Research Involving Human Participants

Research Involving Human Participants

The purpose of this policy and procedure is to assist investigators planning to conduct research involving human participants in designing their research and submitting it for approval. Proposals for participant research must be reviewed if it is conducted by any faculty, staff, students, or any other person under the auspices of Excelsior.

Excelsior Policy

I. In accordance with state and federal regulations and professional standards of ethical conduct, it is the responsibility of Excelsior to reasonably ensure that, in research conducted under its auspices, the rights and welfare of human participants are adequately protected. The primary responsibility for protecting human participants, however, rests with each individual who initiates, directs or engages in research. II. In order for Excelsior to fulfill its responsibility, it has established an Institutional Review Board (IRB). The IRB is authorized to review and approve all research proposals involving research participants conducted under the auspices of Excelsior, regardless of the source of funding.
A. “Participants Research" is defined as a systematic investigation designed to develop or contribute to generalizable knowledge, which involves the collection of data from or about living human beings. It does not include research using published or publicly available documents or research on elected or appointed public officials or candidates for public office. B. The members of the IRB are appointed to a three-year term by the provost and chief academic officer. In addition to other requirements of state and federal regulations, the membership of the IRB shall be composed of individuals of varying backgrounds who are qualified through experience, expertise and the diversity of the members' racial and cultural backgrounds to assure complete and adequate review of activities commonly conducted under Excelsior's auspices, and to ensure respect for its advice and counsel for safeguarding the rights and welfare of human participants. The IRB shall possess the professional competence necessary to ascertain the acceptability of proposals in terms of institutional commitment and regulations, applicable law, standards of professional conduct and practice, and community attitudes. C. The determination regarding whether a given activity should be considered human participants research will be made by the IRB or its designee. D. Certain categories of research involving little or no risk to participants do not need to be reviewed and approved by the full IRB and are eligible for less intensive review procedures. E. The IRB shall develop and promulgate appropriate categories of research and determine the review procedures for each category. F. The IRB shall apply additional criteria during the review of research involving Excelsior prospective and enrolled students, faculty, staff or alumni.

