Introduction to Research Ethics and Informed Consent

Maria Luz Uy del Rosario, M.D.

Office of Research Development

PCMC

Objectives• Provide a brief review of research ethics

• Discuss guidelines for ethical research

• Define informed consent

• Identify the elements of informed consent

• Go over the process of preparing an informed consent form

• Introduce the process of IRB approval of medical research

The “Dark Side” of Medical Research• Nov 1944

20 Jewish children

Dr. Heissmeyer removed the children's lymph glands for analysis, and he injected living tuberculosis bacteria in their veins and directly into their lungs to determine if they had any natural immunities to tuberculosis. They were carefully observed, examined and photographed as the disease progressed. The condition of all the children deteriorated very rapidly and they became extremely ill. 

The “Dark Side” of Medical Research

• 2001-2003

• GSK

• Walter Reed Army Institute of Research

• Hepatitis E vaccine trial

• Katmandu, Nepal

• 2004-2005

• Ventria Bioscience

• Institute of Child Health, Nutrition Research Inst.

• Fortified ORS (with lactoferrin and lysozyme)

• Peru

Bioethics and Medical Research

• Field that strives to create fair and ethical medical procedures ranging from organ transplantation to clinical trials

• Nuremberg Code (1947)

• Declaration of Helsinki (1964)

• Independent Institutional Review boards (1966)

• FDA and informed consent

• Belmont Report (1979 US)

Guidelines for Ethical Research

• Vulnerable research populations require special protection

• Research must be based on knowledge of laboratory and animal experimentation

• Protocol must be reviewed by an independent ethical review committee. Serious adverse reactions must be reported

• Study design must be made available publicly

Guidelines for Ethical Research

• Investigation should cease if risks are found to outweigh benefits

• Research is only justified if there is reasonable likelihood that populations in which study carried out are likely to benefit from the results

• Participation is voluntary and participants informed

• Physician should obtain freely given informed consent

Guidelines for Ethical Research

• Benefits, risks, burdens and effectiveness of new therapy should be tested against those of best currently available therapy. Placebo controlled trials only allowed if no proven therapy exists or under special circumstances

• At conclusion of the study, patients should be ensured access to best proven therapy identified

• When medical research is combined with medical care, patient must be informed which aspect of care are related to the research

What is Informed Consent?

• One of the most important facets of bioethics

• Not just a form, but a PROCESS

• Present information to enable voluntary decision making

• Ensures respect for person via provision of thoughtful consent for a voluntary act

What is Informed Consent?

• Educates people in terms they can understand

• Written form used to document bases for consent and for subject’s future reference

• Most important entrance criteria for subject participation in research

Elements of Informed Consent

• Introduction

• Name of subject

• Title of Research Study

• Investigators and Contact NumbersSponsor of the study (if any)

• Purpose of the research

• Research procedure

Elements of Informed Consent

• Potential health benefits

• Potential health risks or discomforts

• Potential financial risks

• Potential financial benefits

• Compensation for research related injury

• Conflict of interest

Elements of Informed Consent

• Alternatives to participating in the research study

• Withdrawal from the research study

• Confidentiality

• Consent

• Assent (if applicable)

Preparing an Informed Consent Form

• Lay terms at all times

use of second person – you, your child

incorrect: you will undergo an echocardiogram

correct: you will have a procedure called an echocardiogram. This is a

method of taking a picture of your heart with sound waves….

DO NOT COPY WORDS FROM THE RESEARCH PROTOCOLDIRECTLY INTO THE INFORMED CONSENT!!

Preparing an Informed Consent Form

• Make sentences short and to the point

• Avoid empty/difficult words

empty word: along the lines of alternative: like

difficult word: effectivenessalternative: success

Preparing an Informed Consent Form

INTRODUCTION

• Invitation to participate in research

• States the form as a tool to provide patient with information regarding the study

NAME OF SUBJECT

Preparing an Informed Consent Form

TITLE OF RESEARCH STUDY

• Must be identical to title on the protocol, project cover sheet, any abstract submitted to the IRB

PRINCIPAL INVESTIGATOR AND TEL. NO./SPONSOR OF THE STUDY

Preparing and Informed Consent Form

PURPOSE OF THE RESEARCH

• Why research is being conducted• Why subjects are invited to participate• Relevant background information (NOT review of

literature)

“ there is currently no drug which improves Alheimer’s disease. The purpose of this research is to learn if the drug X, either alone or in combination with drug Y, will help improve memory and thinking. Because you have Alheimer’s disease, you are being asked to participate in this research protocol.”

