POLICIES AND PROCEDURES RELATIVE TO THE CONDUCT OF RESEARCH

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RIVIER UNIVERSITY

Authorization

In accordance with its Federalwide Assurance on file with the Department of Health and Human Services, Rivier University has an Institutional Review Board for Human Participants (IRB). The IRB is a standing committee, appointed by and reporting directly to the Vice President for Academic Affairs.

Membership

The Rivier University IRB shall be comprised of one member from each division, where possible and appropriate, and a member of the external community with relevant research expertise. Members shall be appointed by the Vice President for Academic Affairs for a term of at least one year but no more than three continuous years of service. Terms will be staggered. The chair shall be appointed by the Vice President for Academic Affairs.

Rivier Commitment to Upholding Relevant Federal and Other Regulations Regarding Human Participants

The Rivier University IRB is comprised of a group of faculty charged with reviewing proposed research involving human subjects to ensure the protection and ethical treatment of those individuals in accordance with all applicable laws, policies, ethical guidelines, and national standards governing theresearch, including:

  • The Common Rule (
  • State regulations
  • The Federalwide Assurance
  • Institutional policies
  • Ethical Principles and Guidelines for the Protection of Human Subjects of Research outlined in the Belmont Report (

These principles require the balancing of risks to subjects against the scientific knowledge to be gained and the potential benefits to subjects and society.

The primary mission of the Rivier University IRB is to ensure the protection of rights, privacy and welfare of all human participants in research conducted by Rivier University’s faculty, professional staff, and students. The IRB also focuses on the informed consent process to verify that the participant’s involvement in research is voluntary. The IRB has the authority to review, approve, recommend, modify or disapprove research protocols submitted by faculty, staff and student investigators, where the IRB feels it is necessary to protect and ensure the ethical treatment of human subjects. This does not mean the altering of research methods or method not associated with the protection of human subjects. Without exception, all human participant research conducted by Rivier University investigators, students, and staff, and any others conducting research at Rivier or utilizing Rivier resources, must receive prior approval of Rivier University’s IRB.

Definitions

A "human subject" means a living individual about whom a researcher (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.

“Intervention” includes both physical procedures by which data are gathered and manipulations of the participant or the participant's environment that are performed for research purposes. Intervention includes communication or interpersonal contact betweenthe investigator and participant.

“Private information” includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place,and informationthat has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable (i.e., the identity of the participant is or may readily be ascertained by the investigator or associated with the information) in order to obtainthe information to constituting research involving human participants

“Protected Health Information” (PHI), under the HIPAA Privacy Rule, refers to individually identifiable health information. Individually identifiable health information is that which can be linked to a particular person. Specifically, this information can relate to:

  • The individual's past, present or future physical and mental health or condition,
  • The provision of health care to the individual, or,
  • The past, present, or future payment for the provision of health care to the individual.

Common identifiers of health information include names, social security numbers, addresses, and birth dates.

The HIPAA Security Rule applies to individual identifiable health information in electronic form or electronic protected health information (ePHI). It is intended to protect the confidentiality, integrity, and availability of ePHI when it is stored, maintained, or transmitted.

Faculty and students are often asked to participate in “Survey Research”. Survey research involves responding to a paper or online questionnaire or other survey instrument to gather data for further study. Faculty and students can participate in any survey that has been approved by another institution’s IRB. Faculty who may forward a request for participation in survey research shall confirm that the research has been approved by an IRB and communicate clearly that it is not a Rivier University sponsored research project.

A “pilot study” is a preliminary investigation of the feasibility of a study, usually done on a small scale (approximately 10 or fewer subjects) and exploratory in nature. It is designed to help the investigator refine data collection procedures and instruments or prepare a better, more precise research design. Such a pilot study would be considered an Expedited Level I proposal and requires IRB review at this level. Data collected from a pilot study cannot be used as research data. Medical interventions or interactions for research purposes, especially those involving invasive procedures, do require IRB review regardless of the size of the study.

“Research” in the IRB context is considered to be 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 that are described above.

“Institutional research is research conducted within the University for the purposes of program review, program effectiveness, or provision of services or courses that does not involve human subjects. Institutional research falls under the review of the Vice President for Academic Affairs and not the Institutional Review Board”.