Procedures

Planning a Research Project When an investigator plans to conduct research involving human participants, they are advised to contact the chair of the IRB (or a designee) who also functions as the research participants research officer as early as possible. Email them at IRB@excelsior.edu. Aspects of a project which may be problematic can be discussed and alternative procedures suggested. At this point, the research often can be designed in a way which will facilitate approval. The Principal Investigator (PI) must participate in a Protecting research participants training session that is approved by the Health and Human Services/NIH. The PI must submit a certificate of completion that is not over 3 years old. Determining Research Participants Involvement The initial determination as to whether a research project should be considered participant research should be made by the investigator. They should consult the IRB chair (or designee) for advice on this question. Final authority for making this determination rests with the IRB or its designee. In general, research proposals which involve data gathered solely for internal use (e.g., program evaluation or institutional research) would not need to be reviewed. If, however, the results of this research will be disseminated to audiences external to Excelsior, then the research proposal must receive prior approval. If no dissemination is planned at the time the data are gathered, but the possibility of future dissemination exists, the project director is strongly advised to submit the project proposal for approval prior to initiating the research. In the event the project director determines, after the study is completed, that it will be published, the completed project should be submitted via the IRB application/review process prior to any external dissemination in the same manner as an initial research proposal would be submitted. Project Categories Once it has been determined that an activity is to be considered participant research, it will be reviewed under one of four categories. Each researcher should make the initial determination regarding the appropriate category of review, although the IRB or its designee may require review under another category. The researcher can always request a higher level of review than that required. There are four types of IRB reviews: Exempt, Exempt Limited, Expedited, and Full, all of which require submission of an application. While the researcher is expected to identify the level of requested review, the IRB makes the final determination of review category. A brief description of each review type is given below.
  • Exempt Status - Human participants research activities subject to the IRB may be granted exempt status meaning they pose no more than minimal risk and are defined as exempt by federal regulation 45 CFR 46. This status signifies that the research activity is not monitored by the IRB codes of professional conduct.
  • Exempt Limited- A limited IRB review is a type of expedited review process required in the Revised Common Rule (January, 2019). Its purpose is to ensure confidentiality protections are in place with exempt research that involves the collection or use of sensitive, identifiable data.
  • Expedited - Excelsior University’s IRB may use the expedited review procedure to review the following:
    • Anonymous mail surveys on innocuous topics,
    • Anonymous, noninteractive, nonparticipating observation of public behavior,
    • Secondary analysis of existing data,
    • Educational research involving no interaction with students; e.g., passive observance of regular advising activity or test-taking activity,
    • Research involving the use of educational records if information taken from these sources is provided to the researcher in such a manner that participants cannot be identified,
    • Research on individual or group behavior of adults where there is no psychological intervention, or physiological intervention or deception,
    • Interviews and surveys on non-sensitive topics where confidentiality is assured.
  • Full - Research that does not qualify for exempt or expedited levels of review must undergo a full IRB review. Research activities that may require a full review include:
    • Research which might put participants at risk,
    • Research involving psychological or physiological intervention,
    • Noncurricular, interactive research in schools, test sites, hospitals,
    • Research involving deception,
    • Interviews or surveys on sensitive topics,
    • Research on persons who are under age 18, are in prison, or have mental and/or emotional disabilities,
    • Research conducted outside the United States, regardless of the procedures involved.
Review Forms The IRB has developed a unified Human Participants Research Review Form (application form) which is used in submitting proposals in all project categories. The form is designed so that only the information required for the appropriate project category need be included in the proposal. Review Procedures Expedited Review The review may be carried out by an IRB Co-Chair or by one or more experienced reviewers designated by a Co-Chair from among members of the IRB. The designees may approve the project, request additional information, or submit the proposal to the IRB for full review and approval. The investigator is notified in advance of this review. If the investigator questions any determination made under expedited review, they have the option of requesting a full review by the IRB, which will make the final determination. Full review The review is generally conducted at the next convened meeting of the IRB. The IRB meets on an as-needed basis. Investigators are welcome to attend the meeting and answer questions or provide additional information regarding their projects. Conditions of Approval Approval of a project by the IRB applies only to the procedures submitted in the proposal. The investigator must secure prior approval from the IRB for any changes in the procedures that will affect the use of research participants. The investigator must also report to the IRB any problems that arise in connection with the use of research participants. Approval for projects is valid for one year only. Investigators must request a continuation for the approval yearly if the activity lasts more than one year. Only two continuations will be granted for a given project. The criteria for approval by the IRB are the following:
  • The application is complete (including a brief description of the research study) and all required supporting documentation is provided.
  • Recent training certification for every investigator is submitted.
  • Potential risks to participants are identified.
  • Appropriate steps are identified to protect the privacy and confidentiality of research participants.
  • Description of the informed consent language/document to be provided to research participants.
