Study participants are a critical component of all human subjects research and Binghamton University recognizes that you have a right to be fully informed when making a decision of whether or not to participate in a research study. Your participation should always be voluntary and you should always be given the choice not to participate or to discontinue participation at any time. Know that your decision whether or not to participate in research will not affect your current or future relations with Binghamton University. We hope this website will answer any questions you may have.
- How Am I Protected As a Research Participant?
- Bill of Rights for Research Participants
- Questions for Research Participants to Ask
- Who Should I Go To If I Have Questions?
- Participant (Subject) Responsibilities
- Subject Pool Participants
- Research Involving Children
- Federal Office of Human Research Protections
The Binghamton University Institutional Review Board (IRB) Office is responsible by federal law for ensuring the protection of the rights, welfare, and well-being of participants involved in research studies conducted by University faculty, staff, and students. The IRB is a diverse group of diverse, experiences, and qualified faculty and community members (both scientific and non-scientific) who carefully review and monitor research conducted by Binghamton University to ensure that it is carried out legally and ethically. Research studies cannot be started until the IRB has approved the study.
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 learn the nature and purpose of the study;
- To receive an explanation of the study procedures;
- To receive a description of potential discomfort or risks resulting from participation, and measures being taken to minimize them;
- To learn about any benefits you might expect from the study;
- To ask question about the study or the procedures involved;
- To choose to stop being in a study at any time.
- To be given time to ask questions, and to be told whom you can contact if you have any more questions; and
- To decide to consent or not to consent to a study without feeling force, obligation, or coercion.
Questions that you should ask before you agree to participate in a research study:
- Why is the research being done?
- What will be done to me as part of the research?
- How will I benefit from the research?
- Could the research hurt me?
- What will the researcher do with my 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?
The researcher conducting the study you are being asked to participate in should provide you with answers to specific questions about the study. You may contact the researcher with questions at any time before, during or after the study. If you would like to obtain information about a research study, or if you have questions, concerns, complaints or wish to discuss problems or your rights as a research subject with someone unaffiliated with the study, contact the IRB Office at email@example.com or 607-777-3818. Anonymity, if desired, will be protected to the extent possible. As an alternative method of contact, a letter may be sent to IRB Associate Director, P.O. Box 6000, ITC Building, Room 2204, Binghamton NY 13902-6000.
The integrity of research depends upon honest and ethical subject participation.
- Read the consent form and ask the PI any questions you may have. You should understand what procedures will occur before you agree to participate.
- Contact the Principal Investigator (PI) if you desire to terminate involvement in a study.
- Know the start and end dates of your participation.
- Contact the PI, or the IRB Office, with complaints or concerns about study participation.
- Report any and all unanticipated problems to the PI immediately.
- Comply with responsibilities of participation as enumerated on the consent forms unless discontinuing participation in the study.
- Confirm receipt of extra-credit points or monetary compensation.
- Maintain copy of consent form for your records.
- Request study results if so desired.
What is a Subject Pool?
Undergraduate subject pools are comprised of undergraduate students enrolled in particular departmental courses offering course credit for participation in one or more research projects. The Institutional Review Board (IRB) provides guidance to departmental subject pools and reviews all research recruiting from the subject pool.
Criteria for Subject Pools
All student participation in subject pool research must be completely voluntary. It is up to the student to decide whether to participate in any study; instructors cannot mandate or require student participation.
- Alternative assignments must be provided to students who decline from participating in research.
- Departments usually provide students with incentives (e.g., extra credit or credit hours) to participate in the subject pool.
- Subject pools including subjects under 18 years of age are required to obtain parental consent prior to any minor’s involvement in research.
Instructors are strongly discouraged from recruiting subjects they directly supervise or selecting subjects on such basis. In order to ensure that students are fully informed about the research requirements for the course and the compensation offered for their participation, the department should provide a clear explanation of requirements necessary to earn the credit/extra credit. This includes specifying how many hours or units of research participation (or alternative assignment) are required for the course.
