Medicals c i e n t i f i c study

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Medicals c i e n t i f i c study"

Transcription

1 Medicals c i e n t i f i c study design risks medical-ethics review board 2

2 Table of contents M e d i c a l - s c i e n t i f i c study Preface 2 Introduction 4 Medical-scientific study 5 Why participate? 6 Risks and side-effects 7 Scientific drug study 8 Design of a studyk 9 Medical-ethics review board 10 You are asked 11 Your rights and obligations 13 Insurance 16 Researchers 17 Do you know enough? 18 Glossary 19 1

3 Preface Man does not live for himself alone. In all of the areas of life, that can been seen most clearly within the healthcare sector. In our country, we cover the costs of healthcare together, so that everyone in the Netherlands who has been afflicted by illness or accident can profit from state-of-the-art care. The system in our country is based on solidarity. In order to maintain the high level of care and, whenever possible, to improve it, scientific research in the field of healthcare is essential. Medical scientists are continually searching for new treatment methods. Scientific research on human beings is an absolute necessity. Here, too, an appeal is made for solidarity. If we feel able to do so, it is our task and responsibility to help medical science move forward and, where possible, make an active contribution. It goes without saying that, here, we must not lose sight of the interests of the individual. Nobody must ever become involved in medical research against his will and without his knowledge. The reverse is the case; researchers may appeal to a certain feeling of solidarity, but ultimately a person may only take part voluntarily. Research must be valuable; it must increase our knowledge. However, a comparative assessment must be made between the importance of the study and what is asked of the patient. It is the responsibility of a hospital to oversee this. For that reason, there is legislation and there are medical ethics review boards. These boards review every medical-scientific study beforehand that will be carried out on humans. They see if the study is valuable for the progress of medical knowledge and if the study has been carefully designed, with respect for those persons from whom cooperation is requested. 2

4 People who take part in a medical-scientific study can, therefore, be assured that they are not hurtling themselves into an adventure. Every study is assessed beforehand for its scientific value and ethnical admissibility. I hope that this information brochure will enable everyone, freely and responsibly, to make a decision if he/she is asked to take part in scientific research and, thus, to contribute to the quality of medical care -- a task that concerns us all. A.C. van Loenen, hospital pharmacologist, clinical pharmacologist Chairman, medical-ethics review board VU Medical Center The Dutch word onderzoek has several meanings, which can cause some confusion. [note from translator: there are different words in English for the different meanings] If you go the hospital for an onderzoek it is always a diagnostic examination. This means that you will be examined in various ways in order to discover the cause of your symptoms. Such an examination, therefore, only involves you and your complaints. A scientific study is also called onderzoek in Dutch, but this has a much broader objective and sometimes has no bearing at all on your specific complaints. Consent is always requested beforehand for participation in this type of study. Participation is always voluntary. This brochure is about this type of onderzoek. 3

5 Introduction You have been asked to take part in a medical-scientific study. This brochure will help you in making your decision about whether or not to participate. Here, you will find general information about medicalscientific research and about what participation means for you. Your doctor will give you specific information about the study itself, both verbally and in writing. This brochure is intended to supplement that information, not to replace it. In this brochure, the following question will be dealt with: What is medical-scientific research and what does it entail? Are there risks for the test subjects? What rights do the test subjects have? How is the study carried out? At the back of this brochure, you will find an explanatory glossary and space for notes and any questions you may have. A questionnaire has also been included that may possibly be able to help you in deciding whether or not to participate. If, after reading this brochure, you still have questions, then it is best to ask your physician. This also applies to the specific information concerning the study for which your cooperation is requested. 4

6 Medical-scientific research Medical-scientific research is done in order to, among other things, find better treatments for diseases. The researchers investigate whether or not a new treatment satisfies the expectations and if it has side-effects. Such scientific research is only possible with the cooperation of test subjects. These could be patients, but could also be healthy volunteers. The cooperation of patients is essential as the research deals with studying the effects of a treatment. Other names for medical-scientific research are:: scientific research, clinical (scientific) studies, clinical research, clinical trial and medical experiment. In this brochure, we will continually use the term scientific research. Scientific research focuses on various objectives, for example: Methods for diagnosing an illness (diagnostics); Treatment of a disease; Acquisition of more insight into the functioning of the human body and pathological processes. Acquisition of more insight into the functioning of the human body and pathological processes. Scientific research can be focused on a new drug, a new surgical technique, but also on a different treatment or treatment method. Sometimes it is about a combination of treatment possibilities. However, it can also be concerned with research that has no immediate connection to the disease for which you came. Not all scientific research with patients originates with doctors. Scientific research is also done by other professional groups within the healthcare sector. You may also be asked to take part in this type of research. 5

7 Why participate? Scientific research makes it possible to implement newer and increasingly better treatment methods. Scientific research is also necessary to prove that a new drug works and is sufficiently safe before it is allowed to be put on the market and is available in the pharmacy. Without scientific research, medical science would no longer be able to develop further. A great deal of scientific research is only possible if patients provide their cooperation. You may have various reasons for participating in scientific study. A scientific study is done in order to test a new treatment that is probably better than the old one. Whether or not the treatment is, indeed, better must still be proven; that is what this study is for. The treatment has, for example, fewer side-effects than your usual therapy or the treatment is easier for you. There are, however, not always advantages if you take part in a scientific study. Sometimes, the patients themselves do not profit at all from the study they are participating in. The study is then intended to help future patients. That, too, can be a reason to participate. Whatever your reason for wanting to participate in scientific research, it is important that you know beforehand precisely what is involved. 6

8 Risks and side-effects One of the first questions that arises in patients who are asked to be test subjects is: am I at risk if I participate? The answer is: yes, that is possible. The treatments in a scientific study are new and not all of the risks and side-effects are known yet. That is, after all, precisely the objective of the study: the detection of all the effects of the treatment. For that reason, there is a certain risk for the test subject in nearly every scientific study. How large that risk is depends on the type of treatment, the patient and the condition of his illness. The researchers take all kinds of measures to make the possible risks as small as possible. Your doctor will tell you about the possible risks and side-effects of the study you have been asked to participate in. Before you decide to participate, you must weigh the possible advantages against the risks or disadvantages. 7

