Human Subjects Protection & Institutional Review Board (IRB)
All research conducted at Parkland Health & Hospital System is governed by Federal and state regulations pertaining to human research protections, as well as other guidance and local policies and procedures.
In this section:
Regulatory Authority
Parkland’s designated Institutional Review Board (IRB) is governed by federal regulations Title 45, Part 46, Protection of Human Subjects that dictate the scope and purpose of IRB activities. The Office of Human Research Protection (OHRP) is the federal administrative agency that monitors the IRB and its activities. The Food and Drug Administration (FDA) also protects human research subjects through its investigational drug and device regulations. Both the OHRP and the FDA monitor human research subjects protections through educational efforts, site visits, and reporting requirements. Both have the authority to suspend research for failure to adhere to the regulations.
Assurance and IRB Registration
A Federalwide Assurance (FWA) is an institution or organization's assurance to the Federal government that human subject research conducted at that site is in compliance with Federal regulations pertaining to the protection of human subjects.
Parkland’s FWA is FWA00001387 and is filed with the legal name “Dallas County Hospital District.”
The Assurance states that all research involving human subjects that is conducted by Parkland staff or by researchers who fall under the purview of Parkland, or on Parkland premises or under its sponsorship, whether supported by Federal funds or not, must be reviewed and approved by Parkland’s designated IRB. Parkland relies upon an external Institutional Review Board (IRB). The FWA covers the hospital, outpatient clinics, primary care clinics and the Dallas County Jail. The assurance lists the five external IRBs that Parkland primarily relies upon: UT Southwestern IRBs #1, #2, #3 and #4; National Cancer Institute IRB #1.
In order to approve human subject research in accordance with Federal regulations the IRB must determine that all of the following requirements are satisfied:
- Risks to subjects are minimized.
- 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.
- Informed consent will be sought from each prospective subject or the subject’s legally authorized representative.
- Informed consent will be appropriately documented.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.
- When appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
Note
Before research can be initiated using the UTSW IRB, the following training MUST be completed:
- Good Clinical Practice (GCP)
- Human Subjects Training
- Conflict of Interest Training
- Research HIPAA
To learn more, click Training and Education or access the CITI Research Required Training page.
|
Human Subjects Research
All human subjects research (and all other activities, which in part involve human subject research), regardless of sponsorship, must be reviewed and approved by the IRB prior to initiation. This includes all interventions and interactions with human subjects for research, including advertising, recruitment, and/or screening of potential subjects. Please review the information below to understand what activities meet the definition of human subjects research.
Definition of Human Subjects Research
Human subjects research is any research or clinical investigation that involves human subjects.
Investigators conducting human subjects research must satisfy DHHS regulations [45 CFR Part 46] regarding the protection of human subjects research, as applicable. When considering whether an activity meets the definition of human subjects research per DHHS regulations, one must consider two federal definitions: research and human subject.
Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
A “systematic investigation” is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.
Examples of systematic investigations include:
- surveys and questionnaires
- interviews and focus groups
- analyses of existing data or biological specimens
- epidemiological studies
- evaluations of social or educational programs
- cognitive and perceptual experiments
- medical chart review studies
Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations). However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to “generalizable (scholarly) knowledge” makes an experiment or data collection research, regardless of publication. Research that never is published is still research. Participants in research studies deserve protection whether or not the research is published.
Examples of activities that typically are not generalizable include:
- biographies
- oral histories that are designed solely to create a record of specific historical events
- service or course evaluations, unless they can be generalized to other individuals
- services, courses, or concepts where it is not the intention to share the results beyond the UTD community
- classroom exercises solely to train students in the use of particular methods or devices
- quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the Parkland community
A human subject is as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
- Interaction includes communication or interpersonal contact between investigator and subject.
- Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
- Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Other Resources
- Belmont Report | The Belmont Report sets forth basic ethical principles for the conduct of research involving human subjects. Those principles, respect for persons, beneficence, and justice, have been formally adopted by Parkland through its Federalwide Assurance, for all research at Parkland involving human subjects. Belmont is the foundation of the U.S. human subjects regulatory system.
- Certificates of Confidentiality | Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. The certificates may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. A Certificate of Confidentiality will allow the researcher and others who have access to research records to refuse to disclose identifying information on individual research participants in civil, criminal, administrative, legislative, or other proceedings, whether at the federal, state, or local level.
- Certificates of Confidentiality may be secured for any sensitive research, regardless of the funding source, so long as the research is relevant to the mission of the NIH/DHHS. In fact, the research does not have to be funded.
- Office for Human Research Protections (OHRP)
- Frequently Asked Questions About Human Research (HHS)
- IRB Guidebook (OHRP)
- Interpreting the Common Rule for the Protection of Human Subjects for Behavioral and Social Science Research (NSF)
- Informed Consent Checklist (HHS)
- Educational Videos | OHRP Educational Videos (HHS YouTube channel)
|