An “Investigator” is the individual(s) designated to have the appropriate level of authority and responsibility to direct the research project and/or activity.

The IRB for Human Participants has the final determination as to what constitutes Research and the use of Human Participants. The IRB for Human Participants makes the final determination as to whether or not activities meet the definition of Research and if the activity needs to be reviewed and/or approved by the IRB for Human Participants. Investigators cannot exempt themselves and their activities from IRB review and approval. The approval by the IRB for Human Participants cannot occur after the data for a research activity has been collected.

Federal regulations require full IRB review of all proposed research involving greater than minimal risk to human subjects. All new proposals, amendments, and continuing reviews that involve minimal risk to subjects may be reviewed using an expedited review procedure,if the study falls under one of theexpedited review categories, as outlined at:

Committee Charge

The IRB shall ensure the protection of human participants as subjects of research at Rivier University. The IRB shall:

(a)Determine what activities constitute research and the use of human participants.

(b) Review, approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy prior to the commencement of the research.

(c) Require that information given to participants as part of informed consent is in accordance with appropriate law, regulations, and international standards. The IRB may require that additional information be given to the participants when, in the IRB's judgment, the information would meaningfully add to the protection of the rights and welfare of participants.

(d) Require documentation of informed consent or waive documentation in accordance with federal (45 CFR 46.116, the Common Rule), state laws, and other regulations. When research activities are being proposed to be conducted in other states and/or countries by Rivier University faculty, staff, and/or students, the research activities will be approved in compliance with the regulations for those specific research locations.

(e) Notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

(f) Conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and have authority to observe or have a third party observe the consent process and the research.

(g) Suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants. Any suspension or termination of approval shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator, the office of the VPAA, the department head, and Dean.

Procedures

Any outside investigator seeking on-campus study, and any student, faculty or staff of Rivier University who is planning to conduct research involving human subjects must submit an Application for Research Review to the Rivier University Institutional Review Board. A complete Application will consist of the following:

  1. a cover letter introducing the investigator, the title of the proposal, and the type of review requested;
  2. a completed form entitled “Assurance of the Principal Investigator;”
  3. a certificate of completion from The NIH “Protecting Human Research Participants” training course. The training is accessed through the following link: Instructions for NIH: Enter the site. Create a user name and password. Complete the Protecting Human Research Participants modules and print a copy of your training certificate. NIH does not offer a refresher course at this time.
  4. a “Research Review Notification” form bearing the investigator’s name and mailing address;
  5. copies of the complete research proposal (in APA format with page number) as required by the type of review requested (See below);
  6. a plan for periodic review and update for any proposal anticipated to extend one year or longer in duration.

Note: In the event a research project extends beyond one year for unanticipated reasons, resubmission to the Institutional Review Board is required.

Upon completing the requested type of review, the reviewer(s) may do one of several things:

  1. approve the proposal as submitted, forwarding the application to the Chair for notification to the principal investigator and/or faculty advisor;
  1. approve the proposal on the condition that it be revised according to recommended changes, in which case the application is returned to the principal investigator and/or faculty advisor for revision. A clean copy of the revised proposal must then be resubmitted to the Board. Data collection from human subjects may not begin until the investigator is notified by the Chair that the revised proposal has been approved.
  1. if the reviewer(s) conclude upon reading the application that the type of review requested is not appropriate for the proposed research the application may be returned to the investigator, with the suggestion that it be resubmitted in the correct category.
  1. the reviewer(s) may reject the proposal, stating the objections to the research based on inadequate protection of human subjects. The application for Research Review and reviewer evaluation will be forwarded to the Chair, who will notify the investigator of the Board’s decision. The application will be kept on file, along with a copy of the reviewer evaluation. A revised proposal may be resubmitted to the Board.

Expedited-Level I

Research in which the only involvement of human subjects is in one or more of the following categories:

  • Research conducted in established or commonly accepted educational settings, involving normal educational practices.
  • Research involving the use of educational tests (diagnostic, achievement), if information taken from these sources is recorded in such a way that the identity of subjects is not divulged.
  • Research involving survey or interview procedures, except where all of the following conditions are met:

a. responses are recorded in such a way that human subjects can be identified;

b. the subject’s responses, if they became known, could place the subject at risk of criminal or civil liability or financial loss;

c. the research deals with sensitive aspects of the subject’s own behavior, such as illegal conduct, sexual behavior, or use of alcohol or other chemical/controlled substance.

