Policies

Click here to download the following Human Participant Research Procedure 1.13.


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 Executive Director for Institutional Advancement 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 as established by the Department of Health and Human Services (CFR Title 45, Part 46).

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

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.

B. Human Subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information.

C. 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.

D. 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.

E. *Vulnerable populations include children, prisoners, pregnant women, or people with intellectual disability.

*People with intellectual disability are not officially considered a vulnerable population in the current code of federal regulations as there is no subpart devoted to this group. They are included here as their inclusion appears to be consistent with the spirit of the regulations.

Be sure to refer to the current code of federal regulations for information concerning vulnerable populations.

 

PROCEDURE:

I. IRB Configuration

The IRB shall have at least five members, including one from the community with no official affiliation with the college; one from the sciences and one from the non-sciences. As outlined in Part 46 of Title 45 of the Code of Federal Regulations that regulates the Protection of Human Subjects, "the IRB shall be sufficiently qualified, through the experience, expertise, and diversity of the members, to promote respect for its advice and counsel in safeguarding the rights and welfare of human participants. The composition of the IRB should reflect the college’s commitment to diversity." Both males and females must be members.

II. IRB Meetings

Meetings of the IRB will be held as needed. Meeting notices will be distributed by the Executive 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 Executive Director shall be responsible for recording minutes of all IRB meetings.

III. Application for IRB Review

The Executive Director 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 proposals require only notification if confirmed as exempt rather than a full review (see below for criteria for exempt status). Expedited reviews are for proposals that involve no more than minimal risk to the participants (see definition of minimal risk). Both exempt and expedited reviews will be conducted by the IRB chairperson or a designee. The IRB member(s) conducting the exempt or expedited review may approve a research project; however, the reviewer(s) may not disapprove the research. Instead, the reviewer(s) will refer any research protocol which the reviewer(s) would have disapproved to the full committee for review.

V. Criteria for Exempt Status

The following list outlines the criteria for a project to be considered exempt. Exempt does not mean that the project need not be considered by the IRB. Researchers may indicate that they consider their proposal to be exempt; however, the final determination is made by the IRB.

As established by the CFR Title 45, Part 46, Subpart A, the criteria for exempt status are:

A. 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.

B. 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 participants can be identified, directly or through identifiers linked to the participants; and
  2. Any disclosure of the human participants’ responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.

C. 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 (b)(2) of this section, if:

  1. The human participants are elected or appointed public officials or candidates for public office; or
  2. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

D. 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 participants cannot be identified, directly or through identifiers linked to the participants.

E. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:

  1. Public benefit or service programs,
  2. Procedures for obtaining benefits or services under those programs,
  3. Possible changes in or alternatives to those programs or procedures, or
  4. Possible changes in methods or levels of payment for benefits or services under those programs.

F. Taste and food quality evaluation and consumer acceptance studies,

  1. If wholesome foods without additives are consumed or
  2. 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.

VI. IRB Decisions

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

A. Exempt from full review

B. Approve

C. Approve, subject to requested changes/restrictions

D. Disapprove

E. Suspend or terminate (for proposed continuation studies)

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

VII. 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).

VIII. 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.

IX. 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.

X. 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.

Based on the information provided in the progress report, the IRB chairperson will determine whether it is eligible for expedited review or whether it must be reviewed by the full committee. Continuing reviews may be expedited if the research initially was:

  • Approved by expedited review and no changes in risks have occurred.
  • Approved by the full IRB committee but the research is now closed to enrollment of new participants, all participants have completed all research-related interventions, the research remains active only for long-term follow-up of participants, and no changes in risks have occurred.
  • Approved by the full IRB committee but now the remaining research activities are limited to data analysis.
  • The IRB will notify the principal investigator that the research protocol is due to expire at least 30 days prior to the expiration date. It is the responsibility of the principal investigator to ensure that the research protocol does not expire.
  • 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.

XI. 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 (as described by OHRP; see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.115);
  • 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 researchers;
  • List of IRB members, including their degrees, area they represent, relevant experience, and association with the college;
  • IRB procedures and forms, and
  • Evidence of training completion by IRB members and researchers.

XII. 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 them.
  • 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.

XIII. 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.

XIV. 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 evidence.
  • The institution has the burden of proof for making a finding of research misconduct.
  • The respondent has the burden of proving any and all affirmative defenses raised.
  • 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.