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 application 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 partners) run their own IRBs

with jurisdiction over research conducted at their institution. 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

services of a consulting or free-standing IRB. The sponsor of the research may recommend 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.

Prior to performing any procedures on a potential participant (including screening tests

involved in determining eligibility), study staff must go through an approved ICF document with

the potential participant and give them time to read it and decide whether or not they want to

participate. If they choose to participate, the ICF must be signed and witnessed. The signed ICFs

must be retained as part of the official documentation for the project, along with all data collected

(including laboratory reports, ECG tracings, and records of all test products administered to the

participants), as well as records of all procedures performed on participants. The sponsor, the

regulatory agencies, the IRB, and other entities may ask to review these documents at any time as

part of oversight.

Considering data safety monitoring boards and committees

For clinical trials of interventions that are likely to be of low risk (such as drinking green tea),

investigators are usually responsible for ensuring participant safety by tracking unexpected adverse

events, abnormal laboratory tests, and other red flags during the course of the study. But for studies