The Committee on Human Subject Rights in Research at Shenandoah University is the Institutional Review Board (IRB) of Shenandoah University (SU). The SU IRB establishes policies and procedures for the conduct of investigations at SU involving human subjects. These policies and procedures cover all investigations at the University or other sites by SU faculty, staff, and students. The policies and procedures are established in order to:

to protect the rights, well-being, and personal privacy of individuals involved in biomedical and/or social and behavioral research;
to assure a favorable climate for the conduct of scientific inquiry; and
to protect the interests of the institutions within Shenandoah University.

The policies and procedures shall be in compliance with regulations promulgated by the Department of Health and Human Services (DHHS) in 45 CFR 46 and all other applicable federal and state regulations.

[Amendment: Since the University may conduct research projects that are not specifically related to human subjects but would still require a review, Shenandoah University’s Human Subjects Review Board will now be known as the Institutional Review Board (IRB). (September 25, 2006)]

I. General Principles and Policies

The following general principles apply equally to all investigations at the University involving human subjects and to activities carried out at other sites under the aegis of faculty and professional staff of the University.

Throughout this manual, the term ‘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. The term human subject refers to individuals engaged in quantitative research as well as those engaged in qualitative research (commonly referred to as ‘participant’). Operationally defined, in this document, human subject and participant are interchangeable and synonymous.

The University and the individual members of its faculty, staff, and student body engaged in research recognize their responsibilities for safeguarding the rights and welfare of human subjects. Each Principal Investigator (PI) embarking on a research project accepts personal responsibility to study, learn, achieve certification in, and comply with the guidelines presented by the Collaborative Institutional Training Initiative (CITI) Program. Members must complete the appropriate training module for their area of study; training is valid for a period of three (3) years from initial certification.

No investigations shall be undertaken which expose subjects to unreasonable risks to health or wellbeing as determined by the IRB.

The confidentiality of information received from or learned about subjects in experiments, respondents to questionnaires or interviews, or participants in observations shall be fully protected both during and after the conduct of an investigation, subject to the requirements of the law.

Before a prospective human subject is allowed to participate in an investigation, informed consent must be obtained from the prospective subject. The basic elements of informed consent, as required under 45 CFR 46.116-117, must be included in every informed consent document. The research procedure(s), purpose, anticipated outcome, and any anticipated risk or substantial stress or discomfort, shall be described in lay language in the consent document. An explanation of the procedures to be performed should identify specifically those which are the experimental procedures. In addition, the benefits reasonably to be expected should be described, and appropriate alternative procedures that may be advantageous for the subject should be disclosed. The investigator shall offer to answer any questions, and further, they shall be satisfied that the prospective subject, or their legally authorized representative, understands all aspects of the procedure(s) or treatment(s) they are to undergo. In giving consent, the prospective subject or their legally authorized representative must be able to exercise free power of choice without the intervention of any elements of constraint or coercion.

A consent form, which has been approved by the Shenandoah University Institutional Review Board (SU IRB), is to be presented to the prospective human subject and is to be signed by the prospective subject or their legally authorized representative, and the person administering the consent. Approved informed consent forms will be given a stamp that bears the approved protocol number and date of approval. This stamp and information are issued by the Compliance Coordinator of the IRB under the direction of the IRB Chair. The consent form shall be kept as a matter of record that the required disclosure was made. When appropriate, time will be allowed to elapse between the explanation of the study and disclosure of risks, and the signing of the consent form, to allow the subject or their legally authorized representative to give due consideration to the procedures described in the document. The consent form shall contain no exculpatory language through which the subject is made to waive, or appear to waive, any of their legal rights, or to release the institution from liability for negligence. If the subject is under 18 years of age or otherwise legally incompetent, the consent of the parent(s) or legally authorized representative must be procured. Following consent of the parent(s) or legally authorized representative, the subject must provide assent to participate. If prospective participants are adults who may lack the decision-making capacity to make an informed decision, the PI must clarify how capacity to understand and provide informed consent will be assessed. Signed written consent and documentation of assent are required components of all research studies approved by the SU IRB unless a waiver of consent is approved according to federal regulations.

