The NIH Office of Extramural Research's (NIH)

Full Answer Section

We have recently completed the NIH Office of Extramural Research's (NIH) online training course on the basics of human subjects research protections issues. This training course covered a number of important topics, including:

• The Belmont Report and the ethical principles of respect for persons, beneficence, and justice.
• The Common Rule and the requirements for informed consent, risk-benefit analysis, and privacy protection.
• The special considerations for research involving vulnerable populations, such as children, prisoners, and individuals with disabilities.

We have also reviewed the relevant sections of the Code of Federal Regulations (CFR) and the NIH Grants Policy Statement.

Based on our training and review of the relevant regulations, we have developed the following protocols for human subject research:

• All research involving human subjects will be reviewed and approved by our Institutional Review Board (IRB).
• All research participants will be provided with a clear and concise explanation of the research, including the risks and benefits, before they give their informed consent.
• All research will be conducted in a way that minimizes the risks to participants and maximizes the benefits.
• All research data will be kept confidential.

We are committed to conducting ethical human subject research that respects the rights and welfare of all participants. We believe that these protocols will help us to achieve this goal.

If you have any questions about these protocols, please do not hesitate to contact me.

Thank you for your time and consideration.

Sincerely,

Newly appointed Director of Research

In addition to the protocols outlined above, we will also follow the following principles:

• We will always put the welfare of the research participant first.
• We will be honest and transparent with research participants about the risks and benefits of the research.
• We will respect the privacy of research participants.
• We will never coerce or pressure research participants to participate in research.

We believe that these principles are essential for conducting ethical human subject research. We are committed to upholding these principles in all of our research activities.

Sample Answer

To: Chief/Sheriff/Warden From: Newly appointed Director of Research Date: March 8, 2023 Subject: Protocols for Human Subject Research

I am writing to you today to summarize the protocols that my team will follow as they relate to the key ethical issues of human subject research.