9 S c i e n t i f i c D r u g T r i a l Many patients are asked to cooperate in scientific drug trials. Before doctors can try out a new drug on test subjects, that drug has already been through a long trajectory in laboratories and research centers. If laboratory testing has shown that a new drug would work well, the researchers then test the drug to see if it works on animals and whether or not it has side-effects. It is not until animal testing has provided good results and appears safe that it is time for research on people. Therefore, before people cooperate in a scientific drug trial, a great deal of research has already been done. The trial with people is generally carried out in various phases. In the first phase, a small number of test subjects (generally healthy volunteers) are involved. In the following phases, patients are included, first in a small numbers, later in larger groups. The doctors who carry out the study in the hospital are required to ensure that there are as few risks as possible for the test subjects. There are, moreover, various authorities that assess the scientific drug trials beforehand. One of those is the medical-ethics review board (see page 10). The central government also has its own precautionary requirements. 8

10 Design of a study Often, during the trial, the researchers compare the new treatment with the existing treatment. In order to do this, the test subjects are divided into groups. In order to have groups that are as comparable as possible, and so that the study can be done as objectively as possible, the system of randomization is used. Randomization By using a system that resembles drawing lots, it is determined which patients will receive the new treatment and which the existing one. The test subjects are not able to influence the results of the lottery, and neither can the doctor. Which group the patient is put into is entirely a matter of chance. Often, a clinical trial is done double-blind: neither your doctor nor you then known which group you are in. (If, in the case of an emergency, it nonetheless becomes necessary, it is always possible to find out which group you are in). Placebo Sometimes, a researcher wants to know if the positive effect of a new treatment is only due to this specific treatment. Several factors could, namely, play a role here. In order to learn more about this, it is necessary to compare the new treatment with no treatment. This is done by giving the one group of patients the treatment and not the other. This is not so simple, because if you do get the drug and your fellow test subject does not, then you both know which group you are in. In order to be able to compare the new treatment with no treatment, researchers will then make use of a placebo 9

11 treatment. A placebo looks exactly like the drug being tested, except that a placebo does not contain any active substances. Research with placebos is only permitted if there are no negative effects for your disease. The researchers and the medical-ethics review board pay close attention to this. M e d i c a l - e t h i c s review board The Human Medical Research Act (WMO) stipulates that research proposals may not be implemented until they have been approved by an authorized medical ethics review board. Many Dutch hospitals have such a board, as does the VU Medical Center. This board, is composed not only of physicians, but also a nurse, a hospital pharmacist, a general practitioner, a psychologist, a clinical epidemiologist, an expert in the field of medical ethics, a lawyer and person who assesses the study from the viewpoint of the patient. The board examines, among other things, whether or not: the study is worthwhile; there are not too many risks and/or disadvantages for the test subjects who are involved; there is sufficient written information available for the test subjects. 10

12 If the board feels that the study does not sufficiently take the interests of the patient into account or is too heavy a burden for the test subjects, it will not approve the study. This means that the researcher may not implement his study in the present form; he will first have to make adjustments. Doctors may, therefore, not simply carry out a study without assessment and approval beforehand. The study which you have been asked to participate in has been approved by the medical-ethics review board of the VU Medical Center. The medical ethics review board provides a general judgment about the admissibility of the scientific study. That does not mean that the board members are advising you to take part. They do not, after all, know your situation and, therefore, cannot decide this for you. You alone can determine if the possible advantages of the study compensate for the disadvantages. You are asked Your consulting physician or another staff member at the hospital will ask you if you would like to participate in a scientific study. He will discuss the study with you. Whatever he says will also be given to you in writing so that you can read it all again. If the doctor does not offer you the information in writing, you must request it. The information will also include the following: What is the objective of the study? Which treatment is being studied? What is the design of the study? What possible extra burden would there be for you from the study? What are the advantages and disadvantages for you? What will be expected of you during the study? 11

13 Moreover, the doctor will tell you what your rights and obligations are. The following chapter will discuss this more extensively. Before you decide whether or not to participate, you will be given time to think the matter over. Think about all the information and list all the advantages and disadvantages for yourself. Nearly every scientific study means, in practice, more tests and check-ups, more visits to the hospital and, therefore, more time and effort on your part. At any time, you may ask for extra information or explanation. You can find the information about who to ask in the written information about the study. You may also make an appointment with your doctor to discuss your questions. It also often helps to discuss the information with your partner, family, friends or family doctor. You may also ask for information and advice from a doctor who is not involved in the implementation of the study (an independent physician). The name of this doctor can be found in the written information on this study. If you are prepared to participate, you will be asked to sign a written permission form. This is called an informed consent form. Signing it is a kind of statement that you are, in principle, willing to participate; it means that the study has been explained properly to you and that you, subsequently, are voluntarily providing your cooperation to the study. It does not mean that you therefore also obligate yourself to complete the study. At any time, you may withdraw from the study. It is possible that the researcher will ask your permission to save blood or other body substances that are over after the necessary tests have been done. He will ask if this may be used again at a later time to do other tests. Sometimes, blood is necessary to test new laboratory methods or to determine normal levels in the blood. 12

14 This also applies for blood that was drawn from you to repeat certain tests in case something went wrong with the test the first time. Thus, you can avoid having to have blood drawn again in the case that a test failed. These blood samples are then provided solely with a code; thus, without your name and further personal data. In most cases, you will never hear about this again. If, by chance, something is found in the blood that is important for you, then we will attempt, via the code, to find out if you can still be reached. Such a coincidental finding is, however, not to be expected. Your rights and obligations As a test subject, you have rights. In order to protect test subjects, legal guidelines have been established. There are regulations concerning what a doctor may or may not do in a scientific study. The most important rights of the test subjects will now be discussed. T h e r i g h t t o d e t e r m i n e f o r o n e s e l f a b o u t p a r t i c i p a t i o n ( v o l u n t a r i n e s s ) You are never required to take part in a scientific study. It is always your free choice. If the doctor asks you if you want to be a test subject, you are certainly free to refuse. Nobody will blame you. If you decide not to participate, that will not have any negative consequences for your treatment; the doctor will not look down on you for it. 13

15 T h e r i g h t t o r e c e i v e i n f o r m a t i o n a n d a s k q u e s t i o n s You will be given a great deal of information from your doctor, both verbally and in writing. You are entitled to information, not only beforehand but also during and after the study. The doctor is required to provide you with that information. Moreover, you are entitled to time to consider and consult before you make a decision. You may always ask questions yourself: before, during and after the study. You must not be afraid to be considered troublesome. It is important that you know what is going to happen. Your doctor will try to answer your questions. Do not hesitate to ask a question again if you are not certain that you have understood the answer. For the doctor, the information about the study is familiar and obvious. For you, it is new and unfamiliar and, perhaps, not completely clear after only one talk. T h e r i g h t t o s t o p p a r t i c i p a t i n g i n t h e s t u d y b e f o r e i t i s f i n i s h e d Even when you have given your permission, you may withdraw from the study, for example, if you feel, after awhile, that participation in the study is, after all, too difficult for you. Even if you have already started with the scientific study, you always have the right to stop at any time. In some studies, that is not immediately possible once you have started. In those cases, the medication that you have been given must, for example, be cut down. That means that the dose of the drug must be decreased gradually. It is also possible that a medical procedure has already been done. The doctor will then, in consultation with you, decide what the best way for further therapy for you is. 14

