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Conducting Research with Human Subjects
Eckerd College endorses faculty and student research that advances knowledge and supports learning. In order to ensure that research with human subjects is conducted by faculty and/or students in a manner that respects the rights, maintains the well-being and guarantees the privacy of those who participate in it, as well as the ethical principles embraced by Eckerd College, the College has developed pertinent policies and procedures that will be governed by an Institutional Review Board (IRB).
Human Research Instructions
These principles govern whether or not your research will be subject to Full Review by the IRB:
- If it involves children or other vulnerable populations (e.g., the disabled); OR
- If it involves procedures that might cause stress, discomfort, or adverse reactions, including psychological harm (e.g., embarrassment, emotional distress, breach of confidentiality), economic harm, and legal jeopardy beyond levels encountered in daily life; OR
- It involves the deception of participants.
All forms should be submitted via e-mail to email@example.com. Forms that require signatures should be scanned and e-mailed via multi-function copiers located in collegial offices. If you require assistance scanning and e-mailing documents, contact firstname.lastname@example.org.
A. If the research to be conducted is a course-related assignment that does NOT involve any of the principles stated above and has met the conditions stated in "Review by a Supervising Faculty Member, please follow these procedures:
If you are the instructor for a class AND if no student's research will involve any of the three stated principles that govern Full Review AND if no student's research will be presented in a forum outside of an Eckerd classroom, then please submit (using the instructions above), the Faculty Assurance Form. The Faculty Assurance Form singly seeks approval by the instructor for course-related research projects for all students in one section of one course during one semester. (This form must be re-submitted for each section of the same course each semester that research is a required part of the course.)
Each student's proposed project must have been reviewed and approved by the supervising faculty member. The faculty member must maintain for at least three years a file of these submitted Faculty Assurance Forms for each section of a course in which course-related research was required to be conducted by the students.
B. If the research to be conducted is believed NOT to involve any of the three principles stated above and has met the conditions stated in the Exempt/Expedited Review, then the student researcher must submit to the IRB (using the instructions above) ALL of the fully completed forms listed below:
- The fully completed form Information About This Study;
- A full copy of the actual questionnaire or survey or research design; and
- A copy of a certificate that the student researcher has completed the College-prescribed training for research with human subjects; this certificate must have been signed and dated by the faculty member who is supervising the research.
The Chairperson of the IRB or his/her designee will review the content of these forms and notify the supervising faculty member and the student if the research proposal has been approved for Exempt/Expedited Review.
C. If the proposal does NOT meet the standards for an Exempt/Expedited Review OR the research involves one of the three stated principles that require a Full Review, i.e., vulnerable populations, potential harm or deception, then the review process continues under Full Review, as follows:
- If, after review by the IRB Chairperson of his/her designee, the Exempt/Expedited Review is not approved, the student must complete and submit (using the instructions above) the full IRB Proposal Form at least one week prior to the intended date for commencement of the research, as well as the completed Informed Consent for Research Involving Human Subjects Form that will later be signed by participants.
- The IRB will meet within five working days of the student's submission of essential forms (named above) for Full Review and return a decision as soon as possible to the student and supervising faculty member whether or not the research has been approved.
- If approved, the research may begin immediately. If not approved, the Board will present a written explanation of why approval has been denied. At that point, the student may revise the proposed research so as to address the reason for denial OR choose another research design. In either case, the student must re-submit the proposal through the review process above.
If the research involving human subjects is to be conducted by a faculty member, the above procedures must also be followed (with the exception of submission of the Faculty Assurance Form).
Every investigator whether faculty, administrator or student, who conducts scientific, behavioral, social or educational research that involves human subjects, has both the legal and ethical obligation to do so in a manner that:
- involves risk that is no greater than minimal, that is, risk occurring in daily life;
- fully informs the participant of the research goals, procedures, risks and benefits of the research;
- offers the human subject the right to refuse to participate in research or to withdraw from it even after consenting to participate or commencing to participate;
- protects populations that necessitate special consideration, e.g., children, disabled individuals, prisoners, homeless and others;
- has had the proposed research reviewed and approved first by a supervisory individual within the academic discipline, or then by the Institutional Review Board; and
- will protect confidentiality and privacy of its human subjects during the research and after it is completed when appropriate, including precautionary disposal of any papers or tapes or other recorded materials that can identify the participants in the research.
