Frequently Asked Questions about Human Subjects Research
FAQS
IRB is an acronym for Institutional Review Board for Human Use, which by federal law must review all research conducted at UNA or by UNA faculty, staff, and students that involves human subjects. The IRB also has jurisdiction over research involving UNA data on human subjects. The IRB can approve, require modifications in, or disapprove all research activities that fall within its jurisdiction. The IRB review ensures that research involving human participants is conducted ethically. This includes ensuring that risks to participants are minimized, the selection of participants is equitable, and participants are informed fully of their participation and potential risks and benefits. Interaction with human subjects (including recruiting and data collection) CANNOT begin until the IRB approves the research protocol and instruments. At UNA, the IRB is called the Human Subject Committee (HSC).
Yes. There's a good chance such research may qualify for "exempt" or "expedited" review, but only the HSC can decide. For detailed information about these review categories, see the Human Subject Research Review Guidelines section of the UNA Human Subject Research Program Policy.
The HSC coordinates its review with several other offices and must be able to link the research protocol with the funded project, where applicable. Therefore, the title of the research protocol submitted to the HSC must either (1) match the title of the funded project or (2) contain the title of the funded project in parentheses that follow the protocol title. (This is usually the case, for example, in program project grants when many protocols are covered by one funded project. In most cases, each funded award involving human subjects must have HSC approval.)
HSC review is required for studies that meet the definitions of “research” and “human subject.”
According to the regulations, research is any systematic investigation designed to develop or contribute to generalizable knowledge. Any activity that meets this broad criterion and that is conducted by UNA faculty, administration, staff, students, and contracted consultants or that uses UNA facilities is research for the purposes of this discussion. It does not matter whether the activity occurs within and as a part (however large or small) of some other activity, such as a demonstration or service program, or whether the research is the whole project.
Regulations define a human subject as a living individual about whom an investigator obtains either (1) data through intervention or interaction with the individual, or (2) identifiable private information. Intervention generally includes physical procedures by which we gather data (e.g., venipuncture) and manipulations of the subject or the subject’s environment for research purposes. Interactions that include communication or interpersonal contact between the investigator and the subject are more common. Private information includes information about behavior that occurs in a context where the individual can reasonably expect no observation or recording. Thus, the individual will have provided the information for specific purposes and can reasonably expect that the information associated with his or her identity will not be made public.
The following chart will help you determine if your study is subject to HSC review:
The HSC determines the appropriate level of review for a research protocol. The research may be found to be exempt from review, reviewable under expedited procedures, or subject to full HSC review. For more information about the criteria for each level, see the Review Categories (Exempt, Expedited, Full) section of the UNA Human Subject Research Program Policy.
The University has negotiated a Federal Wide Assurance (FWA) with the Federal Office for Human Research Protections (OHRP). Under this assurance—and federal law—the University must reasonably ensure that human subjects are adequately protected in research conducted under its auspices. HSC review of all research involving human subjects is required for the University to uphold its assurance with the federal government.
The HSC Chair/Vice-Chair can review and approve protocols designated as expedited or exempt. Typically, the investigator is notified of the status of their protocol submission within 10 business days. For Full Reviews, the HSC schedules a meeting as needed, and the investigator is notified of the HSC recommendations within 20 business days.
The Common Rule refers to regulations that govern human subjects in research and have been adopted by several federal agencies. It is delineated in Title 45 of the Code of Federal Regulations, Part 46, Subpart A.
The UNA HSC will review your application. The board consists of 12 members, and at least 8 must be present at the review for a full vote. The members have various backgrounds and specialties. In addition, at least one member is always a person not affiliated with UNA and can review applications according to community rather than academic standards. If a study involves using prisoners as human subjects, a prisoners' advocate must sit on the board to review that study's application to the IRB.
The HSC's membership is selected based on the requirements of federal regulations. In general, the HSC comprises faculty or staff at UNA who have expertise in the areas of research that the HSC reviews and individuals who represent other points of view. Attributes of the membership are described in the Human Subject Committee section of the UNA Human Subject Research Program Policy. A current listing of members can be obtained from the Office of Sponsored Programs.
