Frequently Asked Questions - General
IRB stands for "Institutional Review Board." It is a specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research. The mission of Texas Tech University Health Sciences Center at El Paso is to improve the lives of people in our State and our community by focusing on the unique health care needs of socially and culturally diverse border populations through excellence in integrated education, research, and patient care. This mission includes conducting human subjects research in compliance with applicable laws and regulations, including but not limited to the U.S. Department of Health and Human Services (DHHS) regulations and TTUHSC El Paso policy. TTUHSC El Paso has signed an assurance with the DHHS. As set forth in this assurance, TTUHSC El Paso has two registered IRBs whose purpose is to protect the rights and welfare of human subjects participating in research activities conducted at TTUHSC El Paso and any other entity for which TTUHSC El Paso has been designated as the IRB of record in an assurance filed with the DHHS, Office of Research (OR) and by written agreement between the parties. These IRBs are located at the El Paso campus and provide initial and continuing review of research applications and protocols involving human subjects.
Each IRB shall uphold the TTUHSC Federal Wide Assurance (FWA) as filed with the DHHS and OR. As set forth in the assurance, TTUHSC El Paso has two registered Institutional Review Boards:
TTUHSC El Paso IRB #1 – 00009945
TTUHSC El Paso IRB #2 - 00009946
Designation of additional IRBs under the assurance requires prior notification of and approval by OR.
iRIS is an electronic web-based research software that facilitates IRB submissions and management of human subjects research protocols. Use of iRIS is mandated on the TTUHSC El Paso campus for all IRB submissions.
How do I know if my research project requires IRB Review?
All research and other activities, which even in part involve human subject research, regardless of sponsorship, must be reviewed and approved, or acknowledged as Exempt, by the TTUHSC El Paso 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 in this section 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] and FDA regulations [21 CFR Part 50 and 56] regarding the protection of human subjects research, as applicable.
Human subject
A living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Research
Research is 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 plan that incorporates data collection in an organized/consistent way, and data analysis to answer a question (for example, a hypothesis).
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 is never published is still research. Participants in research studies deserve protection whether or not the research is published. Note Thesis or dissertation projects involving human subjects conducted to meet the requirement of a graduate degree are usually considered generalizable, and require IRB review and approval.
Examples of activities that typically are not generalizable (not research) 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 TTUHSC El Paso community
- Classroom exercises solely to fulfill course requirements or 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 TTUHSC El Paso community.
Per federal regulations, the following activities are deemed not to be research:
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
- Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
Clinical Investigation
FDA regulations define a clinical investigation as any experiment that involves a test article and one or more human subjects and that either is:
Subject to requirements for prior submission to the FDA, or
Not subject to requirements for prior submission to the FDA under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit.
A test article is any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act.
Intervention
Includes both physical procedures by which information or biospecimens 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.
Identifiable biospecimen
A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
FDA regulations
Define a human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. Examples of clinical investigations include:
Investigational drug clinical trials
- Research testing the safety and effectiveness of an investigational device
- Medical outcomes study comparing approved drugs/devices
Note:
Research testing the safety and effectiveness of an In Vitro Diagnostic (IVD) device using human tissue specimens (identifiable or unidentifiable) requires IRB review per FDA 21 CFR Parts 50 and 56, even though under DHHS regulations research involving unidentified tissue specimens would not be considered human subjects research.
To download a copy of this form, please click here.
Yes. IRB approval must be obtained regardless of funding source. Research involving human subjects and all other activities that involve such research in any way must be reviewed and approved by the IRB if one or more of the following apply:
- The research is sponsored by TTUHSC El Paso;
- The research is conducted by, or under the direction, of any employee or agent of TTUHSC El Paso in connection with his or her responsibilities to TTUHSC El Paso;
- The research is conducted by, or under the direction, of any employee or agent of TTUHSC El Paso using any property or facility of TTUHSC El Paso;
- The research involves the use of non-public information maintained by TTUHSC El Paso;
- The research is conducted in accordance with an assurance filed with the ORR in which a TTUHSC El Paso IRB is designated as the IRB of record;
- Any employee of TTUHSC is engaged in research in connection with his or her responsibilities to TTUHSC El Paso, but not as PI;
- The research takes place at any property or facility of TTUHSC El Paso.