The researcher also must consider the professional standards for research as endorsed by the State of Florida, as well as professional association of the discipline in which that research is based, e.g., the American Educational Research Association, the American Sociological Association, the American Psychological Association, etc. Each profession may have standards that extend or complement the Federal standards; in these cases, all standards must be considered before engaging in the research. If there is any question about additional standards being applied, Eckerd's IRB should be consulted for clarification before the research is begun.
The guidelines that follow are provided to ensure the safety, privacy, and integrity of human subjects, as well as the legal integrity, professional reputation, and educational standards of Eckerd College. Since the College strongly supports research experiences for its undergraduate students in a variety of disciplines, it is essential that all researchers at the College:
- recognize the importance of the rules and procedures which govern research;
- are familiar with those rules and procedures;
- identify the procedures pertinent to their research and complete the associated processes before beginning research, including completion of prescribed training; and
- report misconduct in the design, implementation or dissemination of Eckerd-based research to the College's Institutional Review Board via email.
For purposes of research at Eckerd College, there are three levels of review, each requiring criteria that must be met in order for the research to pass review at that level:
A. The Review by a Supervising Faculty Member, using the Faculty Assurance Form that is submitted to the Chairperson of the IRB. Research covered under the Faculty Assurance Form must meet ALL of these conditions:
- The research is course-related and required; and
- The results will not be shared outside of the classroom environment; and
- None of the stated conditions that necessitate further review via an Exempt/Expedited or a Full Review by the IRB are involved.
B. The Exempt/Expedited Review is conducted by the IRB Chairperson or his/her designee; it will be completed within two days after the necessary paperwork has been submitted at least one week prior to the proposed commencement of the research. Research submitted for the Exempt/Expedited Review must meet ALL of these conditions:
- The research does not involve vulnerable populations, e.g., children, homeless, disabled individuals, etc.;
- The data collected cannot identify any participant directly or through assigned identifiers;
- The data collected will not put the participant at risk of legal or civil or financial or criminal liability or in jeopardy of damaging employability or reputation;
- The data collected will not be shared outside of the institution or used to further knowledge within the discipline;
- The research will be collected in a manner that is within normal educational practice using techniques that are commonly accepted within educational settings; and
- Participants are fully informed about the purpose of the study, the analysis of the data, the procedures that will be used during the research, and their rights to refuse to participate at any time during the research period.
C. The Full Review, which is conducted by the full IRB, will occur when conditions within the proposed research design do not meet the procedural, ethical and/or legal safeguards to protect human subjects. These may include the following:
- Involvement of more than minimal risk to a participant;
- Features of the research that may be insensitive to the participant's well-being;
- Lack of precaution regarding identifying information about participants on the data collected and/or lack of precaution on sharing or disposal of collected data;
- Lack of sufficient information provided to the potential participants; and/or
- Vulnerable populations as research participants.
Completing the Exempt/Expedited Review or the Full Review process is described in Instructions for Researchers Using Human Subjects.
What is the IRB?
IRB Membership as prescribed by law:
The representative membership of the Institutional Review Board (IRB), as specified in the federal statute, is as follows:
- At least five members, with varying backgrounds…including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes;
- No IRB may consist entirely of members of one profession;
- Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas;
- Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution;
- No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB; and
- An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
IRB Membership at Eckerd
The five members of the IRB at Eckerd College shall include the following:
- Three faculty members, one representing the Natural Sciences, two representing the Behavioral Sciences; and
- One member from the community whose interest or affiliation is in a scientific area; and
- One community member unaffiliated with the College or with any employee of the College.