If you have begun recruiting or in any way interacting with human subjects, you must stop immediately. You cannot continue until your protocol is approved or exempted by the HSC. Contact the HSC to report the situation and submit your application package to the HSC as soon as possible, explaining why HSC approval was not obtained before beginning the study. In addition to reviewing the protocol, based on the information provided, the HSC will conduct an inquiry to determine the extent of noncompliance, whether the research activities engaged so far were conducted ethically, and whether the data may be utilized. See the Research Proposal Submission Forms and Guidelines section of the UNA Human Subject Research Program Policy for guidance on preparing the application package.
Federal regulations require that research on human subjects undergo prior approval or exemption as a result of review by an IRB. The University's policy states that non-compliance may result in, among other things, suspension or termination of the study. For additional information, see the Non-compliance section of the UNA Human Subject Research Program Policy.
Pilot and feasibility studies involving only one human subject require the same scrutiny as full-scale research projects. Pilot studies should be identified in applications to the HSC.
If students conduct human subjects research as part of a class assignment or to satisfy a degree requirement, the HSC must review the proposed research. However, class assignments to teach or practice research methodology generally do not require HSC approval unless the effort is intended to produce generalizable knowledge. When students conduct research as part of a course of study, a faculty member is ultimately responsible for protecting subjects, even if the student is the primary researcher and directs the project. Consultation with HSC staff is recommended for situations in which it is unclear whether a submission is required.
All proposals involving human subjects and conducted by anyone affiliated with UNA must be submitted to the HSC for review and approval/exemption. This requirement applies regardless of the site of research activity.
Human research conducted by UNA, whether in the U.S. or foreign countries, remains under the University's purview, applicable federal regulations, and institutional guidelines. Human subjects in foreign countries merit the same level of protection as subjects in the United States, and acceptable practices may vary from place to place. Different mores, traditions, and institutions may require different research procedures, particularly in informed consent, recruitment practices, and documentation. See the International Standards topic under the Policies, Guidance, and Forms tab on the Office of Sponsored Programs Human Subject Research web page.
Yes, ads used to recruit participants into the research study are considered extensions of the consent process and, therefore, need to be reviewed and approved by the HSC before use. For additional information, see the Recruitment topic under the Policies, Guidance, and Forms tab of the Office of Sponsored Programs Human Subject Research web page.
Faculty, staff, and students (undergraduate or graduate) must obtain HSC approval before involving humans (or data collected about or from humans) as research subjects. If you are unsure whether your research needs approval, contact the HSC for clarification. If you are a student, your advisor may have obtained HSC approval for the study that you are conducting. If you think this is the case, verifying it before you start is crucial. For guidance on determining when research is subject to HSC review, see the FAQ above, How do I know if I need HSC approval for my study?
Protocols are approved for 1 year from the effective date of the approval. Investigators must submit an HSC Continuing Review application annually before expiration, or the research will be suspended until re-approved. Continuing Reviews will be conducted over the project's life as long as data remain identifiable to the PI (links or codes exist that allow identification of participants), even if data collection is closed. The only research-related activity remaining is manuscript development.
Principal investigators are responsible for the actions of the people whom they engage to perform studies. If a member of a research team fails to follow the approved protocol, fails to maintain required documentation, or participates in activities that violate federal regulations or put subjects at risk, the PI and the research team member may be subject to disciplinary action, research suspension, and/or fines. For more information on possible consequences of non-compliance, see the Non-compliance section of the UNA Human Subject Research Program Policy.
As stated in federal regulations and UNA policy, the study's Principal Investigator is responsible for all activities relating to the research study. Delegation of authority does not delegate responsibility or accountability.
All research protocols involving human subjects as participants must include a provision for obtaining signed, voluntary informed consent forms from each participant before their participation, unless a waiver is granted explicitly by the HSC. The HSC may consider waiving some or all of the elements of informed consent if the following criteria are met: 1) the study is classified as minimal risk; 2) the requirement to obtain those informed consent elements is impractical; and 3) the decision to waive those consent elements will not adversely affect the rights and welfare of members of the study population. For more information on consent, see the Informed Assent and Consent Forms and Guidance section of the UNA Human Subject Research Program Policy. See also the Special Consideration for Certain Human Subject Populations section of the policy if your research involves children, the cognitively impaired, military, pregnant women, neonates or fetuses, or prisoners.
