72 PART 2 Examining Tools and Processes

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» ^{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 applied worldwide. The FDA and NIH have

adopted many ICH standards (with some modifications).

Working with Institutional Review Boards

For all protocols that describe research that could potentially be considered human

research, in the United States, an ethics board called an Institutional Review Board

(IRB) must review the protocol and approve it (or find it exempt from human

research laws) before you can start the research. You have to submit an applica-

tion along with the protocol and your plans for gaining informed consent of

potential participants to an IRB with jurisdiction over your research and ensure

that you are approved to proceed before you start.

Most medical centers and academic institutions (as well as some industry part-

ners) run their own IRBs with jurisdiction over research conducted at their insti-

tution. If you’re not affiliated with one of these centers or institutions (for

example, if you’re a freelance biostatistician or clinician), you may need the ser-

vices of a consulting or free-standing IRB. The sponsor of the research may recom-

mend or insist you use a particular IRB for the project.

Getting informed consent

An important part of protecting human participants is making sure that they’re

aware of the risks of a study before agreeing to participate in it. They also need to

be fully informed as to what will happen in the study before they can give consent

to participate. You must prepare an Informed Consent Form (ICF) describing, in

simple language, the nature of the study, why it is being conducted, what is being

tested, what procedures participants will undergo, and the risks and benefits of

participation. The ICF is used to guide study staff when they explain the study to

potential participants, who are then expected to sign it if they want to participate

in the study.

Potential participants must be told that they can refuse to participate with no

penalty to them, and if they join the study, they can withdraw at any time for any

reason without fear of retribution or the withholding of regular medical care. The

IRB can provide ICF templates with examples of their recommended or required

wording.