is clearly long gone in most HIV treatment and is clearly long gone in most HIV treatment and prevention research, and is probably not going prevention research, and is probably not going to be acceptable in COVID research,” he said. to be acceptable in COVID research,” he said. South Africa’s research ethics community South Africa’s research ethics community responded quickly quickly to to the theglobal globalcrisis crisisand and responded began preparing for a possible surge in urgent began preparing for a possible surge in urgent research. When the virus first crossed distant research. When the virus first crossed distant borders, Wassenaar Wassenaar and and aahandful handfulofofcolleagues colleagues borders, spontaneously formed an informal network spontaneously formed an informal network toto quickly share share relevant relevant COVID-19 COVID-19information information quickly among research research ethics ethics committee committeemembers members among across the the country. country. across
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ScientistsininSouth SouthAfrica Africaand andelsewhere elsewhereare aregrappling grapplingwith with ethical ethical dilemmas dilemmas Scientists theybegin beginclinical clinicaltrials trialsofoftherapies therapiesand andvaccines vaccinestotocombat combat COVID-19. COVID-19. asasthey
Conducting research research Conducting in aa pandemic pandemic raises raises in thorny bioethics bioethics issues issues thorny By Susan Scutti By Susan Scutti
Is it ethical to shelve studies of priority conditions to Is it ethical to shelve studies of priority conditions to conduct COVID-related research instead? How do you conduct COVID-related research instead? How do you ensure informed consent among trial participants who are ensure informed consent among trial participants who are extremely ill? Many low- and middle-income countries have extremely ill? Many and middle-income countries have been grappling withlowthese issues. In South Africa, scientists been grappling with these issues. In South Africa, scientists have already developed a large portfolio of coronavirus have already developed a large simple portfolio of coronavirus pandemic research, including observational studies pandemic research, including simple observational as well as multinational, multi-site clinical trials of studies vaccines asand welltherapies. as multinational, multi-site clinical of vaccines In all cases, research ethicstrials committees and therapies. Inaddress all cases, research ethicsbefore committees need to quickly thorny questions granting need to quickly address thorny questions before granting permission to researchers, according to Dr. Douglas permission to Dr. professor Douglas and Wassenaar,toaresearchers, University ofaccording KwaZulu-Natal Wassenaar, a University of KwaZulu-Natal professor and longtime Fogarty bioethics grantee. longtime Fogarty bioethics grantee. Informed consent remains an “ongoing debate” among researchconsent ethics committees nation’s equivalent Informed remains an(RECs)—his “ongoing debate” among of institutional review boards, explainednation’s Wassenaar. “Most research ethics committees (RECs)—his equivalent of us worry about the extent to which people comprehend of institutional review boards, explained Wassenaar. “Most they’re consenting to.” to Study protocols that compare ofwhat us worry about the extent which people comprehend a standard of care control arm versus a study intervention what they’re consenting to.” Study protocols that compare group also prove morally “tricky” because, currently, there a standard of care control arm versus a study intervention is only palliative care for COVID-19. group also prove morally “tricky” because, currently, there
is only palliative care for COVID-19. “HIV has prepared us quite well to review complicated trials,” said Wassenaar. Some South African committees “HIV has prepared us quite well to review complicated have been reviewing HIV research for the past 10 to 15 trials,” said Wassenaar. Some South African committees years and so are accustomed to “applications where the have been reviewing HIV research for the past 10 to 15 standard of care or prevention arm is quite complicated years and so are accustomed to “applications where the with a whole armamentarium of biomedical, social and standard of care or prevention arm is quite complicated behavioral things that should be considered. Placebo alone with a whole armamentarium of biomedical, social and behavioral things that should be considered. Placebo alone 110 Delaware Journal of Public Health – July 2020
Next, they they reviewed reviewed existing existingnational nationalguidance, guidance, last revised in 2015, 2015, and and found found an an enabling enablingclause clausethat that anticipated the need need for for accelerated accelerated research researchduring during an emergency. A committee committee subgroup subgroupthen thendeveloped developed procedures to facilitate rapid review of protocols. procedures to facilitate rapid review of protocols.“It “It basically recommends basically recommends full-committee full-committeereview reviewfor foraaclinical clinical trial or or research trial research that that is is more more than than minimal minimalrisk, risk,but butwe we also encourage encourage RECs also RECs to to find find faster faster ways waysof ofreviewing reviewingand and prioritizing studies prioritizing studies in in the the national national and andglobal globalinterest,” interest,” said Wassenaar. Wassenaar. There said There must must also also be be careful carefultargeting targetingofof stakeholders and opinion leaders, he said, so that everyone stakeholders and opinion leaders, he said, so that everyone is satisfied there has been sufficient engagement with is satisfied there has been sufficient engagement with affected populations. affected populations. Finally, the COVID committee endorsed an informal peerFinally, the COVID committee endorsed an informal peersupport system to empower individual REC chairs to support system to empower individual REC chairs to confidentially share a protocol and receive comments from confidentially share a protocol and“We’re receiveenriching comments other committees within 24 hours. thefrom other committees within 24 hours. “We’re enriching the review process to make sure urgency doesn’t compromise review process to make sure urgency doesn’t compromise quality and rigor,” said Wassenaar. These new measures quality saidsome Wassenaar. These measures seem toand haverigor,” enabled researchers to new receive full seem to have enabled some researchers to receive ethics approval of pandemic-related studies within full 10 to ethics approval of pandemic-related studies within almost 10 to 20 days. Importantly, South Africa’s drug regulator 20 days. Importantly, Africa’s drug regulator almost simultaneously issuedSouth assurance to swiftly review COVIDsimultaneously issuedWassenaar assurancenoted. to swiftly review COVIDrelated clinical trials, related clinical trials, Wassenaar noted. He said he and his research partners have begun to consider pandemic-related changes to have their begun Fogartyto He said he and his research partners bioethics pandemic-related research training program. “We’re to do consider changes to theirgoing Fogarty some retooling to look at lessons learned from COVID bioethics research training program. “We’re going to do and make sure our graduates and leaders on the some retooling to look at lessons learned from COVID continent inour a position to give advice and make are sure graduates andgood leaders on on thehow to respond appropriately in an emergency situation.” An continent are in a position to give good advice on how ethics committee is always both “the good guy and the to respond appropriately in an emergency situation.” An bad guy,” he suggested. Researchers committees ethics committee is always both “the think good guy and the are too bureaucratic, while committee members believe bad guy,” he suggested. Researchers think committees they’re protecting the public. “But if you are too slow and are too bureaucratic, while committee members believe inappropriately difficult—and you delay products getting they’re protecting the public. “But if you are too slow and into the public health system—then you are not on the inappropriately difficult—and you delay products getting side of the public,” said Wassenaar. “Through our program, into the public health system—then you are not on the we want to train people who consider this middle ground side of the public,” said Wassenaar. “Through our program, very seriously and can make the best possible decisions in we want to train people who consider this middle ground difficult circumstances.” very seriously and can make the best possible decisions in difficult circumstances.” 9
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