Human Subjects Research

Policy 6.6
Approved by:	President
Responsible Officer:	Vice President for Research & Economic Development
Responsible Office:	Research & Economic Development
Originally Issued:	01/19/1996
Last Revision:	10/23/2023
Category:	Research, Sponsored Programs, and Intellectual Properties
Related Policy
US Department of Health and Human Services Office for Human Research Protections 45 CFR 46
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research
US Department of Health and Human Services Office of Research Integrity (ORI) Nuremburg Code: Directives for Human Experimentation
National Research Act PL 93-348 (1974)
SDBOR Policy 1.3.5 Research Affairs Council
DSU Institutional Committees Policy X.X. (Under Revision)
CITI Program Computer-Based Training modules required by the Research and Economic Development office
International Compilation for Human Research Standards (2020 Edition)

I. REASON FOR THIS POLICY

This policy describes the major responsibilities of Dakota State University (DSU) and its researchers to protect the rights and welfare of human subjects participating in research. To meet that commitment, DSU ascribes to principles set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects (The Belmont Report) and complies with Department of Health and Human Services (HHS) policies and the Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46).

DSU's Institutional Review Board (IRB) evaluates the degree to which human subjects used in any research activity, in any capacity, are adequately protected as required by federal law in order to minimize potential risks for human subjects, researchers, and the university.

This policy applies to all faculty and staff who conduct research involving human subjects within the course and scope of their organizational duties and students who conduct research involving human subjects within the course and scope of their academic studies.

II. DEFINITIONS

1. Artificial Intelligence (AI). A feature where machines learn to perform tasks, rather than simply carrying out computations that are input by human users. US Department of Health & Human Services, National Institution of Biomedical Imaging and Bioengineering
2. HHS. U.S. Department of Health and Human Services is responsible for regulations for the protection of human subjects.
3. Human Subject. Living individual about whom an investigator (whether professional or student) conducting research:
   1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
   2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. 45 CFR Protection of Human Subjects §46.102(e)(1)
4. Institutional Official (IO). The individual responsible for research compliance oversight, including responsible conduct of research (RCR), research with human subjects, and research-related export controls.
5. Institutional Review Board (IRB). An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.
6. Investigator. May be used interchangeably with Researcher.
7. International/Transnational. May be used interchangeably.
8. IRB Administrator: Provides overall management of the IRB process, assisting both the IO and the IRB Chair with operational tasks.
9. IRB Approval. The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements. 45 CFR Protection of Human Subjects §46.102(h)
10. IRB Chair. Facilitates the completion of IRB meeting agendas and research review priority needs.
11. Machine Learning (ML). An approach to AI in which a computer algorithm (a set of rules and procedures) is developed to analyze and make predictions from data that is fed into the system. US Department of Health & Human Services, National Institution of Biomedical Imaging and Bioengineering
12. Minimal Risk. 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.
13. Office for Human Research Protections (OHRP). Provides leadership in the protection of the rights, welfare, and well-being of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of HHS.
14. Personally Identifiable Information (PII). Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. 45 CFR 46 uses the language “identifiable private information.” 45 CFR Protection of Human Subjects §46.102(e)(5)
15. Principal Investigator (PI). A Principal Investigator or PI is the individual responsible for the preparation, conduct, and administration of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project. PIs must meet certain eligibility requirements as outlined in federal, state, and university rules and restrictions as noted in solicitations for said grants, agreements, contracts, and projects. Most agencies use the PI on a very short list of project contacts. For purposes of this policy, PI refers to any individual submitting or any faculty member advising student research application to DSU's IRB and who must comply with human subjects federal regulations and institutional procedures.
16. Research. means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. 45 CFR Protection of Human Subjects §46.102(l)
17. Researcher. May be used interchangeably with Investigator.

