Human Subjects Research Policy

I. Rationale
Consistent with the principles of the Nuremberg Code, Rider University and its faculty have a responsibility to ensure that the rights of research subjects are not violated. In 1996, the Declaration of Helsinki expressly included a requirement that experimental research protocols be reviewed by a formal, well defined committee independent of the investigators or sponsors of the research. An Institutional Review Board provides a framework for meeting these requirements, acknowledging the University’s responsibility for research conducted under its auspices, and assuring that human subjects are receiving adequate protection.

II. Compliance
The institution acknowledges and accepts its responsibility for protecting the rights and welfare of human subjects of research.

III. Institutional Review Board

  1. Authorization. Rider will establish and maintain an Institutional Review Board for the Protection of Human Subjects (IRB).
  2. Authority. The IRB is assigned the responsibility and authority to propose policy and policy changes, establish procedures, and inform faculty and other researchers affiliated with the University about these policies. It is further assigned the responsibility to review, approve, disapprove and/or require changes in research protocols involving human subjects as well as the authority to suspend or terminate protocols when in its judgment such action is warranted.
  3. Membership. The IRB shall have at least seven members. There shall be one administrator, one student, four faculty members each appointed by his/her college/school APC in Business Administration, Education, Liberal Arts and Sciences, and Westminster Choir College, and 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. The administrator shall be the Associate Provost/Associate Counsel for Academic Affairs. An individual with competence in special areas may be invited to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. The IRB should be diverse with regard to gender, race, ethnicity, and discipline.
  4. Procedures for Approval and Compliance. The IRB will develop specific procedures for applying for IRB approval of research protocols and procedures for monitoring compliance. Only when procedures are in place, will compliance be required.

IV. Appeals
Appeals of IRB decisions shall be directed to the Provost/Vice President for Academic Affairs, whose decision shall be final.

V. Jurisdiction of IRB
All human subjects research shall be submitted to the IRB for review.

VI. Research Covered by this Policy
All research conducted by personnel or students affiliated with Rider University requires review and approval of the IRB. No research will be permitted to commence without express written consent of the IRB. Student research which is a part of the requirements of a specific course may be reviewed by the course instructor; if the course instructor is uncertain whether or not the research is exempt, the instructor should submit to the IRB. (The exception does not apply to thesis.)

Research which is subject to review includes: Research on human subjects which is conducted by Rider personnel or Rider students on the Rider campuses or when using the institutional affiliation as a means of access or as an indication of their legitimacy when conducting off campus research; and research on human subjects which is conducted on the Rider campuses by any non-Rider personnel.

All human subjects research will be classified by the IRB as either exempt or nonexempt. Only the IRB can determine whether a specific research activity is exempt, based upon review of a formally submitted research application.

A. Exempt Research
Research which meets the criteria of the Code of Federal Regulations, Title 45, Part 46-Protection of Human Subjects (June, 1991) is considered exempt. There are four categories of exempt research:

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on effectiveness of or the comparison among instructional technique curricula, or classroom management methods.
  2. Research involving the use of educational tests such as cognitive, diagnostic, aptitude and achievement tests, UNLESS BOTH of the following conditions exist:
    1. information obtained is recorded in such a manner that human subjects can be identified directly or through identifiers linked to the subjects; and
    2. 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 survey or interview procedures, or observation of public behavior UNLESS BOTH of the following conditions exist:
    1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
    2. 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.
  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 subjects.

All research involving human subjects which is not included in the exempt categories listed above is considered non-exempt research.

B. Non-exempt Research
The IRB shall approve non-exempt research based on its determination that the following requirements are satisfied:

  1. Risks to subjects are minimal. Sound research design is used which does not unnecessarily expose subjects to risk.
  2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of knowledge that may reasonably be expected to result.
  3. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with the code of ethics for conducting research within the particular discipline of the researcher. A copy of the informed consent document used in the research project shall be submitted along with the IRB application.
  4. Where appropriate, informed consent will be appropriately documented and maintained for a period of no less than three years after the termination of the project.
  5. Where appropriate, the research plan makes adequate provision for monitoring the data collection to ensure the safety of subjects.
  6. Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. The investigator shall provide a detailed description of the process and procedure by which confidentiality of data will be maintained. This shall be submitted along with the IRB application.

Forms

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