Human Subjects Review Committee

Policy and Procedures

The purpose of this document is to outline the research review process for Corban College. Two factors have pointed to the need for such a process: 1. The institution’s requirement that M.Ed. candidates complete research as part of the course of study, and 2. The increase in faculty interest in conducting research with human subjects.

The Human Subjects Review Committee (HSRC) will be comprised of three full-time faculty members who review research proposals in order to protect human subjects and the integrity of the research and school. The full HSRC policy and procedures will be placed in the Graduate Faculty Handbook and elements of the policy will also be in the Graduate Research Handbook. Portions of it will also be placed in the Graduate Education Academic Bulletin.

I. Purpose

Overview

The HSRC reviews all research conducted by college faculty and/or students involving human subjects for the protection of the rights, welfare, and well-being of the subjects, and the rights of the researcher and of the college. The HSRC is guided in its decisions by the Federal Policy for the Protection of Human Subjects (the Common Rule), published in the Federal Register on June 18, 1991, and by Federal Regulation 45 CFR (Code of Federal Regulation) Part 46 (cf. 34 CFR Part 97), “Protection of Human Subjects in Research,” published in the Federal Register, and applicable ethical standards as published by professional groups and societies.

Committee

The committee is charged with the mission to ensure that all research done under the auspices of the college conforms to state and federal regulations governing health, privacy and safety of human subjects in research. The HSRC is composed of three full-time faculty members from three different academic departments whose research or teaching is affected by these regulations. The chair of the committee will convene meetings on an as-needed basis.

Research Ethics

All researchers should be aware of the following ethical concerns when preparing the research proposal and conducting the research project:

  • The researcher is aware of the potential risks (i.e., psychological, social, physical, spiritual, economic, and legal) involved in the research project
  • The researcher makes the subjects aware of the risks inherent in the research project and takes steps to minimize those risks.
  • The researcher makes the subjects aware of the risks inherent in the research project and takes steps to minimize those risks.
  • The researcher analyzes the risk/benefit ratio for all populations, with special consideration of vulnerable populations (e.g., children, pregnant women, fetuses, mentally disabled, institutionalized persons, prisoners, etc.)
  • The researcher protects the privacy and confidentiality of the subjects.

Researchers must complete the free online course about the rights and welfare of human subjects in research at the National Institute of Health website. Below is the web address. Student researchers will complete this online course as a part of their research course sequence and all researchers must provide documentation that the course was completed. This can be done by printing the certificate after completing the course.
http://phrp.nihtraining.com/users/login.php

For research supported by federal money or by foundations that require Institutional Review Board (IRB) approval, the HSRC will convene an IRB meeting following the guidelines delineated in the definition of IRB (below).

II. Definitions

Institutional Review Board (IRB)

An IRB, as defined by Federal Regulation 45 CFR Part 46 Section 107, is a different body than the HSRC, though the three HSRC members may serve on the board. All research proposals that are federally or state funded or receive money from a private foundation or Corban College must be reviewed by an IRB.

An IRB must consist of at least five members with varying discipline and research methodology backgrounds. Each IRB must include at least one member who is not otherwise affiliated with the institution and who has no conflicts of interest (not part of the immediate family of a person affiliated with the institution nor affiliated with the research study under review). The HSRC policies and procedures will serve as a guide for the IRB, except where those policies or procedures are in conflict with this definition or Federal Regulation 45 CFR Part 46.

Minimal Risk

Federal regulations define “minimal risk” as follows: “The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” In broad terms, a project involves minimal risk if:

  1. The subject experiences no pain or physical danger;
  2. The subject experiences no emotional arousal or psychological stress beyond the levels normally to be expected in everyday life;
  3. The project neither induces nor attempts to induce long-term significant change in the subject’s behaviors (including attitudes toward self and others);
  4. The data would not embarrass or socially disadvantage the subject, were confidentiality to be violated; and
  5. If the investigator conceals information about the specific purpose of the project, there is no reason to believe the subject would choose not to participate if s/he had known that information initially.

III. Process

In order to conduct research with human subjects, all researchers must submit a Human Subjects Review (HSR) application which includes a completed application (Appendix A), an abstract of the research project, and a copy of the informed consent letter or form.

The researcher must submit the application and related material to the chair of the Human Subjects Review Committee. The HSRC uses 3 types of review when evaluating HSR applications.

  • Full Review
  • Expedited Review
  • Exempt Review

From the information provided, the chair will determine which type of review is required. (See below for full description of each review type.) Upon completion of the review, the researcher will be notified whether the proposal is accepted or denied within three days. If there are ethical concerns with the research project, the researcher may be asked to submit additional material or may be requested to meet with the committee to discuss particulars of the research process.

