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About the Human Subjects Committee (UNA’s IRB)

• What is an IRB?

  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 aim of the IRB review is to ensure that research involving human participants is conducted in an ethical manner. This includes ensuring that risks to participants are minimized, the selection of participants is equitable, and participants are informed fully of what their participation will entail and of the potential risks and benefits. Interaction with human subjects (including recruiting and data collection) CANNOT begin until the IRB has approved the research protocol and instruments to be used. At UNA, the IRB is called the Human Subject Committee (HSC).

• Do I need IRB approval to interview people or observe their behavior?

  Yes. There's a good chance such research may qualify for "exempt" or "expedited" review, but only the HSC can make that decision. For detailed information about these review categories, see the Human Subject Research Review Guidelines section of the UNA Human Subject Research Program Policy.

• Why does the title of my protocol have to match the title of the funding application?

  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 its own HSC approval.)

• How do I know if I need HSC approval for my study?
• How do I determine which review process is right for a project?

  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.

• Why is my research subject to review by the HSC?

  The University has negotiated a Federal Wide Assurance (FWA) with the Federal Office for Human Research Protections (OHRP). Under this assurance—and under 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.

• How often does the IRB meet?

  The HSC Chair/Vice-Chair has the authority to review and approve protocols designated expedited or exempt. Typically, the investigator is notified within 10 business days as to the status of their protocol submission. For Full Reviews, the HSC schedules a meeting as needed with the investigator notified of the HSC recommendations within 20 business days.

• What is the "Common Rule?"

  The Common Rule refers to regulations that govern human subjects of research and have been adopted by several federal agencies. The Common Rule is delineated in Title 45 of the Code of Federal Regulations Part 46 Subpart A.

• Who will review my research?

  Your application will be reviewed by the UNA HSC. The board consists of 12 members, and at least 8 of them must be present at the review for a full review vote to be taken. The members have various backgrounds and specialties. In addition, at least one member is always a person not affiliated with UNA and able to review applications according to community, rather than academic, standards. If a study involves the use of prisoners as human subjects, a prisoners' advocate must sit on the board for review of that study's application to the IRB.

• Who makes up the HSC?

  The membership of the HSC is selected based on the requirements of the 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.

• I've already started a research project and didn't realize that I needed to receive HSC approval first. What should I do?

  If you have begun recruiting or in any way interacting with human subjects you must stop immediately and 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, including an explanation for 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.

• What happens if I conduct human research without HSC approval?

  Federal regulations require that research on human subjects must have 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.

• I intend to run a pilot study before my large research project begins. Do I need HSC approval before starting the pilot study?

  Pilot studies and feasibility studies, including those involving only one human subject, require the same scrutiny as full-scale research projects. Pilot studies should be identified as such in applications to the HSC.

• I teach a course and several of my students want to conduct a research project involving human subjects. Do they need to file with the HSC?

  If students are conducting 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 ultimately is responsible for the protection of subjects, even if the student is the primary researcher and actually directs the project. Consultation with HSC staff is recommended for situations in which it is not clear whether a submission is required.

• Do I need IRB approval if my work will be conducted off campus?

  All proposals that will involve research with human subjects and will be 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.

• My research will be done in another country. Do I have to obtain HSC review and approval?

  Human research conducted by UNA, whether in the U.S. or in foreign countries, remains under University 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.

Advertisements

• Do audio, video, print ads have to be approved by the HSC?

  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 prior to use. For additional information see the Recruitment topic under the Policies, Guidance and Forms tab of the Officer of Sponsored Programs Human Subject Research web page.

Approvals

• Who must obtain advance approval if humans are proposed as subjects of research?

  Faculty, staff, and students (undergraduate or graduate) must obtain HSC approval before involving humans (or data collected about or from humans) as subjects of research. 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 that this is the case, it is important to verify it before you start. 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?

• When must a protocol be renewed?

  Protocols are approved for a period of 1 year from the effective date of the approval. Investigators are required to submit an HSC Continuing Review application annually prior to expiration or the research will be suspended until re-approved. Continuing Reviews will be conducted over the life of the project as long as data remain identifiable to the PI (links or codes exist that allow identification of participants), even if data collection is closed, and the only research-related activity remaining is manuscript development.

Compliance

• What will happen if someone working in my study doesn't follow the rules?

  Principal investigators are responsible for the actions of the people that they engage to perform studies. If a member of a research team fails to follow the approved protocol, fails to maintain required documentation, or engages 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.

