POLICIES AND PROCEDURES RELATIVE TO THE CONDUCT OF
RESEARCH
AT
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 the research, including:





The Common Rule (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html)
State regulations
The Federalwide Assurance
Institutional policies
Ethical Principles and Guidelines for the Protection of Human Subjects of Research
outlined in the Belmont Report
(http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html)
These principles require the balancing of risks to subjects against the scientific knowledge to be
gained and the potential benefits to subjects and society.
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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 between the 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 information
that 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 obtain the 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.
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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 the expedited review categories, as outlined at:
http://www.hhs.gov/ohrp/policy/expedited98.html
Committee Charge
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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;”
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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. https://phrp.nihtraining.com/users/login.php
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:
a. approve the proposal as submitted, forwarding the application to the Chair for
notification to the principal investigator and/or faculty advisor;
b. 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.
c. 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.
d. 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.
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
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 I review 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 I application.
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:
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Recording information from subjects 18 years old or older, using
noninvasive procedures routinely employed in clinical practice (e.g.,
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weighing, testing sensory acuity, electrocardiography, and thermography)
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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
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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
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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.
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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.
If the proposal might qualify for Expedited Level II review, the principal investigator must submit to
the Chairperson of the University Institutional Review Board (IRB) all documentation required for a
Expedited Level I review with two (2) copies of the complete proposal. Only one copy is required
for proposals submitted online.
The reviewers will submit a written report of the outcome of the review to Chairperson of the IRB.
The Chairperson of the IRB will notify the principal investigator of the status of the application.
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SUBMISSION OF PROPOSALS FOR FULL REVIEW
If neither of the streamlined reviews are possible, the University will require from the principal
investigator all documentation required for lesser levels of review as well as five (5) copies of the
completed proposal, less any appended material not necessary to an understanding of the project as
part of the Application for Research Review. Only one copy is required for proposals submitted
online. Completed applications will be forwarded to the Chairperson of the Institutional Review
Board.
The Chair will assign one member as principal reviewer for each proposal. A minimum of four
weeks will be necessary for review. Each member of the Institutional Review Board will have a
proposal and associated materials for review. The principal investigator could be asked to clarify
relevant issues, attend the IRB meeting or submit additional materials. The principal investigator is
encouraged to attend the IRB meeting.
At the IRB meeting, the principal reviewer will present the proposal to the Board with his/her
recommendations. Following a discussion of the proposal the Board will determine the disposition
of the proposal. The Board will return the proposal and materials to the Chairperson with a signed
report of action indicating the outcome of the review. The Chairperson of the Review Board will
notify the principal investigator of the decision. (Materials and Institutional Review Board
decisions will be placed on file in the Office of the Vice President for Academic Affairs.)
ARCHIVING RESEARCH PROPOSALS
Proposals for research that are submitted to Rivier University’s Institutional Review Board (IRB)
shall be retained for at least 3 years. Proposals relating to research that is conducted shall be
retained for at least 3 years after completion of the research. Principal Investigators shall maintain
all records and data collected in research studies approved by the IRB for at least 3 years after
completion of the study. All records shall be accessible for inspection and copying by members of
the IRB.
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RIVIER UNIVERSITY
RESEARCH REVIEW BOARD
ASSURANCE OF PRINCIPAL INVESTIGATOR
Principal Investigator: ________________________________
Department: ________________________________________
Title of Proposal/Project
________________________________________________________________________________
________________________________________________________________________________
I CERTIFY as follows concerning the above named research proposal in which I am the principal
investigator:
(1) The rights and welfare of the subjects will be adequately protected.
(2) Risks or discomfort (if any) to subject(s) have been clearly indicated and it has been shown how they are
outweighed by potential benefits to the subject or by the importance of the knowledge to be gained.
(3) The informed consent of subjects will be obtained by appropriate methods which meet the requirements
of the College’s general assurance procedures.
(4) Any proposed changes in research activity will be reported to the Research Review Board. Those
changes may not be initiated without Research Review Board review and approval except where
necessary to eliminate apparent immediate hazard to the subjects.
(5) Any unanticipated problems involving risks to human subjects or others will promptly be reported to the
Research Review Board.
(6) If the study is approved, a report on the progress of the research will be submitted to the Research
Review Board after one year, and each year until completion of the project. The Status Report Form
will be used for this purpose.
Signature: __________________________________________ Date: ______________________
Principal Investigator
Acknowledged: ______________________________________ Date: ______________________
Department Chairperson/Research Advisor (as appropriate)
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GENERAL REQUIREMENTS FOR INFORMED CONSENT
1.
Informed consent must be obtained only under such circumstances that provide the
prospective subject, or the subject’s representative, sufficient opportunity to consider
participation in the research project and where the possibility of coercion or undue
influences is minimized.
2.
The Informed Consent Statement
a.
must be written in language understandable to the subject or representative;
b.
shall not contain any language by which the subject waives any of his or her rights;
c.
shall not contain any language that releases the principal investigator, the College or
the sponsoring agency from liability for negligence.
3.
The Informed Consent Statement should follow the format given in this section. When the
subject is a minor and the parent’s or guardian’s consent is sought, space for the parent’s or
guardian’s signature should be provided. If the subject is an adult requiring guardian
consent, space for the guardian’s signature should be provided. Alternatively, where it is
necessary to separate the consent of the parent/guardian from the assent of the minor or nonconsenting adult, separate forms should be used for each.
4.
Two copies of the Informed Consent statement must be signed; one copy is to be retained by
the individual (or his/her representative/guardian), and one copy is to be kept by the
principal investigator. (NOTE: the signature page may not be completely separated from
the text of the informed consent.)
