UMM Policy and Procedures for Human Subjects Research

I. Policy Applicability
II. Investigator Responsibilities
III. UMM IRB Responsibilities and Functions
IV. UMM IRB Membership
V. UMM Administration Responsibilities

I.    Policy Applicability

A.    All human subjects research conducted at UMM, sponsored by UMM, or conducted by or under the direction of any UMM employee, student, or agent in connection with his or her institutional responsibilities must comply with the University of Maine System policy described in Section 601 of the UMS Policy Manual, as well as this policy.  In addition, whenever UMM becomes engaged in human subjects research conducted or supported by any U.S. federal department or agency that has adopted the Common Rule (unless exempt or under a separate assurance), it must comply with the Terms of the Federalwide Assurance and the Common Rule.

B.    This policy uses the following definitions for guidance as to what qualifies as human subjects research.  Research is defined in 45 CFR 46.102(d) as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”  According to Section 601 of the UMS Policy Manual, “Generalizable knowledge is information which has the potential to be expanded from the isolated circumstances in which it is acquired to any broader context.”  Human subject “means 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)).

C.    Data collection for internal evaluation or management purposes typically does not fit the definition of research and therefore does not require IRB review.  Section 601 of the UMS Policy Manual lists examples of projects that are generally not considered human subjects research.  These include
1)    student surveys of dining preferences;
2)    evaluations of student satisfaction for accreditation reports;
3)    exit surveys for graduates or employees;
4)    surveys to determine residence hall programming needs.
Data collection that is strictly for UMM program evaluation or institutional research purposes with no intention to generalize outside the context of UMM does not require IRB review, unless otherwise determined by a sponsoring department or agency.

II.    Investigator Responsibilities

A.    Research shall be guided by three general ethical principles described in The Belmont Report: respect for persons, beneficence, and justice. These principles and the rules derived from them provide the framework for determining whether and how research with human subjects may be conducted. Investigators must respect and protect the rights, privacy, and welfare of individuals recruited for and participating in research. All human subjects research will be guided by The Belmont Report principles and must comply with the Common Rule (45 CFR 46), 21 CFR 50/56, and other applicable laws and regulations, regardless of funds, funding source, or governing agency.  UMM investigators conducting human subjects research must complete the appropriate CITI online training module on the protection of human subjects.

B.    All human subjects research conducted at UMM, sponsored by UMM, or conducted by or under the direction of any UMM employee, student, or agent in connection with his or her institutional responsibilities must be reviewed by the UMM IRB or designated, external IRB. Human subjects research funded or otherwise supported by a federal department or agency must be reviewed by a designated, external IRB registered with the U.S. Department of Health and Human Services. The University of Southern Maine IRB is designated under UMM’s Federalwide Assurance.  When the scope or nature of research is determined to be beyond the capabilities of the UMM IRB (see Section III.B), regardless of funding source, approval by a designated, external IRB (such as the USM IRB) is required. The UMM Provost also may choose to accept documented approval by an external IRB in place of review by the UMM IRB in other circumstances, such as when the principal investigator is at another university. It is the responsibility of the investigators to initiate review by the appropriate IRB and obtain IRB approval or notice of exemption.

C.    IRB approval or notice of exemption must be received prior to conducting research involving human subjects. An IRB application must be submitted, even if the investigator believes the research fits an exempt category under the Common Rule. For initial review by the UMM IRB, a New Study Application Form must be completed and submitted electronically by the principal investigator or a co-investigator to the UMM IRB Chair.  The UMM IRB Chair will determine the appropriate review category (see Section III.D).

D.    A protocol amendment application must be submitted to the IRB for all non-exempt studies that undergo any type of revision or amendment to the approved research protocol after approval by the UMM IRB is granted.  The investigator (applicant on the new study application form) should complete and submit electronically a Protocol Amendment Form to the IRB Chair.  Research should not proceed until the amended protocol is approved (except when necessary to avoid immediate hazards to the subjects). Protocol amendment applications may be reviewed under an expedited procedure or the full board review procedure (at the discretion of the IRB Chair). For changes to a research protocol that was previously determined to be exempt, the investigator should check with the IRB Chair about the possible need to resubmit an IRB application.

E.    A continuing study application must be submitted for all approved, non-exempt research that continues to involve human subjects past the IRB expiration date. It is the responsibility of the investigator (applicant) to submit electronically a Continuing Study Application Form to the IRB Chair at least 45 days prior to the IRB expiration date of the study. Continuing study applications may be reviewed under an expedited procedure or the full board review procedure (at the discretion of the IRB Chair).

