CHAPTER 5 Conducting Clinical Research 73

Prior to performing any procedures on a potential participant (including screen-

ing 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 (includ-

ing laboratory reports, ECG tracings, and records of all test products administered

to the participants), as well as records of all procedures performed on partici-

pants. 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 involving high-risk treat-

ments (like cancer chemotherapy trials), a separate data safety monitoring board or

committee (DSMB or DSMC) should be arranged. A DSMB is typically required by

the sponsor, the investigator, the IRB, or a regulatory agency. A DSMB typically

has about six members, including expert clinicians in the relevant area of research

and a statistician, who are external to the study staff. A DSMB meets at regular

intervals during the clinical trial to review the unblinded safety data acquired up

to that point. The committee is authorized to modify, suspend, or even terminate

a study if it has serious concerns about the safety of the participants.

Getting certified in human subjects protection

As you may have surmised from the preceding sections, clinical research involves

regulatory requirements that include penalties for noncompliance. Therefore, you

shouldn’t try to guess how to write a research protocol, obtain IRB approval, or

engage in any other research methods with which you are unfamiliar, and just

hope that everything goes well. You should ensure that you, along with any others

who may be assisting you, are properly trained in matters relating to human sub-

jects protection.

Fortunately, such training is readily available. Most hospitals and medical centers

provide training in the form of online courses, workshops, lectures, and other

resources. As you comply with ongoing IRB training, you receive a certification in

human subjects protection. Most IRBs and funding agencies require proof of cer-

tification from study staff. If you don’t have access to that training at your insti-

tution, you can get certified by taking an online tutorial offered by the NIH

(https://grants.nih.gov/policy/humansubjects/research/training-and-

resources.htm).