Human Research Protection Training
Every student in a research course must complete the National Institutes of Health (NIH), Protecting Human Research Participants (PHRP), U.S. Department of Health and Human Services (HHS) Human Research Protection Foundational Training (specifically, Lesson 1), which is free, or other comparable training.
Ethical Review of Student Research Proposals
Firstly, student research proposals must:
Otherwise, the student needs to apply to the CT State IRB. Also, if the student intends to present or publish their research externally, the student needs to apply to the CT State IRB.
All student research proposals that meet the criteria above must be reviewed based on ethical principles and guidelines for research involving human subjects derived from the Belmont Report. Specifically, three basic principles are particularly relevant to the ethics of research involving human subjects: (i) respect for persons, (ii) beneficence, and (iii) justice. These principles are described in further detail below.
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Respect for Persons. Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents and, second, that persons with diminished autonomy are entitled to protection. Respect for persons demands that human subjects enter into the research voluntarily and with adequate information via a consent form.
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Beneficence. Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Two general rules of beneficent actions are (i) do not harm and (ii) maximize possible benefits and minimize possible harms.
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Justice. Who ought to receive the benefits of research and bear its burdens? This is a question of justice in the sense of “fairness in distribution” or “what is deserved.” An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. There are several widely accepted formulations of just ways to distribute burdens and benefits; for example, (i) to each person an equal share, (ii) to each person according to individual need, (iii) to each person according to individual effort, (iv) to each person according to societal contribution, and (v) to each person according to merit.
IT Policies, Data Privacy Guidelines, and Survey Guidelines
The student investigator is responsible for all aspects of the research study including but not limited to the collection, transmission, storage, backup, and security of data. All student investigators must adhere to the Connecticut State Colleges & Universities (CSCU) IT policies and CSCU data privacy guidelines.
Also, please note that survey administration at CT State, if applicable, is subject to the approval of the CT State President or their designee for two or more campuses or the Campus Chief Executive Officer (CEO) for one campus. Also, student investigators must use CSCU approved and licensed applications to conduct surveys at CT State.
Oversight and Monitoring
The faculty member teaching the student research course is responsible for overseeing and monitoring student research studies involving human subjects. If any problems with human subjects or unexpected adverse events, including but not limited to a breach in data security, occur as a result of a student research study, you must immediately notify the CT State IRB at ctstate-irb@ct.edu and the CSCU Information Security Program Office (ISPO) at security@ct.edu.
Record-Keeping
Records must be retained for at least three years after completion of the research (See 45 CFR 46.115(b)) in accordance with the Family Educational Rights and Privacy Act (FERPA) and/or the Health Insurance Portability and Accountability Act (HIPPA), as amended. Additionally, records must be accessible for inspection and copying at reasonable times and in a reasonable manner upon request.