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Protection of Human Subjects

000.250 PROTECTION OF HUMAN SUBJECTS POLICY

A. INTRODUCTION

To meet its legal and ethical obligations to ensure that the rights of human subjects in research are appropriately protected, it is the policy of Wenatchee Valley College to maintain an Institutional Review Board (IRB). The composition and procedures of the IRB will be in compliance with applicable regulations for the protection of human subjects, including Title 45 of the Code of Federal Regulations, Part 46 and RCW 42.48.020.

B. BASIC PRINCIPLES

The basic principles adhered to by the college are drawn from the Belmont Report, written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979.

  1. Respect of Persons: The investigator has an obligation to each participant to treat them as a person fully capable of making an informed decision regarding his or her participation in the research. Each participant must be given a full disclosure of the nature of the study, including any risks or benefits. To ensure the autonomy of the subject, the college requires a signed informed consent form from each participant in the study unless the study meets the exception criteria outlined in the section on exemptions.
  2. Beneficence: The investigator has an obligation to each participant to attempt to maximize benefits for each participant and/or society, while minimizing the risk of harm to each participant.
  3. Justice (i.e. avoiding unfair coercion): The investigator is also obligated to provide for equitable distribution of benefits and burdens among the selected population.

C. REQUIRED REVIEW OF PROPOSED RESEARCH

It is the policy of Wenatchee Valley College (WVC) that all research involving human subjects, including (1) research planned or conducted by students or employees of the college, or (2) research planned or conducted by entities outside the college that will recruit WVC students or employees as participants, or (3) any research involving human subjects that will use college facilities, must undergo review and receive approval by the IRB before research activities are initiated. An IRB review may be requested through the steps outlined in WVC Protection of Human Subjects Procedure 1000.250.

“Research” is defined to mean “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Activities that meet this definition constitute research for purposed of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.” (45 CFR § 46.102). All proposed research activity will be submitted to the IRB for approval, even when it appears that the activity is exempt from human subjects review requirements; the IRB has the sole authority to determine whether a project is exempt from review or may undergo an expedited review procedure as defined in 45 CFR § 46.110.

Experiments or clinical activities conducted in a class setting for the purposes of instruction and student learning are not considered research under this definition; these activities are addressed by WVC Use of Human Subjects in Instructional Activities Policy 300.330.

Requests for research studies to be conducted by entities outside the college without the direct collaboration of WVC faculty (e.g. graduate student research, non-profit organizations, or surveys) will have the purpose of the research reviewed and endorsed by the president’s cabinet before being forwarded to the IRB.

D. SURVEYS

It is the policy of Wenatchee Valley College (WVC) to require a review process for surveys that:

  1. Will be administered on a campus or at a college-operated location or event;
  2. Will recruit WVC students or employees as participants based on their relationship with the college; or
  3. Will be administered outside WVC, either in person or electronically, and will be identified by the name of the college, the WVC logo, or the investigator’s relationship with the college, implying WVC sponsorship.

Proposals for survey projects will be reviewed by the president’s cabinet. A review may be requested through the steps outlined in WVC Surveys Procedure 1000.255.

Survey projects may be considered “research” and are required to go through the IRB review process outlined in WVC Protection of Human Subjects Procedure 1000.250 if:

  1. There is interaction (individual interpersonal contact) between the investigator and the participant, such as personal interviews;
  2. There is individually identifiable information collected in the survey – the identity of participants may be ascertained by the investigator or is associated with the responses; or
  3. The purpose of the survey is to develop or contribute to generalizable knowledge: for example, the results will test a hypothesis and permit conclusions to be drawn, are planned to be presented in a publication or professional meeting, or will be applied to populations beyond WVC.

Survey activities conducted as a course activity for the purpose of instruction and student learning do not need to undergo review, but should include a statement to participants explaining the purpose. Surveys that solicit feedback to be used within WVC for the purpose of evaluating or improving programs and services, such as course evaluations, alumni surveys, or employer surveys, do not require a review.

