How to Write a Clinical Trial Consent Letter

A clinical trial consent letter, or informed consent form (ICF), is perhaps the most important document you will use in your study. It must provide all information relevant to a subject's participation, bring arcane jargon down to earth, and be accurate and easy to read. It must comply with federal regulations, ethics review board requirements and your institution's standards. So many demands are made of an ICF that writing one can be overwhelming. An ICF which does not meet them is not only a breach of the law and ethics, but can even jeopardize your career. Luckily, there is a tried and true roadmap to follow.

Things You'll Need

• Scientific protocol

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Instructions

• 1

  Write a simple introduction paragraph which explains that you are asking the subject to participate in research, not standard of care procedures. Address the subject as "you" throughout the document.

• 2

  Write an explanation of the purpose of the research. For instance, write: "This study is intended to discover if this experimental drug works in the treatment of arthritis."

• 3

  Bullet point a list of all procedures which the subject will be required to participate in from the start of the trial through completion, in clear declarative sentences. If there are optional sub-study procedures which will be discussed in a separate document, list them briefly in the main study ICF.

• 4

  Indicate how long the subject's participation will be throughout the trial. Estimate the time required for each study visit, and state the total amount of calendar time to complete all visits over the course of the study.

• 5

  Ensure that you clearly indicate throughout the document those procedures which are experimental.

• 6

  List in detail any foreseeable risks to participation, starting from most likely to least likely. Within these categories, list most significant possible harm, to the least significant possible harm. For instance, risk of liver failure would come before risk of rash.

• 7

  Indicate the potential benefits of study participation, while avoiding making any promises that the intervention will succeed for your subject. For instance, write, "You may experience a lessening of the affects of your arthritis."

• 8

  Explain how you will maintain subjects' confidentiality. Typically, you will limit knowledge of your subjects' identities strictly to your research team, unless required to divulge this information by law to such agencies as the Food and Drug Administration.

• 9

  State clearly that participation in your study is voluntary, and that the subject can discontinue participation at any time, without suffering any change in his relationship with his clinical care providers.

• 10

  Provide information about what you will do with any data already collected from a subject, should he choose to stop participation before completion. For instance, state, "Any information which has already been gained from examination of your blood samples will be included in the final study data."

• 11

  Explain how a subject will be paid for his participation, and how much. As an example, write, "You will be paid $10.00 in cash for every study visit you complete, on the day of your visit." If you do not plan to compensate your subjects, clearly state that subjects will not be paid.

• 12

  Write, "If you have any questions about this study, please contact..." and enter the name, address and phone number of the Principal Investigator. You should also include a phone number at which the investigator can be reached 24 hours a day in case of emergency.

• 13

  Include contact information for the ethics committee -- such as your Institutional Review Board (IRB) -- which oversees the project, if he has any questions or complaints about his participation in the research.