F.    Investigators must report promptly to the IRB any adverse events or unanticipated problems involving harm (including physical, psychological, economic, or social harm) or increased risk to human subjects related to their participation in the research.   The Adverse Event Report Form should be submitted electronically to the IRB Chair. The IRB may require modification of the research protocol or suspension or termination of approval based on review of the adverse event or unanticipated problem.

G.    If an external IRB is used, it is the responsibility of the investigators to comply with all procedures established by the external IRB.  All UMM investigators involved in federally funded research approved by a designated, external IRB are responsible for notifying promptly the external IRB, the UMM Provost, and the head of the federal department or agency supporting the research of any unanticipated problems involving risks to subjects or others; and any serious or continuing noncompliance with the applicable U.S. federal regulations or the requirements or determinations of the IRB(s).  The UMM Provost has additional reporting responsibilities (described in Section V).

III.    UMM IRB Responsibilities and Functions

A.    The IRB at UMM is a committee charged with reviewing proposed human subjects research studies, based on professional and ethical considerations, in particular to ensure that they meet established criteria for the protection of human subjects.  The IRB also can serve as a source of advice on designing studies to minimize risk to research subjects and may monitor the conduct of approved research.

B.    The IRB at UMM has limited legal expertise and primarily relies on 45 CFR 46 and the Belmont Report for guidance in reviewing research protocols.  The UMM IRB is not registered with the U.S. Department of Health and Human Services and therefore cannot review federally funded research projects or serve as the designated IRB under a federal assurance of compliance.  UMM researchers may conduct federally funded research on human subjects, but only if reviewed by a registered IRB.  The University of Southern Maine IRB is designated under UMM’s Federalwide Assurance. Research studies involving special populations, including minors (under 18), pregnant women, prisoners or parolees, or persons with diminished capacity to give informed consent, unless falling in an exempt category, will typically be referred to a designated, external IRB.  In addition, the UMM IRB does not review biomedical research, genetics research, research involving protected health information (covered by HIPPA), or clinical investigations regulated by the FDA or supporting applications for research or marketing permits for products regulated by the FDA (covered by 21 CFR 50/56).

C.    The UMM IRB will schedule at least three meeting dates each semester (Fall and Spring).  The UMM IRB is not obligated to meet or review applications during the summer (June-August). 

D.    The UMM IRB Chair shall handle inquiries about IRB review, conduct an initial review of all IRB applications, and determine the appropriate review category.  The Common Rule and OHRP guidelines shall serve as guides for determining the appropriate review category of a protocol.  The IRB Chair’s determination shall place the research protocol into one of the following categories:
1)    Not research;
2)    Exempt from further IRB oversight;
3)    Expedited review;
4)    Full board review by the UMM IRB;
5)    Requires review by a designated, external IRB;
The UMM IRB Chair may request additional information from the applicant before a determination can be made. The Chair’s communication to the applicant should include the protocol number and reasons for the determination.  If full review by the UMM IRB is required, the Chair will indicate the date of the meeting at which the IRB will review the application.  The Chair should copy this communication to all IRB members and the UMM Provost.

E.    Human subjects research that qualifies for expedited review may be approved by the IRB Chair or Vice Chair alone, but feedback (via email, phone, or in person) from the other IRB members prior to an approval decision is strongly advised.  Under expedited review, the IRB Chair or Vice Chair may
1)    approve a research protocol as submitted;
2)    approve a research protocol contingent upon specific, minor revisions;
3)    table a protocol until additional information is provided or modifications to the protocol are made;
4)    decide that the protocol must undergo full board review by the UMM IRB;
5)    decide that the protocol must undergo review by a designated, external IRB.
The Chair’s communication to the applicant should include the protocol number, reasons for the decision, and an IRB expiration date for approved studies.  The Chair should copy this communication to all IRB members and the UMM Provost.

F.    Human subjects research requiring full board review by the UMM IRB shall be reviewed at a convened meeting at which a majority of the IRB members are present (and not recused), including at least one member whose primary concerns are in nonscientific areas. Also, the applicant is encouraged to attend the meeting to answer any questions that may arise.  In order for the study to be approved, it shall receive the approval of a majority of those IRB members present (and not recused) at the meeting. The UMM IRB has the authority to
1)    approve a research protocol as submitted;
2)    approve a research protocol contingent upon specific, minor revisions;
3)    table a protocol until additional information is provided or modifications to the protocol are made;
4)    withhold judgment and request review by a designated, external IRB;
5)    disapprove a research protocol.
The Chair’s communication to the applicant should include the protocol number, reasons for the decision, and an IRB expiration date for approved studies.  The Chair should copy this communication to all IRB members and the UMM Provost.

