Please read the following information carefully prior to submitting a Human Subjects proposal. It is the investigator's responsibility to understand and comply with these specifications, which are based on the U. S. Office of Human Research Protections Federal Code of Regulations.
Questions may be directed to Mary Barnas, chair of the Human Subjects Committee.
All research (including surveys) involving human subjects must be reviewed by the Human Subjects Committee (HSC) before any contact with human subjects occurs. Failure to receive prior approval is a serious violation of research ethics.
The duty of the HSC is to protect the welfare of subjects participating in projects and to ensure that research is conducted in an ethical and responsible manner. The purpose of this review process is not to judge the scientific legitimacy of the project design; however, the scholarly and educational outcomes of the research must be considered in balance with the risks to participants.
HSC approval is generally not required for classroom demonstration projects, provided that the demonstration does not involve risks to the subjects. It is the instructor’s responsibility to determine whether risk is involved in a demonstration project. If the instructor is unsure of the level of risk that may be involved, advice from the HSC should be sought.
Researchers should review the criteria presented in the Proposal Form to determine if they should submit a proposal for a long or short review. Depending when a proposal is received, researchers should expect to wait no more than two weeks for a decision from the committee.
The committee feels it is necessary for all researchers to submit a certificate of completion of the Protecting Human Research Participants training module.
HSC members use a standardized Proposal Evaluation Form to guide their evaluations of proposed research studies. Although this form is to be completed by HSC members, investigators may use it as a guide for submission of materials. Once the approval decision has been made, investigators (and faculty supervisors, where appropriate) will receive an electronic copy of the form that summarizes (and explains) the committee members’ decision. If a proposal has been denied, investigators should re-submit the entire revised HSC packet for a second review. Data collection may begin only after receiving notification of approval.
If information provided in the proposal is not complete, or is insufficient in the opinion of the HSC reviewers, then approval of the project may be delayed. The HSC reserves the right to request other information not explicitly requested on the review form that it regards as necessary to judge the safety of the proposed research.
If investigators need to update an approved research protocol revisions to the existing proposal should be sent to the HSC. Substantial changes to research protocol will necessitate the re-submission of the entire review form. Investigators will be notified as to the acceptance or denial of these changes.
If investigators need to renew a previously approved protocol, then they should submit the Renewal form.
Investigators must obtain Informed Consent for all subjects involved in the research project or justify why this is not appropriate, feasible, or practical. Situations in which informed consent may not be necessary include studies with no more than minimal risk, studies in which the lack of informed consent does not adversely affect the rights or welfare of subjects, studies which could not be carried out if informed consent is obtained, studies in which the consent form would be the only link between the subject and the research and potential harm could result from a breach of confidentially, and studies involving no procedures for which written consent is normally required outside of the research context. If a waiver for informed consent is granted, investigators should provide additional information to subjects after their participation in the research, when appropriate. (See Informed Consent Guidelines within the Proposal Form for specific information about this document.)
If the proposed research involves deception of human participants, it is the investigator's responsibility to fully describe the nature of this deception and debriefing procedure(s). The aim of a debriefing is to inform the research participant about the purpose(s) of the study and to minimize any negative effects of the study. When deception is involved, investigators are expected to provide a full explanation after participation is complete. Although studies involving minor deception may be approved using the short review, if the amount or nature of deception in your study is judged by the HSC to be extreme or potentially harmful, investigators will be asked to complete the long review.
Investigators must submit for a long review if ANY of the following describe the proposed study:
- person(s) under 18 years of age
- prisoner(s) or person(s) awaiting trial
- known pregnant woman/women
- any other person(s) who are vulnerable to risks or are possibly not capable of giving informed consent (e.g., elderly, individuals with disabilities)
- potentially painful or purposefully stressful activities/procedures
- the extraction of blood or other bodily fluids
- procedures which might be considered an invasion of privacy (e.g., questions about sexual orientation or sexual experience)
- procedures that involve physical contact between researchers and participants
If none of the above applies to the proposed study, investigators may submit for a short review. The following are categories of research involving human subjects that may be submitted for short review.
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), or questionnaires, if information obtained is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects
- Research involving surveys or interview procedures, where the subjects are legally competent, except where both of the following conditions exist:
- Responses are recorded in such a manner that the subjects can be identified directly, or through identifiers linked to the subjects
- The subjects' responses, if they became known outside of the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing or employability; or the research deals with sensitive aspects of the subjects' own behavior, such as illegal conduct, drug use, sexual behavior, or underage use of alcohol
- (If both of these two conditions apply, submission for a long review is required.)
- Research involving survey or interview procedures, where the human subjects are elected or appointed public officials or candidates for public office
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects
- Research involving the observation of public behavior in places where there is a recognized expectation of privacy, except where both of the following two conditions exist:
- Observations are recorded in such a manner that the subjects can be identified directly, or through identifiers linked to the subjects
- The observations recorded about the subject, if they became known outside of the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing or employability; or the research deals with sensitive aspects of the subjects' own behavior, such as illegal conduct, drug use, sexual behavior, or underage use of alcohol
- (If both of these two conditions apply, submission for a long review is required.)
- Research involving taste and food quality evaluation and consumer acceptance studies, if any of the following conditions exist:
- Wholesome foods without additives are consumed, or
- A food is consumed that contains a food ingredient at or below the level and for use found to be safe by the FDA or approved by the EPA or the USDA, or a
- Agricultural chemical or environmental contaminant is consumed at or below the level found to be safe by the FDA or approved by the EPA or the USDA
- (If none of these conditions apply, submission for a long review is required.)