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Institutional Policies

Committee on Human Subjects Research (for Federal Purposes: Institutional Review Board) Policy

POLICY 

Lewis & Clark College requires that all research conducted by faculty, staff, or students supervised by staff, that involves human subjects be reviewed and approved by the Institutional Review Board (“IRB”) before any of the research is initiated.

 

IRB MEMBERSHIP

Membership on the IRB shall meet the guidelines defined by the Code of Federal Regulations (CFR). The IRB must have at least 5 members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB must be sufficiently qualified through the experience and expertise of its members and the diversity of their backgrounds (including considerations of their racial cultural heritage and their sensitivity to issues such as community attitudes), to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.

The IRB must include one member whose primary concerns are in scientific areas, and at least one member whose primary concerns are non-scientific. In addition, the IRB must include a person knowledgeable in institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB must include a 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 IRB shall consider the type of community from which the institution will draw its research subjects. A representative from that type of community, including minorities shall be considered in the IRB membership.

At Lewis & Clark, the IRB consists of:

  • The Dean of Religious and Spiritual Life;
  • The General Counsel of the College;
  • A faculty member from the Graduate School who has experience in psychological, social, or educational research, named by the dean of the Graduate School;
  • A faculty member from the College of Arts and Sciences who has experience in psychological, social, or educational research, named by the dean of the College;
  • Additional members, including at least one public member, not currently affiliated with the institution (personally or through family).

 

These members are chosen to assure compliance with legal criteria regarding race, sex, occupation, vulnerable subject group advocacy, and community criteria if these are not met through other appointments. The Provost will appoint the chair from among the members.

 

IRB FUNCTIONS

Federal regulations mandate that research involving human subjects must be reviewed and approved by the IRB provided for in its assurance filed with the Office of Human Research Protections and will be subject to continuing review by the IRB. The IRB is responsible for providing guidance and oversight for the human participant protection program and for helping to maintain compliance with applicable laws, regulations, and policies. The IRB is responsible for the following oversight functions: 

  1. Determine what activities constitute human participant research.
  2. Review, approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy prior to the commencement of the research.
  3. Require that information given to participants as part of informed consent is in accordance with appropriate laws, regulations, and international standards. The IRB may require that additional information be given to the participants when, in the IRB’s judgment, the information would meaningfully add to the protection of the rights and welfare of participants.
  4. Require documentation of informed consent or waive documentation in accordance with federal laws and regulations. When research activities are being proposed to be conducted in other states and/or countries by College faculty, staff, and/or students, the research activities will be approved in compliance with the regulations for those specific research locations.
  5. Notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
  6. Conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, (unless the research has been classified as “Exempt”) and have authority to observe or have a third party observe the consent process and the research.
  7. Suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants. Any suspension or termination of approval shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator, appropriate institutional official and the department or agency head.

 

DO CLASS ASSIGNMENTS REQUIRE IRB APPROVAL?

Student class assignments include those conducted during or outside of class with students enrolled in an official course (for credit or not for credit), as well as activities in fulfillment of class assignments involving interactions with individuals other than the members of the class. These assignments are typically initiated and completed within a single term. Faculty members may design assignments that engage students in interaction with individuals or data about individuals to teach research methods or to help students understand concepts covered by the course.

Student class assignments, as a general rule, are not systematic data collection efforts intended to develop or contribute to generalizable knowledge and, thus, do not meet the federal regulatory definition of “research.” Therefore, as a rule, student class assignments do not fall under the jurisdiction of the IRB and do not require IRB application, approval, or oversight. For the most part, they are not intended to create new knowledge or to lead to scholarly publication or dissemination.

If instructors do wish to use such assignments for scholarly presentation or publication, however, they must submit the proposed study to the IRB for review and wait until approval before engaging students in the assignment.

Even when a class assignment is “non-research” and, thus, not under the jurisdiction of the IRB, faculty members have an affirmative obligation to ensure that students understand their ethical obligations in carrying out their assignments. Instructors should provide guidance to students collecting information so as to minimize any unwitting or unintentional harms to other students or to individuals, especially if students will interact with or collect private information about vulnerable individuals.

Although most student class assignments pose little or no risk to students or others, some may warrant enhanced attention because of risks to students or to the individuals outside the class. These risks may include physical harm or potential psychological, social, economic, or legal harm, especially when data is collected about sexual activity, use of alcohol or illegal drugs, or involvement in illegal activities. Such risks can be exacerbated when the individuals outside the classroom are minors, pregnant women, prisoners, or people who are otherwise vulnerable, such as cognitively impaired persons. When instructors assign students to collect information about these vulnerable groups, they should take special care to ensure that students realize the potential for harm and take all possible steps to eliminate the risks to these individuals.