16 Confidentiality of your data During the scientific study, the researchers collect specific data on, for example, the manner in which your body reacts to the treatment. The data collected concerning you is confidential and processed under a code. Your data is, namely, given a number; your name is not used. It is, moreover, not important for the study. The researcher only has access to the data under a number. The medical data that is important for you for the study can be examined by the authority who commissioned the study. Even when the results of the study are published, your name will never be able to be traced. Obligations Alongside of your rights, you, as a test subject, also have obligations. Thus, for some examinations, you will have to have fasted or you must bring the remaining medication with you every time you come. If you do not keep the appointments and adhere to the obligations, the study cannot be well conducted and the outcomes will be unreliable. In that case, your doctor will terminate your participation in the scientific study and discuss a further treatment with you The obligations differ for every study. You will receive information about this from your doctor. 15

17 Insurance Researchers try to ensure that nothing goes wrong during the study. Moreover, the medical-ethics review board sees to it that measures have been taken to avoid, as much as possible, damage due to the study. However, it is always possible that unforeseen problems arise. It is good to know that the hospital or the organization that is having the study done has taken out a special risk insurance for the study. This will pay for any possible damages that are incurred as a result of the study. Just as with any other insurance, you must adhere to certain regulations. Only then can a claim be made for the payment of damages. An insurance company does not compensate if it has not been sufficiently proven that the damage is a result of participation in the study or if you have willfully not followed specific instructions. If you feel that you have suffered damages as a consequence of your participation in a scientific study, you may contact the insurer of the study who is named in the information letter. Complaints For complaints that are connected to the implementation of the study and that you cannot solved with the doctor/researcher, you may turn to the complaints scheme in the VU Medical Center. 16

18 Researchers Some people would like to know who has designed the study or who it is who wants the data. You may ask your doctor who, in your case, started the study. There are various possibilities: 1. The initiative can be taken by the pharmaceutical industry or manufacturers of medical equipment. In their companies, they have developed a new drug or instrument that is not yet on the market. Before it can be put on the market, it must first be well tested to see if its use is effective and sufficiently safe. The company then asks a number of doctors if they will investigate that. If the outcomes are positive, then the drug can be officially registered. Large pharmaceutical manufacturers often ask the cooperation of several hospitals at the same time. In this way, they are able to collect as much data as possible. This is called a multicenter trial or a multicenter study. 2. There are also special research centers or institutes that have scientific studies done, for example, the Dutch Cancer Society. Also, a department of the hospital can itself decide to carry out a study. 3. Many scientific studies are carried out in academic medical centers. There, the task is to increase knowledge concerning disease. The usability of new and also of current -- methods of research and treatment must be tested. 17

19 Do you know enough? Questions that you can ask yourself before agreeing to participate in a scientific study: Have you also received written information about the scientific study? Is the following clear... who has set up the scientific study: what one wants to achieve with the scientific study you have been asked to participate in? what advantages this could have for you? what disadvantages there could be if you participate, such as (the chance of) possible side-effects. whether or not it going to be determined by drawing lots which treatment you will receive? which treatment you will receive or what will happen if you do not participate in the study? what the practical consequences are if you do participate (for example, admittance to the hospital, the necessity to come to the out-patient clinic more often, more frequent blood tests, extra procedures)? who is the physician in charge and how can he be reached? who is the independent physician you can turn to with questions about the study? what you can do if you have concerns in connection with the study? that participation is entirely voluntary? that you may terminate your participation at any time before the trial has ended? that non-participation or terminating your participation in the scientific study will have no adverse consequences for the doctorpatient relationship or for your further treatment? how insurance coverage has been regulated? 18

20 Glossary Clinical trial Literally, this means: clinical testing. See medical scientific study. Double-blind A research design in which neither the doctor nor the patient knows which treatment the test subject has been assigned. Ethics (medical) A system of moral norms and values, in particular in the area of health care. Pharmaceutical industry Drug industry Informed consent Literally, this means: informed permission. The permission that someone gives when he agrees to become a test subject in a clinical trial, after he or she has been given sufficient information about it. Clinical scientific study See medical scientific study Drawing lots See randomization Medical ethics review board The committee which assesses human scientific research in hospitals Medical experiment Legal term for medical scientific research, which is used in legal regulations. 19

21 Medical scientific study Systematic research of the effects of a new treatment or new treatment method according to a scientifically designed plan. Here, patients are often used as test subjects. Multicenter trial A scientific study that is carried out simultaneously in several hospitals, and sometimes even in several countries. Independent physician The physician who is not involved in the implementation of the study to whom the patient can turn for information and advice concerning the study. Researcher The person who carries out the scientific study. This is generally a physician, often the patient s consulting physician. Research protocol Detailed and planned description of a scientific study. Placebo A placebo looks exactly like the drug being tested. However, a placebo contains no active ingredients. Test subject This is a term that is used in scientific research for the healthy or sick volunteer who participates in the clinical trial. Randomization Drawing lots; chance determines which treatment a test subject will receive. 20

22 Second opinion Here, another doctor is asked for his/her opinion concerning the disease or treatment. Standard treatment The usual treatment that, at that time, is given to patients with a specific disease. This treatment is only called standard treatment during medical scientific studies. Study See medical scientific study VU Medical Center The name of the Academic Hospital of the Free University and the Faculty of Medicine of the Free University. WMO The Medical Scientific Research Act using human beings 21

23 22 Notes and questions

24 Information For general information concerning disease and/or treatment, you are welcome to come to the patient information desk of the VU Medical Center. You may come here with general questions about clinical pictures and syndromes and for information about patient organizations. The patient information desk can be found in the outpatient clinic, to the right of the main entrance. The desk is open on weekdays from 9.00am noon and can be reached by phone from 9.00am pm; number: (020) or per 23

25 Colophon Publication VU Medical Center Postbox MB Amsterdam Telephone (020) We would like to thank the research group of the Academic Hospital Maastricht for use of the brochure Participation in medical-scientific clinical trials. Design audiovisual center VU/VU Medical Center Printing document production center VU Medical Center January _E 24

26 VU medisch centrum postbus MB Amsterdam telefoon

Medical Research. General Information for Research Participants

Medical Research. General Information for Research Participants Medical Research General Information for Research Participants Contents Introduction 5 Medical research 6 What is a medical research? Who is classified as a research participant? Who conducts the research?

