2.20.1 Human Subjects Research

Unless specifically exempted by this policy, all research conducted at or sponsored by the  College that involves human participants must obtain Institutional Review Board (IRB) approval prior to any involvement of human subjects. This includes research conducted by faculty, staff, students and agents of the College. All human participants in a research project must provide informed, written consent to participate. Any research that includes human subjects or their data, or use of any College data that is not publicly available, must obtain IRB approval prior to beginning research.

A.  IRB Authority and Composition 

IRB review and approval ensures the protection of the safety, rights and welfare of human participants and compliance with applicable legal requirements. 

The IRB has authority to: 

1. Approve, require modifications for approval, or disapprove research involving human participants; 
2. Suspend or terminate approval of research not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to human participants; 
3. Take appropriate actions necessary, including suspending or terminating the research, to ensure legal compliance and adherence to College policy, and to mitigate unanticipated problems or risks to human participants and others during the research; 
4. Observe, or have a third party observe, the consent process or conduct of the research; 
5. Conduct continuing review of research annually or at intervals appropriate to the degree of risk; and
6. Continually monitor and review research throughout the research project and its conclusion. 

The IRB will have at least five members with varying backgrounds to adequately review the research activities commonly conducted by the institution. The President shall appoint all members of the IRB, including the chair.  No IRB member may participate in the review of a project in which the member is involved or has a financial interest  except to provide the information requested by the IRB. The IRB may invite individuals with competence in special areas to assist in the review of projects. Those individuals may not vote with the IRB.

B. IRB Application and Approval Process

Individuals seeking to conduct research involving human participants may not solicit subject participation or begin data collection until they have obtained permission from the IRB. 

A person intending to conduct research involving human participants should complete the items listed in "Permission to Conduct Research on Human Subjects at Blue Ridge Community College" and obtain signatures of approval from their Program Dean, their Vice President and the Director of Planning, Research, & Institutional Effectiveness at least sixty (60) days prior to the desired opening date of the research. Once signatures are obtained from all three (3), the Vice President will submit the proposal to the College president, who will appoint the IRB committee.

Permission to Conduct Research on Human Subjects at Blue Ridge Community College applications should contain the following information: 

A brief description of the study, including:

1. A brief description of the study, including:
   1. how BRCC employees, students, or data will be used in the research; 
   2. how confidentiality and/or anonymity will be maintained.
   3. the rationale for conducting the research;
   4. the rationale for, and the intended use of, the research data;
   5. the methodology for collecting the research;
   6. the College equipment and/or resources that will be used;
   7. all persons involved in the collection of the research;
   8. any possible concerns regarding the use and/or potential harm of human subjects;
   9. the venue and the time frame for the conducting of the research; and
   10. the timeline and location of secure storage and subsequent destruction of any personally identifiable data;
   11. attestation that the principal investigator has completed recommended training overview with the Director of Teaching and Learning 
2. If conducting research through another institution (e.g., as a graduate student), affirmation from that institution showing IRB approval to conduct the research. If such approval is contingent upon BRCC IRB approval, include a statement from that institution explaining that tentative approval has been granted pending BRCC IRB approval.
3. The cover letter that will be sent/read to participants, including the informed consent form.
4. Projected opening and closing dates of the research. 
5. The steps that will be taken to ensure the College is informed of the research findings so that the College can benefit from the research. Any research involving human participants conducted on behalf of or for a federal or state agency will comply with all applicable laws and regulations of the sponsoring government agency. 

The IRB shall only approve research protocols that satisfy all of the following requirements:

1. Any risk(s) to human participants are minimal and reasonable in relation to anticipated benefits of the research;
2. Selection of subjects is equitable given the purposes and the setting of the research;
3. Researchers will seek Informed Consent appropriate to the research from each subject or the subject's legally authorized representative, and such consent will be appropriately documented in writing;
4. The research plan makes appropriate provision for monitoring the data collected to ensure the safety of participants;
5. Appropriate provisions are made to protect the privacy of participants and to maintain the confidentiality of data; and
6. Where some or all of the participants are likely to be vulnerable to coercion or undue influence, appropriate additional safeguards have been included to protect the rights and welfare of these subjects.

The IRB committee reserves the right to assign specific training to researchers on effective research practices.

If approved by the IRB, the primary responsibility for the responsible conduct of research shall reside with the person or group of persons conducting the research.

C. Informed Consent

It is the responsibility of the researcher to obtain written, informed consent from each human participant in the research project. If minors are included in the study, guardian consent must be obtained. Along with the consent form, the researcher shall provide each potential participant a concise written statement that includes:

1. A summary of the research project;
2. Any potential risks or discomfort to the participant during the project; 
3. Whether any information identifying the participant, including bio-identifiers, will be released as part of the research or whether such information will be maintained as confidential;
4. The compensation for participation, if any;
5. A statement the participant may withdraw consent at any time; and
6. Other important information regarding the research.    

D. Exceptions

This policy shall not apply to internal institutional research conducted by the President in order to improve College operations, practices and student outcomes.