Informed Consent: The Subject’s Right to Know
Here’s what you should ask before you decide to give your informed consent to research.

A 1999 report by the Institute of Medicine (IOM), “To Err is Human,” brought to light the magnitude of preventable deaths resulting from medical errors The IOM report indicated that as many as 44,000 to 98,000 people die in hospitals each year as the result of medical errors. On March 14, 2002, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) launched a national campaign, “SPEAK UP,” encouraging patients to take an active role in their healthcare by becoming active, involved, and informed participants.

The ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) is launching a similar campaign to help ordinary citizens protect themselves from harmful, or unwanted medical research. AHRP is urging all people who are asked to participate in a clinical trial to take an active role in protecting themselves from preventable harmful adverse consequences. Research involves greater risks than standard treatment therefore caution and precautions are advisable. AHRP urges anyone considering taking part in a research project to become informed, to speak up, and to ask the questions suggested below. The doctor conducting the project should provide the answers in writing.

AHRP agrees with the advice JCAHO gives patients: “Don’t be afraid to seek a second opinion. If you are unsure about the nature of your illness and the best treatment, consult with one or two additional specialists. The more information you have about the options available to you, the more confident you will be in the decisions made.”

AHRP urges you to obtain full information about the risks and possible benefits, if any, before signing any consent to research.

Medical researchers do not always inform you (or your family) about the nature of the known and foreseeable risks, discomfort, and possible adverse consequences of medical research. We therefore suggest that anyone considering taking part in a research project should obtain full information, then seek an independent opinion from a doctor not affiliated with the research team to help you make an informed decision.

Before signing any consent to research, you need to ask the following questions, which the doctor conducting the research must answer in writing:

• What is the purpose of the study and how will it affect my daily life? Will I have to be hospitalized? For how long?
• Will this experiment involve any painful or uncomfortable procedures? Will I have to endure spinal taps, intravenous infusions? How many? Will I be deprived of sleep?
• Who is sponsoring and funding the study? Does my Doctor/Researcher or other staff affiliated with the study get a “finders fee” to recruit patients?” If so, what is the amount?
• Does my Doctor/Researcher or other staff affiliated with the study own stock in the company that makes the drug/intervention or serve as a paid consultant to the company?
• Will I be reimbursed for expenses I incur while participating in the study, such as parking fees, meals, pro-rated child expenses, etc?
• Does this protocol include investigational drugs not approved by the FDA? What are the known or potential risks and side effects?
• How many other people have taken the drug before me? What happened to them? Did anyone die?
• Ask to speak to someone who had participated in a similar trial. They can tell you what to expect and what worked best for their recovery.
• For purposes of the research, do some patients get a new drug while others get a sugar pill (placebo)?
• If I get a placebo, what is the benefit for me from participating?
• Is this study designed to benefit me by testing a product or procedure that has a probability of improving my condition? Or,
• is it a non-therapeutic experiment designed to learn about tolerance levels or the physiology of illness?
• Does the study require that I stop taking all medications (drug “washouts”)? For how long? If my symptoms return and I’m uncomfortable, will I be given a medication that helps me right away?
• Who is authorized to prescribe such medications?
• Does this study include drugs such as amphetamine, methylphenidate, ketamine, or any other psychostimulant drug that is likely to induce psychosis and worsen my condition?
• If yes, ask to talk to an independent physician to discuss the potential risks and hazards involved.
• Who is responsible for monitoring my well-being and to make sure proper safeguards are being followed?
• Is there an independent doctor who is not connected with the research team?
• Is there a non-medical patient advocate assigned to help me? What authority does that individual have?
• Can I have a family member or trusted friend as an advocate?
• If the drugs involved are FDA-approved, are they approved for my condition? Will I be given the recommended dose?
• Ask for a photocopy of the Physicians Desk Reference (PDR) discussing the risks and side effects of this medication.
• Are there procedures that involve radiation (e.g., PET scans) in this study? If yes, how many?
• Does the exposure conform to community safety levels for radiation?
• What exactly does the Informed Consent cover and for how long? Does it cover more than one project?
• Is this an “umbrella” consent form that will allow several procedures to be performed at the same time or successively?
• What if I’m harmed or injured, who’s responsible for my after-care? Are subjects of research protected by an insurance policy? Will I get any compensation?
• What alternative care / treatment is available to me if I don’t chose to be a research subject and what are the advantages and disadvantages of each?
• If the drugs used prove to be beneficial to me, what assurance do I have that I will continue to get the drugs after completing the study?
• If there are therapeutic benefits from the study will my medical record indicate these findings?
• Will my record be sent to my doctor to help guide his decisions about my follow-up care?
• Will I (and my family) be informed about these findings in writing?
• What follow-up care is offered to those who complete a study? To those who drop out?
• Who is authorized and available during non-business hours (e.g., at night, during a holiday, or weekend) to help me if problems arise or should I wish to withdraw from the research?
• Do I have the right to my medical research records, and will they be sent upon my request, to me or my doctor?
• Don’t be afraid to seek an independent second opinion. If you are unsure about the nature of your illness and the best treatment, consult with one or two additional specialists. The more information you have about the options available to you, the more confident you will be in the decisions made.
• Review informed consent forms with your advocate or with an independent physician before you sign them and make sure you understand exactly what you are agreeing to.