Preparing an Informed Consent Form

RESEARCH PROCEDURE

• Brief, informative description of procedures

• Describe what subject is likely to experience

• Type and frequence of all tests, follow up visits, etc.

• Expected duration of participation

• Identify which part(s) of protocol are experimental or not

Preparing an Informed Consent Form

RESEARCH PROCEDURE

• State if study is randomized, blinded, etc.

• State amount of blood drawn for tests

• State that investigational drug is regulatedand regulating body may choose to inspect

records identifying patient as a subject

• State if longitudinal follow up is planned

Preparing an Informed Consent Form

POTENTIAL HEALTH BENEFITS

• State whether or not there is direct benefit to individual subject

• Use of placebo – no direct health benefit

• State whether there is possible benefit to others, to medical knowledge or to society

• State whether subject will receive more than standard care

DO NOT OVERSTATE EXPECTED BENEFITS

Preparing an Informed Consent Form

POTENTIAL HEALTH RISKS/DISCOMFORTS

• State risks in such a way that subject can understand meaning of “risk”

decreased WBC = possible infection

• State relative risk. If available, state statistical data

incorrect: Drug X can cause nausea, vomitingcorrect: Drug X can cause nausea, vomiting in 1 out of

10 subjects; can commonly cause nausea, vomiting

Preparing an Informed Consent FormPOTENTIAL FINANCIAL RISKS/BENEFITS

• State financial cost to patient • State whether there is renumeration for certain costs

related to the study (i.e. transportation) or as aresult of adverse events caused by the study

• State if there is any direct financial benefit to patient and describe it clearly

Do not overstate expected benefits…

Preparing an Informed Consent Form

CONFLICT OF INTEREST

• Conflict of interest exists if there is potential benefit to the investigator beyond the professional benefit from academic publication or presentation of results

• Also state if there is no conflict of interest

Preparing an Informed Consent Form

ALTERNATIVES TO PARTICIPATING IN RESEARCH

• Include all options the subject would have if protocol did not exist

“Should you not wish to participate in this study, the alternative treatments are x, y, etc. You may also choose to

receive no or other therapy in which supportive care will be offered to you”

“The alternative is not to participate in this study”

Preparing an Informed Consent Form

WITHDRAWAL FROM RESEARCH

• States that patient can withdraw from the study at anytime and for any reason

• Also describes situations wherein the patient’s participation can be terminated by the investigator without regard to the subject’s consent

• State the consequences of the subject’s decision to withdraw from the study

Preparing an Informed Consent Form

CONFIDENTIALITY

• Clearly states confidentiality of medical records

• If funded or if decreed by Law, certain parties such as sponsors, regulatory agencies or the IRB have the legal right to review records

Preparing an Informed Consent Form

ASSENT

• Agreement of individual not competent to give legally valid informed consent

• Written in age appropriate language

• Describes procedures, discomforts, etc.

Preparing an Informed Consent Form

SIGNATURES

• Investigator/Co-investigator/Person obtaining consent

• Subject or any of the following:

ParentGrandparentsSibling over age 21Legal guardians

• Witness

Research Protocol Approval

Ethics Committee

IRB-EC

RevisionsDisapprovedApproved/Recommended

ORD-IRO

Management

ADRMT

If with funding ORD priorities and endorses to Management

TRAINEE / SI

PL 2/ PL 3/

FELLOW

Research Protocol

DIV/SEC

Approval of Panel:

SIADMRTTechnical Board Adviser

ADMRT

AMDRO

Endorsed by Dept Head for

Research &

Training

Technical Board

W/ revisions

Approved

ADMRT: Asst Dept Mgr for Research and Training