Compensation to subjects is a recruitment incentive and should not be viewed as a benefit. Compensation should never be such as to constitute an undue inducement to participate in investigative work, and should be limited to nominal amounts, including reimbursement for out-of-pocket expenses, as determined by the IRB. Amount and schedule of payments needs to be presented to the IRB at the time of review.

A request by any consenting subject to withdraw their consent and to discontinue participation in the investigation shall be honored promptly and unconditionally.

Whenever possible, the subjects of an investigation shall represent a cross section of society, and the subjects will represent the various income and ethnic groups; for general research projects, excessive solicitation of the indigent, disadvantaged, or other vulnerable subject population is to be discouraged. It is understood that some research is designed specifically to center on the vulnerable populations categories and these individuals will be the subjects of the research with the intent that the information derived will benefit the greater society as the outcomes are analyzed and disseminated. The SU IRB will review closely, and as warranted, deliberate carefully as a full board the proposals that focus on vulnerable populations.

It shall be the obligation of the Principal Investigator, prior to the initiation of the proposed study, to bring any proposal involving the use of human subjects to the SU IRB for review and approval. Investigations involving human subjects conducted by students (full-time, part-time, or summer) must also be reviewed and approved by the SU IRB prior to initiation of the study. It is the responsibility of the SU faculty member who is supervising the student to ensure that the research is approved by the SU IRB and that informed consent is appropriately obtained from each research subject. If a student serves as the Principal Investigator, they must be supervised by a SU faculty sponsor who is ultimately responsible for the research.

No investigation involving the use of human subjects shall be initiated until the SU IRB has reviewed and approved the study or determined that the study is exempt from SU IRB review in accordance with 45 CFR 46.104. Approval or other determination of the SU IRB is valid only when transmitted to the investigator and/or supervising faculty in writing from the SU IRB Chair or as designated by the IRB Compliance Coordinator.

Each Chairperson or head of an academic or clinical department or division shall be responsible to the SU IRB for the supervision and proper conduct of research involving human subjects in their department or division in accordance with procedures prescribed by the SU IRB. The Chairperson or head of an academic or clinical department must provide proof of valid CITI Program training.

Failure to have human subjects research reviewed by the SU IRB, including those protocols believed to be exempt and those approved by other institutions, is a violation of University policy and will be reported to the Provost for disciplinary action, and, where appropriate, to OHRP and/or other federal agencies.

II. Shenandoah University Institutional Review Board (IRB)

Responsibilities

The SU IRB has as its primary concern the protection of the rights and welfare of human subjects involved in research and is responsible for the review and approval, in accordance with the procedures set forth below, of all investigations involving human subjects. No study involving human subjects may be undertaken at the University, or by faculty, staff, or students of the University at other sites, without prior approval of the SU IRB. In addition, the Committee will be responsible for:

Initial review and approval of research involving human subjects to be conducted at the University or approved sites by faculty, staff, or students of the University.
Conducting annual continuing review of expedited and full review protocols approved by the Committee. This will be accomplished by an annual update of ongoing research, which will be requested by the IRB Compliance Coordinator and reviewed by the SU IRB.
Reviewing the University's policies and procedures with respect to the utilization of human subjects in research and the conduct of the SU IRB on a continuing basis.
Providing advice and guidance to investigators regarding the rights and welfare of subjects and the IRB review procedures and adherence to the federal standards.
Reporting to the Provost, any serious or continuing non-compliance by an investigator with the requirements and determinations of the SU IRB; further reporting may be advanced to the Office for Human Research Protection (OHRP), and to other federal agencies as appropriate.

