More than half of studies on sexually transmitted infections (STIs) did not specify if participants ever were notified of test results, according to a recent analysis of 80 studies on prevalence of STIs.1 “Left untreated, some of these infections contribute to poor health outcomes for participants and their partners,” says Joshua Grubbs, the study’s lead author and a research assistant and MD/MPH candidate at Tufts University School of Medicine.

Grubbs and colleagues were surprised to find so many articles did not include language about returning positive test results to participants. “Even though the investigators associated with the studies may have informed participants of their results, there was no documentation to let readers know,” Grubbs reports.

If investigators do try to recontact the study participants about test results, they might encounter logistical constraints. “Participants can be difficult to contact, especially in situations where sample processing occurs at another site separate from sample collection,” Grubbs laments.

For instance, in some large studies, participants may provide samples in one country, after which the samples are mailed to a laboratory in another country for bulk testing. “Investigators need to plan ahead to communicate these results back to the original sites and establish a method for getting these results to the participants themselves,” Grubbs suggests.

One tactic is to mail results to patients. Other sites might prefer to compile a report of test results and ask participants to return to their physician’s office to be informed. “Investigators that do not physically remain on site will need to maintain connections with local partners to disseminate results themselves,” Grubbs notes.

Early communication on how results will be returned can prevent investigators from running into this question for the first time in the field. “Potential obstacles to contacting participants include not having their preferred contact information, and participants themselves not knowing who to contact for follow-up,” Grubbs says.

Typically, journals do not require reporting of treatment status of study participants in the results. “We are not aware of journals that explicitly require documentation of return of results, although individual peer reviewers may raise this point themselves,” Grubbs observes.

Grubbs says investigators should develop a plan to return test results to participants, and document their actions in protocols and manuscripts. IRBs should require researchers to include these details in their proposals. “Planning entails a few critical steps. Interruption along any point can prevent results from reaching participants,” Grubbs says.

Additionally, researchers need to collect appropriate contact information and link it to samples in a secure manner that protects the privacy of study participants. Those results must be communicated from the laboratory to on-site investigators or healthcare personnel involved in conducting the study. Researchers must contact participants (or possibly have already given them notice when and how to collect their results). “We hope the study findings will be a catalyst for ensuring that all clinically relevant positive test results are returned to patients and their providers for treatment,” Grubbs says.


  1. Grubbs JC, Millum J, Rietmeijer CA, Kilmarx PH. Return of positive test results to participants in sexually transmitted infection prevalence studies: Research ethics and responsibilities. Sex Transm Dis 2021;48:834-836.