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RIVIER UNIVERSITY
DEPARTMENT OF: ____________________________________
ADDRESS
Title of Project
CONSENT FORM FOR RESEARCH
Introductory section should begin with words to this effect:
I have been asked to take part in a research project described below. The researcher will explain the
project to me in detail. I should feel free to ask questions. If I have more questions later, { Name
of P.I. }, the person mainly responsible for this study, { Phone }, will discuss them with me.
Description of the project:
I have been asked to take part in the study that {
purpose of the research
}.
here describe the nature of the study and the
What will be done:
If I decide to take part in this study here is what will happen: {
explanation of what will happen
to the subject; how long the subject will be involved in the study; and state what portions, if any are
considered experimental. Explain alternative procedures, if any }.
Risks or discomfort:
{
Explain any risks or discomfort that might reasonably be expected to happen.
are no risks or discomforts, state that here.
} If there
Benefits of the study:
{
Describe benefits to the subject, to others, of this study. If of no direct benefit to the subject,
include a sentence to the following effect: } Although there will be no direct benefit to me for
taking part in this study, the researcher may learn more about
. (NOTE: payment
given to the subject for participation in the study is not a benefit.)
Confidentiality:
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{
Describe the way confidentiality of records identifying the subject will be maintained. Use
words to the following effect, if appropriate: } My part in this study is confidential. None of the
information will identify me by name. All records will
{ Describe how to be maintained }.
{
Or, if the study involves information that legally must be reported to government agencies,
then include the following: } My part in this study is confidential within legal limits. The
researchers at Rivier College will protect my privacy, unless they are required by law to report
information to city, state, or federal authorities, or to give information to a court of law. Otherwise
none of the information will identify me by name. All records will be { Describe how to be
maintained }.
{
Alternatively, if the study is anonymous, then this should be stated here. Indicate to the
subject how anonymity will be preserved.}
Decision to quit at any time:
{
Use words to the following effect: } The decision to take part in this study is up to me. I
do not have to participate. If I decide to take part in the study, I may quit at any time. Whatever I
decide will in no way { penalize me } { affect my grade, status as a student } { etc. } { insert
appropriate language }. If I wish to quit I simply inform { name of principal investigator and
phone number } of my decision.
I have read the Consent Form. My questions have been answered. My signature on this form means
that I understand the information and I agree to participate in this study.
______________________________________
Signature of Participant
______________________________________
Signature of Researcher
______________________________________
Typed/Printed Name
______________________________________
Typed/Printed Name
______________________________________
Date
______________________________________
Date
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MONITORING PROCEDURES
The Code of Federal Regulations empowers the Institutional Review Board (IRB) to “conduct
continuing review of research… at intervals appropriate to the degree of risk, but not less that once
per year, and to observe or have a third party observe the consent process and research.”
All investigators will receive a status report form annually that must be completed and returned to
the Institutional Review Board within 30 days. In addition, you will be asked to submit a copy of the
consent form you are currently using, if different from original, and a summary of the project or the
annual report to a funding agency. The IRB will review these documents with federal and state
regulations as well as the research policies of the College. Continuing research or changes in
ongoing research must be monitored and approved for continued IRB approval annually using the
Status Form. Upon completion of the study the IRB will be notified by the investigator(s), using the
Status Report Form.
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Date:
To:
From: Rivier University Institutional Review Board
Re:
Subject:
This is to certify that the Institutional Review Board has ________the above referenced research proposal
via expedited review procedure under HHS 45 CFR 46.110.
The expiration date of this approval is ______. HHS regulations require that continued review of
research be conducted by IRB at intervals appropriate to the degree of risk and not less than once
per year. When your proposal approval expires all research activities must stop. Please insure that
the IRB receives a renewal request no later than 30 days before the anniversary date of the project, if
the study is expected to extend beyond one year.
Please note that the IRB must be notified if the project is altered in any way (including but not
limited to change in location, number or age of subjects, or any change in the research proposal).
Please contact the Designated Chair of the IRB by email at kfrenn@rivier.edu or by phone at
603.897.8474 with any questions.
Designated Chair: ___________________________________
Dr. Karen Frenn, Chair
Rivier University Institutional Review Board
Approval: __________________________________________
Douglas Howard, PhD
Interim Vice President for Academic Affairs
Rivier University
The Committee wishes you success in your research endeavors.
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RIVIER UNIVERITY RESEARCH REVIEW BOARD
STATUS REPORT FORM
According to Rivier University’s policy regarding research involving human subjects, this form is to
be submitted to the Institutional Review Board annually by investigators until the research is
completed. The purpose of this status report is to monitor the protection of human subjects in
ongoing research. Any changes in recruitment, informed consent, instrumentation, or methods
which may have resulted in increased risk to human subjects should be reported, and a request for
renewed approval must be submitted. Renewal of approval for ongoing research which remains
unchanged since the initial proposal should be noted. If the research has been completed, please
make the appropriate notation.
Completed forms are to be returned to the Chair, Rivier University Institutional Review Board, 420
Main Street, Nashua, NH 03060, within 30 days.
Principal Investigator: _____________________________________________________________
Title of project: __________________________________________________________________
________________________________________________________________________________
Date of original approval: ___________________________________________________________
Current Status of Project:
Research is ongoing, and changes regarding human subjects have been made.___________
(Documentation of revisions must be attached.)
Research is ongoing, no changes regarding human subjects have been made. ____________
Research is completed or project terminated.
__________________________
(Date of completion or termination)
__________________________
Discovery of unanticipated risks to human subjects.
(Documentation of any identified risks must be attached.)
__________________________
Thank you for taking the time to complete and return this form.
__________________________________________
Principal Investigator
_________________
Date
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