More information

Clinical Trials Patient-Education Brochure

Clinical Trials Patient-Education Brochure Release Date November 2005 Revised January 2008 Revised March 2012 Clinical Trials Patient-Education Brochure American Society of Transplantation 1120 Route 73, Suite 200 Mount Laurel, NJ 08054 Phone:

More information

1. Study title Is the title self explanatory to a layperson? If not, a simplified title should be included.

1. Study title Is the title self explanatory to a layperson? If not, a simplified title should be included. These guidelines apply to all research projects where human subjects are involved in the study GUIDELINES FOR RESEARCHERS PATIENT INFORMATION SHEET & CONSENT FORM The guidance, which follows, applies primarily

More information

What Cancer Patients Need To Know

What Cancer Patients Need To Know Taking Part in Clinical Trials What Cancer Patients Need To Know NATIONAL INSTITUTES OF HEALTH National Cancer Institute Generous support for this publication was provided by Novartis Oncology. Taking

More information

Research Ethics Review Committee (WHO ERC)

Research Ethics Review Committee (WHO ERC) Research Ethics Review Committee (WHO ERC) 20, AVENUE APPIA CH-1211 GENEVA 27 SWITZERLAND HTTP://INTRANET.WHO.INT/HOMES/RPC/ERC HTTP://WWW.WHO.INT/RPC/RESEARCH_ETHICS Informed Consent Template for Clinical

More information

Clinical Trials at PMH

Clinical Trials at PMH Clinical Trials at PMH What You Need To Know UHN Patient Education Improving Health Through Education A Guide for Patients, Their Families and Friends in the PMH Cancer Program This information is to be

More information

Phasel clinical trials:

Phasel clinical trials: Phasel clinical trials: what are they all about? Information for people wanting to know more about early clinical trials in cancer, Belfast City Hospital NORTHERN IRELAND CANCER TRIALS CENTRE Introduction

More information

National Cancer Institute

National Cancer Institute National Cancer Institute Taking Part in Cancer Treatment Research Studies U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Taking Part in Cancer Treatment Research Studies If

More information

A Participant s. Guide. to Mental Health Clinical Research

A Participant s. Guide. to Mental Health Clinical Research A Participant s Guide to Mental Health Clinical Research Contents Purpose of this document... 1 What is clinical research?... 2 Why do people choose to participate in research?... 3 What are the different

More information

TAKING PART IN CANCER TREATMENT RESEARCH STUDIES

TAKING PART IN CANCER TREATMENT RESEARCH STUDIES For more infomation about Cancer Clinical Trials at Upstate Cancer Center please call Upstate Connect 1.800.464.8668 TAKING PART IN CANCER TREATMENT RESEARCH STUDIES Information provided by: National Cancer

More information

A Guide to Clinical Trials

A Guide to Clinical Trials A Guide to Clinical Trials For young people with cancer and their parents Children s Cancer and Leukaemia Group www.cclg.org.uk Original booklet produced in conjunction with the CCLG Patient Advocacy Committee.

More information

Taking Part in Research at University Hospitals Birmingham

Taking Part in Research at University Hospitals Birmingham University Hospitals Birmingham NHS Foundation Trust The Trust provides free monthly health talks on a variety of medical conditions and treatments. For more information visit www.uhb.nhs.uk or call 0121

More information

Clinical Trials. Clinical trials the basics

Clinical Trials. Clinical trials the basics Clinical Trials Clinical Trials This brochure is for people making decisions about cancer treatment. You may be thinking about a clinical trial for you or your child but need to know more before you decide.

More information

Taking Part in Cancer Treatment Research Studies

Taking Part in Cancer Treatment Research Studies National Cancer Institute Taking Part in Cancer Treatment Research Studies U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health This booklet is for people with cancer, their family,

More information

Clinical Trials: Improving the Care of People Living With Cancer

Clinical Trials: Improving the Care of People Living With Cancer CLINICAL TRIALS Clinical Trials: Improving the Care of People Living With Cancer Presented by Mary McCabe, RN, MA Memorial Sloan-Kettering Cancer Center Carolyn Messner, DSW CancerCare Learn about: Stages

More information

Patient Handbook on Stem Cell Therapies

Patient Handbook on Stem Cell Therapies Patient Handbook on Stem Cell Therapies Appendix I of the Guidelines for the Clinical Translation of Stem Cells www.isscr.org 2008, International Society for Stem Cell Research 2 Introduction We have all

More information

Add-Aspirin Clinical Trial We are inviting you to take part in a research study called the Add-Aspirin trial

Add-Aspirin Clinical Trial We are inviting you to take part in a research study called the Add-Aspirin trial (To be presented on local headed paper) Version 4.0, 11-Nov-2014 Add-Aspirin Clinical Trial We are inviting you to take part in a research study called the Add-Aspirin trial Before you decide whether to

More information

Patient Information Leaflet: Part 1 select-d

Patient Information Leaflet: Part 1 select-d Patient Information Leaflet: Part 1 select-d Anticoagulation Therapy in SELECTeD Cancer Patients at Risk of Recurrence of Venous Thromboembolism Introduction This

More information

Clinical Trials. I didn t know anything about clinical trials. I d never been in one before and just never thought of it. ~ Albert

Clinical Trials. I didn t know anything about clinical trials. I d never been in one before and just never thought of it. ~ Albert Clinical Trials Clinical Trials This brochure is for people making decisions about cancer treatment. You may be thinking about a clinical trial for you or your child but need to know more before you decide.