Parents are legally authorized representatives for their children. Suppose someone other than a parent asserts that he or she is the legally authorized representative. In that case, you should obtain a copy of the court documents naming the individual as guardian or conservator.
The injury compensation clause should state that “UNA and (the sponsor) have made no provision for compensation in the event of injury resulting from the research."
Publicly available datasets are those that contain data that are available to anyone regardless of occupation, purpose, or affiliation, and have legitimately attained such status; i.e., those individuals who are responsible for posting the dataset had legitimate access to the data and have employed the necessary mechanisms to ensure the privacy and confidentiality of the individuals about whom the data were collected. In general, while the use of such data may meet the regulatory definition of research, the definition of human subjects is not met because data about a living person is not obtained through interaction or intervention, and no private, identifiable information about a living individual is obtained.
The HSC has reviewed the datasets listed below and determined that they meet the criteria for “publicly available datasets.” However, many of the datasets listed have a publicly available component and a restricted use component. The use of data from these UNA HSC-approved public data sets is not considered human subject research as long as the following two criteria are met:
- Research will NOT involve merging any data set so that individuals might be identified.
- Researchers will NOT enhance the public data set with identifiable or potentially identifiable data.
If the two criteria above are met, and the research involves data from a dataset listed below, no UNA HSC review or approval is needed. If both requirements are not met, an HSC review is required.
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Site of Data |
Data Set |
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(ATUS) |
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(ICPSR) |
Public-Use Data Files Only – excludes restricted and enclave datasets |
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(NTDB) |
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(NCES) |
Public-Use Data Files including, but not limited to: |
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(CDC) |
(BRFSS) National Ambulatory Medical Care Survey (NAMCS) and |
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(AHRQ) |
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(NSCAW – General Use Files Only) |
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Public-Use Data Files Only – excludes restricted datasets |
Definitions
For the protection of human subjects, how is research defined? The regulations define research as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." Suppose you are conducting a study that you expect to publish or report in a public forum. In that case, you should consider it research and subject to HSC jurisdiction if it involves human subjects. If you are collecting data only for internal use, for example, to improve customer service in your department, you are not doing research.
Regulations define a human subject as a living individual about whom an investigator obtains either (1) data through intervention or interaction with the individual, or (2) identifiable private information. Intervention generally includes physical procedures by which we gather data (e.g., venipuncture) and manipulations of the subject or the subject’s environment for research purposes. Interactions that include communication or interpersonal contact between the investigator and the subject are more common. Private information includes information about behavior that occurs in a context where the individual can reasonably expect no observation or recording. Thus, the individual will have provided the information for specific purposes and can reasonably expect that the information associated with his or her identity will not be made public. Identifiable data are data where the identity of the subject can be determined directly (e.g., through a Social Security Number (SSN) recorded on the data collection instrument) or indirectly (e.g., by cross-referencing a unique identifier (such as a student identification number) on a data collection instrument back to the SSN or other identifier of the person with whom it was used).
The Common Rule defines minimal risk—for non-prisoners—as risk in which "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." (45 CFR 46.102). For prisoners, minimal risk is defined as risk in which "the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons." (45 CFR 46.303).
Anonymous: Data does not contain any information permitting identification of the individual(s) about whom the data were collected. De-identified: When collected, data contained identifiers or information that would allow identifying the individual(s) about whom the data were collected, but the identifiers or other links to identity have been removed. Coded: Data contains identifiers, but the identifiers are stored separately from the data; a subject identifier or other code is used to link the two. Confidential: Data includes information that would permit identification of the individual(s) about whom the data were collected, but is maintained to protect the information from being released to unauthorized individuals. Identifiable Data: The identity of the subject can be determined directly (e.g., through a Social Security Number (SSN) recorded on the data collection instrument) or indirectly (e.g., by cross-referencing a unique identifier (such as a student identification number) on a data collection instrument back to the SSN or other identifier of the person with whom it was used).
A "medical device" is a diagnostic or therapeutic article that does not achieve its principal intended purposes through chemical action within or on the body. Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, orthopedic pins, and other orthopedic equipment.
Exemption
No. Only the HSC can determine exemption status.
Investigators submitting protocols for studies that qualify for exemption are generally notified within 10 working days or less.
All research involving human subjects must be submitted to the HSC. Only the HSC can grant an exemption.
