When writing an Investigator-initiated clinical research protocol, which method may help limit both conscious and unconscious bias?

In the context of clinical research protocols, employing strategies that minimize bias is vital for ensuring the integrity and reliability of study results. Each of the methods mentioned can play a significant role in this regard.

Utilizing a double-blind approach is particularly effective as it keeps both the participants and the researchers unaware of who is receiving the treatment and who is getting a placebo. This helps mitigate both conscious bias (where researchers may unintentionally influence results based on their expectations or beliefs) and unconscious bias (which occurs without the express awareness of the researcher). By masking both parties, the validity of the outcomes is better protected against any preconceptions.

Similarly, a single-blind approach can also limit bias, particularly from the participants' side. In scenarios where only the participants are blinded to the treatment assignment, it can still reduce their expectations, helping to prevent them from influencing the outcomes based on their opinions about the treatment.

Masking, which generally refers to the broader technique of concealing information regarding treatment assignments, serves as an overarching term that includes both single and double-blind designs. It aims to reduce any possible biases that might arise from knowledge of the treatment being administered, thus further supporting the integrity of the data collected.

Taken together, all these methods contribute