Membership

The SU IRB members shall be sufficiently qualified by certification with CITI Program and through maturity and diversity to ensure respect for their advice and counsel for safeguarding the rights and welfare of human subjects. The SU IRB shall be able, in addition to professional competence, to ascertain acceptability of proposals in terms of organizational commitments and regulation, applicable law, ethics, standards of professional conduct and practice, and community attitudes. Members will therefore be appointed by Academic Deans from among individuals from the University faculty and staff representative of the various fields of study at SU. These may include but are not limited to medicine, nursing, allied health, law, ethics, theology, biological and physical sciences, behavioral sciences, philosophy, health administration and public affairs, the humanities, and performing arts, as well as at least one individual representative of the larger community served by the University.

The SU IRB shall have at least one member who is not otherwise affiliated with the University and who is not part of the immediate family of a person affiliated with the University.
The SU IRB shall have at least one member whose primary area of expertise is in a non-scientific area.
The SU IRB shall include members with diverse backgrounds and varied areas of professional expertise so as to assure competence necessary to review the range of research activities conducted at the University as well as to assure sensitivity to racial and cultural issues and community attitudes. When deemed necessary by the SU IRB, it may seek advice from experts within or outside the University.
The SU IRB shall have a minimum of 12 regular members, comprised of at least two members from each School within the University. Each school may also appoint a minimum of one proxy member to serve when regular appointed members are unavailable or disclose a conflict of interest.
When research is reviewed involving a category of vulnerable subjects (e.g., students, prisoners, children, individuals institutionalized as mentally disabled), the SU IRB may, at its discretion, seek consultation from one or more experts who have as a primary concern the welfare of these subjects.
Members shall be appointed by the Provost, or the Provost’s designee (Dean/Director). A list of potential candidates will be forwarded to the Chairperson of the SU IRB or Compliance Coordinator from the appointing authority.
Members shall serve for terms of three (3) years, and may be reappointed for successive terms.

Members may be:

Appointed at the beginning of the school year, or, in the case of a vacancy occurring during the school year, at the time of the vacancy. If the vacancy is that of a non-mandatory member, the appointing authority may elect to leave the vacancy unfilled. In such instances, the quorum requirement will be adjusted accordingly.
Removed for cause such as:

missing more than 50% of scheduled meetings for the academic year
unethical behavior
faculty handbook violations
conflicts of interest
inability or unwillingness to perform delegated tasks

The Provost shall designate one member of the SU IRB to serve as Chairperson for a three-year term. The chair may be re-appointed for successive terms by recommendation of the Provost.

Chair responsibilities

Conduct SU IRB meetings.
Serve as the SU IRB liaison to the faculty senate, faculty, staff, students, and administration.
Approve informed consents reviewed and accepted by the SU IRB.
Render decisions on requests for emergency or administrative approvals.
Appoint an Executive Committee, and other subcommittees as appropriate.
Training and education of members:

Initial orientation: Each new member will be oriented by the Chairperson of the IRB, and receive a set of policies and procedures.
Annual update: The Chairperson shall be responsible for updating the members on changes from the previous year as they relate to changes in institutional or IRB issues.

Other duties expressed or implied in these policies and procedures.

Executive Committee

An executive committee consisting of the Chairperson and at least two other voting members will be formed for the purpose of developing and reviewing policies and procedures and dealing with other issues as necessary to ensure the proper operation of the SU IRB. This committee will meet at the discretion of the Chairperson.

IRB Compliance Coordinator

Position Description: Reports to Provost. Assist the Institutional Review Board, Executive Committee, and Principal Investigators by coordinating processes and compliance procedures for all research projects involving human subjects.

IRB Compliance Coordinator Responsibilities

Serve as primary liaison between Principal Investigators and SU IRB members.
Screen all human subjects research projects for completeness and adherence to SU standard operating procedures.
Process all proposal applications.
Revise all SU IRB project forms, procedures, and policies (as needed).
Monitor federal regulations impacting SU human subject research projects.
Maintain the SU IRB webpage.
SU IRB Board and Executive Committee Meetings

Receive the agenda from the Chairperson and disseminate it to the members, attend and record the proceedings, develop the meeting minutes for review and adoption by the SU IRB.
Disseminate information resulting from Board meetings to appropriate parties.
Distribute documents one week in advance of Board meetings.