The determination regarding whether a given activity should be considered human participants research will be made by the IRB or its designee. The principal investigator (PI) and Co-PIs listed on an IRB application must have successfully completed a training session that is conducted or approved by the Health and Human Services/NIH. The PI must submit a certificate of completion of training that is not over three years old. Survey Research All surveys which are designed to be sent as a link or document through an e-mail invitation to Excelsior employees, staff and/or students must be distributed by Analytics and Decision Support (ADS). No e-mail addresses of these individuals will be shared with the researchers by Excelsior. Once a research project has received IRB approval, the investigator must contact ADS to discuss scheduling the distribution of their survey instrument in accordance with Excelsior’s Policy on Survey Administration. This email to ADS should be sent to surveyresearch@excelsior.edu with: (1) a copy of the IRB approval letter (2) a copy of the survey or a link to the survey site (3) a detailed description of the in intended audience, for example “please distribute this survey all ADN Nursing students” (4) the anticipated time range (5) The invitation to participate, informed consent letter signed by the PI Researchers must familiarize themselves with the Policy on Survey Administration. In addition, all surveys approved to be distributed to Excelsior employees, staff, and/or students must include the following paragraph in the invitation to participate/informed consent letter: As part of its mission, Excelsior supports educational research. The attached survey has been approved by Excelsior’s Institutional Review Board (IRB) for distribution to potential participants (i.e., faculty, staff and/or students). Any participation on your part is completely voluntary. Student Research: Supervisory Responsibilities All student investigators must have a supervisor (e.g., faculty, staff) who is responsible for ensuring that all procedures of the approval process are complied with by the investigator. The supervisor must sign the proposal certifying that the project is under their supervision. In addition, supervisors must complete the online training once every four years and provide a copy of their certificate of completion to the IRB. The IRB expects supervisors to monitor the student's progress with the research, assist the student in notifying the IRB of changes needed to the research study, and facilitate a renewal request if the student’s research exceeds one year from the approval date. Informed Consent "Informed consent" means the knowing consent of an individual, or their legally authorized representative, who is able to exercise free power of choice without undue inducement or any form of force, fraud, deceit, duress or other form of constraint or coercion. An investigator shall seek consent only under the following circumstances:
  1. Sufficient opportunity is provided to the prospective participant or her/his representative, to consider whether or not to participate;
  2. The possibility of coercion or undue influence is minimized;
  3. The information that is given to the prospective subject, or her/his representative, shall be in language understandable to the participant or representative; and
  4. The participant, or their representative, cannot be made to waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or its agents from liability for negligence.
The federal regulations detail the following basic elements of information necessary to such consent:
  1. A statement that the study involves research, an explanation of the purpose of the research and the expected duration of the participant's participation and a description of the procedures to be followed;
  2. A description of any foreseeable risks or discomforts to the participant;
  3. A description of any benefits to the participant or to others which may be reasonably expected from the research;
  4. A statement describing the extent to which confidentiality of records identifying the participant will be maintained;
  5. An explanation of whom to contact for answers to pertinent questions about the research and research participants' rights and whom to contact in the event of a research-related injury; and
  6. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which that participant is otherwise entitled and the participant may discontinue participation at any time.
For research involving more than minimal risk, it is required to include an explanation that Excelsior does not have a formal plan or program to provide medical treatment or compensation for any injury which occurs as a result of the participant's participation (the participant should also be informed that this does not waive any of their legal rights). When appropriate, one or more of the following elements of information shall also be provided to each participant:
  1. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
  2. An identification of any procedures which are experimental;
  3. A statement that the research may involve risks to the participant which are currently unforeseeable;
  4. Anticipated circumstances under which the participant's participation may be terminated without regard to the participant's consent;
  5. Any additional costs to the participant that may result from participation;
  6. The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant;
  7. A statement that significant new findings developed during the course of the research which may relate to the participant's willingness to participate will be provided to the participant; and
  8. The approximate number of participants involved in the study.
In projects where participants are determined to be at risk, the actual procedure utilized in obtaining "legally effective informed consent" must be fully documented. This is accomplished by using a written consent form embodying all of the elements of information required for the project. The consent form must be read by the participant or their legally authorized representative and signed by the person giving consent. A copy of the consent form must be given to the person signing the form and the signed form must be maintained in the investigator's files for an indefinite period of time following completion of the study. The Institutional Review Board has designated a SAMPLE form that can be used as a guide in preparing the consent form that will actually be used in the research project or activity. PLEASE NOTE that the final form that you administer must first be approved by the IRB before it can be legally administered. In rare cases, where these procedures will surely invalidate important objectives of the project, IRB approval of modified procedures may be sought. In projects where risk to participants has been determined to be no more than minimal, provision may be made for oral or written presentation and consent. Under this procedure, the participant is informed of those basic elements of consent which are applicable to low risk procedures and no signed document is necessary on the part of the participant. However, a sample copy of the presentation must be approved by the Board. A major exception to this policy occurs when research involves persons under the age of 18 as participants, in which case, written consent from a parent or a guardian is usually required. In some cases, the IRB may approve a consent procedure which does not include, or which alters some or all of the elements of informed consent or may entirely waive the requirement to obtain informed consent. How to Apply for a Project Review
  • Complete the Application for Project Review and, if participants are at risk, the Research Participant Agreement. These documents can also be found on the IRB webpage.
  • Researchers requesting an expedited review do not need to submit the Research Participant Agreement page of this application. All other researchers must include these pages in their application. (Note: communication to participants must include information stating that participation in the study is voluntary; the exemption from supplying the Research Participant Agreement relates only to the application process.)
  • The IRB Handbook which can also be located on the IRB SharePoint site or the IRB webpage, provides detailed information on project submission and review.
  • All communications to the IRB Committee should be sent through the IRB official e-mail: IRB@excelsior.edu. These messages will be answered in a timely manner.