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Ethics of Working with Human Subjects

(BIOL/CHEM 397 )

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In brief

 Ethics  Regulations  What is research  Involvement of the IRB   Video example for discussion The “Bottom” line 2

“Doing the right thing”

“Real integrity is doing the right thing, knowing that nobody’s going to know whether you did it or not” - Oprah Winfrey

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Various codes for the proper and responsible conduct of human research have been incorporated into researchers interact with people and how universities conduct business.

Be aware of aspect of being a responsible researcher, know how to conduct research appropriately and understand one’s role in the research process

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http://www.wow4u.com/oprahwinfrey/index.html

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Underlying principles of responsible conduct of research

  discourage research misconduct and questionable research practices ensure integrity of research and scholarly activities 4

To do the right thing, know about the ethics

 45CFR46 - Protection of Human Subjects treatment of research subjects based on past history 

Medical research

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Social and Behavioral Research

ensures minimal standards for the ethical  Foundations of ethics in human research    Freedom from harm Privacy Voluntary participation

Protection from risks and safeguard from harm

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Understand what research is:

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Research:

Systematic investigation that contributes to generalizable knowledge  In other words, an investigator will be "engaged in research", has proposed an intention to explore a particular topic, while interacting with a living person and either publish (e.g., in a journal) or present at a conference.

Human Subjects:

Living individuals about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information 6

Purpose of human research compliance

Required by the federal government as well as the University of Maryland  Ethical review of research   Ensure participants rights are protected and that they are safeguarded from risk and harm Compliance with federal guidelines and principles    Department of Health and Human Services University of Maryland System U.S. Department of Education 7

The IRB

  Members include:  Scientists and non scientists from various disciplines on campus as well as graduate and undergraduate student members  Individuals not affiliated with the Campus who represent the concerns of the Community Provides assurance to the federal government that UMBC will comply with the rules and regulations and provides oversight for the university's human research use program 8

Oversight ensures that there are

Safeguards from harm    

Emotional or psychological harm Social harm Financial harm Legal harm

Protections from Risks 

greatest risk is often a breach of confidentiality

Opportunities for voluntary participation 

the “consent process” – the process that involves a conversation that most of the time uses a document

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Types of research:

Low or less than minimal risk (

pose no or very low risks )  Educational research - improving educational practice in educational settings (no clinical and counseling research)    Educational tests - use of educational tests (cognitive, diagnostic, aptitude, achievement) where subjects cannot be identified, directly or through identifiers linked to the subjects. Surveys, questionnaires, interviews, or observation not involving "sensitive" topics, such as criminal or sexual behavior, alcohol or drug use on the part of the participants unless anonymity is guaranteed and informed consent cannot be reasonably obtained (i.e. anonymous observations). Preexisting data/samples that are publicly available and the data is deidentified and uncoded and stripped of identifiers. If on the IRB’s list of pre approved data holders , no need for IRB review

Minimal Risk

 Survey or interview procedures where responses are recorded in such a manner that subjects can be identified, and if known outside the research, could reasonably place the subject at risk of criminal or civil liability    Research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol, unless data is recorded in such a fashion that identities are kept secure and protection mechanisms put in place Deception Research which include minors (under the age of 18) as participants

May not require IRB review

 Activities that are not hypothesis driven    Data collected for educational or teaching purposes and is not disseminated outside the institution.

Literature review to support research purpose or research question Surveys issued or completed by University personnel for the intent and purposes of improving services and programs of the University 10

What does an IRB expect of an application?

   

Consideration

of how the substantive issues & methods fit with ethical guidelines & IRB requirements

Clarity

in statement of problem, Research Questions & Methods of data collection

Consistency

in content of all documents

Completeness

of all materials

C+C+C+C=

Successful Protocol

Courtesy of University of Louisville Human Subjects Protection Program Office 11

Protection of Human Subjects

   Must comply with relevant Federal regulations as well as institutional guidelines and policies Responsibility for obtaining appropriate approval before conducting research involving human subject Need for approval based on if the work qualifies as research, it involves human subjects, and if it is exempt from IRB (human research compliance) review Syracuse University, Research Ethics and Academic Integrity video vignettes, 2002, http://gradschpdprograms.syr.edu/resources/videos.php

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What is the bottom line for an investigator?

 Be trained and fully aware  Following IRB conditions and requirements  Reporting progress of research  Be aware of your own ethics 13

Expectations from the IRB?

        When in doubt, ask questions; seek help Remember: consideration, clarity, consistency, completeness Don’t initiate research before obtaining IRB approval.

Renew ongoing proposals each year in a timely fashion.

Stay within the approved scope of the project.

Submit modifications to the IRB and wait for approval before initiating the change to the research.

Report Adverse Events. IRBs are more than enforcers/regulators 14

5523 Research Park Drive Suite 310 Baltimore, MD 21228 [email protected]

www.umbc.edu/ressearch/HARPO 410-455-3868 (FAX)

Tim Sparklin: 410-455-2737 Mary Lilly: 410-455-3958

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