HSR & IRB - Iliff Presentation

Welcome to the University of Denver's Institutional Review Board, also

known as the I.

R. V.

My name is Mary Travis, and I am the director

of the Office of Research, Integrity and Education.

Our office oversees many programs involving research, which includes managing

the board that reviews and approves human subjects.

Research. The D u Irby is specifically responsible for ensuring

that all research activities involving human subjects are conducted in

a responsible and ethical manner to protect the rights and

welfare of research participants.

Today's program is making sense of human subjects research, understanding

the IRB process.

I will provide you with a brief overview about the

do You Institutional review board and why it's important to

obtain Irby approval for studies that qualify as human subjects

research. I will also review the ethical principles that guide

the Irbe, outline the steps required for developing a complete

research application and finally provide the resource is available through

do you to assist in developing a comprehensive Irby submission.

Let's begin by looking at the historical perspective of human

subjects, research and how and why IRBs were created.

How did we go from almost no federal oversight of

research in the 19 fifties to the extensive system of

federal laws and regulations that we have today.

The answer to this question is the history of the

modern Irby system.

About 50 years ago, the federal government had a relatively

minor role in regulating how research was conducted.

Ethical standards for conducting research with human subjects was not

uniformly applied or accepted.

Nowadays, the federal government is extensively involved in regulating almost

all aspects of the research process.

For many years, human subjects research was conducted in the

United States as well as around the world, with little

to no regulations or restrictions on how it would be

done. Who would involve and with no consequences if the

risk to the participants outweighed any potential benefits.

After many research projects were conducted around the world, certain

studies involving human subjects were identified That moved our medical

community and the public to demand that the need for

strict regulations that address the ethical problems that were arising

from some of the infamous research that had previously occurred

One of the most horrific experiments were conducted in the

concentration camps in the 19 forties, forcing prisoners to participate

unwillingly in 1948 the Nuremberg code was written to articulate

the basic requirements for conducting research in a way that

respects the fundamental rights of research subjects.

This document was created in response to the Nuremberg trials

in 1945 through 46 against the Nazi leaders who committed

crimes against humanity in their treatment of civilian prisoners under

their control.

In 1964 the World Medical Association met in Helsinki, Finland,

to draft the Declaration of Helsinki to describe the standards

of ethical research involving human subjects.

In 1974 the United States created basic regulations governing the

protection of human subjects and research supported or conducted by

the Department of Health and Human Service is through the

Code of Federal Regulations to HHS departments.

The Office of Human Subjects Research and the Food and

Drug Administration had specific regulations written that apply to how

human subjects research must be conducted.

As part of the national research at in 1974 the

Irbe was established, the mission of the Air B is

to protect the rights and welfare of research participants, and

every decision made by the Irby is driven by this

specific goal.

In 1978 the Belmont report was published that explains the

fundamental ethical principles that guide the conduct of research involving

human subjects.

The Belmont report is an eight page document that clearly

explains the three principles that are the main tools that

all Irby members used to evaluate the ethics of specific

research proposals.

The Belmont report describes three ethical principles that air used

to guide the IRB during the review of research involving

human subjects.

Those ethical principles are respect for persons, beneficence and justice.

Since thes ethical principles drive how research must be conducted,

I will review each of the principles briefly.

Some examples.

The first principle is respect for persons ensuring that individuals

were treated as autonomous agents by allowing them to make

decisions concerning their own actions and well being, and and

that they're provided with sufficient information about the study that

they might enroll in.

One example of violating the first principle is the Will

Brooke hepatitis study.

This particular study was started to study hepatitis at this

facility since so many of the Children became infected after

being admitted.

As the study progressed, more than 700 Children were enrolled,

with half of them injected with protective antibodies and the

other half as a control group.

The sub group of the experimental group was deliberately infected

with the virus as a.

As this study progressed, parents and Children were not truly

informed about the potential risk of this study.

