3655P Use of Human Participants in Research Activities (Procedures)
Original Date: 4/21/2009 * Last Revision Effective: 9/11/2012
Policy Contact: Vice President, Administrative Services
The following procedures are established to meet the requirements for implementing policy #3655 – Use of Human Participants In Research Activities.
All research requests meeting the conditions outlined in the Appendix A titled Research Guidelines on Human Subjects must be reviewed by the institutional review board (IRB) or its designee. This procedure is intended to ensure that college staff and students who may be affected by the research can be certain that the research is sound and does not violate college policy, or federal regulations concerning protection of human participants.
Research investigators shall make an initial determination whether the research will involve human subjects as defined in 45 CFR 46.102 (f). If it is not clear whether research involves human subjects as defined in 45 CFR 46, research investigators will seek assistance from the IRB in making this determination. It is the responsibility of researchers to refer their projects to the IRB whenever human subjects are used in research, even if they do not think that the subjects are at a high risk level. Federal legislation places the burden of liability for negligence and harm directly on the researcher and the college. Although the college is exempt under federal law for most classroom activities, should the faculty member share the information with entities outside of the college such as a conference or intends to publish the results, the proposed research must be reviewed by the IRB.
As required by federal regulation (45 CFR 46) Bellevue College has an institutional review board (IRB) consisting of at least five (5) members with varying backgrounds to promote complete an adequate review of research activities commonly conducted by the college. One (1) of the five (5) members has no connections to the college community. The IRB is composed of the vice president of administrative services or his/her designee, one administrator, two faculty members, and one person from outside Bellevue College. Additional faculty or staff members may serve in an advisory capacity where appropriate. The college’s institutional review board meets as needed to review research by members of the institution. At the initiation of any new grant project, the designated grant personnel will submit the project for review by the IRB to assure compliance with this policy.
Types of Review
There are two types of review conducted by the IRB. The first one only requires review by one member of the board, preferably its chairperson. In all instances the appropriate review must be conducted if there is any possibility that the information will be shared with entities outside of the college such as at a conference or published in a journal that is either in print or in an electronic format. The IRB review process must also be followed if the agency funding the sponsored project requests a copy of the college’s human subject research policies and procedures. An expedited review will be conducted by the IRB chairperson or by one or more of the experienced IRB members so designated by the chairperson to conduct the review.
Type I reviews are those that involve research using human subjects who are not students in the class and do not:
- involve students of a special population such as children, pregnant women, prisoners, mentally challenged persons, economically or educationally challenged persons
- involve sensitive topics such as sex education
- involve deception
- involve more than minimal risk to subjects.
Research that involves human subjects as part of a Type I review must maintain an adequate standard of informed consent as well as confidential data. Any information that is gathered on the subjects must be safeguarded so as insure that the data cannot be linked either directly or indirectly to the subject. If the results of the project are to be presented outside the college, e.g. in a conference, the project must undergo a Type I review.
Type II reviews research that involves special populations, sensitive behavioral research, research involving deception, or research that has the potential to harm the subjects. A Type II review requires a meeting involving a quorum of the IRB members. Federal regulations require that Bellevue College IRB give special consideration to protecting the welfare of special populations, such as children, prisoners, pregnant women, mentally challenged persons, and economically or educationally disadvantaged persons.
Student research requires instructors to be responsible for screening student research projects and determining if they require IRB approval. If the project is assigned for the purpose of producing generalized results that may be presented outside of the class, be published, or has the potential to put the participant’s at risk, the researcher must comply with these policies. Submission of an application to the IRB prior to starting the research is required. It is important to note that not all classroom research assignments require IRB approval. Only those assignments that will be presented outside of the college need such approval.
Cooperative research with another institution – There may be times when the college engages in cooperative research with another institution. In such circumstances, one institution may agree to delegate responsibility for initial and continuing review of all or portion of the research activity to the other institution’s IRB. For any portion of the research that the college’s researchers do not delegate to another IRB, the researchers remain responsible to complying with Bellevue College’s policies and procedures. Any research conducted on any of this college’s campuses must be reviewed by the college’s IRB. The agreement with another institution must be in writing with copies provided to all parties involved in the agreement and to those responsible for ensuring compliance with the IRB policies and procedures. If Bellevue College receives IRB approval from another institution it must provide a copy of the approval letter to its IRB. Irrespective of the agreement, each institution is responsible for safeguarding the right, welfare and confidentiality of the human subjects.
