Guidance for Research Study Participants

The purpose of this webpage is to provide information about research. By reviewing the world history of human experimentation, one can understand the basis for the creation of federal regulations. Education regarding research is necessary in order to promote a healthy relationship between investigators and research participants. Finally, this site is designed to inform the research participant about the Department of Health's Institutional Review Board; a board designed to protect and advocate for the research participant.

Background Information

As early as the 6th century B.C., there are records of meat and vegetable experiments conducted on young prisoners. As late as the 21st century A.D., there are still reports of unethical research being conducted within the United States, despite oversight by the Food & Drug Administration and the Office of Human Research Protection, a division of the Department of Health and Human Services. In between these centuries, the most horrific human experiment atrocities were committed during the WWII era. As evidence shows, humans were and (still) are capable of overlooking the basic ethical principles when it comes to furthering our knowledge of science, further strengthening the adage - the end does not justify the means.

The following is a brief overview of how medical ethics evolved, beginning with the trial of the Nazi physicians post WWII:

  • Nuremberg Military Tribunal of the Nazi physicians (1947):
    Outcome - The Nuremberg Code which, in essence, states it is "essential to obtain subject's voluntary consent for research" taking into consideration the capacity of the subject to provide consent, freedom from coercion to consent and comprehension of the risks and benefits involved in the research.
  • World Medical Association (1964):
    Outcome - Declaration of Helsinki adopts the Nuremberg Code and goes on to further delineate research as therapeutic vs. non-therapeutic.
  • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978):
    Outcome - The Belmont Report defined boundaries between "practice" and "research" and developed three basic tenets for research involving human subjects: respect for persons, beneficence and justice. Respect for persons involves the recognition that individuals are afforded dignity and autonomy in making their own choices; in addition, those persons with diminished autonomy are afforded special protection. Beneficence is the obligation to protect persons from harm by maximizing benefits while minimizing potential harm(s). Justice encompasses the fair distribution of research burdens among socio-economic, race, age and gender strata.

In 1981, three years after the Belmont Report was issued, the Department of Health and Human Services (formerly Department of Health and Education Welfare) and the Food and Drug Administration restructured and revised their regulations regarding human subjects. The Department of Health and Human Services regulations are codified at Title 45 CFR (Code of Federal Regulations) Part 46 Protection of Human Subjects. The Food and Drug Administration's regulations are codified at Title 21 CFR Parts 50 and 56; Part 50 outlines Informed Consent requirements and Part 56 addresses institutional review boards. Other FDA regulations regarding institutional review boards and how they relate to investigational new drugs and investigational device exemptions are found in Parts 312 and 812, respectively. (More information can be found at the DHHS and FDA websites. The links are found below.)

All research protocols that receive federal funding must comply with the federal regulations. The Department of Health's Institutional Review Board was created to ensure that investigators follow the federal regulations. It should be noted that non-federally funded research projects here at the NYS Department of Health are also reviewed following federal regulations.

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The Role of the IRB

The IRB is designed to protect and advocate for the research participant. The goal of this site is to provide helpful information to people who may be interested in research participation. Education regarding research is important in order to promote a healthy relationship between investigators and research participants. So, if you have ever been approached by an investigator or you have sought out an investigator to pursue participation in research, this information is for you - the prospective subject of human research.

Synonyms Used In Research

The activity known as "research" can be called many different things:

  • Research Study/Study
  • Experiment
  • Investigation
  • Inquiry

Likewise, people recruited for research are referred to by many names:

  • Participant
  • Study Participant
  • Research Participant
  • Research Subject
  • Subject
  • Clinical Subject

(Please note: Research professionals do not refer to subjects as "guinea pigs;" unfortunately, this term is sometimes used by study participants.)

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What Is Human Research?

