institutional review boards and human subjects protectionfaculty.nps.edu/rdfricke/oa4109/lecture 4-1...
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Institutional Review Boards and Human Subjects Protection
Professor Ron Fricker!Naval Postgraduate School!
Monterey, California!
6/25/12
Goals for this Lecture!
• A nasty little bit of history!• The Belmont Report and ethical principles for
human subjects research!• The NPS IRB!• Approval requirements for surveying outside
of NPS!
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Nuremberg Code!
• End of World War II, 23 Nazi doctors and scientists were put on trial for the murder of concentration camp inmates who were used as research subjects!
• Since no accepted standards existed regarding the conduct of human research, the court could not convict the defendants of violating the rights of research subjects!
• The court did convict 15 of the 23 of murder!
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But US Scientists Not So Innocent!
• Watson’s “Little Albert” experiment (1920s)!
• Tuskegee Syphilis Study (1932 – 1972) Penicillin 1940’s - 28 deaths!
• Milgram’s obedience to authority experiment (1963)!
• Stanford prison experiment (1971)!
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Ethical Principles!
• On July 12, 1974, the National Research Act signed into law (Pub. L. 93-348) !– Created the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research!
– Commission charged with identifying the basic ethical principles that should underlie the conduct of research involving human subjects !
• Belmont Report (1979) established three fundamental principles: beneficence, justice, and respect for persons!
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Derived Rules: Beneficence Principles!
• Minimize risks to participants by using procedures which!– Are consistent with sound research design !– Do not unnecessarily expose participant to risk!
• Risks to participants are reasonable in relation to expected benefit and the importance of the knowledge that might reasonable be expected to result!
• There are adequate provisions to maintain the confidentiality of the data!
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Derived Rules: Justice!
• Selection of participants is equitable:!– Risks and benefits of the research equitably
distributed in population!– Particular groups of people (e.g., welfare patients,
junior employees, or persons confined to institutions) should not be 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!
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Derived Rules: Respect for Persons!
• Informed consent will be sought from perspective participants!
• There are adequate provisions to protect the privacy of participants!
• When some or all of the participants are likely to be vulnerable to coercion or undue influence, additional safeguards are included in the study to protect their rights and welfare!
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Ethical Issue #1: Voluntary Participation!
• Voluntary participation means survey respondents are free from: !– Coercion: the use of a credible threat of harm or
force to control another person !– Undue Influence: the misuse of a position of
confidence or power to lead another to make a decision he/she would not otherwise have made!
– Manipulation: deliberate management of conditions or information in such a way as to lead another to make a decision he/she would not otherwise have made!
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Ethical Issue #2: Informed Consent!
• Federal regulations list of specific elements that must be provided:!– 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, and identification of any procedures that are experimental!
– Description of any foreseeable risks!– Description of the benefits !
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Ethical Issue #2: Informed Consent (cont’d)!
• Explanation of how confidentiality of records will maintained !
• If more than minimal risk, explanation whether medical treatment is available if injury occurs!
• Contacts for further information about the research study, rights of the subjects, and whom to contact should injury occur!
• A statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits, and that the subject may discontinue at any time!
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Model Informed Consent Form!Navy Postgraduate School
Informed Consent Form Introduction. You are invited to participate in a research study entitled add name of study. Procedures. Provide a thorough statement regarding the purpose and methodology of the research, the expected duration, and the procedures of the subject’s participation. This experiment will take approximately [time] to complete. Risks. The potential risks of participating in this study are: Outline the possible risks (e.g. risk of breach of confidentiality. Benefits. Anticipated benefits from this study are add the potential benefits to the Navy, science, and possibly the participants. Compensation. No tangible compensation will be given. A copy of the research results will be available at the conclusion of the experiment (explain how).
Confidentiality & Privacy Act. Any information that is obtained during this study will be kept confidential to the full extent permitted by law. All efforts, within reason, will be made to keep your personal information in your research record confidential but total confidentiality cannot be guaranteed. [Insert a description of how records and data/specimens will be stored and maintained and who will have access. Describe any study specific issues that may increase the risk of breach of confidentiality.] However, it is possible that the researcher may be required to divulge information obtained in the course of this research to the subject’s chain of command or other legal body.
Voluntary Nature of the Study. Participation in this study is strictly voluntary, and if agreement to participation is given, it can be withdrawn at any time without prejudice. Points of Contact. It is understood that should any questions or comments arise regarding this project, or a research related injury is received, the Principal Investigator, Dr. Joseph Researcher, 656-9999, [email protected] should be contacted. Any other questions or concerns may be addressed to the Navy Postgraduate School. IRB Chair, LCDR Paul O’Connor , 831-656-3864, [email protected]. Statement of Consent. I have read the information provided above. I have been given the opportunity to ask questions and all the questions have been answered to my satisfaction. I have been provided a copy of this form for my records and I agree to participate in this study. I understand that by agreeing to participate in this research and signing this form, I do not waive any of my legal rights. ________________________________________ __________________ Participant’s Signature Date ________________________________________ __________________ Researcher’s Signature Date
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Ethical Issue #3: Minimize Risk of Harm!
