NYSDOH Research Participant Information

Welcome! The New York State Department of Health (NYSDOH) is committed to ensuring the ethical conduct of research. The NYSDOH Institutional Review Board (IRB) is an internal ethics committee that reviews NYSDOH human research plans to ensure they protect the health, safety, and welfare of research participants. When reviewing research plans, the IRB considers the following points along with applicable regulations, laws, ethical standards, and policies for human research:

  • Purpose and scientific value of the research
  • Research methods and what participants will be asked to do
  • Potential risks of participation and the safeguards to minimize those risks
  • Potential benefits to the participants and society
  • Protections for participants' privacy and the confidentiality of their information
  • Whether the proposed consent process ensures informed and voluntary decision-making about participating in the research

When the IRB determines that the research plan meets all criteria for protecting participants, the IRB may approve the research and will then provide ethical oversight until the project is completed.

Frequently Asked Questions

The NYSDOH IRB oversees public health research conducted by the New York State Department of Health. All other agencies and institutions that conduct human research must seek approval from their own IRBs.

The federal Office of Human Research Protections (OHRP) has an excellent web site for people who would like information about research participation. It includes informational videos, questions to ask before enrolling in research, describes protections for research participants, and has other valuable information.

Human research has been conducted for thousands of years to gain insights into human health and behavior. Research results have expanded our scientific knowledge and enabled technological innovations, medical treatments, and improved human health and well-being. If you have received medical or behavioral health treatments, you have benefited from human research. None of these advances would be possible without people who volunteer to participate in research. Some people volunteer to receive experimental medical treatments, to gain health insights, or to learn about science or scientific practices. Many people volunteer simply because they want to help others and contribute to the greater social good.

All human research must offer potential benefits to certain people, such as those with a disease, and/or to society as a whole. Only research that offers the prospect of benefit may be approved by an IRB. However, a specific research project may or may not benefit individual research participants. The research team can answer any questions you may have about potential benefits. The IRB-approved informed consent document will also provide information about potential benefits and who can expect to receive them.

Many research procedures are considered "minimal risk," which means the risks are no greater than situations typically encountered in people's daily lives, such as routine medical or psychological tests, surveys, interviews, or educational activities. Some minimal risk procedures, such as a blood draw, may involve minor physical discomfort. A survey or interview may involve questions that are embarrassing or uncomfortable for some people. The research staff will disclose any known risks during the informed consent process and, if you agree to participate, will be available to answer questions for the duration of the research project.

The private information you provide to the research team is confidential. Research records are accessible to the people who conduct and oversee the project, which may include not only the research team but also the IRB members who approve the project, the organizations that manage and fund the project, and various government oversight agencies. However, access to people's private information is typically granted on a "need to know" basis, which means that access is limited to just the information needed to perform specific research or oversight tasks. In many cases, identifying information (such as your name) is removed before that access is granted.

Research participation is always voluntary, and there is no penalty for withdrawing. If you wish to withdraw from the project, notify the research team using the contact information provided in the consent form.

If the research offers compensation to participants and you have not received it within the specified timeframe, notify the research team using the contact information provided in the consent form.

If you have questions or concerns about the research or believe you have a research-related injury, start by contacting the research team. The researchers should be informed of any issues. The name of the Principal Investigator, who leads the research team, and the research team's contact information is included in the consent form. If you are unable to resolve the concerns with the research team, have concerns about your rights as a research participant, or would like to discuss concerns with someone other than a researcher, you may contact the IRB office. Some additional guidance is provided below.

Contact the Research Team if:

  • You would like to ask questions before deciding to participate in a project
  • You would like to enroll in a project
  • You have questions about any forms or documents provided by researchers
  • You have questions about how the research is conducted
  • You have questions about compensation or payment
  • You believe you have a research-related injury
  • You have concerns or a complaint about the research
  • You would like to withdraw from the research

Contact the IRB Office if:

  • You have contacted the research team but your concern was not resolved
  • You wish to discuss concerns with someone who is not a researcher
  • You have questions or concerns about your rights as a research participant
  • You wish to report suspected misconduct by a member of the research team