Human Subject Research

Frequently Asked Questions

About the Human Subjects Committee (UNA’s IRB)

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  • 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

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.

Other FAQs Sources

Do I need HSC approval?
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