III. STATEMENT OF POLICY

1. Providing an Institutional Review Board (IRB) in compliance with 45 CFR Part 46.
   1. Monitoring IRB membership in compliance with 46.107.
   2. Establishing research jurisdiction. A proposed research application shall be considered under the jurisdiction of the IRB if any of the following are true:
      1. The research is sponsored by the university.
      2. The research is conducted by or under the direction of any employee or agent of this institution:
         1. In connection with his or her institutional responsibilities, or
         2. Using any property or facilities of this institution.
      3. The research involves the use of the university's non-public information to identify or contact human research subjects or potential subjects.
   3. Designating the Vice President of Research and Economic Development as the Institutional Official (IO).Institutional Responsibilities. Institutional responsibilities to protect human subjects are, but not limited to, the following:
   4. Providing free access to research compliance training.
2. Institutional Official (IO) Responsibilities. The IO (or designee) responsibilities to protect human subjects are, but not limited to, the following:
   1. Maintaining registration with Health and Human Services (HHS) pursuant to §46.501 through 505.
   2. Appointing individuals to the IRB in consultation with others.
   3. Managing a system that supports IRB member capacity to fulfill their committee role in being knowledgeable in research, administrative, and other substantive issues that would come before the committee.
   4. Monitoring dissertation committee members' completion of research compliance training when a student's dissertation contains research with human subjects.
   5. Monitoring completion of research compliance training.
   6. Monitoring compliance with informed consent pursuant to 46.116.
   7. Ensuring that sufficient resources, space, and staff are available to support the IRB's review and record-keeping duties.
   8. Reviewing, recommending, and reporting to the institution and federal officials any disciplinary actions taken as a result of non-compliance with 45 CFR Part 46 and DSU IRB procedures.
      1. Unanticipated problems involving risks to subjects or others.
      2. Serious or continuing noncompliance with the federal regulations of the requirements or determinations of the IRB(s).
      3. Suspension or termination of IRB approval.
   9. Monitoring the effectiveness of the University's use of the expedited review procedure.
   10. Developing and following University procedures for a functioning IRB pursuant to §46.108.
3. IRB Administrator. IRB Administrator responsibilities to protect human subjects are, but not limited to, the following:
   1. Assisting in initial and continuing research project review.
   2. Assisting in making determinations for exempt and expedited applications.
   3. Coordinating IRB activities with other compliance activities and committees as needed.
   4. Overseeing IRB member training.
   5. Maintain documentation of informed consent pursuant to §46.117.
   6. Maintain IRB records pursuant to §46.115.
   7. Assisting the IO in filing annual updates and other reports to HHS.
   8. Monitoring federal and state regulations and suggesting revised policies and procedures to remain in compliance with those regulations.
   9. Providing administrative support to the IO by scheduling meetings of the IRB, arranging for meeting space, taking minutes, and maintaining records.
   10. Communicating IRB actions through periodic reports to the IO.
4. IRB Chair. IRB Chair responsibilities to protect human subjects are, but not limited to, the following:
   1. Arranging initial research review to rule applications as exempt or expedited.
   2. Calling upon other reviewers from within the IRB or non-voting, ad hoc reviewers (consultants) as necessary, to assist in the initial review, exempt or expedited.
   3. Keeping IRB members advised on research proposals determined approved through the expedited review process.
5. Principal Investigator (PI) Responsibilities. PI responsibilities to protect human subjects are, but not limited to, the following:
   1. Conducting research projects in accordance with federal regulations and principles regarding the protection of human subjects in research HHS 45 CFR 46.
   2. Completing research compliance training.
   3. Submitting forms according to IRB processes.
   4. Ensuring that all key research project personnel are trained in the protection of human subject research.
   5. Following approved applications.
   6. Notifying the IRB of any changes to the research or informed consent prior to making changes. The only changes possible without prior consent are those necessary to eliminate apparent immediate hazards to subjects which must be reported in a timely manner.
   7. Filing an immediate report of any unanticipated problems or anticipated, serious adverse events.
   8. Reporting on research progress.
   9. Filing necessary Human Subjects Continuing Review or Request for Modification forms.
   10. Submitting a full application to the IRB for review prior to beginning classroom research if the research will at any time be presented or published.
   11. Faculty Advisors acting as PI in student-led research for academic degrees shall ensure all advisees follow responsibilities as outlined in this policy.
6. IRB Responsibilities. IRB responsibilities to protect human subjects are, but not limited to, compliance with 46.109 and §46.110:
   1. Review of Research (46.109)
      1. Approving or disapproving all research activities covered by this policy, including exempt research activities under §46.104 for which limited IRB review is a condition of exemption.
      2. For Full Board Review, the research shall receive the approval of a simple majority of members present at the IRB meeting.
      3. Requiring that information be given to subjects (or legal authorized representatives, when appropriate) as part of informed consent is in accordance with §46.116.
      4. Requiring documentation of informed consent or may waive documentation in accordance with §46.117.
      5. Notifying investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity.
      6. Conducting a continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once a year, except as described in §46.109(f).
      7. Observing or having a third party observe the consent process and the research.
      8. Not approving application requests after classroom projects have been conducted. If the faculty member/supervisor has concerns or doubts, he/she should consult with the IRB Administrator or the IRB Chair.
      9. Following criterion for IRB approval of research pursuant to §46.111.
      10. Conducting or directing others to conduct random audits of any approved project or laboratory facilities for the purposes of post-approval project monitoring or continuing review.
      11. Consulting with expert outside entities, as needed, to determine levels of risk when the IRB reviews research involving AI/ML data. Consultation may include, but is not limited to, the following areas:
          1. Data Traceability
          2. Data Reliability
          3. Data Governance
          4. Data Bias
   2. Expedited Review of Human Subjects Research. 46.110
      1. The IRB shall comply with Health and Human Services (HHS) categories of research that may be reviewed through an expedited review procedure.
      2. The IRB may use the expedited review procedure to review the following:
         1. Some of or all of the research appearing on the HHS category list, unless the reviewer determines that the study involved more than minimal risk;
         2. Minor changes in previously approved research during the period for which approval was authorized; or
         3. Research for which limited IRB review is a condition of exemption under §46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8).
      3. Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in §46.108(b).
      4. The IRB shall adopt a method for keeping all IRB members advised of research proposals that have been approved under the expedited procedure.
      5. The IO may restrict, suspend, or choose not to authorize the IRB's use of the expedited review procedure.
   3. Criteria for IRB Approval of Human Subjects Research. 46.111 C. In order to approve research covered by this policy, the IRB shall determine that all of the following requirements are satisfied:
      1. Risks to subjects are minimized.
      2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
      3. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
      4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, §46.116.
      5. Informed consent will be appropriately documented or appropriately waived in accordance with §46.117.
      6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
      7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
      8. For purposes of conducting the limited IRB review required by §46.104(d)(7)), the IRB need not make the determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations:
         1. Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements of §46.116(a)(1)- (4), (a)(6), and (d);
         2. Broad consent is appropriately documented, or waiver of documentation is appropriate, in accordance with §46.117; and
         3. If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
      9. When some or all subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
   4. International Research
      1. The IRB shall follow the current human research standards as established by the OHRP.