Data collection may not begin until the researcher receives written confirmation that the proposal has been approved.

IV. Types of Review

Full Review

If the research project involves any of the following, the project will receive a full review by the IRB Board. The following are the criteria that determine whether a project will receive a full review:

  • Support from non-university sources (e.g., government agencies) that requires an Institutional Review Board (IRB) approval. *The chair of the HSRC will be responsible for assembling an IRB that fulfills the specified requirements of an IRB. The HSRC will serve as the core of the IRB, but will not constitute a full IRB. (See section 5 below.)
    The likelihood of risk or substantial stress or discomfort to the subject(s)
  • Personality tests, inventories or questionnaires of a personal and sensitive nature where subjects’ identities will not be anonymous to the researcher
  • Sensitive aspects of a subject’s behavior that could reasonably place a subject at risk of criminal/civil liability or be damaging to a subject’s financial standing or employability
  • Sensitive aspects of a subject’s behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol
  • Health care procedures that are not conducted for the primary benefit of the subject
  • Diagnostic or therapeutic assessments, interventions, or measures that are not standard, generally acceptable, or common practice
  • Deception or procedures that are not known to the subject (e.g., the subject will not be fully informed about study objectives.)
  • Special populations (e.g., children, prisoners, pregnant women, or individuals who are mentally or psychologically ill, or incompetent)
  • Greater than minimal risk to subjects  (cf. Section V)
  • Collection of blood samples or other body fluids in any amount

Expedited Review

If none of the above descriptors apply to the research proposal, the project may require a less rigorous, expedited review. The following are the criteria that determine whether a project will receive expedited review:

  • Minimal risk (If more than minimal, it needs full review.)
  • Data recorded from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice
  • Voice recording analysis made for research purposes
  • Moderate exercise by healthy volunteers
  • Research on individual or group behavior, or characteristics of individuals, without manipulation of a subject’s behavior and in a manner that does not cause stress to subjects

Exempt Review

If none of the preceding descriptors for full or expedited review apply to the project, the research proposal falls under the category of exempt review.
Such proposals still require HSRC approval. Exempt review means that the application only requires a review by one single HSRC member to confirm that the proposal does not warrant a more in-depth review by the full committee. The following are the criteria that determine whether a project will receive an exempt review:

  • Investigations of commonly accepted educational practices in established or commonly accepted settings (e.g., a faculty member or teacher is examining a new method of teaching instruction to determine educational effectiveness)
  • Analysis of information from educational tests that will be recorded in such a manner that subjects cannot be identified
  • Surveys or interviews in which responses will be recorded in such a manner that a subject cannot be identified directly or through identifiers linked to a subject.  To qualify for exempt status, the surveys would not involve vulnerable populations (e.g., juveniles) or ask questions about sensitive aspects of a subject’s behavior (e.g., criminal behavior)
  • Observations of public behavior (subject observation)
  • Collection or study of publicly available existing data, documents, records or specimens
  • Collection or study of existing data, documents, records or specimens in which information will be recorded or reported in such a manner that a subject cannot be identified directly or through identifiers linked to a subject

V. Informed Consent

Informed consent must be obtained from research subjects depending on the level of HSR review determined by the chair of the HSRC and must address the basic elements listed below. If required, the informed consent form must be signed by each subject or the subject’s legally authorized representative before participation in the research. If the subject is under the age of 18, the consent form must also be signed by a parent or legal guardian. A copy of the written consent shall be provided to the person signing the form. (In most cases of Exempt level reviews, no informed consent form will be required, but this will be determined based on the review of individual proposals.)

The Basic Elements of Informed Consent

  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 which are experimental
  2. A description of any foreseeable risks or discomforts to the subject
  3. A description of any benefits to the subject or to others which may reasonably be expected from the research
  4. A disclosure of appropriate alternative procedures 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 medical treatments or counseling are available if injury or distress 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 subjects’ rights, and whom to contact in the event of a research-related injury to the subject
  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

In addition, where appropriate, one or more of the following elements shall be provided to the subject:

  • A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable
  • Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent
  • Any additional costs to the subject that may result from participation in the research
  • The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject
  • A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject
  • The approximate number of subjects involved in the study

VI. Institutional Approval Letter

One of the documents to be submitted with the research proposal is a letter from an authorized representative of any institution involved in the research design other than Corban College and Graduate School. This letter must acknowledge permission to conduct the research and detail any required specific limitations or procedures in addition to those specified by Corban College representatives.

This approval letter will be required of all researchers before proposal approval regardless of the level of HSR review required.

*The description of the types of review, informed consent and minimal risk are taken from the University of Portland’s policies regarding their IRB. (See http://www.up.edu/irb/)