SU IRB Database

Create, monitor, and maintain the SU IRB database.
Ensure security monitoring of all human research documents.
Maintain IRB membership list status including term dates, term number, area of expertise, gender, and relevant background.

Retention of Records

All hard and electronic copies of projects shall be kept a minimum of three years from the termination date of the project.
All hard and electronic copies of the minutes shall be kept for a period of five years.
The above time limits shall be revised if so dictated by state or federal law.

Meetings

The SU IRB shall meet as needed, as deemed by the Chairperson. The Chairperson may cancel a regular meeting if there are no protocols submitted for full review and there are no other issues needing the attention of the full committee. Additional meetings may be called at the discretion of the Chairperson. For the purposes of approving policies and procedures and other administrative matters, voting by phone, online video/conference call (Skype, Google Hangouts, Zoom, etc.) or email is permitted, provided the number of members needed to constitute a quorum responds. For votes that involve approval or disapproval of a protocol only members involved in the discussion of the study can vote by email.

Meetings are confidential and closed to non-members. Non-members may attend with invitation by the chair or at the discretion of the chair to address or clarify specific protocols.

Quorum
All members of the committee are expected to attend meetings. A quorum is defined as fifty percent plus one of the voting members, including at least one non-scientific member. No business, including review of protocols, will be conducted without a quorum.
Minutes and Other Records

Minutes

Minutes are confidential and are not to be shared in any form outside the IRB membership.
Written minutes shall be prepared for each SU IRB meeting and shall be sent to the Chairperson and committee members within 10 business days. The minutes shall include:

Attendance at the meeting;
Approval of the prior meeting’s minutes;
Actions taken by the SU IRB;
The SU IRB vote on the actions taken, including indication of any dissenting votes or abstentions;
Title and brief description of protocols for review;
A summary of discussion of controverted issues and their resolution;
SU IRB findings regarding waiver or alteration of informed consent requirement;
SU IRB findings regarding waiver of the requirement for written consent documents;
SU IRB findings with regard to involvement of prisoners in research or added protection for children when serving as research subjects;
Indicate when members have conflicting interest regarding a project and their absenting themselves from the discussion under such circumstance;
The basis for requested changes in research proposals or consent documents or for disapproval of research proposals;
The SU IRB determination as to the handling of responses to requests for information or revisions in protocol or consent documents;
Substance of discussions of reports of adverse reactions;
Substance of discussions of allegations of non-compliance with human subjects regulations;
Substance of discussions of suspension of a research project and the reasons for which the action was taken;
Summary of other discussions or actions of the SU IRB.

Other Records

The following additional records shall be maintained to document SU IRB activities:

Copies of research proposals reviewed and evaluations of them;
Copies of approved consent documents;
Progress reports by investigators;
Reports of adverse events;
Records of continuing review of research;
Copies of all correspondence between SU IRB and investigators;
List of SU IRB members;
Statements of significant new findings provided to subjects.

All of these records shall be maintained for a period of at least three (3) years after completion of the research. Minutes and other records shall be available for inspection by authorized representatives of the Department of Health and Human Services, and other individuals as required by law.

III. Review Procedures

Protocol Submission
Investigators who wish to conduct a research project involving human subjects shall submit a protocol describing the research on SU IRB forms prepared for that purpose. Protocols will only be accepted electronically via Sitero Mentor. Submitted paper copies will be returned to the PI(s) for electronic submission.

