Research Committee Overview
The Human Subjects Research Review Committee (HSRRC) is an Institutional Review Board (IRB), responsible for ensuring that all research at Daemen College involving human subjects is appropriately reviewed in accordance with pertinent legal and ethical requirements. Faculty and students who receive the committee's approval for research projects are responsible for conducting the research as approved, without changes pertaining to the treatment of subjects, and are responsible for maintaining ethical standards while conducting research.
THE COMMITTEE’S APPROVAL IS REQUIRED BEFORE ANY DATA MAY BE COLLECTED.
This web page is established to provide faculty and students with the necessary information to seek approval for, conduct, and report their research in the most appropriate and efficient manner. Click on this link for the complete text of the Daemen College Research Review Policy. These policies are derived from US government requirements for federally-funded research, and from ethical guidelines in the medical and behavioral sciences. Both funded and non-funded Human Subjects research by Daemen College faculty, students and staff, must follow these procedures. Researchers should also become familiar with the Research Integrity Policy of Daemen College.
Students and faculty who are seeking approval for research with human participants must first determine the category of review that pertains to their planned research, and then submit the required documents.
Which Review Category Applies to My Research Project?
The Human Subjects Research Review Committee, like other Institutional Review Boards (IRBs), has three review categories depending on the risk assessment (completed by the applicant, the faculty supervisor, and later the HSRRC): Exempt, Expedited and Full Review. It is important for student and faculty researchers to read these guidelines thoroughly in order to submit their proposals correctly. Proposals that are complete and correctly categorized will be reviewed and approved more quickly.
Exemption from Review:
The EXEMPTION FROM REVIEW must be certified by the IRB. Studies that are submitted for an exemption do not require submission of the longer application for Expedited or Full proposals. Carefully read the following to determine if your study appears to qualify for a Certificate of Exemption.
Proposals are eligible for a Certificate of Exemption if they involve one of the following (1-4):
1. Survey research in which the survey instruments or questionnaires are DISTRIBUTED AND COLLECTED in a public place, and the names or other identifying information of participants are not recorded AT ANY TIME. Surveys designed to be returned by mail may be exempt ONLY if those answering the surveys are instructed to return them without writing their names and addresses on the envelopes. Surveys conducted in schools, hospitals or other institutions may be exempt only if the researcher provides a location or box for participants to deposit the returned surveys in.
Survey research is NOT EXEMPT if any of the following apply:
- Research participation credit or other compensation is provided to participants. (These proposals are not exempt because participants’ names are recorded.)
- You are doing a chart review or other study of medical records
- Researchers keep a list of those who returned surveys in order to follow up.
- Surveys are conducted by telephone.
- Surveys are distributed by handing them to individuals personally known to the researcher, and handed back to the researcher.
- Surveys involve behavior about intimate matters such as sexual behavior, drug use, or law breaking.
Survey research must be ANONYMOUS to be considered as exempt—meaning that no identifying information is collected and the identities of the respondents are not known to the researcher. “Anonymous” is different from “Confidential.” Data are CONFIDENTIAL when the researcher obtains personal identifying information and follows rules for guarding the privacy of participants, such as coding, keeping names in a locked location, and destroying identifying information when it is no longer needed. All Human Subjects research must observe confidentiality rules.
2. Educational Research that is conducted as part of on-going classroom procedures may be exempt research; for example, data collected as part of classroom lessons and management, such as pre-and post-tests before and after a lesson, or unobtrusive observations of classroom behavior (Unobtrusive means that others in the classroom would not be aware that students are being observed.) Behavioral modification research may be considered exempt IF it is part of the educational program. Research using audio or video recordings in which individuals could be identified, is not exempt. Studies using interviews or questionnaires with children, that are not part of regular lesson plans, are not exempt.
3. Studies based on existing educational records, such as standardized test scores, but ONLY IF the identifying information is removed BEFORE it is provided to the researcher.
4. Studies of behavior in public places, such as streets, malls or college student centers, but ONLY if there is no videotaping or other data collection methods that would make it possible to identify individuals.
If your proposal fits the description of Exempt research, you should submit:
(1) Application for a Certificate of Exemption, including:
(2) A brief description of your research plan, including procedures for ensuring anonymity, as defined above. For survey research, include a copy of the survey instrument.