More information

[Informed Consent Form for ] Name the group of individuals for whom this consent is written. Explanation Example

[Informed Consent Form for ] Name the group of individuals for whom this consent is written. Explanation Example [YOUR INSTITUTIONAL LETTERHEAD] Please do not submit consent forms on the WHO letter head [Name of Principle Investigator] [Informed Consent Form for ] Name the group of individuals for whom this consent

More information

Entering a Clinical Trial

Entering a Clinical Trial Entering a Clinical Trial Is It Right for You? Paula Chandoha, Chandoha Productions About This Program THIS AUDIOVISUAL PROGRAM AND BOOKLET WERE produced by Dana-Farber Cancer Institute in collaboration

More information

A guide to prostate cancer clinical trials

A guide to prostate cancer clinical trials 1 A guide to prostate cancer clinical trials In this fact sheet: What is a clinical trial? Why are trials done? What are trials looking into at the moment? How are clinical trials done? Should I take part

More information

Understanding Clinical Trials

Understanding Clinical Trials Understanding Clinical Trials The UK Clinical Research Collaboration (UKCRC) is a partnership of organisations working to establish the UK as a world leader in clinical research, by harnessing the power

More information

Clinical Trials: What You Need to Know

Clinical Trials: What You Need to Know Clinical Trials: What You Need to Know Clinical trials are studies in which people volunteer to test new drugs or devices. Doctors use clinical trials to learn whether a new treatment works and is safe

More information

Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research

Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research 1. Objective: The objective of this SOP is to contribute to the effective functioning

More information

Rights and Responsibilities of Patients

Rights and Responsibilities of Patients RIGHTS AND RESPONSIBILITIES OF PATIENTS Rights and Responsibilities of Patients Patient Rights and Responsibilities At Mayo Clinic, we are concerned that each patient entrusted to our care is treated with

More information

LUNG CANCER CLINICAL TRIALS

LUNG CANCER CLINICAL TRIALS UNDERSTANDING LUNG CANCER CLINICAL TRIALS 1-800-298-2436 LungCancerAlliance.org A GUIDE FOR THE PATIENT 1 TABLE OF CONTENTS INTRODUCTION TO CLINICAL TRIALS What Is a Clinical Trial?...4 Types of Clinical

More information

Family Caregiver s Guide to Hospice and Palliative Care

Family Caregiver s Guide to Hospice and Palliative Care Family Caregiver Guide Family Caregiver s Guide to Hospice and Palliative Care Even though you have been through transitions before, this one may be harder. If you have been a family caregiver for a while,

More information

Clinical Trials: Questions and Answers

Clinical Trials: Questions and Answers Clinical Trials: Questions and Answers Key Points Clinical trials are research studies that test how well new medical approaches work in people (see Question 1). Every clinical trial has a protocol, which

More information

Ask Us About Clinical Trials

Ask Us About Clinical Trials Ask Us About Clinical Trials Clinical Trials and You. Our specialists and researchers are at the forefront of their fields and are leading the way in developing new therapies and procedures for diagnosing

More information

Cancer Clinical Trials: The Basics

Cancer Clinical Trials: The Basics Cancer Clinical Trials: The Basics What Are Cancer Clinical Trials? Research studies involving people Try to answer scientific questions and find better ways to prevent, diagnose, or treat cancer 2 Why

More information

Clinical Trials: Information and Options for People with Mood Disorders

Clinical Trials: Information and Options for People with Mood Disorders Clinical Trials: Information and Options for People with Mood Disorders We ve been there. We can help. National Depressive and Manic-Depressive Association 2 National DMDA, its advisors and consultants,

More information

Brief Communications. Awad Mohamed Ahmed, MD. Abstract

Brief Communications. Awad Mohamed Ahmed, MD. Abstract Awad Mohamed Ahmed, MD Professor of Medicine, University of Bahr Elghazal, Khartoum, Sudan For correspondence Professor Awad Mohamed Ahmed E-mail: awad.sd@gmail.com Tel.: +249 912344936 Abstract Randomized

More information

INFORMATION LEAFLET. If anything is not clear, or if you would like more information, please

INFORMATION LEAFLET. If anything is not clear, or if you would like more information, please BIO INFOBK 1492 0410:Layout 1 21/04/2010 15:24 Page 1 INFORMATION LEAFLET You are being invited to take part in a major medical research project called UK Biobank. The purpose of UK Biobank is to set up

More information

And in the Medical Power of Attorney document itself, the principal may limit the agent's decision-making authority.

And in the Medical Power of Attorney document itself, the principal may limit the agent's decision-making authority. Printed from the Texas Medical Association Web site. Durable Power of Attorney Medical Power of Attorney Patient and Health Care Provider Information September 1999 General Information To be read by the

More information

North Central Cancer Treatment Group

North Central Cancer Treatment Group North Central Cancer Treatment Group Working with Mayo Clinic to Bring the Latest Cancer Treatment to the Community NCCTG Dedicated to you More than 1.3 million people in the United States will be diagnosed

More information

The Clinical Trials Process an educated patient s guide

The Clinical Trials Process an educated patient s guide The Clinical Trials Process an educated patient s guide Gwen L. Nichols, MD Site Head, Oncology Roche TCRC, Translational and Clinical Research Center New York DISCLAIMER I am an employee of Hoffmann-

More information

GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE

GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE ICH E6 GCP: Consolidated Guideline: Investigator 1/7 Institutional Review Board Services ICH HARMONIZED TRIPARTITE GUIDELINE E6: GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE 4. INVESTIGATOR 4.1 Investigator's

More information

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by

More information

The ACCURE-UK Trial: The feasibility of undertaking Appendicectomy to impact upon the Clinical Course of UlceRativE Colitis

The ACCURE-UK Trial: The feasibility of undertaking Appendicectomy to impact upon the Clinical Course of UlceRativE Colitis The ACCURE-UK Trial: The feasibility of undertaking Appendicectomy to impact upon the Clinical Course of UlceRativE Colitis Patient Research Interview Information Sheet ACCURE-UK non-participants Version

More information

Cancer Clinical Trials & You:

Cancer Clinical Trials & You: Cancer Clinical Trials & You: Source: National Cancer Institute What Are Cancer Clinical Trials? Research studies involving people Try to answer scientific questions and find better ways to prevent, diagnose,

More information

CORD BLOOD TRANSPLANTATION STUDY EXPANDED ACCESS PROTOCOL APPENDIX A SAMPLE CONSENT FORM

CORD BLOOD TRANSPLANTATION STUDY EXPANDED ACCESS PROTOCOL APPENDIX A SAMPLE CONSENT FORM APPENDIX A SAMPLE CONSENT FORM CORD BLOOD TRANSPLANTATION (COBLT) STUDY SAMPLE CONSENT FORM FOR THE EXPANDED ACCESS PROTOCOL You (your child) are being asked to take part in a clinical research study.

More information

I have a complaint about health care, what to do? Landelijk Meldpunt

I have a complaint about health care, what to do? Landelijk Meldpunt I have a complaint about health care, what to do? Landelijk Meldpunt Z0rg The National Health Care Report Centre can help! Sometimes your contact with a health care provider can fall short of your expectations.