The protocol shall include:

the background to the proposed research;
the current state of knowledge in the field;
a complete description of the research procedures and methods to be employed;
nature of the research subject population, including sex, age, racial, and ethnic characteristics;
procedures for recruiting subjects;
recruitment materials;
number of subjects to be studied;
procedure for obtaining informed consent and informed consent document;
all risks to the subjects which can be anticipated as a consequence of their participating in the research;
procedures to be employed to minimize risks to subjects;
the significance of the research proposed;
any benefits to the subjects which might reasonably be expected from their participation in the study;
alternative procedures for diagnosis and/or treatment and their benefits and risks;
procedures to be employed to maintain confidentiality of patient related data;
procedures employed to maintain privacy of participant related data;
source of funding to support the research;
financial compensation, if any, for the research subjects.
verification of CITI training for all PIs and Co-PIs

The protocol shall be written in layman language, to the extent practical. Protocols shall be signed electronically in Sitero Mentor by the Principal Investigator and Department Chair prior to review.
If the research is to be supported by a grant from an external agency, a copy of the complete grant application, as submitted to the granting agency, must accompany the protocol and consent document. If the research is to be supported by an industrial sponsor, a draft of the proposed contract between the industrial sponsor and the University, as well as any sponsor developed research "protocol" must be submitted to the SU IRB together with the protocol and consent document. The consent document shall normally contain all of the basic elements of informed consent as per 45 CFR 46.116-117.

Conflict of Interest
If an SU IRB member believes that they might have, or be perceived as having, a conflict of interest in reviewing a given protocol, or if one member of the SU IRB suggests that another member might have such a conflict then, the member who might have a conflict of interest will recuse themselves from the meeting during the discussion and voting of that protocol. If a disagreement arises as to whether the potential for a conflict of interest exists, it shall be resolved by vote of the Committee after discussion of the issues involved.
Protocol Review
As part of its review, the SU IRB shall determine whether investigations involving use of human subjects will place these subjects at risk of injury, including physical, psychological, or social injury. If so, the review will determine if the risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks. In addition, the review will determine if the risks and possible benefits are adequately described in the consent document to assure that the subject is fully and fairly informed in accordance with 45 CFR 46.109 and 45 CFR 46.116-117.
The SU IRB will also consider the proposed procedures for recruitment of research subjects and for obtaining informed consent from potential research subjects to assure that the procedure and document are consistent with 45 CFR 46.116-117. The SU IRB will also consider whether appropriate protections are provided for vulnerable populations such as prisoners, children and mentally disabled individuals as per 45 CFR 46.305-306, and 45 CFR 46.404-409.
The SU IRB may request additional information, clarifications, or revisions in the protocol or consent document.
A primary reviewer system will be employed. One member of the SU IRB will be assigned to each review categorized as Exemption Requested. Two members of the SU IRB will be assigned to each protocol categorized as Expedited Review Requested. The primary reviewer(s) will be responsible for submitting critiques of the protocol, which will then be submitted to the IRB Compliance Coordinator.
If the primary reviewer(s) requests additional information, clarifications, or revisions in the protocol or consent documents, approval or disapproval will be deferred. For any expedited or full review research protocol that is approved, the SU IRB will state the duration of approval shall not exceed one year. If approved, the protocol will be stamped with the protocol number and the approval date for the study.
Before approving a research proposal the SU IRB shall determine that the following requirements are satisfied:

That risks to subjects are minimized;
That risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result;
That selection of subjects is equitable, taking into account the purposes of the research and the setting in which it will be conducted;
That informed consent will be sought from each prospective subject or subject's legally authorized representative in accordance with 45 CFR 46.116;
That informed consent will be appropriately documented in accordance with 45 CFR 46.117.
That the research plan appropriately monitors the data collected to ensure the safety of subjects;
That subject’s privacy is appropriately protected and confidentiality of subject related data maintained;
That appropriate additional safeguards are included to protect the rights and welfare of subjects who are likely to be vulnerable to coercion.

