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NDSU Human Research Protection Program 2.2 NDSU Engagement in Human Subjects Research
2 Applicability:
2.2 NDSU Engagement in Human Subjects Research
Effective Date: 1/15/
Revised: 8/9/
Human subjects research projects, regardless of source of funding or support, in which NDSU employees or agents are ‘engaged’ require prospective IRB review and oversight under the human research protection program. Such projects may be under the direction of NDSU researchers, or researchers from another institution.
1.0 Engagement in human subjects research. Based on federal guidance, NDSU has defined specific research activities and responsibilities which constitute ‘engagement’ on the part of an institution’s employees or agents. Human subjects research projects in which NDSU is considered ‘engaged’ require NDSU IRB review, unless arrangements are made for cooperative review of collaborative projects.
1.1 Engaged in research. An institution or entity is considered to be engaged in human subjects research when their employees or agents perform any of the following:
1.1.1 Receive a direct award, grant or contract for human subjects research.
1.1.2 Direct or supervise the human subjects research project.
1.1.3 Intervene with participants for research purposes by performing invasive or noninvasive procedures. (Exceptions – when an institution’s activities are limited to those described in 1.2.1 – 1.2.4 below, the institution is not engaged). Examples may include, but are not limited to:
- administering counseling or psychotherapy
- drawing blood
- obtaining buccal mucosa cells using a cotton swab
- administering drugs or other treatment
- utilizing physical sensors, or other measurement procedures
1.1.4 Intervene with participants for research purposes by manipulating the environment. (Exceptions – when an institution’s activities are limited to those described in 1.2.1 – 1.2.4 below, the institution is not engaged). Examples may include:
- controlling environmental light, sound, or temperature
- presenting sensory stimuli
- orchestrating environmental events or social interactions
1.1.5 Interact with participants for research purposes. (Exceptions – when an institution’s activities are limited to those described in 1.2.1 – 1.2.4 below, the institution is not engaged). Examples may include, but are not limited to:
- engaging in protocol dictated communication or interpersonal contact
- asking someone to provide a specimen by voiding or spitting into a container
NDSU Human Research Protection Program 2.2 NDSU Engagement in Human Subjects Research
- conducting research interviews
- administering questionnaires
1.1.5 Obtain informed consent of human subjects for non-exempt research. (Exceptions
- when an institution’s activities are limited to those described in 1.2.3 – 1.2.4 below, the institution is not engaged).
1.1.6 Obtain private identifiable information or specimens from any source for research purposes. (Exceptions – when an institution’s activities are limited to those described in 1.2.1, 1.2.6, and 1.2.8 below, the institution is not engaged). Examples may include, but are not limited to:
- observing or recording private behavior
- using, studying or analyzing private identifiable information or specimens provided by another institution
- using, studying or analyzing private identifiable information or specimens already in the possession of the investigator(s).
1.1.7 Utilize private information or human specimens (including de-identified materials) from any source for research subject to FDA regulations. This would include clinical investigations performed to assess the efficacy and/or safety of an FDA-regulated article (drug, biologic, medical device or other article regulated by the FDA). Refer to 11. FDA-Regulated Research for more information.
1.2 Not engaged in research. When the involvement of an institution’s employees or agents is limited to one or more of the following activities, the institution is considered NOT engaged in human subjects research:
1.2.1 Perform commercial or other services for investigators, provided that:
- services do not merit professional recognition or publication privileges,
- services are typically performed for non-research purposes, and
- employees or agents do not administer any research intervention being evaluated under the protocol. Some examples of services may include: interview transcription performed by a transcription company, blood draw or analysis performed by a hospital lab, data collection or analysis performed by a survey firm.
1.2.2 Permit use of facilities to allow another institution’s investigators to intervene or interact with subjects.
1.2.3 Assist with recruitment by informing or providing prospective subjects with information about research (may include a consent document or other IRB-approved materials) or contact information for investigators; provided they do not obtain consent or act as a representative for the research.
1.2.4 Seek or obtain prospective subjects’ permission for investigators to contact them directly.
NDSU Human Research Protection Program 2.2 NDSU Engagement in Human Subjects Research
engagement, as described in Section 1. Cooperative IRB review arrangements may be possible; consult HRPP staff for specific requirements.