More information

Professional Certificate in Primary Care Psychology

Professional Certificate in Primary Care Psychology Professional Certificate in Primary Care Psychology The NAPPP Primary Care Psychology Certificate training program requires the completion of 10 courses. Each course awards 15 CE credit hours. NAPPP is

More information

Consultation Response Medical profiling and online medicine: the ethics of 'personalised' healthcare in a consumer age Nuffield Council on Bioethics

Consultation Response Medical profiling and online medicine: the ethics of 'personalised' healthcare in a consumer age Nuffield Council on Bioethics Consultation Response Medical profiling and online medicine: the ethics of 'personalised' healthcare in a consumer age Nuffield Council on Bioethics Response by the Genetic Interest Group Question 1: Health

More information

THE EMPLOYMENT ACT AND YOU GUIDE FOR EMPLOYEES

THE EMPLOYMENT ACT AND YOU GUIDE FOR EMPLOYEES THE EMPLOYMENT ACT AND YOU GUIDE FOR EMPLOYEES An explanation of your rights, benefits, protection and duties as an employee, under the Norfolk Island Employment Act. 20081106 Norfolk Island has its own

More information

Palliative Care for Children. Support for the Whole Family When Your Child Is Living with a Serious Illness

Palliative Care for Children. Support for the Whole Family When Your Child Is Living with a Serious Illness Palliative Care for Children Support for the Whole Family When Your Child Is Living with a Serious Illness Palliative care provides comfort and support to your child and family. When a child is seriously

More information

BUPA BY YOU YOUR MEMBERSHIP GUIDE

BUPA BY YOU YOUR MEMBERSHIP GUIDE BUPA BY YOU YOUR MEMBERSHIP GUIDE bupa.co.uk ABOUT THIS GUIDE Welcome to your Bupa By You guide. We know that insurance can be hard to follow. That s why we ve made this guide as simple as possible. You

More information

INFORMATION BROCHURE GLUCAM study The Blood Glucose and Insulin Responses After Drinking of Camel Milk December 2011 January 2012

INFORMATION BROCHURE GLUCAM study The Blood Glucose and Insulin Responses After Drinking of Camel Milk December 2011 January 2012 INFORMATION BROCHURE GLUCAM study The Blood Glucose and Insulin Responses After Drinking of Camel Milk December 2011 January 2012 Division of Human Nutrition, Wageningen University - 1 - Contact information:

More information

BUPA SELECT YOUR BUPA MEMBERSHIP GUIDE. Essential information explaining your Bupa cover. Please retain. bupa.co.uk

BUPA SELECT YOUR BUPA MEMBERSHIP GUIDE. Essential information explaining your Bupa cover. Please retain. bupa.co.uk BUPA SELECT YOUR BUPA MEMBERSHIP GUIDE Essential information explaining your Bupa cover Please retain bupa.co.uk ABOUT THIS GUIDE Welcome to your Bupa Select membership guide. At Bupa, we know that insurance

More information

Know your medical rights.

Know your medical rights. Know your medical rights. Everyone hopes to stay in good mental and physical health. Because of technological advances, medical treatment options are available that were unimaginable just a few years ago,

More information

JANET PURCELL, PH.D. 1818 N.E. IRVING STREET PORTLAND, OR 97232 PSYCHOTHERAPIST-PATIENT SERVICES AGREEMENT

JANET PURCELL, PH.D. 1818 N.E. IRVING STREET PORTLAND, OR 97232 PSYCHOTHERAPIST-PATIENT SERVICES AGREEMENT JANET PURCELL, PH.D. 1818 N.E. IRVING STREET PORTLAND, OR 97232 PSYCHOTHERAPIST-PATIENT SERVICES AGREEMENT This document contains important information about my professional and business policies. It also

More information

PARTICIPATING IN CLINICAL TRIALS A GUIDE FOR PEOPLE WITH MS

PARTICIPATING IN CLINICAL TRIALS A GUIDE FOR PEOPLE WITH MS PARTICIPATING IN CLINICAL TRIALS A GUIDE FOR PEOPLE WITH MS If you have ever taken a medication or received rehabilitative physical therapy, then you have experienced the benefits of clinical research.

More information

Clinical Trial Compensation Guidelines

Clinical Trial Compensation Guidelines Clinical Trial Compensation Guidelines Preface These guidelines contain two distinct sections: Phase I Clinical Trials Compensation Guidelines Phases II, III and IV Clinical Trials Compensation Guidelines

More information

Participant Information Sheet/Consent Form. Norfolk & Norwich University Hospital NHS Foundation Trust. Marc Moncrieff

Participant Information Sheet/Consent Form. Norfolk & Norwich University Hospital NHS Foundation Trust. Marc Moncrieff Participant Information Sheet/Consent Form Norfolk & Norwich University Hospital NHS Foundation Trust Short Title The Melanoma Margins Trial (MelMarT) Title A Phase III, Multi-centre Randomised Control

More information

Lifetime Maximum Applies to all expenses; Part A and Part B expenses cross accumulate to the lifetime maximum

Lifetime Maximum Applies to all expenses; Part A and Part B expenses cross accumulate to the lifetime maximum This is a summary of benefits for your Joint Trusteed Health and Welfare Medicare Supplement (Part A & B) plan. Medicare Part D prescription drug plan deductibles, out-of-pocket maximums, copays and annual

More information

CENTERS FOR MEDICARE & MEDICAID SERVICES. Medicare & Clinical Research Studies

CENTERS FOR MEDICARE & MEDICAID SERVICES. Medicare & Clinical Research Studies CENTERS FOR MEDICARE & MEDICAID SERVICES Medicare & Clinical Research Studies You may have the choice to join a clinical research study to diagnose or treat an illness. If you join a covered clinical research

More information

Frequently Asked Questions (FAQs)

Frequently Asked Questions (FAQs) Frequently Asked Questions (FAQs) Research Rationale 1. What does PrEP stand for? There is scientific evidence that antiretroviral (anti-hiv) medications may be able to play an important role in reducing

More information

REGISTRATION FORM. How would you like to receive health information? Electronic Paper In Person. Daytime Phone Preferred.

REGISTRATION FORM. How would you like to receive health information? Electronic Paper In Person. Daytime Phone Preferred. Signature Preferred Pharmacy Referral Info Emergency Contact Guarantor Information Patient Information Name (Last, First, MI) REGISTRATION FORM Today's Date Street Address City State Zip Gender M F SSN

More information

If you are signing for a minor child, you refers to your child throughout the consent document.