The second principle is beneficence, evaluating that the risk to

subjects are reasonable in relation to anticipated benefits.

One study that did not follow this principle had to

do with the thalidomide experience in this study.

The risks outweighed any possible benefit if any benefit was

ever present.

In the 19 fifties, a new sleeping pill was prescribed

to pregnant women to help with unpleasant symptoms.

At the time the drug was being used, it was

not a standard practice to be informed of the investigational

nature of the drug.

As a result, the drug caused severe growth deformities in

the infants.

1962. The public outrage led to an amendment to the

Food, Drug and Cosmetic Act to ensure greater drug safety.

The third principle is justice ensuring that the selection of

subjects is equitable and that no individual or population is

exposed to risk of harm, while other individuals or populations

received the benefits all individuals must be treated equally.

The Tuskegee Syphilis Studies was a clinical trial that studied

the natural progression of untreated syphilis.

Researchers knowingly failed to treat patients appropriately even after the

19 forties, validation of penicillin as an effective cure for

the disease.

This study was ended in 1972 and led to major

changes in U.

S. Law and regulations on the protection of participants in

clinical studies.

As you began to develop your own research project, please

keep in mind the ethical principles that your project will

be evaluated on as you evaluate how your project will

be reviewed.

One question that must be answered is whether your research

protocol actually requires IRBY review.

Do you think all research projects require IRB review?

The answer lies in whether the project is human subjects

research per the regulatory definition.

A project must meet the regulatory definition of both research

and human subjects.

To require Irby review, let's review the first question.

Does the activity involve research?

Research is defined as a systematic investigation designed to develop

or contribute to generalize a bill knowledge.

Now not every research project may meet the criteria for

research. For the definition but there are types of activities

that don't usually fall into the research definition.

Those would include potentially scholarly and journalistic activities, public health

surveillance activities, criminal justice purposes and operational activities for national

security purposes.

If you aren't sure if your project meets this definition,

I encourage you to talk first with your faculty sponsor,

refer to the Irby website on this topic, or contact

the Irby office directly.

The next question that must be answered is whether the

research involves human subjects.

A human subject is defined as a living individual about

whom an investigator conducting research one obtains information or bio

specimens through intervention or interaction with the individual and uses

studies or analyzes the information or bio specimens or two.

Obtains uses studies, analyzes or generates identifiable private information or

identifiable bio specimens.

In order to require Irby review, your project must meet

both of these definitions.

If it is determined that your project is not human

subjects research, what should you do?

Do you has created a determination form that we encourage

investigators to complete and submit for formal assessment through the

Air B office In the world of compliance, documentation is

important if an assessment is done on your research and

it does not qualify as human subjects research.

A formal letter will be issued to document and confirm

that your project does not require IRBY review.

This type of documentation is important.

If your dissertation committee inquires about Irby approval, these type

of requests are submitted to a specific email address provided

on the top of the determination form.

This form should not be submitted through the Normal Irby

Review process via Irby.

Net. If your project is determined to be human subjects

research, you will also receive a formal letter stating this

and that you will then need to submit your project

for Irbe.

Review. If your project qualifies this human Subjects research what

type of review will be required?

All protocols that require Irby review must be submitted.

Elektronik Lee through Irby Net.

The Elektronik submission system used it to you before we

look at three types of Irby reviews.

Let's look at what factors may determine the type of

review that may be required.

Some of the questions that may be raised during a

review would be what are the potential risks and benefits

does the research involve of vulnerable population like Children, prisoners,

individuals who may be cognitively impaired, a non English speaking

individual, educationally or economically disadvantaged or an undocumented immigrant.

Other factors may involve are the subject's privacy and confidentiality

at risk?

How are you protecting potentially sensitive or private information about

the individual?

How will you record the data safely and securely, and

are you asking about a subject that is considered sensitive

in nature?

HSR & IRB - Iliff Presentation

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