Chapter 1 - Section 13 - Human Participant Research Policy

Policy

In compliance with federal policies and regulations, Renton Technical College requires the review of research linked to the College in order to protect the human participant involved. To ensure that researchers conduct their research ethically with the benefits outweighing any risks to participants, researchers must submit research proposals and supporting documentation to an Institutional Review Board (IRB) prior to initiating research.

This policy applies to both:

• Those affiliated with the College, including faculty, staff and students, who plan to conduct a research project involving human participants; and
• Those not affiliated with the college, but seeking to conduct research that involves faculty, staff and students or records of the college.

To enact this policy, the college will establish and maintain an IRB under the chairmanship of the Director for Institutional Research & Effectiveness or a designee who will oversee the application and review process.

The purpose of the IRB is to review all proposed research involving human participants to ensure their rights and welfare are protected and that participants are treated ethically. It will determine whether research proposals are exempt from review, have minimal risk to allow for an expedited review or involve vulnerable populations or more than minimal risk requiring a full review (see definitions and procedures for guidelines). RTC takes seriously the responsibility of safeguarding individuals who may participate in research projects and strives to act in compliance with federal guidelines for research involving human participants. RTC IRB follows the established guidelines provided by the Department of Health and Human Services, CFR Title 45, Part 46.

1. Definitions (CFR Title 45, Part 46, Subpart A):

Research means 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 purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

• Systematic investigation means a detailed or careful examination that has or involves a prospectively identified approach to the activity based on a system, method, or plan.

• Generalizable knowledge means the information is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:

Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied

Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study

1. Human Subject means a living individual about whom an investigator (whether professional or student) conducting research:
   • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
   • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable
2. IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
3. Minimal risk means that 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.
4. Vulnerable subjects are individuals who have difficulty providing voluntary, informed consent arising from limitations in decision-making capacity, situational circumstances, or because they are especially at risk for exploitation.
   • Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
   • Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
   • Additional Protections for Children Involved as Subjects in Research

Procedure

I. IRB Configuration

The IRB will consist of members as outlined in CFR Title 45, Part 46, Sec. 46.107.

There must be at least five (5) members of the IRB. These individuals must represent various backgrounds to promote complete and adequate review of research activities commonly conducted by the institution, and ensure research protocols are reviewed by individuals with different perspectives.

The following, at a minimum must be included on the IRB:

1. A scientist
2. A non-scientist
3. An individual not associated with the research institution

II. IRB Meetings

Meetings to review IRB applications will be scheduled as needed by the Director at least seven (7) days in advance of a meeting.

To have quorum, a majority of the IRB members, including at least one member whose primary concerns are in nonscientific areas, must participate in all decisions and actions of the committee, except in the case of an exempt or expedited review procedure. Each member has one vote. No proxy voting is allowed, though participation of a designated alternate member may vote. Members who have a conflict of interest may not vote or be present for deliberations.

The Director shall designate an individual responsible for recording minutes of all IRB meetings.

III. Application for IRB Review

The Director or designee will serve as the first and primary point of contact for all inquiries and submissions related to the IRB. Investigators seeking to conduct research on the RTC campus, or involving RTC employees or students, are required to review RTC IRB guidelines, procedures and frequently asked questions available on the RTC website to determine whether an IRB review is necessary.

Investigators are required to submit the appropriate applications to the IRB one month prior to the anticipated start date of the research project. The IRB must take action within thirty days of application submission.

IV. Types of Review

There are three types of review of research proposals, based on an evaluation of the risks and benefits of the study and protection of participant confidentiality.

• Exempt Review – There are certain situations where research with human subjects is exempt from following the regulations at 45 CFR 46 and some IRB policies and This subset of human research must be minimal risk to research subjects and fall into one or more of the following categories:
  • Educational Exemptions
  • Public Benefit/Service Program Research
  • Taste or Food Quality Evaluation and Consumer Acceptance
  • Storage or Maintenance of Identifiable Data/Biospecimens Obtained with Broad Consent
  • Benign Behavioral Interventions
  • Surveys, Interviews, Educational Tests, and Observation of Public Behavior
• Expedited Review – Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB.
  • In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the proposed research.
  • A proposed research activity may be disapproved only after being reviewed at convened meetings at which a majority of the members of the IRB are present.
  • For research studies to meet the expedited review process, they must pose minimal risk to the research subject.
• Full Review – Federal regulations require a full IRB review to be conducted if a research study involves more than minimal Studies referred by a subcommittee, an expedited reviewer or the IRB Chair are subject to a review by the full IRB committee. A full review is also required in the following instances, regardless of the level of risk:
  • Research studies involving vulnerable populations, especially those who are
  • Research studies involving sensitive topics such as illegal behavior, which may also require a National Institutes of Health (NIH) Certificate of Confidentiality (COC). A COC protects the individuals’ information from full disclosure.
  • A research study that is so complex that it requires the expertise of several members of the IRB.

Summary of reviews conducted by an IRB.