Approved by the president’s cabinet: 2/7/12, 8/26/14, 6/4/19
Adopted by the board of trustees: 3/21/12, 9/11/14, 6/19/19
Last reviewed: 5/7/20
Policy contact: Institutional Effectiveness

Related policies and procedures
000.250 Protection of Human Subjects Procedure
300.330 Use of Human Subjects in Instructional Activities Policy
1000.255 Surveys Procedure
1300.330 Use of Human Subjects in Instructional Activities Procedure

1000.250 PROTECTION OF HUMAN SUBJECTS PROCEDURE

A. PURPOSE

The purpose of this procedure is to ensure that the rights of human subjects in research are appropriately protected and that Wenatchee Valley College and its authorized representatives are in compliance with applicable regulations for the protection of human subjects, including Title 45 of the Code of Federal Regulations, Part 46 and RCW 42.48.020.

B. INSTITUTIONAL REVIEW BOARD MEMBERSHIP

The membership of the institutional review board (IRB) shall include college faculty and staff with relevant experience and training and at least one external member as defined in 45 CFR § 46.102. Board members must have completed DHHS compliant human subjects review training in the past two years to serve on the IRB.

C. REVIEW PROCESS

The researcher or investigator responsible for the research study shall contact the IRB prior to initiating any contact with students or employees that are intended as research subjects. The contact person shall be the WVC Executive Director of Institutional Effectiveness. The researcher or investigator will provide, in writing, the following information:

  1. A complete, signed IRB request for review and approval form (available on the HR webpage).
  2. A brief statement describing the intent/purpose of the research project and the question under investigation.
  3. A description of the intended participants in the research (employees; students; specific programs or courses, etc.).
  4. A copy of the informed consent information to be provided to participants.
  5. A copy of any advertisements or recruiting materials and/or a description of participation incentives to be offered (if any).
  6. A statement describing how confidentiality of data will be maintained, if personal information is to be collected. Statement should include a description of measures to be taken to protect anonymity of response for non-personal information to be collected.
  7. A copy of the instrument/s to be used, or a summary of the research procedures as experienced by the participants.
  8. If the researcher or investigator is a WVC faculty or staff member, a statement of support from the appropriate administrator/supervisor. If a WVC student, a statement of support from the supervising faculty member. Faculty/staff statements should address workload and/or release time if applicable.
  9. Evidence that the principal researcher(s) or investigator(s) have completed training in the protection of human research participants that addresses principles of ethical research and federal regulations.

D. REQUEST FOR EXEMPTION

Some research with human subjects is exempt from the requirements of this procedure if it meets the following criteria (taken from the Code of Federal Regulations, 45 CFR § 46.101).

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
    1. Research on regular and special education instructional strategies, or
    2. 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:
    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 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 researcher or investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

If the researcher or investigator believes that the project meets one of the above criteria for exemption, this must be indicated in the space provided on the IRB request for review and approval form. The IRB will make a final determination of eligibility for exemption; research may not proceed until verification of the exemption is received by the researcher or investigator from the IRB.

E. IRB DEFERMENT TO PRIOR REVIEW

A researcher or investigator may ask WVC’s IRB to defer to the ruling of a prior Institutional Review Board of another institution. That institution’s IRB must meet WVC’s standards for review and be compliant with federal and state regulations on human subjects’ research and review. The researcher or investigator will indicate a request for deferment on their request for review form (available on the HR website) and provide all documents related to the prior institution’s IRB’s actions. If WVC’s IRB grants deferment, it may later choose to withdraw this different at any time.

F. IRB DECISIONS

The IRB will review all requests and will contact the investigator with a decision to approve the project; approve with modifications or restrictions; grant an exemption from review; defer to a prior IRB of another institution, table the request pending receipt of additional information; or disapprove. To ensure adequate time for review, requests should be submitted with complete documentation at least six weeks prior to the intended start of the research.

Approved by the president’s cabinet: 2/7/12, 1/7/14, 6/4/2019
Presented by the board of trustees: 2/15/12, 2/26/14, 6/16/2019
Last reviewed: 5/7/20
Procedure contact: Institutional Effectiveness

Related policies and procedures
000.250 Protection of Human Subjects Policy
300.330 Use of Human Subjects in Instructional Activities Policy
1000.255 Surveys Procedure
1300.330 Use of Human Subjects in Instructional Activities Procedure