If you are signing for a minor child, you refers to your child throughout the consent document. CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY Adult Patient or Parent, for Minor Patient INSTITUTE: National Cancer Institute PRINCIPAL INVESTIGATOR: Raffit Hassan, M.D. STUDY TITLE: Tissue Procurement

More information

Impact of Breast Cancer Genetic Testing on Insurance Issues

Impact of Breast Cancer Genetic Testing on Insurance Issues Impact of Breast Cancer Genetic Testing on Insurance Issues Prepared by the Health Research Unit September 1999 Introduction The discoveries of BRCA1 and BRCA2, two cancer-susceptibility genes, raise serious

More information

To precertify inpatient admissions or transitional care services, call 1-866-688-3400 and select option #1.

To precertify inpatient admissions or transitional care services, call 1-866-688-3400 and select option #1. Security Health Plan provides coverage of various mental health/aoda (alcohol and other drug abuse) benefits to individual and employer group members. These benefits are managed by Security Health Plan.

More information

Mediation Services, Throughout the UK Guide to Mediation

Mediation Services, Throughout the UK Guide to Mediation mediation Mediation Services, Throughout the UK Guide to Mediation let sstarthere Why Mediate? Pg 3 The Mediation Day Pg 4 Preparing for the Mediation Pg 5 Quality Assured Pg 6 Flexible Fee Policy Pg 7

More information

Script/Notes for PowerPoint Presentation. Medication Use Safety Training for Seniors (MUST for Seniors)

Script/Notes for PowerPoint Presentation. Medication Use Safety Training for Seniors (MUST for Seniors) Script/Notes for PowerPoint Presentation Medication Use Safety Training for Seniors (MUST for Seniors) Instructions: You can use the following script to help you prepare your remarks to your organization

More information

Your right to compensation for treatment and medicine-related injuries

Your right to compensation for treatment and medicine-related injuries Your right to compensation for treatment and medicine-related injuries www.patientforsikringen.dk 1 Everyone that is treated in the public or private health service is covered by the Danish Act on the

More information

Technical Assistance Document 5

Technical Assistance Document 5 Technical Assistance Document 5 Information Sharing with Family Members of Adult Behavioral Health Recipients Developed by the Arizona Department of Health Services Division of Behavioral Health Services

More information

Advance Health Care Directive Instructions

Advance Health Care Directive Instructions Advance Health Care Directive Instructions 1) Review the form completely before filling in any section. 2) If possible, name a first agent AND at least one alternative agent (in case something happens

More information

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18 th WMA General Assembly Helsinki, Finland, June 1964 and amended by

More information

Accreditation of health informatics programs: How to accomplish? A.Hasman VP Special Affairs IMIA

Accreditation of health informatics programs: How to accomplish? A.Hasman VP Special Affairs IMIA Accreditation of health informatics programs: How to accomplish? A.Hasman VP Special Affairs IMIA Introduction There are many institutions throughout the world that provide one or more programs in (bio)medical

More information

Kathleen Long, Ph.D. 510 A Pollock Street New Bern, NC 28562 Phone: (252) 636-2286 Fax: (252) 636-5677

Kathleen Long, Ph.D. 510 A Pollock Street New Bern, NC 28562 Phone: (252) 636-2286 Fax: (252) 636-5677 Kathleen Long, Ph.D. 510 A Pollock Street New Bern, NC 28562 Phone: (252) 636-2286 Fax: (252) 636-5677 Welcome! Please take a minute to complete the following information. Your name: Phone Number: Address:

More information

Patient Billing. Questions/ Answers. Assistance Programs

Patient Billing. Questions/ Answers. Assistance Programs Patient Billing Questions/ Answers Assistance Programs Table of Contents Patient billing: an introduction... 1 Patient financial responsibilities... 2 Our promise to you... 3 Frequently asked questions...

More information

Top Ten Things to Know About Stem Cell Treatments

Top Ten Things to Know About Stem Cell Treatments Top Ten Things to Know About Stem Cell Treatments Many clinics that are offering stem cell treatments make claims about what stem cells can and cannot do that are not supported by our understanding of

More information

CenterWatch. volunteering. clinical trial. for a. www.centerwatch.com

CenterWatch. volunteering. clinical trial. for a. www.centerwatch.com volunteering for a clinical trial www.centerwatch.com :: about this pamphlet This pamphlet provides an overview of the clinical trials process and answers frequently asked questions that many potential

More information

Guidelines approved under Section 95A of the Privacy Act 1988. December 2001

Guidelines approved under Section 95A of the Privacy Act 1988. December 2001 Guidelines approved under Section 95A of the Privacy Act 1988 December 2001 i Commonwealth of Australia 2001 ISBN Print: 1864961074 Online: 1864961139 This work is copyright. Apart from any use as permitted

More information

Information about research

Information about research Information about research Welcome to Papworth Hospital a focus on research As a specialist centre we pride ourselves on the quality of care that we provide for our patients. Knowledge in health care

More information

Sterman Counseling and Assessment

Sterman Counseling and Assessment Information for Clients Welcome to Sterman Counseling and Assessment. We appreciate the opportunity to be of assistance to you. This packet answers some questions about therapy services. It is important

More information

informed consent process

informed consent process understanding the informed consent process www.centerwatch.com :: about this pamphlet Millions of volunteers participate in government-and industry-sponsored clinical trials each year. Prior to agreeing

More information

What to do if called to give evidence

What to do if called to give evidence What to do if called to give evidence An information guide for witnesses Contents Being a witness 2 Inquiry centre 2 Support and assistance 2 Before attending the inquiry How the case is prepared 3 What

More information

A guide for the patient

A guide for the patient Understanding series LUNG CANCER CLINICAL TRIALS 1-800-298-2436 LungCancerAlliance.org A guide for the patient TABLE OF CONTENTS The Basics What is a Clinical Trial?...3 Types of Clinical Trials... 3 Phases

More information

A guide to prostate cancer clinical trials

A guide to prostate cancer clinical trials Treatment Helpline 0800 074 8383 prostatecanceruk.org 1 A guide to prostate cancer clinical trials In this fact sheet: What is a clinical trial? Why are trials done? Who works on trials? What are the different

More information

The Clinical Trial Protocol Guide. BioStrategics Consulting Ltd.

The Clinical Trial Protocol Guide. BioStrategics Consulting Ltd. The Clinical Trial Protocol Guide 2011 BioStrategics Consulting Ltd. BioStrategics Consulting Ltd THE CLINICAL TRIAL PROTOCOL The clinical trial protocol to test one s product, to confirm or reject a specific

More information

3. Jackson Health System workers receive information about patient s rights and responsibilities when they begin working at the hospital or clinic.

