Box 4.5

Lessons learned regarding ethical clearance for communications efforts

By Mitzy Gafos, Co-investigator of the MDP 301 study at the Africa Centre site, South Africa

Research Ethics Committees (RECs—as IRBs are called in South Africa) are required to review study-related information sheets. The REC for the Africa Centre reviewed all participant information relating to the MDP 301 study, a multicentre trial that investigated the safety and effectiveness of the candidate microbicide PRO 2000. However, our REC wanted to review all information that the study team disseminated in the community even if it was not directly related to the study—for example, talks about World AIDS Day or the No Violence Against Women campaign. The Africa Centre had to get REC approval for all forms of media; this included study updates in community magazines and drafts of talks for radio shows, even a draft Q&A sheet that would be used during radio phone-in shows.

The turnaround times for the review and approval of the materials proved to be a real challenge. For example, when the cellulose sulfate (CS) microbicide trial closed unexpectedly, the Africa Centre MDP team immediately produced a leaflet explaining why the CS study had closed, reinforcing that the products being tested in the two trials were different and that the MDP study testing PRO2000 would continue. We submitted the CS information sheet to the REC in early February 2007 but only received approval, with no recommended changes, three months later despite regular requests for approval. By then, our research team had already verbally informed all of the participants about the closure of the CS trial and its implications for the MDP 301 study.

Following the CS closure, we adopted various strategies at the Africa Centre to reduce the time between review and approval of communications resources, including:

Flagging urgent communications needs. When the 2% PRO 2000 gel arm of the MDP 301 study was unexpectedly discontinued, we built on the lessons from the CS closure and were better prepared in terms of managing the turnaround time of communications. As soon as we were informed of the Data and Safety Monitoring Board (DSMB) recommendation, I contacted the chair of the ethics committee and informed him that we would be submitting an information sheet about the discontinuation within 24 hours. I stressed the urgency of being able to inform the community and requested an urgent approval by the chair to use the materials, pending a full review by the committee. This time the materials were turned around within seven days, and we were able to support verbal explanations about the protocol change with written materials, which helped participants further explain the discontinuation to partners and family members.

Getting materials pre-approved. We put together a series of documents with standard messages about the study, which we submitted for pre-approval by the ethics committee. These materials were not used regularly but could be utilized immediately if needed.

Scenario planning for upcoming results. Two months before the investigators were aware of the MDP 301 trial results, we submitted three separate information sheets to the ethics committee for review: all with a standard background section, then three different scripts based on the possible outcomes of the trial—not effective, marginally effective, and effective—and the related implications of each scenario. All of the information sheets were pre-approved by the ethics committee, so the minor changes that were required once the results were known could be addressed within 24 hours by e-mail. This enabled the site to disseminate the information sheet on the day of public release.

Get it in writing. Different ethics committees and chairs interpret international and national regulations differently. We learned that asking the committee to put in writing what they expected of the study, and proactively asking for updates if committee members changed, helped enormously in streamlining the ethics review and approval process.