Exclusions (Exempt Research)

1. Exempt Categories. Unless otherwise required by law or the IO, research activities in which the only involvement of human subjects will be one or more of the following categories are exempt from the requirements of this policy. §46.104:
   1. Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
   2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
      1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
      2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
      3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
   3. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
      1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
      2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
      3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
   4. For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
   5. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
   6. Research that is already exempt by existing federal policy.
2. Waiver of IRB Application. DSU's IRB may waive a full IRB Application if the research that involves human subjects meets all of the following conditions. The research . . .
   1. Exists as a normal part of the student's coursework.
   2. Is supervised by a faculty member.
   3. Develops the student's research skills as a primary purpose of the coursework.
   4. Meets all criteria for an Exempt or Expedited Review as defined by HHS 45 CFR 46.
   5. Does not present more than minimal risk to subjects or to the student investigator.
   6. Does not include any individuals under the age of 18 as research subjects.
   7. Does not include any individuals as research subjects who are classified as protected populations or sensitive subjects according to Federal regulations HHS 45 CFR 46.
   8. Does not involve sensitive, personal, or incriminating topics.
   9. Does not include any activity defined as a clinical investigation or involves medical intervention or procedures, even when they are a part of a course curriculum. These types of protocols always constitute human subjects research and require prior IRB review and approval.
   10. Will not be presented at local, state, national or international conferences, published, used for thesis/dissertation projects, or otherwise disseminated beyond the classroom.

Exceptions

None

IV. PROCEDURES (MAJOR)

1. Confidentiality. During the process of initial, exempt, expedited, full, or continuing review of research activity, the IRB shall consider provided material privileged information and assure confidentiality of the data contained therein.
2. Initial Review
   1. A researcher uses the institution-designated submission process.
   2. The IRB Chair, or a trained designee(s) reviews the completed submission. The research will be provided a response with one of the following determinations:
      1. Your project does not involve humans and therefore does not require IRB review;
      2. Your proposed research, though it involves humans, is eligible for “exempt” review;
         1. If a research proposal is determined to be exempt from HHS 45 CFR 46, the IRB shall not require ongoing review.
         2. However, the investigator shall report any proposed changes to the application (such as those that may change the activity, so it is no longer exempt) and report any unanticipated or anticipated but serious adverse events.
      3. Your proposed research must be submitted to the IRB for further review using the institution-designated submission process.
3. Expedited Review
   1. One or more IRB Members shall review research submissions to determine if the research should be expedited.
   2. Under expedited review, reviewers shall make one of the following determinations:
      1. Approve,
      2. Approve with modifications,
      3. Request a resubmission of the application, or
      4. Refer the application to the full IRB.
   3. All actions approved using expedited review shall be presented at the following IRB meeting for information and discussion.
4. Full IRB Review
   1. The IRB shall review applications for research that are not exempt from the policy and do not meet criteria for expedited review.
   2. If a Board member has been or expects to be engaged in or has a direct financial interest in the activity of a research project, that member shall not be involved (except to provide information requested by the Board) in the review or approval of said project.
   3. The Board may require the resubmission of an application before it takes action.
   4. The IO may review Board decisions, impose additional modifications, or disapprove research activity approved by the IRB.
   5. The IO or any other official may not approve research that the Board has disapproved.
   6. Under full IRB review, the Board shall make one of the following determinations through simple majority voting:
      1. Approved
      2. Approved subject to modifications to the application
         1. Modifications may be provided electronically or in writing.
         2. The chair, or designee, shall determine if the modifications follow Board requirements.
      3. Disapproved
         1. The Board shall provide the investigator with detailed comments/reasons for disapproval.
         2. The investigator may appeal the decision for disapproval to the Board.
   7. The Board, through the IRB Administrator, shall report IRB application results, electronically or in writing, to the principal investigator following the IRB meeting in which the Board made the application determination. The communication shall contain one of the following application determinations:
      1. Notification of approval.
      2. Request for administrative changes.
      3. Request for application resubmission in order to secure approval at a subsequent IRB meeting.
      4. Notification of disapproval with reasons for disapproval.