2.3 NDSU faculty performing private consulting services NDSU is not engaged in research when its employees or agents provide external consulting services that will not be used for any NDSU purpose or NDSU publication. Such activities do not require IRB review or oversight.
3.0 Cooperative research. Human subjects research may involve the assistance or collaboration of multiple research institutions or other entities. The role of each entity in human subjects research will determine any requirements for training, IRB review, and signed agreements.
3.1 Projects directed or supervised by NDSU. When a cooperative research project is under the direction and supervision of an NDSU employee or agent as PI, review by the NDSU IRB is required, unless cooperative review arrangements are made. For more information refer to SOP 2.3 Collaborative, Multi-site and Off-site Research.
3.2 Project directed or supervised by a non-NDSU entity. NDSU employees or agents may provide assistance or collaborate on research under the direction and supervision of a PI from another institution. When such involvement constitutes NDSU ‘engagement’ in human subjects research, NDSU IRB review is required, unless cooperative review arrangements are made.
4.0 IRB review. Human subjects research projects involving the engagement of NDSU employees or agents are under the jurisdiction of the NDSU HRPP, requiring NDSU IRB review and oversight. Refer to SOP Section 7 IRB Review Process for more information. NDSU IRB may enter into cooperative review arrangements when research involves another institution. Refer to SOP 2. Collaborative, Multi-site, and Off-Site Research for more information.
5.0 Investigator training. NDSU employees and agents performing activities that constitute ‘engagement’ in research are required to complete appropriate human subjects protection training. Refer to SOP 5. Training, Education and Outreach: Research investigators and team members for more information.
6.0 IRB determination of NDSU engagement. An investigator may request a written determination from the IRB regarding whether or not a particular project constitutes the engagement of NDSU in human subjects research. A determination from the IRB is generally not required, with the exception of some uses of existing data or specimens. Refer to SOP 11.2 Human Biological Specimens and 11.3 Secondary Analysis of Existing Data for more information.
When requesting a determination from the IRB, submit a written description of the project including:
NDSU Human Research Protection Program 2.2 NDSU Engagement in Human Subjects Research
- a description of the intended purpose and goals of the project
- specific role of any NDSU faculty, staff, or student
- cite the section(s) concerning engagement (section 1.0) that may be relevant to NDSU’s involvement in the project
- describe role(s) of any other entities
DEFINITIONS:
Employees or agents: an institution’s employees or agents are individuals who: 1) act on behalf of the institution, 2) exercise institutional authority or responsibility, or 3) perform institutionally designated activities. Such individuals may be staff, students, contractors, or volunteers, among others, regardless of whether they are receiving compensation.
Cooperative research: research projects involving more than one institution.
Performance site: physical location where research procedures are performed.
Anonymized (de-identified): identifiers were originally collected, but have been irreversibly removed from previously identified samples or data; an individual can no longer be identified or linked with their information
Anonymous: no identifiable information exists; individual identity cannot be known or deduced, no possibility of linkage with additional information or future data collection
Coded: 1) identifiable information has been replaced with a number, letter, symbol, or combination thereof (e.g., the code); and 2) a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens
Individually identifiable: the identity of the subject is or may be readily ascertained or associated with the information; data can be linked to specific individuals either directly or indirectly through coding systems. Would also include some demographic information, or other unique information or key details that would allow individual identification to be deduced (e.g., using internet search engines or other means).
Investigator: anyone involved in conducting the research; e.g., study design or supervision, data collection, obtaining informed consent, performing research procedures, obtaining coded private information or specimens, analyzing data (note that this would not include someone whose sole role is providing coded private information or specimens to an investigator).
Interaction: includes communication or interpersonal contact between investigator and subject.
Intervention: includes both physical procedures by which data are gathered, and manipulations of the subject or their environment that are performed for research purposes.
Obtaining: receiving or accessing identifiable private information for research purposes; includes an investigator’s use, study, or analysis for research purposes of identifiable private information already in the possession of the investigator.