The IRB members shall be appointed/re-appointed for two-year terms by the Dean of Faculty. The Chairperson of Eckerd College's IRB shall be an employee of Eckerd College; he/she will be elected by the IRB's membership to serve a one-year term with the opportunity for re-election to serve subsequent one-year terms.
A list of IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution; for example: full-time or part-time employee, member of governing panel or board, paid or unpaid consultant" shall be maintained in the office of the Dean of Faculty.
IRB Meetings and Voting
The Board will meet three times per year: once each in fall and spring semesters and once during the summer. Each meeting must be attended by a majority of the membership and that majority must contain at least one member whose representation is non-scientific. This constitutes a quorum.
If the quorum requirements for a regularly scheduled meeting can not be met, the official meeting will be rescheduled within that same semester.
The full Board does not need to meet to address each request for an Exempt/Expedited Review. Rather, the Board's Chairperson or his/her designee can make that determination of Exemption for individual research projects.
If it is necessary for the IRB to meet in addition to its regularly scheduled meetings in order to address the specifics of a research proposal submitted for review but not approved under the conditions for Exempt/Expedited Review, the Board will meet within five working days of the request for special consideration of that proposal. Each member will cast one vote and a decision to approve or not approve a research project will be made by simple majority. The Board will complete its review and notify the researcher of its decision, including the reason(s) for the decision, within two working days of its meeting.
If, because an IRB member has a vested interest in a research project that comes before the Board for Full Review and that member recuses him/herself from voting, the Dean of Faculty will serve as a voting member for that Review if the votes of the participating four IRB members result in a tie.
Records of IRB Work
The minutes of the regularly scheduled IRB meetings shall follow a format that will provide sufficient information to a reader to understand who was in attendance, the issues addressed, the results of any voting that occurred and actions taken, and the raising of issues to be addressed in subsequent meetings.
The IRB will review the operating Policies and Procedures for Reviews of Research Involving Human Subjects at least every five years. Minutes of those reviews and the related actions taken will be maintained in the office of the Dean of Faculty until after the subsequent periodic review the operating Policies and Procedures for Reviews is completed.
The minutes of the three regularly scheduled IRB meetings shall be maintained in the office of the Dean of Faculty. The written results regarding decisions of the IRB meetings when Full Review of proposals is required also shall be maintained in the office of the Dean of Faculty for at least three years as prescribed in federal law.
History of the Institutional Review Board (IRB) Process
In the early 1970's, the federal government commissioned a group of scientists and ethicists operating within the Department of Health and Human Services to identify the ethical principles that should govern research and serve as the foundation of a new law that delineated the guidelines and limits of scientific research with human subjects. Out of this process was born the concept of the "Institutional Review Board", a supervisory group to be created at laboratories, hospitals, academic institutions where research is conducted, to protect the human subjects as well as the integrity of the researchers.
Background: The Principles and the Law
In 1974, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, created by the National Research Act under the U.S. Department of Health, Education and Welfare (renamed the US Department of Health and Human Services in 1979), became the responsible group for identifying the basic ethical principles for the conduct of biomedical and behavioral research involving human subjects. The Commission also was charged with the development of guidelines to implement the principles it identified. In 1979 the Belmont Report was issued – so-called because the Commission met in the Smithsonian Institution's Belmont Center. (Click here for related history) The official law, Title 45 (Public Welfare) Code of Federal Regulations (CFR), Part 46, Protection of Human Subjects or 45 CFR 46, revised in 2009, is available here.
The law is based on the following three overarching principles:
- Respect for individuals and their capabilities: …"individuals should be treated as autonomous agents, and that persons with diminished autonomy (i.e., capability for self-determination based on age, illness, external demands) are entitled to protection."
- Beneficence: "Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms."
- Justice: This principle considers two features, that the selection of research subjects is not based on expedience but …"for reasons directly related to the problem being studied;" and that the benefits derived from publicly funded research be made available to all, not only those who can easily afford them.