• Beneficence: an ethical principle discussed in the Belmont Report that entails the obligation to protect persons from harm!
• The principle of beneficence can be expressed in two general rules: !– Do not harm!– Protect from harm by maximizing possible benefits
and minimizing risks of harm!
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Ethical Issue #4:Confidentiality (and Anonymity)!
• Confidentiality: respecting a participant’s right to be free from unauthorized release of information, particularly if it could be prejudicial to his/her interests!– Confidentiality concerns records of private information
relating to the participant, particularly the researcher’s agreement with the participant regarding the handling, management, and dissemination of his private records!
• Anonymity: for research to be considered anonymous, no identifiers of any kind (e.g. name, code number, etc.) are used that can link the data to individual who provided it!
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Survey Ethical Issues!
• Surveys should be designed and executed in a manner that minimizes risks to participants!– No one should suffer any adverse consequences
as a result of participation in the survey!• Informed consent: Always honestly disclose:!
– The purpose of the survey!– How the results will be used!– Participation is voluntary (if it is)!– Whether the responses will be kept confidential!
• If you promise confidentiality, keep your promise!
• If you collect personal information, you are ethically and legally obligated to safeguard it!– DoD 5400.11-R, “Department of Defense Privacy Program”!
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Human Subjects Research!
• Human Subject: “A living individual about whom an investigator… conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”!
• Research: “A systematic investigation designed to develop or contribute to generalizable knowledge.”!
ü This determination can only be made by the IRB Chair!
Source: 32 CFR 219.102!6/25/12 16
NPS IRB!
• Federal regulations: All research involving human subjects conducted or supported by a Federal department or agency must be reviewed and approved by an IRB!
• IRB website: www.nps.edu/Research/IRB.htm!– Contains complete set of forms for application
package!– Forms change over time…!
• Types of review: exempt, expedited, full!
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NPS IRB Website
NPS IRB website: http://www.nps.edu/research/IRB.htm! Forms: http://www.nps.edu/research/IRB_Applications.htm!
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Application Must Include:!
• Complete application form!• Copy of final survey instrument!• If survey is of personnel in other units,
approval letter from unit CO/commander!• Application may also include:!
– Waiver of signed informed consent (with justification)!
– Consent for video or audio recording!– Data safeguarding plan not required, but I always
submit one – makes the process go smoother!
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A Bit About Safeguarding Data!
• Assign each respondent a unique ID and remove identifying information (e.g., names, SSNs, addresses, etc) from analysis file!– Keep file linking IDs to identifying information in a locked
cabinet!• Limit access to those with a need to know!
• Once analysis complete, destroy link file with identifying information!
• When presenting results, also ensure identities cannot be inferred!
Link File!Name SSN <<etc>> ID!
Analysis File!ID Variable 1 Variable 2 Variable 3 Variable 4 <<etc>>!
xxxxx xxxxxx xxxxx 1!
xxxxx xxxxxx xxxxx 2!
xxxxx xxxxxx xxxxx 3!
xxxxx xxxxxx xxxxx 4!
1 xxxxxx xxxxx xxxxx xxxxx xxxxxx!
2 xxxxxx xxxxx xxxxx xxxxx xxxxxx!
3 xxxxxx xxxxx xxxxx xxxxx xxxxxx!
4 xx x xxxxx xxxxxx !
xxx 5 ! xxxx xxxxx!
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Common Risks to Research Subjects at NPS!
• Breach of confidentiality or loss of data (e.g. laptop theft or loss) !
• Directly quoting someone without consent!• Inducing PTSD (this has occurred at NPS)!• Injury through the use of experimental
equipment (e.g., retinal scan)!ü The goal of the IRB is to mitigate these risks!
– However, this can only occur if the research has been reviewed by the IRB!
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Approval to Survey (Outside of NPS)!
• DoD Instruction 1100.13, “Surveys of DoD Personnel,” 11/21/1996:!– If you are conducting a survey within one military service, you must
get that service’s approval!• There is a POC for each service with the responsibility to
review and approve!– If you are conducting a survey across services, you must have
OSD’s approval!• DoD 8910.1-M, “Department of Defense Procedures for
Management of Information Requirements,” June 1998:!– If you are conducting a survey across branches of the Federal
government, you must have GSA’s approval and perhaps OMB!– If you are conducting a survey of the general public, you must have
OMB’s approval!• Depending on purpose of survey, “general public” can include
Federal employees, reservists, and even active duty personnel and their families!
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What We Have Covered!
• How research can go wrong in the absence of IRB oversight!
• The Belmont Report and ethical principles for human subjects research!
• The NPS IRB!• Approval requirements for surveying outside
of NPS!
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