The alternative assignment should meet some basic standards to ensure that students are not unduly influenced to participate in research. Faculty and staff should make every effort to ensure that they do not exert undue influence on students to participate in research rather than the alternative assignment. The alternative assignments should be clearly described in a way and at a time that allows students to make an informed choice about which method they will use to earn credit. To assure issues of fairness and justice, the alternative assignment should require approximately the same commitment of time and effort as research participation.
Requirements for Principal Investigators Using Subject Pools
In research proposals and consent forms, specify how many hours or units of research credit are available for participation in each research study. Clearly state limits on the amount of credit that may be awarded for a particular type of study or alternative assignment prior to or at the time of enrolling in the subject pool.
In order to ensure that the student’s time and effort are respected, clearly delineate the requirements and deadlines in documentation provided to the students. The documentation should include how to enroll in research projects, what to do in case a research study is canceled and clear information of the consequences of not showing up for or completing a research study or the alternative assignment by the listed deadlines.
IRB Review of Subject Pool Requirements
Subject pool registration advertisement(s) and appendices (copies of information provided to the students) should be submitted for review as part of the IRB study application process. Furthermore, any changes in the information in the registration advertisement should be provided to the IRB prior to the implementation of the changes. Minor changes in the information provided to students that do not impact the information in the registration form – for example, course deadlines for each semester – do not need to be reviewed by the IRB.
Information for Parents
Many types of research studies use children as subjects including: studies about learning styles, early language, social development, and literacy. Children are considered a vulnerable population of human subjects because of their special physical and cognitive capacities. Therefore, special ethical and regulatory considerations must be made to protect their rights.
Research involving children is divided into two categories: 1) minimal risk research (classroom observation, curriculum evaluation, and standardized testing analysis) and 2) greater than minimal risk research (experimental learning techniques, sensitive data collection, and therapeutic interventions). Many studies of greater than minimal risk should provide the prospect of a direct benefit to a child. Otherwise, studies approved to recruit this vulnerable population as subjects should do so because it presents a reasonable opportunity to further our understanding, or our ability to prevent, or alleviate a serious problem affecting the health or welfare of children.
As the child’s parent or guardian it is your responsibility to ensure your child’s wellbeing and safety, and to ask any questions you may have about your child's involvement. You will be asked to provide informed consent for your child’s participation in the research study. Moreover, researchers will provide your child a description of the study and what it involves in a manner that is appropriate for the child's cognitive development. It is important for investigators to acquire the assent of children to the extent possible as well as the informed consent and permission of parents.
Since each child is a unique individual it is up to you to consider if participation is right for your child. It is paramount for parents to weigh the risks and benefits to your child before entering your child into a study as a research participant. All consent forms are required to list the risks and benefits of the study. Pay close attention to this information as you review the consent form. Additionally, here are some items you’ll want to think about while contemplating your child’s participation:
- What is being asked of my child?
- What are the direct benefits?
- What are the risks?
- Is the data being collected sensitive?
- How much time is required for participation?
- How is my child’s identity protected?
- Does the study require that my child be removed from class?
- Does my child want to participate?
- What are the advantages (or disadvantages) of participating (or not participating)?
Important definitions of terms frequently used in consent forms with children as human subjects, according to the Office of Human Subjects Research of the National Institutes of Health, include:
- Assent: means a child’s affirmative agreement to participate in research. Failure to object should not be construed as assent.
- Benefit: is a valued or desired outcome.
- Children: are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under applicable law of the jurisdiction in which the research will be conducted. Generally the law considers any person under 18 years old to be a child.
- Risk: is the probability of harm (physical, emotional, social or economic). Both probability and magnitude of possible harm may vary from minimal to significant.
- Minimal risk: means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. A list of procedures which may be considered minimal risk are provided in 45 CFR 46.
- Permission: is the agreement of parent(s) or guardian(s) to the participation of their child or ward in research.”
More information on the use of children in research can be found at the Office of Human Subjects Research website.
The Office for Human Research Protections (OHRP) works to protect the rights, welfare, and wellbeing of volunteers who participate in research supported by the U.S. Department of Health and Human Services (HHS). Below are links to some additional information that you can reveiw regarding your rights as a research participant: