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Red tape hampers research for vulnerable groups treatment

There is an urgent need to develop a clear risk standard in law that is consistent with national and global ethics guidelines – or South Africa’s research data vacuum will expand  and clinicians won’t know how to treat vulnerable key populations.

Describing the clash between Section 71 of the National Health Act and national and global ethics guidelines as ‘a disaster, Professor Mark Blockman, chair of the University of Cape Town’s Ethics Committee, says HIV and TB research among adolescents and pregnant teenagers suffers the most.

He was addressing an ethics session at the 6th HIV Clinician Society Conference in Cape Town last week, reports Chris Bateman for MedicalBrief.

“Nobody wants to do this research because there are all these bureaucratic hurdles. You need parental consent for adolescents, buy-in from all the players – so the researchers simply say, no it’s too hard, I’ll stick to adult research,” he said.

The result was a paucity of research into adolescent health problems via clumsy legal over-protection.

While finding a balance between protecting people and doing research was important, the opposite of this was that if you did not collect the data, or made it too difficult to do so, you were not protecting anybody, he added.

Blockman gave examples of knowledge gaps in treating TB and/or HIV in adolescent and/or pregnant teenagers.

“We have no clue. We’re guessing! But we’ve made them more vulnerable because of these barriers to researching them. Nobody wants to enrol them," he stressed.

What was needed was to unlock, (or temper), some of the legislation that was preventing research from occurring, such as the mandatory duty, when doing sexual debut research, to report the number of prior sexual encounters a young woman has had.

“And then you tell her, because you must, “Oh, and by the way, I’m also going to tell the social worker. Do you think she’ll enrol with me? Never – so I must find another mechanism, like giving her sufficient information to understand that if there are any problems, these are the channels she can go to, especially if there’s abuse. A more nuanced ethical approach is needed.”

There was a need for clear ethical guidelines that considered complex intersections between the nature of the research, age-related factors, social determinants of health, cultural factors, and gender inequality – all of which influenced adolescent vulnerability.

Post clinical trial and ancillary care were essential ethical considerations, while the framework could be broadened to include an ethical obligation to address structural inequities. For informed consent to work, strategies to diminish the intrinsic legal/ethical dissonance were vital, while the higher the congruence between the researcher and the participant, the greater the likelihood of consent.

Independent consent was crucial – and recruitment to trials was rendered more difficult by the requirement that their parents be informed about the nature of the research – which was not always in the best interests of the adolescent.

Blockman said he saw the solution as convincing every ethics chair on every university campus, ‘that this madness must stop, and then thrashing it out,’ at the country’s most powerful relevant committee, the national health research ethics committee.

“We can then look to see where the constitutional problems are – we don’t want to cause harm, or have this play out in the courts -we need buy-in. If we must be forceful, then so be it. If we must apologize to one another afterwards, that’s fine.  But the red tape is resulting in unnecessary suffering out there and it needs to be undone,” he stressed.

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