G.    The IRB shall consider additional information presented by the applicant subsequent to the initial application.  The IRB and the applicant are encouraged to work together to resolve any concerns about risk to human subjects.  The IRB may reconsider a prior decision in light of new information provided by the applicant.

H.    As described in Section II investigators are required to notify the IRB Chair of any changes, revisions, or amendments to an approved research protocol; continuation of a study beyond the IRB expiration date; and any unanticipated problems involving risks to subjects or adverse events encountered during the course of a research study. The IRB Chair shall be responsible for ensuring review of all such notifications.  Also, the UMM IRB may monitor approved research for adherence to protocol and compliance with IRB recommendations.  The UMM IRB has the authority to suspend or terminate approval of research based on noncompliance with IRB requirements or harm to subjects.  A notice of suspension or termination must include reasons for the IRB decision and be reported to the UMM Provost.

I.    When an IRB member has a direct stake in the research process or outcomes, either as an investigator, family member of an investigator, or having a close relationship with a sponsoring organization (other than UMM), there is a potential for conflict of interest.  IRB members with a real or apparent conflict of interest should recuse themselves from deliberations on the particular protocol and not vote on that protocol.  When the IRB Chair has a conflict of interest, the IRB Vice Chair shall take the Chair’s role in leading review of the research protocol.

J.    The IRB Chair shall lead IRB activities; communicate with applicants, other IRB members, and the UMM Provost; and keep appropriate records.  IRB applications, other forms submitted, communication with applicants, findings from monitoring activities, reports of unanticipated problems or adverse events, and all IRB decisions shall be shared promptly with other IRB members and the UMM Provost.  Reasons for IRB decisions shall be included in the written notifications.  The IRB Chair shall keep records of IRB meetings, the names of those attending, agenda items covered, and IRB votes. Specific details of IRB deliberations and votes of individual IRB members shall be kept confidential.   When the IRB Chair has a conflict of interest or is otherwise recused or unavailable, the IBR Vice Chair may temporarily take the roles of the IRB Chair.   

K.    The IRB is responsible for providing investigators with guidelines for IRB applications and a timeline for review of applications.  In addition, the IRB may develop internal guidelines for IRB members and review procedures.

IV.    UMM IRB Membership

A.    The IRB at UMM will include three faculty members, one UMM professional staff person, and one member of the community having expertise in one or more aspects of IRB responsibility. The IRB Chair should be a tenured faculty member.

B.    The three IRB faculty members will be elected by the faculty at large. The IRB Chair and a Vice Chair will be elected by the full IRB at its first meeting of each academic year. The President, or delegate, will appoint the UMM professional staff person and invite a community member to serve on the IRB.  All IRB members are formally confirmed by the President (or designee) of the University; any designation must be specific and in writing.

C.    IRB members should have expertise in research on human subjects and be knowledgeable of ethical guidelines for research, standards of professional conduct, and applicable regulations.  The IRB shall consist of members representing a diversity of disciplines, professions, and cultural backgrounds.  Following 45 CFR 46.107, “every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women.”

D.    All IRB members are expected to complete the CITI IRB Members Basic Course or similar training within 30 days of becoming an IRB member.

E.    The faculty and staff members typically serve for staggered three-year terms and may be re-elected or re-appointed.  The community member typically serves for a two-year term and may be re-invited for additional terms.

F.    The IRB Chair and UMM Provost will keep a list of IRB members identified by name, along with relevant details on each member (title, degrees, licenses, etc.) and term expiration date.

V.    UMM Administration Responsibilities

A.    The UMM Provost shall serve as the Human Protections Administrator, overseeing implementation of this policy, serving as the primary liaison with OHRP for Federalwide Assurance (FWA), and overseeing compliance with the Terms of Federalwide Assurance.

B.    The UMM Provost shall maintain on file a written agreement with a registered, external IRB to review federally funded research at UMM and adhere to the requirements of UMM’s FWA. The UMM Provost shall ensure that the IRB designated under the FWA has established written procedures required under the Terms of the Federalwide Assurance.

C.    The UMM Provost shall report promptly to the head of the federal department or agency supporting the research and OHRP any unanticipated problems involving risks to subjects or others; serious or continuing noncompliance with the applicable U.S. federal regulations or the requirements or determinations of the IRB(s); and suspension or termination of IRB approval.

D.    The UMM Provost shall be responsible for determining whether documented approval or notice of exemption from an external IRB will be accepted in place of review by the UMM IRB.

E.    The UMM IRB shall be provided with adequate resources to fulfill its duties.  Resources include membership as described in Section IV of this policy, meeting space, and access to training for IRB members.

 

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