Informed Consent

Field Assessment of a Comprehensive Manual for Hepatitis C Counseling and Testing

Informed Consent

What is the purpose of the field assessment?

Battelle Centers for Public Health Research and Evaluation are working with the Centers for Disease Control and Prevention (CDC) to conduct a field assessment of a comprehensive counseling and testing manual for Hepatitis C (HCV). With the expansion of HCV testing and the introduction of the rapid HCV antibody test, Hepatitis C counseling and testing may become more widespread. The manual is intended to serve as a resource for counselors and health care providers who may be conducting Hepatitis C counseling and testing. The purpose of the field assessment is to obtain your feedback on the manual so that CDC can improve it. Each participant in the field assessment will be asked to review the manual, try it out with patients, and provide us with feedback on how the manual can be improved.

What will I have to do if I participate in the field assessment?

If you participate in the field assessment, we will ask you to review the manual and use it with patients or clients with whom you would like to counsel about HCV testing. We would like you to use the manual at least once a week for four weeks. At the end of the four weeks, we will ask you to participate in an interview where we will ask you to provide your feedback on the manual. This interview will take no more than 30 minutes of your time. In addition to this interview, we will also check-in with you on a weekly basis, at your convenience, to see if you have any questions about the manual. The weekly check-ins should not take more than 15 minutes of your time.

Will I receive any payment if I participate in the field assessment?

You may be eligible to receive up to $140 for participating in the field assessment.

You will receive $40 for participating in the interview at the end of the four weeks. You will also receive $25 for each week that you use the manual and participate in the weekly check-in call during the four-week period.

What are the risks to being in the field assessment?

There are no foreseeable risks related to participation in the field assessment. You can choose whether or not you want to participate.

What are the benefits to being in the field assessment?

You may not directly benefit from being in the field assessment. However, the information that you provide may be used to help improve the manual.

Will information about me and my participation be kept secure?

Your answers will be kept secure and your responses will not be linked to you personally; they will be reported as a group. The interview will be audio taped for transcribing purposes only. You have the right to review, edit, or erase the research tapes of your participation in whole or in part. Once the interviews have been transcribed, the tapes will be erased.

Do I have to agree to participate in the field assessment?

Your participation is completely voluntary. You can decide whether or not to take part in the field assessment. If you do agree to participate, you many stop at any time. You may also chose to not answer any questions that we may ask you.

What if I have questions?

If you have any questions about the field assessment, you may call the Battelle Task Leader, Gary Chovnick, at 206-528-3013. If you have any questions about your rights as a research participant, please call the Battelle Institutional Review Board toll free at 877-810-9530, ext. 500.