• Ultimately, who is responsible for all research activities that are part of a project?

  As stated in federal regulations and UNA policy, the Principal Investigator of the study is responsible for all activities relating to the research study. Delegation of authority does not delegate responsibility or accountability.

Consent

• Are signed consent forms always required when doing human subject research?

  All research protocols involving human subjects as participants must include a provision for obtaining signed voluntary informed consent forms from each participant prior to their participation unless a waiver is specifically granted 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.

• How do we assure someone is the participant’s “legally authorized representative?"

  Parents are legally authorized representatives for their children. If someone other than a parent asserts that he or she is the legally authorized representative, you should obtain a copy of the court documents naming the individual as guardian or conservator.

• If a sponsor is making no provision for injury compensation how should this be stated in the consent form?

  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."

Datasets

• Is HSC review required for use of public datasets?

Definitions

(See also Glossary section of the UNA Human Subject Research Program Policy)

• For purposes of human subjects protection, how is research defined?

  For purposes of human subjects protection, how is research defined? Research is defined by the regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." If you are conducting a study that you expect to publish or report in a public forum, 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.

• How do I know if I’m collecting or using “human subject” data?

  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 both physical procedures by which we gather data (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Much more common are interactions which include communication or interpersonal contact between the investigator and the subject. Private information includes information about behavior that occurs in a context in which the individual can reasonably expect that no observation or recording is taking place. Thus, the individual will have provided the information for specific purposes and can reasonably expect that the information as 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).

• What does minimal risk mean?

  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).

• What is the difference between "anonymous", “identifiable” and “confidential” data?

  Anonymous: Data does not contain any information that would permit identification of the individual(s) about whom the data were collected. De-identified: When collected, data contained identifiers or information that would permit identification of 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 contains information that would permit identification of the individual(s) about whom the data were collected, but is maintained in a manner that protects the information from release 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).

• What is a medical device?

  A "medical device" is defined as a diagnostic or therapeutic article that does not achieve any of 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, and orthopedic pins or other orthopedic equipment.

Exemption

• Can a PI, department head, or faculty mentor approve an exemption?

  No. Only the HSC can determine exemption status.

• How long does approval of an exemption take?

  Investigators submitting protocols for studies that qualify for exemption are generally notified in 10 working days or less.

• If my project appears to meet the requirements for an "exemption," does that mean I don't have to do anything else?

  All research involving human subjects must be submitted to the HSC. Only the HSC can grant exemption.

HIPAA

• What is HIPAA?

  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 to 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

• Once my protocol is approved and my research is underway, are there reporting requirements to the HSC?

  Yes, reports are due to the HSC when the following events, milestones, or conditions occur. For additional information on each topic and appropriate forms to use, see the respective section in the UNA Human Subject Research Program Policy. Report modification to the research protocol prior to 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 in the course of the research. Report any incident of non-compliance with policy or deviation from an approved protocol to the HSC. All instances of serious or continuing non-compliance 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 unanticipated 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 -

(See also the Special Consideration for Certain Human Subject Populations section of the UNA Human Subject Research Program Policy)

• What additional requirements apply to research with pregnant women or fetuses?

  Under the terms of 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, review the regulations at: http://www.hhs.gov/ ohrp/humansubjects/guidance/45cfr46.htm#subpartb

• What additional requirements apply to research with prisoners?

  Under the terms of 45 CFR 46, Subpart C, prisoners are considered to be members of a vulnerable population and therefore entitled to special protections if they participate in research activities. Subpart C defines both the types of permissible research with prisoners, and the safeguards that must be followed. For additional information, review the regulations at: http://www.hhs.gov/ ohrp/humansubjects/guidance/45cfr46.htm#subpartc

• What additional requirements apply to research with children?

  Under the terms of 45 CFR 46, Subpart D, children are considered to be members of a vulnerable population and therefore entitled to special protections if they participate in research activities. Subpart D defines both the types of permissible research with children, and the safeguards that must be followed. For additional information, review the regulations at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd

• What additional requirements apply to cognitively impaired and military subjects?

  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

(See also Education and Training tab of UNA Office of Sponsored Programs Human Subject Research web page)

• 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.
      
      
  • 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.
      
      
• How often should I complete HSC Training?

  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.
      
      
  • 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.
    
    
• What are adverse events and do they have to be reported to the HSC?

  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 Unanticipated Problems and Adverse events section of the UNA Human Subject Research Program Policy for guidance and form.

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