Human Subjects Review Tutorial

Why do human subjects project need to be reviewed so carefully?

On July 12, 1974, the National Research Act was signed into law, there-by creating the National Commission for the Protection of

Human Subjects of Biomedical and Behavioral Research.

The Commission was charged with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which

should be followed to assure that such research is conducted in accordance with

those principles.

Thus the Belmont Report was created.

What is the Belmont Report?

The Belmont Report consists of three principles, or general prescriptive

judgments, that are relevant to research involving human subjects. They are stated

at a level of generalization that should assist scientists, subjects, reviewers and interested

citizens to understand the ethical issues inherent in research involving human

subjects

What are the three basic ethical principles?

1. Respect for Person1. Respect for Person Individuals should be treated as autonomous agents. Persons with diminished autonomy are entitled to

protection.

These include, but are not limited to pregnant women, mentally disabled persons, economically or educationally disadvantaged persons, individuals with diseases such as cancer, asthma, diabetes, cardiac disorders, psychiatric disorders, dyslexia, AIDS, etc., children/minors, and prisoners.


2. Beneficence2. BeneficenceDo not harm.Maximize possible benefits and minimize possible harms.

One should not injure one person regardless of the benefits that might come to others. It must be decided when it is

justifiable to seek certain benefits despite the risks involved, and when the benefits should be forgone because

of the risks.


3. Justice3. JusticeThe selection of research subjects needs to be scrutinized in order to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.Research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.

What is an Institutional Review Board (IRB)?

An IRB is a committee that must evaluate the potential physical and/or psychological risk of research involving

human subjects.

All proposed human research must be reviewed and approved by an IRB BEFORE experimentation begins.

This includes any surveys or questionnaires to be used in a project.

What are the IRB membership requirements?

Federal regulations REQUIRE local community involvement, therefore, an IRB should be established at the

school level to evaluate human research projects.

An IRB must consist of a minimum of three members:a) A science teacher

b) A school administratorc) Someone who is knowledgeable and capable of

evaluating the physical and/or psychological risk involved in a given study: A medical doctor, physician’s assistant,

registered nurse, a psychiatrist, psychologist, or licensed social worker.

What are some tips for a successful IRB? The Adult Sponsor, parents, Qualified Scientist and

Designated Supervisor of a project MUST NOT be a member of the IRB reviewing that project.

Have two science teachers as members of the IRB to avoid a conflict of interest if one of them is the Adult Sponsor of a project needing review.

Include a medical person to review medical human subjects projects and a behavioral specialist to review psychology human subjects projects.

Ask for help of the state SRC or international SRC if there are questions about how to advise a student.

Who has jurisdiction?

If the project includes subjects limited to where the researcher goes to school or lives, then the local (school) IRB should be reviewing a project.

If the researcher is working at a university or other regulated institution, then the initial approval must come from that institution’s IRB and the local IRB is responsible must ensure the research is appropriate for that age of student and that all ISEF rules are followed.

If the project includes subjects from places such as other schools, universities, or nursing homes, then those facilities have the right and obligation to review the project as well.

What exactly is human subject research?A human subject is a living individual about whom a researcher, conducing research obtains:

(1) Data through intervention or interaction with the individual

OR

(2) Identifiable private information.

Research is a systematic investigation designed to develop or contribute to generalizable knowledge.

Quiz – Is it human subject research?

A researcher is conducting a study testing the reflex capabilities of different groups of

athletes.

Hit Enter to see the answer.

Yes – the researcher is collecting data through direct interaction with people. Any project where subjects

participate in physical activities (physical exertion, ingestion of any substance or any medical procedure) are considered

human subjects projects.


A researcher is having people test a newly engineered device that replaces the traditional

computer mouse.


No – product testing of engineering projects are not considered human subject projects, although if a student

wishes to restrict the subject population to one of the at-risk groups, it would be best to have IRB approval.


A researcher is using a survey to collect the opinions of fellow students on different types of

music.


