- US funding for clinical research in South Africa is incrementally being cancelled.
- This is happening through at least two processes. The first is by banning certain kinds of foreign grants called sub-awards (which is affecting everyone globally).
- The second is by failing to issue routine renewals of grants for clinical studies in South Africa.
On 1 May, the US National Institutes of Health (NIH), which is the largest public funder of biomedical research globally, published a new policy prohibiting all foreign sub-awards. As a result, billions of rands in research grants for South African clinical studies are unlikely to be renewed over the next year.
Sub-awards occur when the principal recipient of an NIH grant passes some of the money to a second research group with which they are collaborating (often overseas). For instance, a university in the US may receive an NIH grant to test an experimental HIV medicine. In turn, they may provide some of the grant money to researchers in South Africa so that the medicine can be trialled in a country where HIV is more prevalent.
Under the new NIH policy, this is no longer allowed. Awards that have been directly provided to foreign institutions by the NIH can remain in place, but any NIH-funded projects that rely on a foreign subgrant will not be renewed.
South African researchers receive a few billion rand in NIH funding each year, only a minority of which comes from direct awards. It’s thus expected that most of the NIH funding for research groups in the country will effectively be cancelled.
The new policy doesn’t apply retroactively, so researchers aren’t receiving termination notices, but it does prevent the renewal of existing programs. NIH grants are typically provided in annual instalments. Recipients that were due to have their subgrant renewed on 1 May have thus lost their funding immediately, while those that are only due for their next instalment later in the year should have a few months’ of funding left.
As a result of the policy, a number of active NIH-funded clinical trials in South Africa are already grinding to a halt. Some of these trials had been going on for years and were close to providing answers about the efficacy of new HIV and TB drug regimens. In many cases, patients were already on experimental treatments – the trial staff that were monitoring them will now be axed.
Since the new NIH policy is aimed at all foreign sub-grants, trials across other parts of the world are also likely being affected.
The policy announcement stated that the NIH was developing a new funding mechanism which will ensure that all new grants are provided directly. The announcement makes clear that “if a project is no longer viable without the foreign sub-award, NIH will work with the recipient to negotiate a bilateral termination of the project”.
It’s conceivable that some foreign sub-grants could be reorganised so that they continue as direct awards. But Spotlight and GroundUp understand that in South Africa specifically, clinical trials have little hope of being funded under any new mechanism.
Sean Wasserman, an associate professor at UCT, was running a clinical trial that was sponsored by an NIH sub-award. He explained to Spotlight and GroundUp that senior NIH officials met with him and his team last week and told them that their award (which was three years in) was not being immediately renewed as planned. Components of the programme that are run outside of South Africa might be funded in the future, the officials told them, but those taking place in the country would not.
“They were saying in this very murky language that all NIH money to South Africa would stop, and that South Africa would not receive funding in the future, while other foreign components might,” he said.
Crucial TB research brought to a halt
The clinical trial that was being run by Wasserman’s team had been investigating a new experimental TB treatment regimen, which is administered to patients for three months, rather than the usual six. If the regimen is successful (both in Wasserman’s study and in future trials), it would halve TB treatment time, making it easier for patients to adhere to their full course of medication.
A shorter treatment regimen would not only improve adherence in South Africa, but also in the US, which faces sporadic TB outbreaks in parts of the country.
Wasserman’s research was funded through a sub-grant from the NIH. The principal recipient had been the Brigham and Women’s Hospital in Boston, which had in turn awarded two sub-grants: one to UCT so that they could test the regimen on patients in Cape Town, and another to researchers in Haiti. The NIH had agreed to fund this for four years.
As part of the trial, Wasserman’s team had recruited 52 participants at a site in Khayelitsha.
On 1 May, the research was due to receive its fourth and final routine annual instalment. But the night before, NIH officials told Wasserman’s team that this wasn’t happening. Instead, Wasserman says they were told that “all activities at the South African site need to cease”.
For Wasserman, immediately cutting a clinical trial which is already active poses straightforward ethical problems. “We’ve got staff members employed on this grant who basically don’t have a source of salary from 1 May,” he says. “And we have trial participants who are on experimental treatment [regimens] that need to be cared for and put back into routine care, and there’s no one to do that, because we can’t pay trial staff”.
Wasserman said that the patients in the trial will now need to be transitioned to standard six-month TB treatment. They’d have to start this process from the beginning, even if they had already begun taking the experimental treatment.
This is unfair to them, says Wasserman, as they will wind up taking TB treatment for longer than if they had never been part of the trial in the first place. “TB treatment is not easy to take, and it requires people with TB to engage with health care services, potentially losing income and causing inconvenience… they didn’t consent to the need for longer treatment than routine care.”
Wasserman’s team is not the only one facing these dilemmas. Professor Ntobeko Ntusi, the CEO of the South African Medical Research Council (SAMRC), says the agency “received several terminations in the days leading up to the announcement [of the new ban on sub-awards]”. Most of the terminated grants were for HIV-related clinical trials, he said.
The ban on sub-grants is likely to have wide-reaching effects globally – figures published in Nature suggest that only a minority of foreign NIH grants are direct.
The same is true in South Africa, although there is some uncertainty over the exact numbers. Ntusi recently told Spotlight that South Africa gets around R3 billion from the NIH per year, only a minority of which comes from direct grants. The majority either comes from subawards or through cases in which South Africa is part of a network of global researchers collaborating on a project.
Meanwhile, Bhekisisa recently reported that South Africa receives around 6.65 billion rand from the NIH, with less than a billion of this in the form of direct grants.
Ntusi told Spotlight and GroundUp that the SARMC is assuming that all NIH subawards and network study grants are suspended or terminated, i.e. the vast majority of NIH funding. (Even before the announcement of the new policy, Science magazine reported that networks were no longer allowed to use NIH funds to enrol patients in South Africa.)
Direct grants also on hold
It appears that even direct NIH grants to South Africa are effectively being suspended. One South African researcher told Spotlight and GroundUp that his grants (which are direct NIH awards) had been due for routine renewal earlier this year, but that this simply never happened. When he contacted the NIH, officials simply said that no information could be provided.
Thus, although the NIH never formally issued any termination notices, the research has effectively been suspended. The same has been happening to others in the country whether their grants are direct or not, according to the researcher, who spoke on condition of anonymity.
On 25 March, an internal NIH memo, which was leaked to Nature and Bhekisisa, instructed NIH institutes and centres to “hold all awards to entities located in South Africa…”. It appears that this order has effectively been actioned.
Endless waves of grant cuts
The current culling of NIH grants is only the latest obstacle that South African medical researchers have faced this year.
In late February, the US Agency for International Development (USAID) began cancelling the bulk of its grants globally. In South Africa, many of the terminated programmes were providing HIV treatment and prevention services, but others were also research-based. For instance, USAID cut a large research programme that was developing an experimental HIV vaccine.
In early March, NIH subgrants from Columbia University were then cancelled, which affected several clinical researchers around the world, including in South Africa. Then, later in March, the NIH directly sent termination notices to several grant-holders in South Africa, alleging that they were promoting “DEI” (diversity, equality and inclusion). It seems that researchers at WITS were hit particularly hard during this wave.
The SAMRC has been coordinating efforts to address the crisis. Business Day recently reported that the SAMRC had secured 400 million rand in commitments from donor organisations to fund the shortfall, conditional on the government matching this rand for rand.
In the meantime, the cuts are only continuing. The latest approach appears to be to cancel NIH grants incrementally and discreetly, by refusing to renew them or to communicate that this is even happening.
