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

3. Elements of a Successful Informed Consent
Presented by the National Institute of Mental Health within the National Institute of Health

4. Code of Federal Regulations TITLE 45 PUBLIC WELFARE DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 46 PROTECTION OF HUMAN SUBJECTS

5. NIH Office of Human Subjects Research Website

6. 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

7. 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.

8. 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.

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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)