Office of Research Administration Sponsored Programs Technology Transfer Research Protections & Compliance Research Opportunity Development ORA/Research

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Research Protections & Compliance

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ORA/Research Protections and Compliance www.umbc.edu/research

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Responsible Conduct of ResearchResponsible Conduct of Research

Working with participants, reducing risks and doing the right thingWorking with participants, reducing risks and doing the right thing


updated: 10/1/2013updated: 10/1/2013

Take aways from todayTake aways from today

• Basic info about the UMBC compliance program• Contributes to the discussion of what it means to be

a responsible researcher and how to conduct research “responsibly”

• recognize ethical choices, make appropriate decisions and take appropriate actions based on those choices

• encourage best practices in the conduct of research and scientific investigations

• know that consequences will result from not complying with policies and procedures

• Doing the “right thing”


Responsible Conduct of Responsible Conduct of ResearchResearch

The aim of discussing research ethics is to encourage integrity in the pursuit of scientific investigation and practice among of scientists, scholars, and professionals.

Office of Research Integrity, Department of Health and Human Services

44ORA/Research Protections and Compliance www.umbc.edu/research

Human Research Protections Program

Evaluate risks Protect the rights and welfare of individual

research subjects, Ensure voluntary participation via the

“consent process” – conversation and documentation

Provide assurance to the federal government the institution will comply with the rules and regulations and provides oversight for the institution's human research use program


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Understand What has Happened in the Past to Help Leads to Ethical and

Responsible ResearchThe decisions of our past are the architects of our present - Dan

Brown, “Inferno”History teaches us that knowing about the past will help ethical and

responsible decisions today.

Nazi Medical Experiments

Tearoom Sex Study THN1412 Drug Trial

Milgram Experiments

Tuskegee Syphilis experiment

Henrietta Lacks

Guatemala syphilisexperiment

The Monster Study Stanford Prisoner Experiment


Understand What Research is and Who are Human Subjects:

Systematic investigation that contributes to generalizable knowledge– "Research" is defined in the Code of Federal

Regulations, in part, as "a systematic investigation that contributes to generalizable knowledge“.

In other words, for the most part, an investigator will: be "engaged in research” proposed an intention to explore a particular topic interact with a living person and have a plan to “generalize “ the information

“Human subjects” are living persons about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information


Understand What Minimal Risk Is:

HHS regulations found in Subpart A (46.102) - 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 the performance of routine physical or psychological examinations or tests

Risks associated with the research and consider the subject population (vulnerable people, such as children, older persons, cognitively impaired, etc. may experience different types of risk) and describe procedures to deal with them.


““Doing the Right Thing” in Human research

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Principle Application

Respect for personsIndividuals should be treated as autonomous agentsPersons with diminished autonomy are entitled to protection.

Informed consentSubjects, to the degree that they are capable, must be given the opportunity to choose what shall or shall not happen to themThe consent process must include three elements:

information,comprehension, andvoluntariness.

BeneficenceHuman subjects should not be harmedResearch should maximize possible benefits and minimize possible harms.

Assessment of risks and benefitsThe nature and scope of risks and benefits must be assessed in a systematic manner

JusticeThe benefits and risks of research must be distributed fairly.

Selection of subjectsThere must be fair procedures and outcomes in the selection of research subjects

Code for the proper and responsible conduct of human research have been incorporated into how researchers interact with people and how universities conduct business.•Led to creation of 45CFR46 - Protection of Human Subjects (the Common Rule)•Incorporate the foundations of ethics in human research •Requirements for IRBs•Provide for protection from risks and safeguard from harm•Create procedures for compliance


Responsible Conduct of Responsible Conduct of Research (RCR)Research (RCR)

Part of the planning, conduct, and reporting of research Ethics protects the interests of the public, the subjects of

research, and the researchers themselves in the:– Collection, use, and interpretation of research data– Reporting and reviewing research plans or findings– Relationships among researchers with one another– Relationships between researchers and those that will be

affected by their research (e.g. human and animal subjects)