No. Research records, data, and specimens are the property of TTUHSC El Paso and shall not be transferred to another entity without prior approval of the VPR.
At TTUHSC El Paso, a single IRB will be required for the following types of non-exempt cooperative (multisite) research carried out within the United States:
- New studies approved on or after January 20, 2020 supported by an agency that has signed on to the Common Rule. For a full list of HHS Departments and Agencies that follow the Common Rule, please click here.
- Research supported by NIH. Click here for the official notice from NIH: NOT-OD-16-094. There are some exceptions. For more about the NIH exceptions and additional information on the single IRB requirement for NIH supported research (in effect since January 25, 2018) click here.
For additional information, please visit this page Single IRB Process.
A case report is a description of an unusual or unique presentation of a disease or condition. A case report is not considered a report of research and does not require review by the IRB or verification of exempt status. Please ensure that the following conditions are satisfied:
a) record review is done by those already involved in the patient's care. This is to ensure that no new confidentiality risks are created by the activity;
b) information about the patient is presented in an anonymous fashion or with the explicit consent of the patient, if not; and
c) no changes were made in the patient's care or diagnostic testing for the sake of reportability.
Regardless of whether a case report does or does not qualify as a report of research, investigators must at all times be sensitive to protecting the privacy and confidentiality of the subject of the reports.
A case report is considered to be research and will require verification of exemption or IRB review if:
a) it is presented in a manner that states or implies generalizability;
b) changes were made in the patient’s care for the sake of reportability; or
c) the patient’s records were examined for reasons not directly related to patient care or quality assurance.
Regardless of whether a case report does or does not qualify as a report of research, investigators must at all times be sensitive to protecting the privacy and confidentiality of the subject of the reports.
A master list is a document that links participant or subject identifiers to a unique code, pseudonym, or ID number to identify the participant or subject’s data. The use of a master is deemed a best practice in research when personally identifiable information is collected from or about participants or subjects.
For biomedical research projects involving retrospective chart review, the master list is typically used to record direct identifiers (e.g., subject name, MRN) and assign a unique study ID number to each subject. See Example A.
For qualitative research projects involving interviews, the master list is typically used to record personally identifiable information collected about participants during the screening/recruitment process and assign each participant a study ID number. The transcribed interview will be stripped of personally identifiable information and the participant will instead be referred to by their study ID number.
The master list must be stored securely and separately (e.g., in completely different location) from the study data to prevent a loss of participant or subject confidentiality. Access to the master list must be restricted. Only study team members who have a legitimate need to use it during the research project should have access to it.
When the master list is in existence, the data is deemed ‘coded’. The study data is not deemed ‘de-identified’ until the master list has been destroyed (because the existence of the master list allows an opportunity for the participant or subject to be re-identified). Any data collected, whether paper (e.g., interview notes) or electronic (e.g., interview transcripts, data abstraction form, electronic filenames) should be identified by the subject’s study ID number as assigned in the master list in place of the participant or subject’s name or other identifying information.
Best practice dictates that the master list be destroyed at the earliest opportunity during the research project. For qualitative research projects involving interviews, the master list is typically destroyed after all transcripts have been verified for accuracy. For biomedical research projects involving retrospective chart review, the master list is typically destroyed after data abstraction has been completed for all subjects.
• PI name and address.
• Condition under study and/or purpose of the research.
• Summary of inclusion / exclusion criteria.
• Brief list of procedures involved.
• Time commitment required.
• Compensation/reimbursement and amount.
• Location of research and contact person for further information.
• IRB stamp of approval displaying the IRB number and approval date.