Yes – research that involves psychological, educational and/or opinion studies using such tools as surveys,

questionnaires and tests are human subjects projects.


A researcher conducts a study observing whether or not cars come to a complete stop at

certain intersections.


No – behavioral studies of unrestricted, public settings in which all of the following apply (1) The researcher has no

interaction with the individuals being observed; (2) the researcher does not manipulate the environment is any

way and (3) the researcher does not record any personally identifiable data, are not human subjects projects.


A researcher is conducting a study in which he/she is the subject of the study.


Yes – all studies where the researcher is the subject of the research is considered human subjects projects.

Quiz – Is it human subject research?A researcher is conducting a study on people’s responses to a person greeting them outside of a store while holding a puppy, holding a balloon

and then holding nothing.


Yes – behavioral observations that either (1) involve any interaction with the observed individual(s) or where the

researcher has modified the environment, (2) that occur in a non public or restricted access setting, or (3) involve the

recording of personally identifiable information are considered human subjects projects.


A researcher is doing a statistical analysis of crime statistics in different types of cities.


No – data/record review studies in which the data are taken from pre-existing data sets that are publicly available or published are not considered human subjects projects.


A researcher is conducting a study on the correlation between GPA and extra-curricular

activities.


Yes – data/record review projects that include identifiable data are considered human subjects projects.

Quiz – Is it human subject research?A researcher is looking at de-identified x-rays of

head injuries obtained from a doctor’s office.


No – studies where the student receives the data in an anonymous format is not considered a human subjects

project as long as the student also receives a certification from the doctor that they are in compliance with all privacy and HIPAA laws and they have been properly de-identified.

What are the risks that should be considered during the review?Many kinds of possible harms and benefits need to be taken into account:Psychological harm or benefitPhysical harm or benefitLegal harm or benefitSocial harm or benefitEconomic harm or benefit

Risks and benefits of research may affect the individual subjects, the families of the individual subjects and society (or special groups of subjects in society) at large .

What criteria should an IRB use in reviewing research proposals?

Risks to subjects are minimized (1) by using procedures which are consistent with sound

research design and which do not unnecessarily expose subjects to risk, and

(2) whenever appropriate, by using procedures already being performed on the

subjects for diagnostic or treatment purposes.


Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that

may reasonably be expected to result.


Selection of subjects is equitable. In making this assessment, the IRB should take into account the purposes of the research and the setting in which the research will be

conducted and should be particularly cognizant of the special problems of

research involving vulnerable populations.


Informed consent will be sought from each prospective subject or the subject’s legally

authorized representative (guardian).


When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.


When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

What kind of determination can the IRB make of a research project?Minimal Risk where informed consent is recommended, but not required. The IRB must provide a justification for this waiver if the subjects are under 18 years of age.Minimal Risk where informed consent is required.More than minimal risk where informed consent and a Qualified Scientist are required.Rejection of proposed research.

Whenever possible, the IRB should review the research plan with a critical eye that not only assesses risk, but also the soundness of the research and provide guidance to the student in making his/her research the best it can be.

What does No More Than Minimal Risk mean?

No more than minimal risk exists when the probability and magnitude of harm or

discomfort anticipated in the research are not greater (in and of themselves) than

those ordinarily encountered in DAILY LIFE or during performance of routine physical or

psychological examinations or tests.

Quiz – Is it more than minimal risk?

A researcher is testing resting pulses before and after running four laps around a ¼ mile

track using both trained and untrained runners.


Yes – exercise other than that ordinarily encountered in daily life by a subject (in this case, the untrained runners) is

more than minimal risk.


A researcher is testing the affects chewing gum, eating breath mints, or using mouth wash have on the accuracy of a breathalyzer testing

device.


Yes – ingesting any substance or exposure to any potentially hazardous material is more than minimal risk.


A researcher is conducting a survey of classmates that includes questions asking

about divorce, depression, anxiety and suicide.