This level of review is not applicable when subjects are minors. All survey research is eligible for Expedited –Level I when subjects are elected or appointed officials, or are candidates for public office.

  • Research involving the observation of public behavior, except when all of the three conditions described above exist.
  • Research involving the collection or study of existing data, documents, records, pathological specimens, if the sources are publicly available or if the information is recorded such that the subject cannot be identified.
  • Unless specifically required by statute, research and demonstration projects that are conducted or approved by the U.S. Department of Health and Human Services that are designed to study or evaluate the following:

a. programs under the Social Security Act or other public benefit or service programs

b. procedures for obtaining benefits or services under those programs

c. possible changes in or alterations to those programs or procedures

d. possible changes in methods or levels of payment for benefits or services under those programs.

Applicants may request an Expedited Level Ireview based upon the above conditions, which must be specified in the Application Form. One member of the Institutional Review Board will review the Expedited Level Iapplication.

Expedited Level II

Research in which there is no more than minimal risk to human subjects. Types of research that may be considered in this category are:

  • Recording information from subjects 18 years old or older, using noninvasive procedures routinely employed in clinical practice (e.g., weighing, testing sensory acuity, electrocardiography, and thermography)
  • Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters, in an 8-week period from subjects at least 18 years old, in good health, and not pregnant
  • Collection of excreta and external excretions, including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane before or during delivery
  • The study of existing documents, records, pathologic specimens, or diagnostic specimens in such a way that the subject’s identity is linked to the data.
  • Research on individual behavior or characteristics where the researcher does not manipulate the subject’s behavior and where the study will not involve stress to the subjects.

One or two members of the IRB designated by the Chairperson, will review applications for Expedited-Level II review.

Full Review

All research not falling in either of the above categories, all research involving vulnerable populations such as minors, mentally or emotionally ill or incompetent subjects, as well as research in which there is considerable risk to the subjects, requires a full review. Research that may extend longer than one year will also require a full review and must include a plan for periodic updates to the Institutional Review Board. Research requiring full review will be reviewed by a majority of the Institutional Review Board, meeting in committee.

Meetings

The Rivier University Institutional Review Board shall meet monthly, unless no applications requiring full review are received. The Institutional Review Board shall meet at least once per year to hear progress reports and review policies and procedures.

Minutes

Minutes will be recorded at all meetings and distributed to members within two weeks. Copies of all minutes as well as records of all exempt, expedited, and full reviews will be kept on file in the office of the Vice President for Academic Affairs.

SUBMISSION OF PROPOSALS FOR EXPEDITED-LEVEL I REVIEW

If it is determined that human subjects are involved, the principal investigator and/or department chairperson shall make preliminary determination on the appropriate level of review. In situations where the principal investigator is a student, the decision regarding level of review status shall be the responsibility of the student’s research advisor and/or chairperson of the department in which the student is enrolled. Where it is clear that the project is in the “Expedited Level I” category, the research work may proceed after review by the Chairperson of the Institutional Review Board or his/her designee. An extension of previously approved research protocols may qualify for expedited review.

In requesting Expedited Level I status, the principal investigator will submit a letter to the Chairperson of the Institutional Review Board indicating which of the reasons for this level of review applies to the proposed research. (See Procedures for Expedited Level I review). When the principal investigator is a student the letter must be endorsed by the student’s research advisor. In addition to the letter, a completed Application for Research Review including one copy of the complete proposal shall be submitted to the Chairperson of the Institutional Review Board. The proposal should be submitted in APA format with page numbers. The Chairperson will assign a member of the Board as reviewer. Upon review, the reviewer will inform the Chair of the outcome in writing.

SUBMISSION OF PROPOSALS FOR EXPEDITED LEVEL II REVIEW

In the case of research work involving the activities described above (See Procedures for Expedited Level II Review) an “Expedited Level II” is possible. The principal investigator must specify in the cover letter the request for this level of review, briefly describing the particulars of the research study and the involvement of human subjects.