HIPPA
HIPAA is the Health Insurance Portability and Accountability Act. Although most commonly referred to as "HIPAA," it is the Privacy Standard of HIPAA that many researchers need to address, and which may require submission of authorization, waiver of authorization, or preparatory research documents to the HSC. See the Health Insurance Portability and Accountability Act (HIPAA) topic under the Policies, Guidance, and Forms tab on the Office of Sponsored Programs Human Subject Research web page.
Reporting
Yes, reports are due to the HSC when the following events, milestones, or conditions occur. For additional information on each topic and appropriate forms, see the respective section in the UNA Human Subject Research Program Policy. Report modification to the research protocol before implementation, including changes to research design, research staff, assent/consent document(s), or data collection instruments or methodologies. The only exception to the requirement for obtaining prior HSC approval is where a change needs to be implemented to eliminate an apparent, immediate hazard to a subject during the research. Report any non-compliance with policy or deviation from an approved protocol to the HSC. All serious or continuing non-compliance instances shall be reported in writing to the HSC Chair within five days. Report unanticipated problems (including some adverse events) as soon as practicable, but no longer than five days. An unexpected problem includes any untoward sign, result, event, misadventure, injury, dysfunction, adverse drug reaction, or any other undesirable happening or unanticipated problem that involves risks to subjects or others not previously reported, and that could reasonably be related to the activities of the study.
Special Classes (Populations) of Subjects
Under 45 CFR 46, Subpart B, pregnant women and fetuses are considered to be members of a vulnerable population and, therefore, entitled to special protections if they participate in research activities. Subpart B defines both the types of permissible research with pregnant women and fetuses and the safeguards that must be followed. For additional information, please review the HHS
Under 45 CFR 46, Subpart C, prisoners are considered members of a vulnerable population and, therefore, entitled to special protections if they participate in research activities. Subpart C defines the types of permissible research with prisoners and the safeguards that must be followed. For additional information, review the HHS .
Under the terms of 45 CFR 46, Subpart D, children are considered members of a vulnerable population and, therefore, entitled to special protections if they participate in research activities. Subpart D defines the types of permissible research with children and the safeguards that must be followed. For additional information please review the HHS .
Other classes of human subjects include cognitively impaired and military. If the research protocol includes subjects in this population, contact the Office of Sponsored Programs for additional guidance.
Training
Who should complete UNA HSC training?
- You need HSC training if you are an employee or student at UNA and you
- are listed as an Investigator or "key personnel" (i.e., engaged in the design, conduct, analysis, or reporting of research) on the protocol or funding application; or screen potential participants and/or obtain informed consent;
- collect, analyze or access the data, or have HSC-related responsibilities.
- are listed as an Investigator or "key personnel" (i.e., engaged in the design, conduct, analysis, or reporting of research) on the protocol or funding application; or screen potential participants and/or obtain informed consent;
- You do not need HSC training if
- are not affiliated with UNA in any way (e.g., student, employee, consultant);
- and work at another institution that has its own IRB.
- are not affiliated with UNA in any way (e.g., student, employee, consultant);
PI training certificates are valid for the duration of the approved protocol, but not to exceed three years from the certificate date. PIs who submit certificates with their ‘Protocol Submission Form’ due to expire during the approved protocol research period must retake the training and submit an updated training certificate.
Unanticipated Problems/Adverse Events
What is an unanticipated problem?
- Unanticipated problems are any incident, experience, or outcome that meets all of the following criteria:
- unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the HSC-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied
- related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
- suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
- unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the HSC-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied
- Unanticipated problems must be reported to the Director, Office of Sponsored Programs and HSC Chair as soon as practicable but no later than five days after the occurrence. See Unanticipated Problems and Adverse events section of the UNA Human Subject Research Program Policy for guidance and form.
Adverse events are any undesirable and unintended event that involves human subjects, which could be reasonably related to participation in the study, regardless of whether it was listed on the informed consent document as an expected risk. Adverse events that meet the criteria for unanticipated problems must be reported to the Director of Sponsored Programs and HSC Chair as soon as practicable, but no later than five days after the occurrence. See the Unanticipated Problems and Adverse Events section of the UNA Human Subject Research Program Policy for guidance and form.