentioned TRREE training, a formal induction workshop was offered to REC members on 12 February 2019. A two-day interactiveworkshop entitled “Responsible and ethical conduct of research – from research policy to good practice” took place at SPU on 4 and 5 February 2019. The REC administrator and internal deputy chairperson, as well as one of the two HSRC Research Integrity Officers (RIOs) incumbent at the time presented and facilitated discussions involving senior management and academic staff at SPU. One of the outcomes of the workshop was that the HSRC REC will provide support to SPU in terms of protocol reviews as well as capacity development in the area of REC administration. Research Integrity The HSRC remains committed to improving and implementing research ethics and research integrity policies and procedures. The HSRC Board approved a formal policy on research integrity in 2011. The approved HSRC policy is complemented by a “Statement on dealing with allegations of research misconduct under United States Public Health Service (USPHS) research-related activities for foreign institutions”. Two persons, Dr Christa van Zyl and Dr Njeri Wabiri, were appointed to serve as HSRC RIOs, during the reporting period. They work closely with the deputy CEO of Research and the chairperson of the HSRC REC, and benefit from collaboration with research programmes and various support units in the HSRC. The term of appointment of Dr Van Zyl came to an end on 31 March 2019, and she was replaced by Ms Khutšo Sithole in the new financial year to work with Dr Wabiri, whose appointment remains in place. The following responsibilities are entrusted to the RIOs of the HSRC: • Promoting the responsible conduct of research through awareness raising and capacity building activities, in collaboration with relevant resource persons, as well as research and support units in the HSRC; • Ensuring that there are procedures and systems in place to receive, appropriately assess, and correctly refer allegations of research misconduct; • Taking responsibility for record-keeping and reporting of possible cases of researchmisconduct, as may be required by the HSRC, as well as local and international funders, including the USA Department of Health and Human Services; and • Ensuring that confidential information made available to the RIO is treated with discretion and in accordance with principles outlined in the policy on research integrity. In terms of compliance requirements, the HSRC met all the requirements as set by the Office of Research Integrity (ORI) in the United States of America, for research funded by their Department of Health and Human Services (DHHS), and an annual report covering the 2017 calendar year, dealing with research funded by the DHHS was submitted in April 2018. During the year under review, one allegation of potential misconduct by an HSRC staff member was received. This particular case did not involve funding from the US DHHS. After due investigation, the matter was referred to the executive director of the research programme concerned. Other enquiries dealing with issues falling outside the jurisdiction of the HSRC and its RIOs were also received, and advice offered. Training and awareness raising to promote responsible conduct of research continued. Apart from the workshop held at SPU in February 2019, 3 Training and Resources in Research Ethics Evaluation (TRREE): an online training programme on the ethics and regulation of health research involving human participants (http://elearning.trree.org) HSRC INTEGRATED ANNUAL REPORT 2018/19 / 75