Section: Research
Policy Number: 6-4
Policy Name: Involvement of Human Subjects in Research and Research-Related Activities
Date: April 15, 1975
Revisions: June 5, 1989; March 1, 1996; September 1, 2005; January 18, 2008; February 28, 2008

  1. PURPOSE

    To insure the protection of the rights and welfare of individuals used as subjects in research projects.

  2. POLICY

    1. University Responsibility

      The University of Delaware bears full responsibility for the performance of all research involving human subjects, including complying with federal, state, and local laws as they may relate to such research. In meeting its obligations in this area, the University is guided by the ethical principles set forth in the report of the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report"), and adheres to the regulations of title 45, Part 46 of the code of Federal Regulations (45CFR46) and the University's Federalwide Assurance with the U.S. Department of Health and Human Services for the protection of human research subjects. Some research involving human subjects could require additional federal agency approvals (e.g.FDA, EPA).

      The University requires that all projects involving human subjects are reviewed and approved by the Human Subjects Review Board (HSRB), which is constituted according to the above-referenced regulations, to assure the following:

      1. The benefit to the subject and the importance of the knowledge to be gained outweigh the risks to the subject to the extent that a decision to allow the subject to accept these risks is warranted;

      2. The rights and welfare of subjects will be adequately protected;

      3. Informed consent will be obtained by adequate and appropriate methods; and

      4. The activity will be reviewed at regular intervals.

    2. Investigator's Responsibility

      University investigators planning research projects involving the use of human subjects are required to (1) make available to the HSRB the plans for anticipated research before beginning the projects and in sufficient time to allow the board to take action; (2) make clearly evident in the written research plan or through any further information that may be needed precisely how the rights and welfare of the research subjects are to be protected, how informed consent of human subjects is to be obtained, and whether written consent forms are to be used; and (3) during the course of the project make known to the committee any changes in protocol or any emerging problems of investigation that may significantly alter the original concept; (4) report to the HSRB any instances of injuries or unexpected problems involving risks to subjects or others within one week of the occurrence; (5) make certain that all researchers working with human subjects have received formal training for human subject research protections; and (6) carry out the continuing responsibilities delineated in Section E.6, "Responsibilities of the Research Investigator."

    3. Definition of Human Subject

      "Human subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

    4. Applicability

      This policy applies to every project that includes research procedures that go beyond the diagnostic and therapeutic needs of the subjects as determined by the HSRB. Such projects may involve the procurement of human materials or services; may be categorized as research, training, development, or related activities; and may be internally supported by University funds or externally supported through grants, contracts, fellowships, or traineeships. The applicability of this policy is most obvious in medical and behavioral science research involving procedures that may induce a potentially harmful altered state or condition. Surgical procedures; the removal of organs or tissues for biopsy, transplantation or banking; the administration of drugs or radiation; the use of indwelling catheters or electrodes; the requirement of strenuous physical exertion; subjection to deceit, public embarrassment, or humiliation are all examples of procedures that require thorough scrutiny by the HSRB.

      Many medical, social and behavioral research projects involve no immediate risk to subjects. However, some of these may impose varying degrees of discomfort, irritation, and harassment. In addition, there may be substantial potential injury to the subject's rights if attention is not given to maintenance of the confidentiality of information obtained from the subject and the protection of the subject from misuse of findings. In this category are projects that may involve the use of data obtained previously for purposes other than the research in question.

      Research concerned solely with discarded human materials obtained at surgery or in the course of diagnosis or treatment requires a review of the circumstances under which the materials are to be procured.

      Except for research that is exempt (see section IIG), this policy applies to all research if one or more of the following apply:

      1. the research is sponsored by the University, or

      2. the research is conducted by or under the direction of any employee or agent of this University in connection with his or her institutional responsibilities, or

      3. the research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or

      4. the research involves the use of the University's non-public information to identify or contact human research subjects or prospective subjects.

    5. Implementation

      1. Human Subjects

        The HSRB will have responsibility for the final review and approval of projects involving human subjects. The HSRB, which shall have at least five members, must include the following:

        1. Male and female members;

        2. Representatives from a variety of professions;

        3. At least one member whose primary expertise is in a scientific area and at least one whose primary concerns are in nonscientific areas.

        4. At least one member who is not otherwise affiliated with the University and who is not part of the immediate family of a person affiliated with the University.

          Whenever it is deemed advisable, independent consultants may be called up to assist the HSRB. A quorum, which consists of a majority of members of the board, is required to make decisions.

      2. Information Required for HSRB Consideration

        The proposal in its final form shall be submitted to the HSRB. The submission form is available on the University Research website, and may be submitted electronically.