Review Type	Risk	Description
Exempt	Minimal risk (often anonymous or deidentified data)	Briefer application and typically reviewed in the IRB office
Expedited	Minimal risk (identifiable, personal or sensitive information)	Reviewed in the office by one or more IRB members. If expedited reviewer does not approve, the study may go to the full board
Full Review	Greater than minimal risk (could include minimal risk research that does not fit in exempt or expedited review categories)	All studies involving prisoners and certain research with vulnerable populations regardless of risk such as children, fetuses, and neonates. Projects can only be disapproved at a convened meeting.

V. IRB Decisions

The IRB may take one of five actions, in writing, in regard to proposed human subject research:

1. Exempt from full review
2. Approve
3. Approve, subject to requested changes/restrictions
4. Disapprove
5. Suspend or terminate (for proposed continuation studies)

Investigators may not solicit participants or begin data collection until they have received IRB approval.

VI. IRB Approval of Research

IRB approval of research will be based on a determination that the potential risks to human participants are minimal and "reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result" (CFR Title 45, Part 46.111, Subpart a2).

Selection of participants must be equitable, and oral or written informed consent must be obtained from each subject or the subject's legally authorized representative. In addition, there must be "adequate provisions to protect the privacy of participants and to maintain the confidentiality of data" (CFR Title 45, Part 46.111, Subpart a7).

VII. IRB Requirement for Modification of Research

The IRB may require modifications, major or minor, to some part of the proposed study. Major modifications may be required when the IRB believes that it has insufficient information to take action, or when it believes that the research design contains significant risks to human participants and should be revised to minimize the risks. Examples of minor modifications that might be required include revising the consent form to explain the procedures more clearly or adding a version of a consent form in a language other than English.

VIII. Appeals

If an application is denied, the researcher has a right to appeal to the IRB. The researcher should submit a letter to the IRB chairperson requesting another review, and a rationale should be provided. An attempt will be made to resolve the problem(s) identified with the proposal. The IRB is the final authority over whether the proposal is approved.

IX. Continuing Review

The IRB will review ongoing research projects at least once per year. Requirements for continuing review will be provided to the principal investigator in the IRB approval letter.

The principal investigator is responsible for submitting a progress report (Application for Continuing Review) and updated informed consent form(s) (when applicable) to the IRB for review and approval. Most research studies require only annual review, but some studies (e.g. those with higher risks) may require more frequent review. The required frequency of review will be determined by the IRB and will be stated in the IRB approval letter.

The IRB will apply the same criteria for approval of continuing review applications (progress reports) as it does for initial applications. The progress report should include the following information: adverse event information, subject complaints, any changes in the protocol, a description of findings of the study, and any presentations or publications of study findings. Any additional information concerning the state of knowledge about the study question (particularly other information that might change the assessment of risks versus benefits) should be presented as part of the progress report.

The continuation of research after expiration of IRB approval is a violation of the federal regulations. If the IRB has not received and approved continuation of a research study by the study's current expiration date, all study related activities must cease (including enrollment, study interventions, long-term follow-up and data analysis). An email notification of the study expiration will be sent to the principal investigator by the IRB.

X. Record Keeping

IRB records must be maintained and easily accessible for at least 3 years after the research is completed. These records include:

• Research proposals, sample consent documents, updates from the researchers, and documentation of unanticipated problems.
• Minutes of IRB meetings that document who attended; a record of voting; rationale for accepting, rejecting, or requiring changes to research proposals; and, where there is conflict among the IRB members, a summary of the issue and its resolution.
• Copies of communication, including email, between the IRB and
• List of IRB members, including their degrees, area they represent, relevant experience, and association with the college.
• IRB procedures and
• Evidence of training completion by IRB members and researchers.

XI. Research Misconduct

If there is any suspicion of research misconduct, the Chair of the IRB should be contacted to determine whether an investigation is needed. The Federal Policy on Research Misconduct is as follows:

Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

• Fabrication is making up data or results and recording or reporting
• Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
• Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.

Research misconduct does not include honest error or differences in opinion.

XII. Findings of Research Misconduct

A finding of research misconduct requires that all of the following be met:

• There must be a significant departure from accepted practices of the relevant research community,
• The misconduct must be committed intentionally, or knowingly, or recklessly, and
• The allegation must be proven by a preponderance of evidence.

XIII. Evidence of Research Misconduct

Allegations of research misconduct will be responded to in compliance with Public Health Service regulation (CFR Title 42, Part 93).

• An institutional finding of research misconduct must be proven by a preponderance of
• The institution has the burden of proof for making a finding of research
• The respondent has the burden of proving any and all affirmative defenses
• The respondent has the burden of proving any mitigating factors that are relevant to the decision to impose administrative actions following a research misconduct proceeding.

XIV. Registration of Institutional Review Boards

The Director of Institutional Research & Effectiveness will be responsible for registering and renewing RTC's IRB with the Department of Health and Human Services, as per the guidelines outlined in CFR Title 45, Part  46, Subpart E.