Participants in concurrent trials a challenge for HIV research

Many research organisations use biometric systems to identify study participants, but these systems do not communicate with each other and can therefore, not identify instances when participants enrol in multiple studies.

It is problematic when participants are enrolled in more than one clinical trial concurrently or sequentially, because the ethical conduct of clinical research is founded on two essential principles.

Firstly, potential participants must understand the risks and benefits and make the decision whether or not to participate, free from coercive influence.

Additionally, researchers are under the obligation to maximise the potential benefits for participants while minimising the risk of potential harm, and to protect their privacy, with the understanding that their personal information, if disclosed, could potentially be used to harm them.

Secondly, research integrity requires that clinical studies are conducted in such a way that methods used and the findings are verifiable and that the resulting data is accurate, reliable, and can be used in decision-making.

RESEARCH

When participants do not adhere to research protocols, they may view the tangible benefits of being in a trial, such as reimbursement for time and travel, or medical examinations, as a commodity to be shared with others or to be maximised by participation in multiple trials.

When a participant in one trial at a given site enrols in the same or different trial at a different site, it may put him or her at risk, either by receiving two medications that are incompatible or by giving more blood than they should safely give.

In addition, co-enrolment could lead to research data that is not correct. For example, medication from one trial might affect the results in the other trial. A trial that could have proved the value of a new medication may be discredited, and the intervention not approved.

This would result in a waste of money, the effort of researchers and the risk and time devoted by participants in the trial.

Moreover, researchers ask people to volunteer in order to gain knowledge that can help the community, so when research cannot be interpreted, the community is cheated out of the answer they deserve.

To prevent co-enrolment, biometric identifiers – such as face, fingerprints, iris or retina – can positively identify patients and control access to resources. In clinical trials, personal identifier information (identity cards, private names, birthdates, family members’ names, photographs, is stored separately from the study data.

Each person is assigned a code number and the link to identifiers is carefully guarded. Biometric identification is applied to make sure that a person is who they say they are. Biometric measurements are encrypted to protect privacy.

Such data can be linked to participants’ identifiers only by a small number of people who work at the study site.

DATABASES

Networking databases across clinical trial sites would help in the prevention of co-enrolment, but to protect privacy, this must be based on the use of code numbers that cannot be traced back to individuals by outsiders.

Already, some countries including France, Switzerland, UK and South Africa are using national registries accessible to different clinical sites to protect volunteers from the risks posed by co-enrolment in multiple studies. This requires each clinic to use the same coding system, and to share the codes (but not other data such as pictures, fingerprints, names).

However, it is difficult to completely guarantee data privacy, either because of increased abilities of computers to invade systems and decode them, or due to legal or extra-legal methods that might be used to force study staff to reveal codes.

Such breeches of confidentiality could result in harm from loss of privacy, including repercussions from revealing a person’s disease or risk status; or legal trouble for people in situations such as immigration without proper documentation or certain sexual behaviours that are illegal in some countries.

Successful use of biometric systems to prevent co-enrolment would be dependent on high levels of access control, collecting as little personal data as required, and using fail-safe systems such as remote storage of codes and methods of ‘wiping’ the record if it is stolen.

A shared biometric participant enrolment system holds great potential to reduce co-enrolment and protect the integrity of clinical trial data.

As the search for a safe, effective HIV vaccine, and for improved HIV biomedical prevention and treatment tools intensifies, a robust system that will enable tracking of participants across different sites while protecting participants’ privacy is needed

Prof Kaleebu is the director of the Uganda Virus Research Institute, while Ms Fast is senior technical advisor, research and development executive office at the International AIDS Vaccine Initiative