Exempt proposals are reviewed by the HSRRC Committee Chair or a designated committee member. If the researcher is not sure that the proposal qualifies for exempt status, she or he should submit the form for Expedited and Full reviews. All proposals must be submitted in electronic version. If a proposal submitted as expedited is found to qualify as Exempt research, it will be reviewed as Exempt.
Frequently Asked Questions:
If the research is exempt from review, why do I have to submit anything?
ALL RESEARCH CONDUCTED UNDER THE AUSPICES OF DAEMEN COLLEGE AND/OR FOR COURSE CREDIT WITH HUMAN PARTICIPANTS MUST BE APPROVED BY THE HSRRC. A Certificate of Exemption shows that the HSRRC certifies that your research is exempt from HSRRC review. It provides documentation that you have complied with IRB requirements.
What kinds of projects are not human subjects research and do not need to be submitted, even for a Certificate of Exemption? (The definition of Human Subjects research is still under discussion in research communities. If in doubt, please consult the chair, or submit an application.)
Market research, such as questionnaires on consumer preferences or satisfaction, is not Human Subjects research and does not need to be submitted. (Consumer preference studies involving samples of foods, cosmetics, etc, are slightly different—under FDA guidelines, they should be submitted as Exempt.)
Political opinion polls, such as preferences for candidates or awareness of issues, are not generally considered Human Subjects research. In-depth interviews about individual beliefs and values are Human Subjects research.
Classroom projects to teach students about basic research methods are considered instructional rather than human subjects research IF the studies do not constitute complete research projects, and the results are not reported anywhere outside the course. However, ethical rules apply to classroom projects—self-disclosure about sensitive topics should not be required, confidentiality should be observed, and if observations or interviews with minors are used as class assignments, parents and guardians should be informed and asked to give written permission.
Expedited Review Proposals
Research that fits ALL of the following criteria may be reviewed as Expedited:
- Involves adult participants (18 years of age or older) who are able to give informed consent. Studies with mentally disabled individuals require full review.
- Does not involve risk to participants beyond the risks encountered in everyday activities.
- Does not involve highly personal and controversial topics such as personal sexual behavior, drug use, or illegal behavior.
- Does not subject participants to deception or humiliation. (Note: avoiding deception does not mean that you must inform participants of your hypotheses in advance; it means that you do not actively mislead them about the purpose of the research.)
If your research fits the description of Expedited, you should complete the Application for Investigation Involving Human Subjects, and follow the submission instructions found on the HSRR homepage.
Expedited proposals are sent electronically to the entire Human Subjects Research Review Committee, but they are given a preliminary review by one committee member, and if they are found to be satisfactory, the researcher will receive permission to begin the study. At the next committee meeting, the committee will review the proposal. If the committee agrees with the expedited reviewer, a letter of approval will be sent to the researcher. If the proposal does not receive a majority vote of approval, the researcher will be contacted and required to stop data collection until the issues involved are addressed and approved by the majority of the committee. Please note that most applications require slight revisions.
Full Review Proposals
If your proposed research involves collecting data from children or youth less than 18 years of age, (and is not exempt educational research as defined in the Exempt section), OR involves adults with reduced ability to give informed consent, such as persons with cognitive impairments, OR involves more than minimal risk, or any of the other conditions listed above in the Expedited section, it is in the FULL REVIEW category.
Full Review proposals must be submitted at least 2 weeks prior to the meeting where a review is requested and are discussed at meetings of the HSRRC and are approved by majority vote. Approval by the full committee is required before the researcher is permitted to collect data. The committee meets approximately once a month during the academic year, and one or more times during the summer. Meeting dates may be obtained from the Committee Chair.
If your research fits the description of Full Review, you should complete the Application for Investigation Involving Human Subjects, and follow the submission instructions found on the HSRR homepage.
The procedures for submitting Full Review proposals are the same as for Expedited Review proposals. Both printed copies and electronic copies must be received before the proposal can be reviewed, and must include all required sections.
Note: All studies involving collecting data directly from children are either Exempt or Full Review Proposals. There is no Expedited research with children. Interview or questionnaire studies that obtain data from parents ABOUT their children may be Expedited. In such cases, the parent, not the child, is the participant and the Informed Consent form should be directed to the parent.
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