5. Continuing Project Review and Modification Requests
   1. A minimum of two IRB members complete continuing reviews, review modifications to an existing application, or review to accept research approved by another institution's IRB.
   2. Continuing review shall use Full Board review or expedited procedures, in accordance with HHS 45 CFR 46 and any appropriate OHRP guidance documents.
   3. The IRB shall approve a non-exempt project for up to one year.
   4. The IRB shall grant a non-exempt project four, one-year extensions (five years total duration).
   5. During initial or continuing review, when the IRB discusses the level of risk associated with an application, it may also determine more frequent review is appropriate. PIs shall be required to submit an extension using the institution-designated process.
   6. The IRB may conduct or direct others to conduct random audits of any approved project or laboratory facilities for the purposes of post-approval project monitoring or continuing review.
   7. If an application is determined to be exempt from HHS 45 CFR 46, no continuing review will be required. The PI must report any proposed changes to the application (such as those that may change the activity, so it is no longer exempt) and report any unanticipated or anticipated but serious adverse events.
   8. Any changes in expedited or non-exempt applications shall be reported to the IRB electronically or in writing prior to initiation, using correspondence approved by the IRB. The Chair or designee will make a determination as to accept the change using expedited procedures or through IRB review, in accordance with the Common Rule. The only exception to this requirement shall be when an investigator initiates a change to eliminate apparent immediate hazards to subjects. Unexpected or serious adverse events shall be promptly reported to the IRB.
6. Suspension or Termination of Approved Research

7. Application Closure

The approved research shall be closed using the intuition-designated submission process upon completion of research or within 1 year of IRB approval.

8. Communications
   1. The IRB Administrator shall promptly communicate issues necessitating immediate notification, such as adverse events or non-compliance, to the IO.
   2. The IRB Administrator shall provide IRB minutes to the IO at the same time they are provided to the Board.
   3. The IRB Administrator shall use the IRB Web site to provide additional information to the institution regarding human subjects protection issues.
9. Disciplinary Action
   1. When a researcher is found to be in noncompliance with HHS 45 CFR 46 or other Federal, State, or DSU regulations, including this policy and procedures, the IRB may recommend disciplinary action to the IO. Such recommendations may include, but are not limited, to the following:
      1. Verbal warning from the IO or the College Dean.
      2. Written warnings from the IO or the College Dean that would become part of the investigator's permanent personnel file.
      3. Re-inspection to substantiate the facility/laboratory is subsequently in compliance.
      4. Inability to use the results of the research in publications or other public dissemination.
   2. Failure to comply with warnings will result in suspension of research activities and publications (planned or in progress) until all appropriate activities have been corrected or completed.
   3. The IO will refer serious issues of noncompliance to the federal Health and Human Services Office for Human Research Protections (OHRP) and the federal oversight agency, as appropriate.
   4. The university President, upon consultation with other officials as necessary, shall have final authority as to the IRB recommended or additional disciplinary action.

10. Transnational Research
    1. Research shall be approved by an IRB in the area where the study will be conducted. It is not enough that a U.S.-based IRB approve a study; it must also be approved by a board made up of members of the community in which the study will be performed.
    2. Research shall comply with the host country's national guidelines or regulations.

V. RELATED DOCUMENTS, FORMS AND TOOLS

• IRB Human Subjects Evaluation
• IRB Human Subjects Application
• IRB Human Subjects Continuing Review and Request for Modification
• IRB Human Subjects Project Closure Form

VI. POLICY HISTORY

Adopted: 01/19/1996

Revised: 03/24/2015

Revised: 10/23/2023