3. Jackson Health System workers receive information about patient s rights and responsibilities when they begin working at the hospital or clinic. The Patient s Bill of Rights and Responsibilities Jackson Health System The healthcare facilities of the Jackson Health System support the Patient s Bill of Rights and Responsibilities, which are recognized

More information

Your Health Care Preferences. Questions & Answers. Advance Directive & Durable Power of Attorney for Health Care Decisions. CarondeletHealth.

Your Health Care Preferences. Questions & Answers. Advance Directive & Durable Power of Attorney for Health Care Decisions. CarondeletHealth. Your Health Care Preferences I have AN ADVANCE DIRECTIVE. In case of MEDICAL EMERGENCY CONTACT: Name: Address: Telephone: Advance Directive & Durable Power of Attorney for Health Care Decisions Questions

More information

What is a clinical trial? An introduction for patients and families

What is a clinical trial? An introduction for patients and families What is a clinical trial? An introduction for patients and families Introduction Life expectancy in Europe in the first decade of this century has continued to rise. We owe this fortunate development to

More information

The RADICALS trial Radiotherapy Timing Randomisation (RADICALS-RT) Clinical trial of treatment after surgery for prostate cancer

The RADICALS trial Radiotherapy Timing Randomisation (RADICALS-RT) Clinical trial of treatment after surgery for prostate cancer Stoke Mandeville Hospital Mandeville Road Aylesbury Buckinghamshire HP21 8AL Tel: 01296 315 908 www.buckshealthcare.nhs.uk The RADICALS trial Radiotherapy Timing Randomisation (RADICALS-RT) Clinical trial

More information

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects Policy WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended

More information

Information guide. How to make a complaint

Information guide. How to make a complaint Information guide How to make a complaint How you can comment, compliment or complain about your treatment or service We are committed to providing you with the best service possible. We are always looking

More information

WELCOME TO STRAITH HOSPITAL FOR SPECIAL SURGERY OUR PHILOSOPHY JOINT NOTICE OF PRIVACY PRACTICES

WELCOME TO STRAITH HOSPITAL FOR SPECIAL SURGERY OUR PHILOSOPHY JOINT NOTICE OF PRIVACY PRACTICES WELCOME TO STRAITH HOSPITAL FOR SPECIAL SURGERY During your stay with us, our goal is to make your hospital experience as favorable as possible by providing information and open channels of communication.

More information

Sample Consent. Transfusion of Prematures (TOP)

Sample Consent. Transfusion of Prematures (TOP) Final: October 8. 2012 Revised: February 8. 2013 Appendix A: Sample Consent ~ Penn Medicine,~. Informed Consent Form and HIPAA Authorization Protocol Title: Short Title: Principal Investigator: Emergency

More information

United States Fire Insurance Company: International Technological University Coverage Period: beginning on or after 9/7/2014

United States Fire Insurance Company: International Technological University Coverage Period: beginning on or after 9/7/2014 or after 9/7/2014 Summary of Benefits and Coverage: What this Plan Covers & What it Costs Coverage for: Individual Plan Type: PPO This is only a summary. If you want more detail about your coverage and

More information

Understanding Your Medical Bill

Understanding Your Medical Bill Understanding Your Medical Bill THANK YOU for choosing University of Maryland Medical Center (UMMC) as your healthcare provider. We are committed to providing excellence in the delivery of healthcare.

More information

Great Bay Mental Health Associates, Inc. Notice to Clients and Consent to Mental Health Treatment Agreement Courtney A. Atherton, MA, LCMHC, MLADC

Great Bay Mental Health Associates, Inc. Notice to Clients and Consent to Mental Health Treatment Agreement Courtney A. Atherton, MA, LCMHC, MLADC Great Bay Mental Health Associates, Inc. Notice to Clients and Consent to Mental Health Treatment Agreement Courtney A. Atherton, MA, LCMHC, MLADC Patient Name (please print): Welcome to the therapy services

More information

Research on Research: Learning about Phase 1 Trials

Research on Research: Learning about Phase 1 Trials CLINICAL CASE STUDY SERIES Research on Research: Learning about Phase 1 Trials Phases of clinical trial investigation are described in some detail in the Code of Federal Regulations. Phase 1 is described

More information

Advancing research: a physician s guide to clinical trials

Advancing research: a physician s guide to clinical trials Advancing research: a physician s guide to clinical trials Recruiting and retaining trial participants is one of the greatest obstacles to developing the next generation of Alzheimer s treatments Alzheimer

More information

Measures Taken from the Aspect of Nursing Jobs to Prevent Medical Accidents

Measures Taken from the Aspect of Nursing Jobs to Prevent Medical Accidents Patient Safety Measures Taken from the Aspect of Nursing Jobs to Prevent Medical Accidents JMAJ 45(3): 91 96, 2002 Yoshiko SHIMAMORI Executive Officer, Japanese Nursing Association Abstract: Those engaged

More information

Consent Form: Example 2 (DNA Sequencing)

Consent Form: Example 2 (DNA Sequencing) Consent Form: Example 2 (DNA Sequencing) Important note: This model language was developed for the NHGRI Medical Sequencing Project (MSP). It is included here only as an example of how to describe a sequencing

More information

Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health

Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health We are responsible for acquiring, analyzing, and protecting medical information vital to providing quality patient care HIM professionals ensure

More information

THE DEPRESSION RESEARCH CLINIC Department of Psychiatry and Behavioral Sciences Stanford University, School of Medicine

THE DEPRESSION RESEARCH CLINIC Department of Psychiatry and Behavioral Sciences Stanford University, School of Medicine THE DEPRESSION RESEARCH CLINIC Department of Psychiatry and Behavioral Sciences Stanford University, School of Medicine Volume 1, Issue 1 August 2007 The Depression Research Clinic at Stanford University

More information

A Guide To Claiming Compensation For Clinical Negligence

A Guide To Claiming Compensation For Clinical Negligence A Guide To Claiming Compensation For Clinical Negligence Introduction In order to bring a claim for Clinical Negligence, it is necessary to establish that the Doctor or Nurse involved in your medical treatment

More information

The Appeals Process For Medical Billing

The Appeals Process For Medical Billing The Appeals Process For Medical Billing Steven M. Verno Professor, Medical Coding and Billing What is an Appeal? An appeal is a legal process where you are asking the insurance company to review it s adverse

More information