Yes – answering questions related to person experiences such as sexual, physical or child abuse, divorce and/or

psychological well being MUST be considered more than minimal risk..


A researcher is testing subject’s reactions to a particularly violent video game.


Yes – exposing subjects to stimuli or experimental conditions that could potentially result in emotional stress

MUST be considered more than minimal risk.


A researcher comparing different ethnicities’ fingerprint patterns.


Yes – any activity that could potentially result in negative consequences for the subject due to invasion of privacy or breech of confidentiality should be considered more than

minimal risk.

How can risks be minimized?

Consider using adults rather than children/minors in any human subjects

project being proposed.


Always allow subjects to withdraw from the research at any time.


Collect the data anonymously or develop data collection procedures that make it

impossible to link any identifying information with an individual’s responses or data.

Anonymity - no way to identify participant

Confidentiality – methods and limitations in protecting the identity of participants and their data (link lists or coding

schemes)

What is Informed Consent?

The process of obtaining informed consent provides information to the subject about the

risks and benefits associated with participating in the research study and

allows the subject to make an educated decision about whether or not to participate.


Describe the purpose of the study as clearly as possible.

For Example:

The purpose of this study is to identify and map sulfate concentrations in water and forage samples.


List ALL of the research procedures in which the subject will be involved. If there are

different procedures for different groups of people, then SEPARTE consent forms need

to be completed for each group.

For Example:

A survey regarding sulfate toxicity in cattle will be given to those land owners who are cattle producers.


Include the duration of the subject’s involvement.

For Example:

The survey should only take 15 to 20 minutes to complete.

What is Informed Consent?Describe and assess any potential risk or discomfort, and, if any, potential personal

benefits that may be reasonably expected by participating in the research. If there are none,

use the following statements:No known risks.

No personal benefits to the subject.

For Example:

There are no known risks to the subjects by participating in this study – potential benefits include receiving information from the sulfate analysis done on the water and forage from their land.


Describe the procedures that will be used to minimize risk, to obtain informed consent

and/or assent and to maintain confidentiality.

For Example:

All landowners will receive a detailed project overview, a copy of the survey, a map and a release form. All properties will be identified by a code and not by the land owner’s name. All landowners will be allowed to withdraw their participation at any time during the research.


If documented informed consent is not required, subjects must give their

consent/assent to participate in the study. The procedure for obtaining consent/assent

should be included in the research plan.

Quiz – Is documented informed consent necessary?

A researcher is working with a teacher to see what effects different testing strategies have on

student’s scores.


No – research involving normal educational practices does not require documented informed consent. The researcher should send a note home to parents informing them of the research that their children will be taking part of in an effort

to increase test scores.

Quiz – Is documented informed consent necessary?A researcher is observing different intersections

in town and documenting whether cars are coming to a complete stop. Information about

the car and driver are not collected.


No – research on behavior or characteristics of individuals where the researcher does NOT manipulate the subjects’ behavior does not require documented informed consent.

Quiz – Is documented informed consent necessary?

A researcher is looking at the memory capabilities of girls and boys at different grade

levels using pictures and words.


No – surveys and questionnaires that involve perception, cognition or game theory and do not involve gathering person information, invasion of privacy or potential for

emotional distress (what are the pictures and words being used?) do not require documented informed consent.

Quiz – Is documented informed consent necessary?A researcher is looking at the best angle to use

when shooting free throws, using basketball team players as subjects.


No – studies involving physical activity where the probability and magnitude of harm or discomfort anticipated

in the research are not greater than those ordinarily encountered in daily life or during performance of routine physical activities do not require documented informed

consent.

What if . . . ?

The researcher doesn’t want the subjects to see the survey prior to completing it, but parental/guardian consent is needed?

A copy of the consent form and a sealed copy of the survey/questionnaire can be sent home to parents with

instructions not to divulge the survey contents to the subjects. Always offer the subjects the opportunity to not

have their survey included in the study even after they have completed it.

Human Subjects Review Tutorial

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