CHAPTER 5 Conducting Clinical Research 71

It will also contain administrative details, like names and contact information for

the research team, a table of contents, a list of abbreviations, description of poli-

cies 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 doc-

ument, 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 tri-

als. 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 Institu-

tional 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).