An Informed Parent is a Responsible Parent

If you are asked to give permission for research on your child, you might also want to ask the following:
What condition does my child have and does it require medical intervention?

• Does a treatment for this condition already exist?
• What are the known unfavorable health outcomes of that condition if no treatment is provided?
• Might my child outgrow the condition naturally without medical intervention?
• Is this experiment designed to test a treatment or to screen for a condition? (If there is no treatment, then what’s the point of screening and labeling a child?)
• Is the study designed to benefit my child? How many children have benefited?
• Is there a placebo control (dummy pill)? What’s the chance my child will derive no benefit?
• Does the research involve more than minimal risk?
• Will my child feel any pain or discomfort from any of the procedures? How will pain be minimized?
• How many other children have tested the treatment? What happened to them?
• What is the probability that my child is likely to benefit directly from the research or the procedures?
• How does the degree and probability of harm from the research compare with of the probability of risk from the condition?
• How many of those recruited to test the experimental treatment (or procedure) were children of the doctors testing the treatment? How many were the children of those who approved the research?
• How many were the children of drug company executives?
• Get an independent second opinion about the alternative treatment possibilities, and ask to speak to a family whose child had participated in a study such as this to find out what to expect.

Read about Research Protection for Children.

Read what former Senator John Glenn had to say about informed consent.
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Here’s what you should ask before you decide to give your informed consent to research. 

A 1999 report by the Institute of Medicine (IOM), “To Err is Human,” brought to light the magnitude of preventable deaths resulting from medical errors The IOM report indicated that as many as 44,000 to 98,000 people die in hospitals each year as the result of medical errors. On March 14, 2002, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has launched a national campaign, “SPEAK UP,” encouraging patients to take an active role in their healthcare by becoming active, involved, and informed participants.

The ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) is launching a similar campaign to help ordinary citizens protect themselves from harmful, or unwanted medical research.  AHRP is urging all people who are asked to participate in a clinical trial to take an active role in protecting themselves from preventable harmful adverse consequences.  Research involves greater risks than standard treatment therefore caution and precautions are advisable. AHRP urges anyone considering taking part in a research project to become informed, to speak up, and to ask the questions suggested below.  The doctor conducting the project should provide the answers in writing. 

 AHRP agrees with the advice JCAHO gives patients: “Don’t be afraid to seek a second opinion. If you are unsure about the nature of your illness and the best treatment, consult with one or two additional specialists. The more information you have about the options available to you, the more confident you will be in the decisions made.”

AHRP urges you to obtain full information about the risks and possible benefits, if any, before signing any consent to research.  

Medical researchers do not always inform you (or your family) about the nature of the known and foreseeable risks, discomfort, and possible adverse consequences of medical research. We therefore suggest that anyone considering taking part in a research project should obtain full information, then seek an independent opinion from a doctor not affiliated with the research team to help you make an informed decision.

Before signing any consent to research, you need to ask the following questions, which the doctor conducting the research must answer in writing:

1. What is the purpose of the study and how will it affect my daily life? Will I have to be hospitalized? For how long?

2. Will this experiment involve any painful or uncomfortable procedures? Will I have to endure spinal taps, intravenous infusions? How many? Will I be deprived of sleep?

3. Who is sponsoring and funding the study? Does my Doctor/Researcher or other staff affiliated with the study get a “finders fee” to recruit patients?” If so, what is the amount? Does my Doctor/Researcher or other staff affiliated with the study own stock in the company that makes the drug/intervention or serve as a paid consultant to the company? Will I be reimbursed for expenses I incur while participating in the study, such as parking fees, meals, pro-rated child expenses, etc?

