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REVIEW COMMITTEES AND PROTOCOLS

Black Hills State University is committed to the highest standards of research integrity in all work conducted at the institution. These standards reflect a commitment to the protection of all who are involved in or are the subject of research. This protection includes ensuring that anyone involved in research fully understands his or her rights as the subject of research. It also includes the welfare of animals that contribute so much to the advancement of science and medicine, and the protection of the environment from biohazards.

Policies:
SD BOR Policy 4:32: Investigator Financial Disclosure
SD BOR Policy 4:35: Conflict of Interest
SD BOR Policy 4:32.1: Financial Disclosure Policy to meet the Public Health Service Regulation

Research Integrity and Misconduct Policy (Model Policy)

Black Hills State University has assured federal, state, and local agencies that all faculty, staff, and student researchers will comply with established regulations and procedures regarding the use of animals, humans, and biomaterials in research. Before engaging in such research at BHSU, all researchers are required to obtain approval from established review committees to ensure that all research is conducted in a responsible, legal, and ethical manner. These committees include:

Institutional Animal Care and Use Committee (IACUC) for research involving animals

Institutional Review Board (IRB) for research involving human subjects, including surveys and interviews intended for publication

Institutional Biosafety Committee (IBC) for research involving recombinant DNA or potential biohazards

Responsible and Ethical Conduct of Research (RECR) for all undergraduates, graduate students, postdoctoral researchers, faculty and other senior personnel who will conduct federally funded research.

Contact the Sponsored Programs office for assistance with compliance requirements for externally-funded projects.

TO REPORT RESEARCH MISCONDUCT OR OTHER RESEARCH COMPLIANCE ISSUES:

To make an online private and confidential report, click here. You may also call a toll-free hotline at 844.390.0005 (English speaking) or 800.216.1288 (Spanish speaking). The online report and hotlines are provided by Lighthouse Services, Inc. Lighthouse is an off-campus company that specializes in providing independent third-party ethics hotline services. You may choose to remain anonymous when providing information.

Animals

Institutional Animal Care and Use Committee Overview:

Approval from the Institutional Animal Use and Care Committee (IACUC) is required before any research involving animals is allowed at BHSU. To request IACUC approval:

Complete the online Responsible Conduct of Research course and the Animal Care and Use course. Certificates are valid for three years, so if you have certificates of completion from other RCR or Animal Care and Use courses taken within the past three years you do not need to repeat the course--please attach those certificates to your protocol.
Complete the full protocol, short protocol (for invertebrates).
Submit your completed protocol to the Sponsored Programs office, Woodburn 203, Unit 9504.
Await review and formal written approval before beginning research.

Additional Resources and Training

PHS Policy on the Humane Care and Use of Laboratory Animals
Guide to the Care and Use of Laboratory Animals
BHSU's Instructions to Complete Research Training
Online resources from the Office of Research Integrity
Policy for responding to scientific misconduct at BHSU

Project Conclusion / Cancellation

Please complete the Institutional Animal Care and Use Committee Project Closure Form via docusign when an approved IACUC protocol is concluded or cancelled. The docusign template can be accessed on the Templates tab and completed and routed for signature. Alternatively, you can download the form at the above link, complete it and submit it via email to iacuc@bhsu.edu.

Human Subjects

Institutional Review Board Overview

All proposals for research projects involving human subjects are subject to review by an institutional review board (IRB) according to Federal Regulation 45 CFR 46, Protection of Human Subjects. This university-wide policy affects all projects that use human subjects, not just those receiving external funding. Student projects, both undergraduate and graduate, must comply with the policy. No work can begin on a project involving human subjects until approval has been received.

To determine whether your survey, interview, data analysis, or other project involving human subjects qualifies as research and therefore requires IRB approval, complete the Research and Review Level Determination Form and/or consult a member of the IRB. If the answer is not clear-cut, the IRB needs to review your protocol. For all projects requiring IRB review and approval:

All individuals who will be involved in the research must register and complete the online training courses in Human Subjects Research and Responsible Conduct of Research. The certificates of completion are valid for three years, so if you have already completed the courses and have recent certificates of completion, you do not need to repeat the courses--please attach your certificates of completion to your completed protocol.
Complete the Human Participants Research Application according to the instructions.
Submit completed materials to irb@bhsu.edu.
Await formal written approval before starting any research.

Additional resources and training

BHSU's Instructions to Complete Research Training, including human subjects
More information sheets from the NIH Office of Human Subjects Research
Online resources from the Office of Research Integrity
Investigator Responsibilities and Informed Consent (Office of Human Research Protections)--click "continue" on the right-hand menu to move through the tutorial
Informed Consent - Phone Script Template

Project Conclusion / Cancellation:

Complete the Human Subject Project Closure Form via docusign when an approved human subject research project is concluded or cancelled. Projects that involve long-term follow-up of subjects must remain open, even if enrollment of new subjects has ended. The docusign template can be accessed on the Templates tab, where you can complete and sign electronically. Alternatively, you can download the form at the above link, complete it and submit it via email to irb@bhsu.edu.

Biohazards

Institutional Biosafety Committee Overview

The mission of the Institutional Biosafety Committee is to ensure compliance with the NIH Guidelines concerning research and projects involving recombinant DNA and potential biohazards. The committee will review all research proposals involving recombinant DNA and/or infectious materials to guarantee 1) safe laboratory practices are used, 2) adequate containment measures are implemented, 3) appropriate facilities, procedures, practices and training of personnel are in place and used, and 4) the annual report to NIH is completed, reporting all reviewed projects and subsequent recommendations.

To request IBC approval:

Complete the Application for Institutional Biosafety and submit it to Dave Bergmann, Life Sciences Laboratory 121, or Dave.Bergmann@bhsu.edu
Await formal committee approval before beginning research

Additional Resources and Training

Policy for responding to scientific misconduct at BHSU
Biosafety in Microbiological and Biomedical Laboratories, US Dept. of Health & Human Services
NIH guidelines for research involving recombinant DNA molecules
Online resources from the Office of Research Integrity

REVIEW COMMITTEES AND PROTOCOLS

Animals

Institutional Animal Care and Use Committee Overview:

Additional Resources and Training

Project Conclusion / Cancellation

Human Subjects

Institutional Review Board Overview

Additional resources and training

Project Conclusion / Cancellation:

Biohazards

Institutional Biosafety Committee Overview

To request IBC approval:

Additional Resources and Training

Spearfish

Rapid City

Students

Resources

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