Elements of a Successful Informed Consent Training for Investigators and Research Staff

Elements of a Successful Informed Consent Presented by the National Institute of Mental Health within the National Institute of Health https://www.youtube.com/watch?v=l26hdCD9g2I

Code of Federal Regulations TITLE 45 PUBLIC WELFARE DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 46 PROTECTION OF HUMAN SUBJECTS http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#

NIH Office of Human Subjects Research Website http://ohsr.od.nih.gov/OHSR/pnppublic.php

Updated TTUHSC El Paso ICF Template Log into iRIS Go to “Help” on the homepage Review the section labeled “IRB Forms” Select the most appropriate template for your study

Recommendations… Informed consent is an ongoing conversation with the research subject that begins with the initial contact Research vs Clinical Care Ensure that the subject knows that the primary mission of the study is to conduct research and that the care that the subjects will receive on the study will be different than the standard medical care in the community. Prospective subjects should understand that they may derive no direct medical benefit from participating on the research study. Review the informed consent prior to discussing the informed consent with the subject.

Recommendations… Consent Preview Give the subject sufficient time to review the informed consent, and allow the subject to take the consent home if they would like to review it further prior to signing the form. The informed consent can be mailed to subject for review prior to the informed consent interview, but after the principal investigator has had the opportunity to discuss the study with the subject. An informed consent form cannot be signed by a participant and be mailed back to the study coordinator unless prior IRB approval is obtained. A subject can mark their own copy of the consent but must receive an exact copy of the signed informed consent form. Per GCP guidelines, the original consent form should not have any extra marks or items crossed out.

Recommendations… Presentation Style Review entire informed consent with the subject Present the details in the form of a conversation Encourage a relaxed and open atmosphere in which the subject feels comfortable asking questions Maintain good eye contact Aim for a fluent conversational tone

Recommendations… Body Language Be aware of your professional appearance Be aware of your rate of speech One Subject One Consent It is not advisable to consent a subject with more than one consent in a single session Reasonable exceptions can be made but multiple consents can be overwhelming and intimidating and is less likely to result in meaningful understanding of study involvement

Recommendations… Language The consent should be written and discussed in simple language that is consistent with an 7th grade education per TTUHSC EP Guidelines Consider that some subjects may not be literate or have achieved an 7th grade reading level Be sensitive and responsive to the level of understanding of the subject

Recommendations… Environment Conduct the consent conversation in an area where there is privacy Conduct the consent conversation in an area where the subject can have enough time to review and digest the content The room should be well lit and the amount of staff present should be limited for confidentiality and to make it easier for the subject to ask questions Give them the option of having a significant other present during this process

Recommendations… Clinical Research Advocate An independent consent monitor may be present for studies that are greater than minimal risk, involve a vulnerable population, or require an extra layer of protection but are not required unless mandated by the IRB or the principal investigator

Summary Introduction, including voluntary nature of research Study Purpose Qualifications to participate Design and duration Risks and discomforts Right of withdrawal Benefits New findings Alternative Treatments Confidentiality Policy regarding research related injuries Compensation Problems or questions (contact information)