4. Does this protocol include investigational drugs not approved by the FDA? What are the known or potential risks and side effects?

5. How many other people have taken the drug before me? What happened to them? Did anyone die? Ask to speak to someone who had participated in a similar trial. They can tell you what to expect and what worked best for their recovery.

6. For purposes of the research, do some patients get a new drug while others get a sugar pill (placebo)? If I get a placebo, what is the benefit for me from participating?

7. Is this study designed to benefit me by testing a product or procedure that has a probability of improving my condition? Or, is it a non-therapeutic experiment designed to learn about tolerance levels or the physiology of illness?

8. Does the study require that I stop taking all medications (drug “washouts”)? For how long? If my symptoms return and I’m uncomfortable, will I be given a medication that helps me right away? Who is authorized to prescribe such medications?

9. Does this study include drugs such as amphetamine, methylphenidate, ketamine, or any other psychostimulant drug that is likely to induce psychosis and worsen my condition? If yes, ask to talk to an independent physician to discuss the potential risks and hazards involved.

10. Who is responsible for monitoring my well-being and to make sure proper safeguards are being followed? Is there an independent doctor who is not connected with the research team?

11. Is there a non-medical patient advocate assigned to help me? What authority does that individual have? Can I have a family member or trusted friend as an advocate?

12. If the drugs involved are FDA-approved, are they approved for my condition? Will I be given the recommended dose? Ask for a photocopy of the Physicians Desk Reference (PDR) discussing the risks and side effects of this medication.

13. Are there procedures that involve radiation (e.g., PET scans) in this study? If yes, how many? Does the exposure conform to community safety levels for radiation?

14. What exactly does the Informed Consent cover and for how long? Does it cover more than one project? Is this an “umbrella” consent form that will allow several procedures to be performed at the same time or successively?

15. What if I’m harmed or injured, who’s responsible for my after-care? Are subjects of research protected by an insurance policy? Will I get any compensation?

16. What alternative care / treatment is available to me if I don’t chose to be a research subject and what are the advantages and disadvantages of each?

17. If the drugs used prove to be beneficial to me, what assurance do I have that I will continue to get the drugs after completing the study?

18. If there are therapeutic benefits from the study will my medical record indicate these findings? Will my record be sent to my doctor to help guide his decisions about my follow-up care? Will I (and my family) be informed about these findings in writing?

19. What follow-up care is offered to those who complete a study? To those who drop out?

20. Who is authorized and available during non-business hours (e.g., at night, during a holiday, or weekend) to help me if problems arise or should I wish to withdraw from the research?

21. Do I have the right to my medical research records, and will they be sent upon my request, to me or my doctor?

22. Don’t be afraid to seek an independent second opinion. If you are unsure about the nature of your illness and the best treatment, consult with one or two additional specialists. The more information you have about the options available to you, the more confident you will be in the decisions made.

23. Review informed consent forms with your advocate or with an independent physician before you sign them and make sure you understand exactly what you are agreeing to.

 AN INFORMED PARENT IS A RESPONSIBLE PARENT:

If you are asked to give permission for research on your child, you might also want to ask the following:

1. What condition does my child have and does it require medical intervention?

2. Does a treatment for this condition already exist?

3. What are the known unfavorable health outcomes of that condition if no treatment is provided? Might my child outgrow the condition naturally without medical intervention?

4. Is this experiment designed to test a treatment or to screen for a condition? (If there is no treatment, then what’s the point of screening and labeling a child?)

5. Is the study designed to benefit my child? How many children have benefited?

6. Is there a placebo control (dummy pill)? What’s the chance my child will derive no benefit?

7. Does the research involve more than minimal risk?

8. Will my child feel any pain or discomfort from any of the procedures? How will pain be minimized?

9. How many other children have tested the treatment? What happened to them?

10. What is the probability that my child is likely to benefit directly from the research or the procedures?

11. How does the degree and probability of harm from the research compare with of the probability of risk from the condition?

12. How many of those recruited to test the experimental treatment (or procedure) were children of the doctors testing the treatment? How many were the children of those who approved the research? How many were the children of drug company executives?

13. Get an independent second opinion about the alternative treatment possibilities, and ask to speak to a family whose child had participated in a study such as this to find out what to expect.

Click here to read about Research Protection for Children.

To read what former Senator John Glenn had to say about informed consent, click here.