Vol IX, Nov `04

Beavers suggested some tips to ensuring an effective and ethical consent process:

• Ensure ethical recruitment. "Put the subject first," Beavers said. "Set up clear guidelines about what is and is not acceptable recruitment practice."
• Write the consent document in language that is understandable regarding relevant information about the study. "Avoid using technical or clinical terms-even if you include definitions," Beavers suggested.
• Go over the contents of the form verbally with the subject. "Don't expect that patients will read and comprehend every word of a seven-page document," she offered, adding, "Discuss the form with them, ask them to explain their interpretation of the study's purpose, what will take place, and how they will be involved."
• Ask open-ended questions, e.g.: What are your expectations of this study? How do you expect to benefit?
• Make sure the form includes key elements such as reasonably expected benefits, alternatives to participation, compensation/treatment for research-related injuries, contact information for questions/concerns, disclosures/conflicts of interest, purpose of the research, explanation of the protocol, voluntary nature of the study, subject's responsibilities, and reasonable foreseeable risks/inconveniences.
• Avoid exculpatory language. A general definition of this is language through which the subject or his or her representative is made to waive or appear to waive any of the subject's rights.
• Ensure that the consent is written according to IRB guidelines; obtain IRB approval for the consent form.

Alan Milstein, JD, an attorney who has represented clients in research-related litigation, emphasized the importance of effective informed consent to protect both the researchers and the subjects. He cautioned, "If you dummy down the document, you have violated the purpose of informed consent." He further stated that "this document you spend so much time on is not evidence that the subject is informed or that he or she consents." Therefore, researchers should retain documentation regarding the entire consent process, not just the signed form.