Research Ethics
Ray Block, Jr.
PS 585
Research Methods
Today’s Blueprint
Last Class: Surveys and Interviews:
- Interviews
- Surveys
- Defining them
- Why we use them
- How to do them
- Strengths and Weaknesses
Today’s Class: Research Ethnics
- Definitions
- Documents, Regulations, and Guidelines
- Roles and Responsibilities
Definitions
Key Questions:
- Is the activity research?
- Does the research involve human subjects?
If the answer to each of these questions is “yes”, the research must be performed
in accordance with federal regulations to assure that research participants
are protected.
Is the activity research?
- The Belmont Report (1979):
- “[Research is]"an activity designed to test a hypothesis, permit
conclusions to be drawn and thereby contribute to generalizable knowledge.
Research is usually described in a formal protocol that sets forth an objective
and a set of procedures designed to reach that objective"
- Code of Federal Regulations (45 CFR* 46):
- [Research is] “a systematic investigation, including research development,
testing and evaluation designed to develop or contribute to generalizable
knowledge”
- The Belmont Report:
- [Professional practice is] performing “interventions that are designed
solely to enhance the well-being of an individual patient or client…. The
purpose is to provide diagnosis, preventative treatment or therapy to a particular
individual.”
- Practice or Research?
- Professionals such as professors, teachers, physicians, psychologists,
counselors, etc. may engage in activities that, depending on the circumstances,
may be either research or professional practice.
- If the intent of the activity is to contribute to generalizable knowledge,
typically by publishing the results, the activity should be considered research.
Does the research involve “human subjects”?
- A human subject is:
- A living individual about whom an investigator conducting research
obtains:
- data through intervention or interaction with the individual, or
- identifiable private information.
- Additional Considerations:
- Research may also involve “indirect activities”
- Analysis of human specimens
- Data collected by others
- These kinds of indirect activities are considered research with human
subjects.
Documents, Regulations, and Guidelines
Documents, Regulations, & Guidelines
- Regulations = the government’s response to egregious violations of
human rights and dignity
- Nazi war crimes (1940’s)
- “Tuskegee” experiment (1932 - 1972)
- “Human Radiation Experiments”
- Overview
- Documents, regulations and guidelines dealing with the protection
of human subjects derive from several sources.
- The primary responsibility of Institutional Review Boards (IRBs):
- Protecting human research subjects by implementing various requirements
- Important Documents, Regulations and Guidelines:
- Belmont Report, 1979
- 45 CFR 46, 1974 - revisions in 1981, 1998
- Multiple Project Assurance of Compliance with 45 CFR 46
- Food and Drug Administration (FDA) regulations (21 CFR 50 and 56)
- FDA: Good Clinical Practice Guidelines
- FDA: International Conference on Harmonization
Belmont Report
- Articulates the boundaries between “practice” and “research”
- Articulates basic ethical principles to be applied to research involving
humans
- Respect for Persons
- Beneficence
- Justice
- Discusses applications of ethical principles
1) Respect for Persons: Researchers are required to:
- Acknowledge the autonomy of subjects
- Protect subjects with diminished autonomy
- An autonomous person is capable of deliberating about personal goals
and acting on that deliberation
- Respect for Persons: Application
- To the extent that they are able, subjects must be given the opportunity
to choose what will, or will not, happen to them.
- The process of providing information that subjects can comprehend
in a manner that assures voluntary participation in the research represents
the application of this ethical principle
2) Beneficence
- Do no harm
- Minimize possible harms and maximize possible benefits
- Creates the obligation to secure the well-being of individuals without
intentionally injuring any individual
- Beneficence: Application:
- Avoiding harm requires learning what is harmful
- Assessing the nature and probability of harms and benefits in a systematic
manner, prior to performing the research, represents the application of this
ethical principle
3) Justice: Consider the following questions:
- Who receives the benefits of the research?
- Who bears the burdens of the research?
- There should be a fair sharing of burdens and benefits
- Justice: Application
- Selecting subjects by fair procedures that take into account who
may benefit from the research represents the application of this ethical
principle
Department of Health and Human Services Regulations .45 CFR 46
- Codifies the manner in which ethical considerations are applied to
research involving human subjects by requiring institutions receiving federal
funding to have the research reviewed prospectively and on a continuing basis
by Institutional Review Boards (IRBs)
- Referred to as “the Common Rule”
Multiple Project Assurance of Compliance (MPA) M-1238
- A document negotiated between the Department of Health and Human Services
and the OSU Vice President for Research, which assures compliance with 45
CFR 46.
- The MPA outlines principles and guidelines that govern the institution,
faculty and staff in the discharge of responsibilities for protecting human
subjects taking part in research conducted at or on behalf of OSU, regardless
of the source of funding.
FDA Regulations .21 CFR 50 and 56
- Codify FDA regulations pertaining to human subjects research including
the requirement of informed consent and prospective and continuing review
of research by IRBs
- FDA regulations govern sponsors and investigators, as opposed to Health
and Human Services regulations, which govern institutions.
Additional FDA Guidelines
- The Good Clinical Practice (GCP) and International Conference on Harmonization
(ICH) guidelines:
- Help investigators and sponsors meet the FDA regulations by articulating
standards for performing research involving human subjects. (see in particular
E6 )
Roles and Responsibilities
Investigators
- Responsible for conducting the research properly and maintaining adequate
records, which includes:
- Seeking approval prior to initiating the research
- Obtaining legally effective informed consent from subjects and documenting
the consent using an IRB-approved consent form, unless specifically waived
by the IRB
- Investigators also responsible for:
- Reporting adverse events or unexpected occurrences to the IRB promptly
- Requesting changes to the protocol and receiving permission from
the IRB before implementing them
- Requesting continuation of IRB approval if the duration of the research
extends beyond the period of initial IRB approval (which, by regulation,
is a maximum of 365 days)
Institutional Review Boards (IRBs):
- Determine that the risks of participation in the proposed research
are reasonable in relation to the anticipated benefits
- Ensure that legally effective informed consent will be obtained and
documented in a manner that meets federal requirements
- Have the authority to review and approve, require modification in,
or disapprove all research activities, including proposed changes in previously
approved research
Office of Research Risks Protection (ORRP)
- Provides administrative support to IRBs and investigators
- Maintains official institutional records regarding human subjects research
- Determines, in consultation with the IRB Chair, whether applications
meet federal requirements for exemption from IRB review
- Determines, in consultation with the IRB, whether applications meet
federal requirements for expedited review
- Is responsible for procedural and record-keeping audits
Vice President for Research
- Assures institutional compliance with 45 CFR 46 and other federal,
state or local laws
- Assures sufficient resources to support the IRBs
Shared Responsibilities/Accountabilities
- Failure of any party to comply with the MPA when performing or administering
research involving human subjects can result in:
- Harm to research participants
- Harm to the reputation of the institution and its faculty
- Federally imposed suspension of all research, and/or
- Disciplinary actions
Allegations of Noncompliance
- Allegations of suspected noncompliance should be reported to the IRB
or the OSU Office of Research Risks Protection.
- The process for reporting and responding to these allegations is described
in the Human Subjects Violations Policy.
References (FYI):