NOTE: This policy exemption applies to student class assignments only. Those independent research projects conducted by students, such as theses, honors projects, and independent study projects, that collect data through interactions with living people or access to private information and which are intended to develop or contribute to generalizable knowledge do fall under the jurisdiction of the IRB. Application to the IRB for these student research projects must include an endorsement and acceptance of overall responsibility by a faculty member.

TYPES OF IRB REVIEW

When a research protocol is submitted to the IRB, the chair assigns each human subjects research protocol to a specific category of review, depending on the purpose, methods, and risk-to-benefit ratio of that study. The federal regulations detail the three categories of research review: full committee review, exempt review, and expedited review of non-exempt research. This section will describe each category, followed by examples of projects that would be assigned to that category.

Full Committee Review of Non-Exempt Research:

Any research project involving human subjects that poses more than minimal risk to participants must go through full IRB review for approval.

  • “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
  • “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.”
  • Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.
  • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.”

Minimal risk: “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” (from 45 CFR 46.102).

Certain categories of research automatically require full committee review:

  • Research involving vulnerable populations (prisoners, fetuses, pregnant women, children, the seriously ill, or mentally or cognitively compromised adults as subjects).
  • Research involving the collection or recording of behavior which, if known 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.
  • Research involving the collection of information regarding sensitive aspects of the subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).
  • Research involving deception (NOTE: research involving minor deception or omission that poses no risk of adverse effects to the participants may qualify for expedited review: see below)

EXPEDITED REVIEW

To qualify for expedited review (see 45 CFR 46.110), an activity must involve no more than minimal risk, and be found on the list of Expedited Review Categories of Research (see attached)

Expedited research protocols must meet all of the following criteria:

  • The research does not include vulnerable populations as participants (minors, prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults)
  • The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
  • The research does not involve the collection of information regarding sensitive aspects of the subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).

In addition to these categories, continuing research that was originally determined at a full committee meeting to involve minimal risk and where administrative reviewers cannot identify any additional risks to the participants typically qualifies for expedited review.

If the research qualifies for expedited review, it will be examined by an expediting reviewer (either the chair or a designated member of the IRB). Expedited reviews are conducted weekly on a “rolling” basis as applications are submitted. Once all required documents are received, the expediting reviewer will examine your application and issue a decision.

The IRB member conducting the expedited review may exercise all of the authorities of the IRB except that the reviewer may not disapprove the research. The reviewer shall refer any research protocol which the reviewer would have disapproved to the Full IRB for review. The reviewer may also refer other research protocols to the Full IRB whenever the reviewer believes that Full IRB review is warranted.

When the expedited review procedure is used, the IRB chairperson or member(s) conducting the review shall inform IRB members of research protocols which have been approved under the procedure.

At a convened IRB meeting, any member may request that an activity which has been approved under the expedited procedure be reviewed by the IRB in accordance with non-expedited procedures. A vote of the members shall be taken concerning the request and the majority shall decide the issue.

EXEMPT REVIEW STATUS

DHHS Guidelines (45 CFR Part 46.101) define research as exempt from further IRB review when the research involves no risk to the subject, and falls into one of six specific categories (see below). Research that is considered exempt from full IRB review must still be submitted to the IRB and screened for exempt status. The final determination of risk level and level of review will be made by the IRB upon receipt of the application form.

Use the Exempt Review Categories of Research to decide which exemption category might apply to your research. If you don’t see a category for your research, expedited or full IRB review is probably required.

Keep in mind that exempt research involves no risk. Therefore, any research that manipulates the participant or the participant’s environment is not exempt. In addition, any survey or interview research with adult subjects that includes sensitive or stressful information or that involves deception is not exempt. Examples of exempt research include:

  • No risk survey/interview research with non-vulnerable adult subjects; the use of nonidentifiable laboratory specimens; review of nonidentified existing records; observation of the public behavior of subjects where there is no manipulation of the subject; and some educational testing and classroom activity.

Categories of Exempt Human Subjects Research

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:

  • information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects and
  • 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 (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under paragraph # 2 (above) if:

  • the human subjects are elected or appointed public officials or candidates for public office, or
  • federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4.   Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or the information is recorded by the investigator in such a manner that the subjects cannot be identified directly or through identifiers linked to the subjects.

5.   Research and demonstration projects which are conducted by or subject to the approval of (federal) department or agency heads and which 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, if:

  • wholesome foods without additives are consumed or
  • 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.

 

*Important Notes:

  • IRB registration is required for all exempt research.
  • “Existing” means at the time the research is proposed.
  • These exemptions do not apply to research involving prisoners (45 CFR Part 46 Subpart C).
  • Exempt, Category 2 does not apply to research with children (45 CFR Part 46 Subpart D) except for research involving educational tests (cognitive, diagnostic, aptitude, achievement) or observations of public behavior when the researcher(s) do not participate in the activities being observed.
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