        The following information is required in the protocol:

        1. The title of the project and the investigator's name.

        2. The research objectives.

        3. A description of the study with particular respect to methodology and plan of action, including information on the following:

          1. The manner and the extent to which human subjects will be involved;

          2. The procedures, tools, etc. to be employed. (Examples and a description of all questionnaires must be included; copies of the questionnaires must be submitted to the board for review before use.);

          3. What the subjects will be told about their involvement in the study;

          4. How informed consent will be obtained and recorded;

          5. Whether there will be any potential risks to the subjects;

          6. What measures will be taken to safeguard the welfare of the subjects, their right of privacy, and the confidentiality of information being handled;

          7. Whether minors will be involved;

          8. Whether personality tests or inventories will be used (to be included in the protocol);

          9. What inducements or compensation, if any, will be offered to the subjects.

      3. Informed Consent

        Informed consent means the knowing consent of an individual or his or her legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress or other form of constraint or coercion. The basic elements of information necessary to such consent include the following:

        1. a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;

        2. a description of any reasonably foreseeable risks or discomforts to the subject;

        3. a description of any benefits to the subjects or to others which may reasonably be expected from the research;

        4. a disclosure of appropriate alternative procedure or courses of treatment, if any, that might be advantageous to the subject;

        5. a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

        6. for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

        7. an explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the event of a research-related injury to the subject; and

        8. a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

        No informed consent, oral or written, shall include any exculpatory language. The consent will be documented in one of the three following forms:

        1. A written consent document embodying all of the basic elements of informed consent, which is signed by the subjects after they have been given adequate opportunity to read it and which is approved by the HSRB.

        2. A short, written consent form document indicating that the basic elements of informed consent which have been presented to the subject orally. Use of the short form requires prior approval by the HSRB. A written summary of what is to be said to the subjects when the consent form is signed must be submitted to the HSRB. The short form must be signed by the subjects and by a witness to the oral presentation and to the subjects' signatures.

        3. The HSRB may waive the requirement for the investigator to obtain a signed consent form if it finds either (1) that the only record linking the subject and the research is the consent form, and that the principal risk would be potential harm resulting from a breach of confidentiality or (2) that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

      4. Confidentiality

        The identity of human subjects shall not be revealed without prior consent. If the data are used in connection with additional research, the consent of the subjects must be obtained before the subjects are identified with the additional research. The records identifying the subjects with the research must be kept under secure conditions. Consent forms must be kept in a secure location on campus.

      5. Proposal Review

        1. Every proposal involving human subjects must be reviewed before the start of the project. To initiate review the investigator submits the proposal to the Chair, Human Subjects Review Board (HSRB). Sixteen copies are required.

        2. Ongoing projects will be reviewed annually unless the HSRB specifies more frequent review.

        3. Following preliminary review, the HSRB may request that the investigator make revisions or additions to the proposal or consent form before approval will be granted. When the board's review is complete, the chair will communicate the results of the review to the investigator.

        4. The decision of the HSRB will be on the basis of a majority of those voting.

      6. Responsibilities of the Research Investigator

        1. Iinvestigators acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable laws and regulations.

        2. Investigators who intend to involve human research subjects will not make the final determination of exemption from applicable regulations.

        3. Investigators are responsible for providing a copy of the approved and signed informed consent document to each subject at the time of consent, unless the HSRB has specifically waived this requirement. All signed consent documents are to be retained in a manner approved by the HSRB.

        4. Investigators will promptly report proposed changes in previously approved human subject research activities to the HSRB. The proposed changes will not be initiated without review and approval by the HSRB.

        5. Investigators are responsible for reporting progress of approved research to the HSRB, as often as and in the manner prescribed by the HSRB on the basis of risks to subjects, but no less than once per year.

        6. Investigators will promptly (within one week of occurrence) report to the HSRB any injuries or other unanticipated problems involving risks to subjects and others.

        7. No investigator will seek to obtain research credit for, or use data from, patient interventions that constitute the provision of emergency medical care without prior approval by the HSRB. A physician may provide emergency medical care to a patient without prior review and approval by the HSRB, to the extent permitted by law; however, such activities will not be counted as research nor the data used in support of research.

    6. Expedited Review

      When research involves no more than minimal risk and consists only of activities in the nine federal categories which may be reviewed by expedited procedures (45CFR46), research may be conducted after approval by a departmental review committee*, with concurrence of the Chair, HSRB. The Chair of the departmental review committee must be a regular member of the Human Subjects Review Board. The departmental review committee may not disapprove research; they may either approve or refer projects to the full board. A copy of the research protocol and the departmental approval will be sent promptly to the Chair, HSRB who will in turn notify the HSRB members of the approval.

      *The Department of Psychology, Individual and Family Studies, School of Education and the School of Urban Affairs and Public Policy have internal review committees.

    7. Exempted Research

      In most instances, the following research categories are exempt from review by the Human Subjects Review Board (45CFR46.101(b), 6/18/91). Exemptions may be granted only by the Chair, HSRB or his/her designee. All research approved as exempt under one or more of these categories will be conducted in accordance with ethical principles for using humans in research as specified in the Belmont Report.

      1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

      2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects and (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

      3. Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior that is not exempt under category 2, if (a) the human subjects are elected or appointed public officials or candidates for public office or (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

        * The Department of Psychology, the Departments of Consumer Studies, Hotel, Restaurant and Institutional Management, Individual and Family Studies, School of Education and the School of Urban Affairs and Public Policy have internal review committees.

      4. 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.

      5. Research and demonstration projects that are conducted by or subject to the approval of department or agency heads and that are designed to study, evaluate, or otherwise examine (a) public benefit or service programs, (b) procedures for obtaining benefits or services under those programs, (c) possible changes in or alternatives to those programs or procedures, or (d) possible changes in methods or levels of payment for benefits or services under those programs.

      6. Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome food without additives are consumed or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Submitted by: Research Office