Human research is defined as an activity designed to test a hypothesis (theory). The testing of this hypothesis lets an investigator draw conclusions as to whether the hypothesis is true, false or null (neither true nor false). The results of hypothetical investigations ultimately contribute to generalizable knowledge; that is to say these investigations, although tested in relatively small numbers, may be applied to larger numbers.

Human research begins when an investigator develops a study protocol to test a hypothesis. A study protocol is a uniform set of directions the investigator follows during a research project. The study protocol defines the objective, or goal, of the research project; for example, does substance B work better than substance A? The protocol defines what sort of activities or tests will be carried out in order to answer the hypothetical question.

Once the investigator has developed a protocol to test the hypothesis, the investigator sends this information to the Institutional Review Board. The Institutional Review Board makes sure the protocol follows Federal and University rules and regulations for protecting human subjects. Once the protocol has been approved, the investigator may begin the study. From that point on, the investigator will continue to give the Institutional Review Board (at least) yearly updates on the study. This is a Federal Requirement to help ensure that the conduct of the study continues to protect human research subjects.

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The Principal Investigator

The principal investigator (PI) is responsible for personally conducting or supervising the conduct of human-subjects research and for protecting the rights, safety, and welfare of the subjects enrolled in the research. The PI must ensure that all human-subjects research is conducted in an ethical manner and in accordance with all federal, state, and local laws and regulations, institutional policies, and requirements or determinations of the IRB.

Every Research Participant Has the Following Rights

  • To be treated with respect, including respect for your decision whether or not you wish to enroll in, continue in, or stop being in a study.
  • To choose to stop being in a study at any time.
  • To be given time to read the consent form and have the research study explained to you.
  • To be given time to ask questions, and to be told whom you can contact if you have any more questions.
  • To be given a copy of the consent form after you have signed it.
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Questions to Ask Before Agreeing to Participate in a Research Study

  • Why is the research being done?
  • What will be done to me as part of the research?
  • What are the real risks and real benefits to me from participating in the research?
  • Could the research hurt me?
  • What will the researcher do with my information, who will see my records/information?
  • Will the research cost me anything?
  • Who pays if I'm unexpectedly injured in the study?
  • How long will the study last?
  • What happens if I decide to leave the study early?

A – S – K

A - Assume nothing (think in terms of self-protection, not blind trust)

S - Speak up (question the investigator and consult with others), such as:

  • Family
  • Friends and significant others
  • Doctors not connected to the research (if a clinical study)
  • Others (persons with needed expertise or experience)

K - Know - then decide (e.g., ask about prior review by a research ethics board, confidentiality of my private information, investigator conflicts of interest, and availability of compensation to me if an injury result from participation).

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Who Sponsors Research?

Research is funded by state and federal agencies, private industry, and non-profit organizations.

Whom Do I Contact For Questions?

You should contact the Principal Investigator:

  • If you are considering being a research participant
  • If you have questions about the research study procedures
  • If you have questions about the research study procedures
  • If you have questions about the informed consent process
  • If you experience a research related injury
  • If you have concerns or complaints about the research

Information for the investigator will be located in the Informed Consent Document when you volunteer to participate in a research study. This document will have the Study Title on the front page along with a description of the study. Also included in the document, is a section, "Whom Do I Call if I Have Questions." In this section, the name of the investigator will be listed along with a telephone number(s).

You should contact the Institutional Review Board:

  • If you cannot reach the investigator
  • If you wish to discuss your questions or concerns with someone other than the investigator
  • If you have questions about your rights as a research participant
  • To report suspected investigator misconduct

You are encouraged to contact the Administrative Director of the Institutional Review Board at (518) 474-8539. The Director can also be reached via email at irbbml@health.ny.gov or through regular mail at:

  • Institutional Review Board
    New York State Department of Health
    ESP Corning Tower, Room 474
    Albany, NY 12237-0001

Based on the content of your communication, your comments or concerns will be appropriately directed. Please remember, our primary purpose is to protect participants involved in human research.

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Office for Human Research Protections (OHPR) Pamphlet

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