Research Compliance - Human Subjects

The COVID-19 pandemic has introduced unique challenges to research studies involving human subjects.  SDSU’s guiding principles and framework for reaccelerating all University research, scholarship, and creative activity in the face of the pandemic can be found here [https://www.sdstate.edu/jacksrback/principles-and-frameworks]. Until an effective vaccine or therapeutics for COVID-19 is widely available, face-to-face human subject research will need to follow the following requirements:

  • Study personnel and participants must self-screen for COVID-19 symptoms prior to in-person interactions.
  • A distance of 6 feet must be maintained between study personnel and participants throughout in-person interactions, unless participation requires closer contact.
  • Cloth, surgical, or N95 masks are highly recommended for study personnel and participants throughout in-person interactions. If study participation necessitates contact closer than 6 feet, N95 masks, gloves, and safety glasses are highly recommended. Where standard procedures for data/specimen collection require PPE use, adhere to those requirements.
  • Study spaces, facilities, and equipment must be thoroughly cleaned and disinfected before and after in-person interactions.
  • Adequate supplies of equipment, disinfectants, and PPE must be ensured before the study begins, and must not detract from the local community’s ability to respond to a potential surge.

Because human subject and clinical research may be conducted off-campus or within affiliated medical units, research teams should also be familiar with and follow the guidelines, procedures, and timelines developed by those entities. As new information about COVID-19 becomes available and its prevalence within our environment changes, these guidelines will be periodically re-evaluated and adjusted, and researchers may need to modify their plans accordingly.


The Human Subjects Committee (also known as the Institutional Review Board, or IRB) assures that risks to human research subjects are minimized, consent is voluntary and informed, and confidentiality is protected. The Committee upholds the principles articulated in the Belmont Report and applies the regulations articulated in the Common Rule.

To determine if your study/research/project requires Committee review, go to: https://decisionchart.questionpro.com and answer a few targeted questions.

 

Training:

All researchers conducting human subjects research are required to complete training in the protection of human research participants found at www.citiprogram.org.

Submitting a proposal:

Any research project in which University faculty, staff, or students will collect and analyze data on human subjects must be reviewed and approved by the IRB before data collection begins. To submit a proposal, first complete the online Human Subject Research Application Form and print it as a PDF. Next, go to InfoReady, SDSU’s internal submission platform, click Apply, and log in with your SDSU credentials. Fill out the basic information screen, upload the completed application form and all relevant attachments (such as consent forms, survey instrument, etc.). To finalize your application, accept the certification statement, and click the Submit button.

Amendments to approved proposals should also be submitted via InfoReady.

Reporting a problem:

Researchers must report any incident that is unexpected (given the research procedures and population), 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. In addition to adverse events/effects, you should also report any breaches of confidentiality and complaints about the study from subjects or staff.

If any such problem occurs, please take the following action:

  1. Attend to the safety and care of the research participant.
  2. Consider whether any more participants should be used in the research and consider immediately stopping the study until the occurrence is investigated.
  3. If the problem is serious (harmful, fatal or life threatening), report the event either orally or in writing to the Research Integrity and Compliance Officer within three days. [Dianne.Nagy@sdstate.edu; 605-688-5051]

For all problems, submit the Unanticipated/Serious Problem Reporting Form on InfoReady within ten working days. The Research Integrity and Compliance Officer will review the report to follow up and take appropriate action.