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Prior to the Nuremberg Code, there was no generally accepted code of conduct which governed the ethical aspects of human research.

Protecting Human Research Subjects

Why do

they need

protection?

As a direct result of this trial, The Nuremberg Code was established.

This stated that the voluntary consent of a participant is essential, and any benefits of that participant's involvement in the study should outweigh the risks.

The Nuremberg Code was the first international document which advocated voluntary participation and informed consent.

On December 9, 1946, criminal proceedings were opened against leading German administrators and physicians for their voluntary participation in war crimes and crimes against humanity.

These German physicians conducted medical experiments on thousands of prisoners in concentration camps without their consent. The majority of these uninformed subjects and victims died or were permanently crippled as a result.

Kimberly Betz, Anthony Delorenzo, Katherine Haynes, Jason Reece, Emily Simone

Principles of The Belmont Report

Respect for persons

This principle is

1. to protect the participant from exploitation

The Belmont Report was created following a series of unethical research practices, most importantly being the...

The Belmont Report

2. ensure that subjects enter into research studies voluntarily and with enough information regarding the study

3. participants should be treated as individuals capable of acting under their own decisions

4. people with "diminished autonomy" (young children, mentally disabled people, the very ill) are entitled to protection from exploitation and activities that may harm them

Assent

The system the U.S. currently uses for their protection of human research subjects was influenced by The Belmont Report

Assesses the willingness of participation in a study by people who are

  • "too young" to understand the proposed research study

OR

  • adults who lack the capacity to give informed consent for any reason.

Assent is not sufficient by itself. Informed consent must also be obtained from the parents or primary caregiver.

written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

The Tuskagee Syphillis Experiment

1932-1972

600 African American males took part in a study which investigated the effects of syphilis.

They were given free medical care, meals, and free burial insurance in exchange for their participation in the study.

None of the subjects were ever told he had the disease, nor were they treated for it with penicillin, a proven effective treatment for syphilis.

  • It outlines the basic ethical principles that must be followed when using humans as research subjects.
  • In 1981, with this report as a foundation, the Department of Health and Human Services and the Food and Drug Administration revised the existing human subjects regulations.

This experiment led to major changes in U.S. laws and regulation on the protection of participants in clinical studies.

Informed Consent Checklist

Institutional Review Boards (IRB)

"A specifically constituted review body or designated by an entity to protect the rights and welfare of human subjects recruited to participate in biomedical, behavioral or social science research" (Mayo Clinic, 2015).

• A statement that the study involves research

• An explanation of the purposes of the research

• The expected duration of the subject's participation

• A description of the procedures to be followed

• Identification of any procedures which are experimental

• A description of any reasonably foreseeable risks or discomforts to the subject

Justice

Often times, assent takes place as a conversation rather than a document-based procedure.

It includes the nature of the study, the risks and benefits of participating and all the information necessary to make an educated decision about participating.

Subjects must be selected fairly.

Participants must not be selected based on any single criteria (easy availability, compromised position, or racial, sexual, economic, or cultural biases)

Inclusion and exclusion criteria must be related solely on factors that most effectively address the research problem.

TIPS FOR DRAFTING CONSENT FORMS

  • If possible, keep words to 2 syllables or less
  • Use familiar words and limit the use of medical jargon
  • Write short, simple, and direct sentences
  • Keep paragraphs short and limited to one idea
  • Use the second person (you) instead of the third person (the participant) to increase personal identification
  • Highlight important points
  • Use visual aids such as graphs, photos, and tables to help clarify procedures
  • Use a word processing tool to check grade level
  • If possible, consent form should not exceed an 5th grade reading level

Thank You!

John Hopkins Medicine, 2007

CHALLENGES AND OBSTACLES

Informed Consent Checklist(continued..)

Readability- Consent must be provided in a way that is comprehensible to the patient.

Factors Influencing Readability

  • Local literacy rates of populations
  • Federal oversight
  • Level and complexity of research

  • A description of any benefits to the subject or to others which may reasonably be expected from the research
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
  • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.

Overview of Institutional Review Boards (IRBS)

Created in 1966, in order to protect human subjects before, during, and after the research has been completed.

Adhere to the principles of the ~Belmont Report~

U.S. Department of Health & Human Services, 2014

Beneficence/Non-maleficence

People are to be treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being

What is informed consent?

An obligation to do no harm and to

  • Maximize possible benefits
  • Minimize possible harms

to the individual research participant

Asking individuals who are potential research subjects to sign a consent form once the procedures & risks written within it have been explained & their privacy acts have been assured

The subject must:

  • Give consent voluntarily without coercion
  • Have the capacity and ability to understand the study in order to give consent
  • Be provided with enough information to make an informed decision

IRB's determine whether or not the research is safe for the participants and if the research contributes to general knowledge.

Central IRB's review a variety of research. Local IRB's only review research conducted at their own specific academic institution.

1964

The Declaration of Helsinki is developed for the medical community by the World Medical Association.

As a collection of ethical principles regarding human experimentation, it addresses clinical research, reflecting changes in medical practice.

The fundamental principles are respect for the individual, their right to self-determination and the right to make informed decisions regarding participation in research.

It has gone through seven revisions,

the most recent being in 2013.

ECG

62

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