table of contents, a list of abbreviations, description of policies of data handling, and financing and

insurance agreements.

Carrying Out a Clinical Trial

After you’ve designed your clinical trial and have described it in the protocol document, it’s time to

move on to the next step. The operational details will, of course, vary from one study to another, but a

few aspects apply to all clinical trials. In any study involving human participants, the most important

consideration is protecting those participants from harm.

Since the end of World War II, international agreements have established ethical guidelines for

human research all over the world. Regardless of the country in which you are conducting

research, prior to beginning a human research study, your protocol will need to be approved by at

least one ethics board. Selection of ethics boards for human research depends upon where the

research is taking place and what institutions are involved (see the later section “Working with

Institutional Review Boards”).

Protecting clinical trial participants

In any research involving humans, two issues are of utmost importance:

Safety: Minimizing the risk of physical harm to the participant from the drug or drugs being tested

and from the procedures involved in the study

Privacy/confidentiality: Ensuring that data collected during the study are not breached (stolen)

and are not made public in a way that identifies a specific participant without the participant’s

consent

The following sections describe some of the infrastructure that helps protect human subjects.

Surveying regulatory agencies

In the United States, several government organizations oversee human subjects’ protection:

Commercial pharmaceutical research is governed by the Food and Drug Administration (FDA).

Most academic biological research is sponsored by the National Institutes of Health (NIH) and is

governed by the Office for Human Research Protections (OHRP).

Because research ethics are international, other countries have similar agencies, so

international clinical trial oversight can get confusing. An organization called the International

Conference on Harmonization (ICH) works to establish a set of consistent standards that can be