The researcher must file a Bellevue College research proposal form with the vice president of administrative services. After receiving the completed request from the researcher, the institutional review board will verify the following items:
- The research proposal form has been completed, including the researcher’s certification of completion of training for protection of human subjects.
- The appropriate signatures have been obtained by the researcher.
- The proposed research is compatible with Bellevue College’s mission and purpose and is education-related. The research should deal with the teaching/learning environment or with the college’s policies, procedures, or operations.
- The proposal meets the requirements of Protection of Human Subjects (45 CFR 46).
- The results will be disseminated in a fashion which would protect the identity of the participants and, if appropriate, the college. It must be understood that names of individuals will not be used in the study unless the individuals grant permission in writing. The name of Bellevue College will be used only if the institutional review board grants permission.
Criteria for Approval
Individuals requesting authorization to conduct research must complete a Bellevue College research proposal form. Each IRB member will review the proposal independently. Approval of the proposal will be based on the following criteria:
- Compatibility with the college’s mission and purpose.
- Soundness of rationale for conducting the research project.
- Soundness of rationale and appropriateness of the sampling, methodology, instrumentation, and treatment of data.
- Acceptability of the potential effects the collection of data and the dissemination and use of results may have on Bellevue College students, personnel, operations, and the community.
- Evidence of support of other involved individuals or groups internal or external to Bellevue College.
If the IRB has questions regarding the completeness, relevance, or other aspects of the proposed project, an IRB member will contact the requestor to arrange a meeting.
Under certain circumstances, the institutional review board will submit the request to the appropriate vice president or the president for approval. This submission will occur if the project:
- has political or broad community implications for the college,
- involves board policy,
- involves all or a significant portion of the staff,
- involves all or a significant portion of the students, or
- involves established operating procedures and/or board policies.
Timeline and Notification of Approval or Disapproval
Research considered to be “exempt” and/or research that must be expedited will be immediately evaluated by an IRB designee. Other research will be reviewed by the full institutional review board (IRB) for their approval.
Ordinarily the requestor will be contacted concerning the status of the request within ten (10) working days of receipt of the proposal. If possible, approval or denial of the request will be made at that time. If a delay is necessary, an appropriate timeline will be negotiated with the requestor.
If a research request is denied, the notification will include the reason(s) for the denial. A revised proposal, or sections thereof, may be submitted for reconsideration.
The IRB will provide for the maintenance of records relating to a specific research activity for at least three (3) years after termination of the last IRB. In turn, IRB records will be available for inspection and copying by authorized representatives of the federal office of human research protection (OHRP) at reasonable times and in a reasonable manner or the requested records will be copied and forwarded to OHRP when requested by an authorized department of health and human services representative which is the parent agency for OHRP.
The IRB maintains adequate documentation of IRB activities including the following:
- Copies of all research applications reviewed, approved sample consent forms, and reports of any injuries to subjects.
- Minutes of all IRB meetings to include the names of people attending the meetings, actions taken by the IRB, the vote taken on those actions including who voted for the action, who voted against and who abstained from voting. The reasons for any requested change in the project or project disapproval, a written summary of the discussion of issues and their resolutions, and any dissenting reports or opinions. If a member of the IRB has a conflicted interest in the project, the minutes must show that the member did not participate in its review except to provide information requested by the IRB.
- Records of any continuing reviews of project activity.
- Copies of all correspondence between the IRB and the researchers.
- Written procedures for the IRB as required by 45 CFR 46.103 (b) (4).
- Statements of significant new findings provided to subjects as required by 45 CFR 46.116 (b) (5).
- A list of all IRB members as required by 45 CFR 46.103 (b) (3). A list of the IRB members by name, earned degrees, representative capacity, indications of experience such as board certifications, licenses, etc. sufficient to describe each member’s chief anticipated contributions to IRB deliberations, and any employment or other relationship between each member and the institution
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.
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.
Evidence of Research Misconduct
Allegations of research misconduct will be responded to in compliance with Public Health Service regulation (42 CFR 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.
- is defined as a systematic investigation, including research development, testing and evaluation that are designed to develop or contribute to generalizable knowledge. Activities which 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 (45 CFR 46.102 (d)). Human subject is defined as 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 (45 CFR 46.102 (f)).
As noted in 45 CFR 46.101 (b) unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:
(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices such as (i) research on regular and special education instructional strategies, or (ii) 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: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place subjects at the 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 (b) (2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) 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 if the information is recorded by the investigator in such a manner that 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 department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
Revisions 5/21/2009; 9/11/2012
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