Att 14A_08AU_Informed Consent Physician Focus Group

pg.3 of 3 Informed Consent - Physician

Assessing Problem Areas in Referrals for Chronic Hematological Malignancies and Developing Interventions to Address Them

HSC–SPH–07-0187

INTRODUCTION

You are taking take part in a behavioral research study being conducted by MD Anderson Cancer Center and the University of Texas Health Science Center at Houston. Your participation in this study is strictly voluntary, and you may refuse to take part, or choose to stop taking part in the study at any time. This form explains why we are conducting this research study and what your role will be if you choose to participate. This form also describes the possible risks and benefits connected with being in this study. We ask that you read this form, ask any questions pertaining to your participation, and then decide if you are willing to be a participant in this study.

DESCRIPTION

Purpose of Study

Many advances have been made in cancer screenings and treatments. The best way that these advances can benefit patients is if they are implemented quickly and correctly. The purpose of this study is to build the foundation of the development and evaluation of a program to improve early referral and treatment for cancers of the blood (chronic hematological malignancies).

Description of Research

For this study, you will participate in a group discussion about your experiences with hematologic malignancies. We are particularly interested in finding out physician’s experiences with diagnosing hematologic malignancies, treatment and referral. For example, what factors or scenarios lead a physician to (1) recognize a patient with a malignancy, (2) consult another physician, (3) make a referral, and/or (4) diagnose a hematologic malignancy? Specifically, we will ask about your background, general demographics of your patients, and specific examples of your experiences in diagnosing, referring and treating patients with possible hematologic malignancies. The information we obtain from these focus groups will assist us in developing an educational intervention with the purpose of improving practice and patient care.

This focus group discussion will take about 1 hour of your time. If at any time you do not feel comfortable discussing any of these topics, you may choose not to discuss the topic or you may leave the focus group. There is no cost associated with you participating in this research study; however, we will compensate you for your time. Confidentiality will be maintained by not collecting any personal identifying information. Participants may choose to discontinue participation at anytime, if they feel uncomfortable or deem it necessary. In a focus group discussion there are no correct answers and all participants are encouraged to express views. The focus group discussion will be lead by a trained facilitator who will use a set of standard questions and interview probes.

What Will Happen if You Agree to Participate

We will ask you to discuss your professional experience with hematologic malignancies. Throughout this focus group, we may ask you questions that will help you elaborate on your professional experiences with hematologic malignancies.

Benefits

There are no direct benefits to you for being a part of this study. However, the information you provide may be able to help future cancer patients. Your answers will help us learn how to do a better job of giving doctors the information they need to help their patients. The results of this study may lead to future interventions or programs that may help with diagnosing and referring patients with blood cancers.

Time

The total time you will spend talking with us will be about 1 hour minutes.

Risks

There is no physical or employment risk to you. What you decide will not affect your professional relationship at MD Anderson. Participation in this study will take away from your professional or personal time, possibly causing an inconvenience. At times, you may feel awkward about discussing your experience. All efforts will be taken to minimize any possible risks, side effects, or discomforts from participating in this study.

Alternatives

You may choose not to take part in this study. You may refuse to answer any question that makes you feel uncomfortable, at any time.

Payment

There is no cost to you for participating in this research study. We will pay you $50 for your time in talking with us about your professional experience.

Your Rights

If you want to take part in this study:

• You must sign this consent form. We will give you a copy of this signed form for you to keep.

• If you do not want to be a part of this study, please tell the research assistant now.

• Taking part in this study is your choice. You can choose not to be in the study. You can choose to stop taking part, at any time, even after you have signed this form. You can refuse to answer any of the questions we ask, whether we are asking you in person, on paper, or on the phone.

• The plan for this research has been reviewed by a group of people at each institution. Their staff can answer your questions and concerns about your rights as a research participant:

At MD Anderson Cancer Center:

The Institutional Review Board

Phone: 713-792-2933

Study Code:

At the University of Texas Health Science Center:

The Committee for the Protection of Human Subjects

Phone: 713-500-3985

Study Code: HSC–SPH–07–0187

Your Health Information (HIPPA)

No personal identifying or health information will be collected from you. This includes your name, age, birth date, contact information, etc.

Questions and Signature

Check below only if

• You understand what we have said in this form

and

• You wish to join the study.

Make sure your questions have been answered.

If you have any questions about the study itself, please call Dr. Kay Bartholomew at 713-500-9080 or Dr. Lewis Foxhall at 713-792-2202. They will be glad to talk to you and answer any questions.

Written consent

_________________________ _______________________________ ____________

Participant’s Name (Print) Participant’s Signature Date

_________________________ _______________________________ ____________

Research Interviewer Name Research Interviewer Signature Date

_________________________ _______________________________ ____________

Translator Name (if applicable) Translator Signature Date

Time: _______:______am / pm (circle one)