– Means for responding to misunderstandings, disputes, or misconduct

– Promotion of ethical conduct in research


http://research-ethics.net/introduction/what/#research-ethics

Research ethics fall within Research ethics fall within RCRRCR

Data Acquisition, Management, Sharing and Ownership

Accurate collection of data and managed properly for confidentiality and privacy purposes

Conflict of Interest & Commitment Management of real or perceived interference to assure that the interests do not adversely influence the research

Research Misconduct Avoid and deal with issues of egregious behavior (i.e. fabrication, falsification, or plagiarism – FFP)

Publication Practices & Responsible Authorship Accurate report of the results and an honest and open assessment of the finding

Mentor / Trainee Responsibilities Clear understanding of mutual responsibilities/proper supervision and a commitment for a productive environment

Peer Review Evaluation by colleagues with similar knowledge and experience for self-regulation of the discipline

Collaboration Collaborative research roles should be clarified early discussing and reaching agreement on the details

Human Subjects Protection of subjects and compliance with relevant Federal regulations as well as institutional guidelines and policies

Research Involving Animals Humane care and use and compliance with relevant Federal regulations as well as institutional guidelines and policies


RCR casesRCR cases

Gerrman education minister quits in plagiarism case – Baltimore Sun, February 10, 2013 http://www.baltimoresun.com/news/nation-world/sns-rt-us-germany-minister-resignationbre9190bg- 20130210,0,5002015.story?track=rss

Hwang Woo-Suk•South Korea•Stem cell research•Indicted on fraud, embezzlement, and bioethics violations

Andrew Wakefield•British gastroenterologist•No Ethics Review Board approval•Guilty of failure to disclose CoI, medical and scientific misconduct•The Lancet and British Medical Journal retracted papers

Eric Poehlman•Obesity scientist•First scientist to be imprisoned for falsifying information on a grant application•Plead guilty to falsifying 17 NIH grant applications and fabricating data in 10 of his papers (1992-2000)

Diederik Stapel•Dutch Psychologist•Admitted that he had falsified data in some of his publications•Many/most of his experiments never happened•150 publications he co-authored are under review•14 of 21 PhD theses that he supervised are in question


More examples at http://www.umbc.edu/research/ORPC/rcr_training_casestudies_faqs.html

FFPFFP

Fabrication (making up data or results and recording or reporting them)

Falsification (manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record)

Plagiarism (taking another person's ideas, processes, results, or words without giving appropriate credit)


Research misconduct

Research misconduct means fabrication, falsification or plagiarism in proposing, performing or reviewing research, or in reporting research results.

Research misconduct does not include honest error differences of opinion.


Other compliance areas

Animal Care and Use – ethical, appropriate and humane care and

use of animals in teaching and research– compliance with federal and state animal-

welfare laws – overall purpose is to oversee all research

and instruction that involves vertebrate animals, in order to ensure that the highest ethical and animal welfare standards are met


Export Controls

– Regulations that control distribution of certain exports to foreign nationals and foreign countries

– Include:– information, including technical data, that is

transferred to persons and entities outside the United States;

– physical items, such as scientific equipment, that is shipped from the United States to a foreign country;

– disclosure of verbal, written, electronic, or visual disclosures of controlled scientific and technical information related to the above export controlled items to foreign nationals;

– travel to certain sanctioned or embargoed countries for purposes of teaching or performing research


Conflicts of InterestConflicts of Interest

Occur when university members are in a position or in situations in which financial or other personal considerations may compromise or have the appearance of compromising an employee’s professional judgment in administration, management, teaching, research and other professional activities

Conflicts must be disclosed and, if required, managed in a fashion to , reduce, or eliminate any actual or perceived conflicts of interest.


Data UseData Use

Access archives or restricted data sets that may contain identifiable information about individuals for the purpose of conducting research

Involves:– What data will be released or shared– Who has ownership of the data– What, if any, identifiers will be included– And much, much more


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QuestionsQuestions

[email protected] http://www.umbc.edu/research/ORPC

410-455-2737


Documents

Office of Research Administration Sponsored Programs Technology Transfer Research Protections & Compliance Research Opportunity Development ORA/Research