Informed Consent For Research

Idara C.E.

Ethical Principles for Research

Three ethical principles guides research with human participants.

1. The principle of Autonomy requires investigators to obtain informed and voluntary consent from research participants , to protect participants with impaired decision making capacity, and to maintain confidentiality.

Conditions for Informed Consent

There are pertinent issues the prospective subject needs to be told and understand to give informed consent.

a. The nature of the research projectb. The procedures of the studyc. The potential harms and benefits of

the studyd. Assurances that participation in the

research is voluntarye. Misconceptions about research – if it is

going to be therapeutic or nontherapeutic

f. Who's doing it, competency of investigators

g. Privacy and confidentiality of information

h. Right to withdraw without penalty

I. Provisions for adverse circumstances

The greater the risk the higher the standards of information

2. The principle of beneficence requires that the research design be scientifically sound and that the risks of the research be acceptable in relation to the likely benefits.

The risks of participating in the study must be minimized, for example , by screening potential participants to exclude those likely to suffer adverse effects and by monitoring participants for adverse effects.

Risks to participants include both physical harm from research interventions and also psychosocial harm, such as breaches of confidentiality, stigma and discrimination. Under federal regulations, the risks of the research must be minimized and acceptable in light of the anticipated benefits.

3. The principle of justice requires that the benefits and burdens of research be distributed fairly. Vulnerable populations, such as people with poor access to health care or with impaired decision making capacity, may lack the capacity to make informed and free choices about participating in research. Furthermore, they may be at increased risk for adverse effects.

Vulnerable populations should not be targeted for research if other populations would also be suitable participants.

Case 1

A new urinary catheter has been developed. A clinical trial is proposed to evaluate whether it is more effective and safer than the conventional catheter. Nursing home residents with Alzheimer’s disease and incontinence will be recruited as participants because enrollment and follow- up will be easier than in ambulatory patients.

Overview of Research Ethics

Federal regulations require that many types of research with human subjects be approved by an Institutional Review Board ( IRB).

The IRB is charged with ensuring that the research is ethically acceptable and the welfare and rights of the research participants are protected.

Specifically, the risks of the research must be appropriate in light of the prospective benefits, and the risks of the research must be minimized.

The IRB is a response to the Nuremberg War Crimes Tribunal, during which the world had a consensus that experimentation without consent is unethical and not allowed.

Nazi experimentation during world war II was coerced , without consent of the participants, and collected data that involved the unnecessary and willful harm of human subjects.

Risks and Benefits of Research

Even though a research study has been approved by an IRB, the balance of risks and benefits may not be appropriate for an individual patient.

In other cases, a patient may be at unacceptable risk in a trial because she/ he is more susceptible to adverse effects of a drug being tested- e.g. pre- existing impairment in an organ system in which side effects commonly occur.

Selection of Participants in Research

Participants in research assume risks to gain potential benefits for themselves as well as the society as a whole. The potential benefits and harm of participation in research should be distributed equitably among groups eligible for the study. Vulnerable, disadvantaged, or minority groups should not be overrepresented in dangerous studies nor underrepresented in trials of promising new therapies.

Patients Who Lack Decision Making Capacity

When prospective research participants lack decision making capacity, surrogates may give permission for the patient to participate in research.

Treating physicians as well as investigators have to make sure that participation in research by people lacking capacity is appropriate and surrogates act in the patient’s best interests.

Financial Disclosure

Investigators or treating physicians in a research project should disclose any financial interest in a research project.

This is done to avoid conflict of interest and help ensure an objective interpretation of the research data.

Note: if an investigating physician holds a patent on the experimental intervention or has a management position or stock options in the company manufacturing it, then he should not be the one who requests informed consent from participants in the research.

Quiz

A 34-year-old woman with major depressive disorder comes to the physician for a follow-up examination. She says that her depressive symptoms are worsening. Multiple medication regimens have been ineffective. The patient says that she spoke recently with a former college roommate who also has depression. Her friend is currently enrolled in a clinical trial for a new antidepressant at a local center. The patient says, "My friend seems to be doing really well with this new medication, and I think I'd like to try it out to see if it would work for me, too. Can you write me a referral to the center where my friend is enrolled?" Which of the following is the most appropriate initial response by the physician to this patient's request ?

(A) Decline to refer the patient because she has treatment-refractory depression that

typically is not accepted into clinical trials (B) Discuss the conduct of clinical trials so that the

patient has a clear understanding of howthey operate(C) Inform the patient that she cannot receive future

care from the physician if she enrolls in the clinical trial

(D) Inform the patient that she will not get the best care possible if she enrolls in an experimental trial

(E) Refer the patient to the center because so many other treatment options have failed