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Coulter I, Hardy M, Shekelle P, et al. Best-Case Series for the Use of Immuno-Augmentation Therapy and Naltrexone for the Treatment of Cancer. Rockville (MD): Agency for Healthcare Research and Quality (US); 2003 Apr. (Evidence Reports/Technology Assessments, No. 78.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Cover of Best-Case Series for the Use of Immuno-Augmentation Therapy and Naltrexone for the Treatment of Cancer

Best-Case Series for the Use of Immuno-Augmentation Therapy and Naltrexone for the Treatment of Cancer.

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Appendix D: Letters to Patients Including (3) Consent Forms

Letters to Patients Including (3) Consent Forms-Dr. Clement Patients

June, 2001

Dear

We are currently conducting a national study of patients using alternative and complementary medicine. Dr. John Clement of the Immunology Research Centre in the Bahamas has agreed to participate in this study. As part of the study we wish to obtain the records of patients enrolled in complementary and alternative care to determine the outcomes of these treatments.

You are one of approximately 20 patients from The Centre selected to take part in this Study and your participation is very important to the validity of the results. However, you do not have to participate and your decision whether or not to take part will not affect any services you receive from any health care provider. You were selected by Dr. Clement as a patient who he feels has responded well to Immuno-Augmentive Therapy (IAT).

To complete the study we would like to have access to your files in Dr. Clement's office. In addition, if you are also being treated by any other health provider (s) for the same health problem we would like permission to obtain those records. We would also like to complete a short telephone interview (10–15 minutes) with you regarding the impact these various treatments have had on your health and on the quality of your life.

No provider will be informed by us that you are receiving other care. All the information we obtain from your files is for research purposes only. We will protect the confidentiality of this information, and will not disclose your identity or information that identifies you to anyone except as required by law. We will not identify you in any reports we write. We will destroy all personal information from our files at the end of the study or sooner if no further information is required.

We will not be asking you to take part in any experimental treatments or therapies. We will be simply reviewing your medical records and asking you some questions. There are no direct benefits to you by participating in the Study but it might benefit other patients in general by showing which types of treatment benefit which types of patients.

If you are willing to participate please complete the enclosed authorizations and return them to us. A pre-stamped, addressed envelope is enclosed for this purpose.

You can request additional information about the Study or discuss problems related to the Study by calling the Principal Investigator for the Study, Ian Coulter, Ph.D. at 310–393–0411, ext. 6759.

Yours sincerely,

Ian D. Coulter, Ph.D. RAND

Mary Hardy, M.D. RAND

PLEASE NOTE THAT IF YOU ARE NOT THE PATIENT, YOU HAVE BEEN SENT THIS BECAUSE IAT HAS NOTED THAT YOU ARE THE NEXT-OF-KIN AND YOUR INPUT IS VERY IMPORTANT TO THIS NATIONAL STUDY OF ALTERNATIVE TREATMENT.

Enclosed are the following authorization forms:

Document A: Release for patient records from Dr. Clement (IAT)

Document B: Allowing us (SCEPC) to call you for a short interview

Document C: Release for patient records from any other health providers (3 forms enclosed - feel free to copy this form if there are more than 3)

You may consent to A, B or C, or all three.

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Letters to Patients Including (3) Consent Forms -Dr. Bihari Patients

June, 2001

Dear

We are currently conducting a national study of patients using alternative and complementary medicine. Dr. Bernard Bihari and his medical clinic have agreed to participate in this study. As part of the study we wish to obtain the records of patients enrolled in complementary and alternative care to determine the outcomes of these treatments.

You are one of approximately 20 patients from Dr. Bihari's practice selected to take part in this Study and your participation is very important to the validity of the results. However, you do not have to participate and your decision whether or not to take part will not affect any services you receive from any health care provider. You were selected by Dr. Bihari as a patient who he feels has responded well to Naltrexone.

To complete the study we would like to have access to your files in Dr. Bihari's office. In addition, if you are also being treated by any other health provider(s) (both conventional and alternative) for the same health problem, we would like permission to obtain those records. We would also like to complete a short telephone interview (10–15 minutes) with you regarding the impact these various treatments have had on your health and on the quality of your life.

No provider will be informed by us that you are receiving other care. All the information we obtain from your files is for research purposes only. We will protect the confidentiality of this information, and will not disclose your identity or information that identifies you to anyone except as required by law. We will not identify you in any reports we write. We will destroy all personal information from our files at the end of the study or sooner if no further information is required.

We will not be asking you to take part in any experimental treatments or therapies. We will be simply reviewing your medical records and asking you some questions. There are no direct benefits to you by participating in the Study but it might benefit other patients in general by showing which types of treatment benefit which types of patients.

If you are willing to participate please complete the enclosed authorizations and return them to us. A pre-stamped, addressed envelope is enclosed for this purpose.

You can request additional information about the Study or discuss problems related to the Study by calling the Principal Investigator for the Study, Ian Coulter, Ph.D. at 310–393–0411, ext. 6759.

Yours sincerely,

Ian D. Coulter, Ph.D. RAND

Mary Hardy, M.D. RAND

Enclosed are the following authorization forms:

Document A: Release for your records from Dr. Bihari

Document B: Allowing us (SCEPC) to call you for a short interview

Document C: Release for your records from any other health providers (3 forms enclosed - feel free to copy this form if there are more than 3)

You may consent to A, B or C, or all three.

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