If the SU IRB votes to disapprove a research proposal it shall notify the Principal Investigator in writing of the disapproval and the reasons for it. The Principal Investigator or their representative may respond to the SU IRB in writing or in person at a convened meeting of the SU IRB.
Review of Responses to SU IRB Requests for Additional Information, Clarification, or Revision

Non-Substantive Revisions
Non-substantive revisions refer to specific revisions which are stipulated by the convened SU IRB and which require simple concurrence by the investigator. The appropriate inclusion of such revisions as stipulated by the SU IRB will be confirmed by the Chairperson of the SU IRB who can approve the research on behalf of the SU IRB. If the convened SU IRB has stipulated non-substantive revision(s) and has voted for approval of the research, then, after confirmation by the Chairperson of the inclusion of the stipulated revisions the investigator will be sent written notification of approval, effective as of the date of the approval letter.
Substantive Revisions
Response to requests by the SU IRB for additional information, clarification, or revisions of protocol or consent document, other than non-substantive revisions discussed above, will be reviewed by the SU IRB at a convened meeting. The written response of the investigator will be sent to the members of the SU IRB one week in advance of the meeting, except in those cases where the convened SU IRB stated without dissent that the response should be sent only to the primary reviewer(s). In the latter case, a copy of the response will be available at the SU IRB meeting in the event that any member wishes to see it. The same primary reviewer(s) who were assigned the protocol at the time of its initial consideration by the SU IRB will be responsible for reviewing the response in detail and presenting their critique of the response to the convened SU IRB. The convened SU IRB will approve or disapprove the proposed research by majority vote of the members present. If additional information, clarification or revision of protocol or consent document is required by the SU IRB, approval or disapproval will be deferred pending subsequent review of the new response by the convened SU IRB.
Review of Requests by the Investigator for Changes in an Approved Protocol
When changes are made to a protocol by an investigator, research using the newly proposed methods may not be initiated prior to receiving approval from the SU IRB.

Minor Change

The expedited review procedure by the SU IRB Chairperson will be used to review minor changes in previously approved research during the period for which approval is authorized. A minor change is defined as one which does not alter the consent procedure or the information provided in the consent document regarding risks and benefits and could not conceivably increase the risks to the patient or adversely affect the validity of the research. The SU IRB Chairperson shall determine if the proposed change is minor and can therefore be approved by this procedure. If the SU IRB Chairperson approves the requested minor change he/she shall so notify the investigator in writing. The SU IRB Chairperson shall so inform the SU IRB during its next convened meeting of the approval of the requested minor change.

Substantive Changes

All requests for changes in previously approved research (other than minor changes discussed above) shall be reviewed by a primary reviewer, who shall prepare a written critique of the proposed change(s) and present this critique to the convened SU IRB for its discussion. After discussion the SU IRB shall vote to approve or disapprove the proposed change or shall request additional information, clarification, or revisions in which case approval of the proposed change shall be deferred. The decision of the SU IRB shall be communicated to the Principal Investigator in writing.

Continuing Review of Research
The SU IRB shall conduct continuing review of approved research at intervals determined by the SU IRB as being appropriate to the degree of risk but not more than once a year or otherwise required by the DHHS. The SU IRB shall have the authority to observe or to designate a third party to observe the conduct of the research and the consent process.

The Principal Investigator shall submit annually:

description of modifications to research since the last review;
a description of any adverse events or unanticipated problems involving risks to subjects or others;
total number of subjects enrolled since last annual report;
total number of subjects enrolled in study to date;
total number of subjects withdrawn per subject’s request; and
total number of subjects still active.

If applicable to the study design, the Principal Investigator may choose to report the following additional items:

a summary of findings obtained to date;
a summary of plans for publication/dissemination;
a summary of any new information regarding risks to the subjects since the last review;
total number of screening failures (consented but ineligible);
total number of subjects currently active/on study;
total number of complete active study & in long-term follow-up only;
total number of subjects who have completed study; and
total number of subjects lost to follow-up.

If the aims, objectives, or research procedures employed have changed since the last review by the SU IRB, such changes should be clearly indicated.
Failure of the Principal Investigator to submit proposals for continuing review by the date stipulated by the SU IRB will automatically result in termination of the research.
The continuing review will be processed using a primary reviewer system. The same procedures will be used for continuing review as for the review of the initial protocol described above.
Conducting continuing review of research approved by the Committee will be accomplished by an annual update of ongoing research which will be requested by the IRB Chair and reviewed by the SU IRB. This summary of ongoing research will be reported and circulated to the members of the SU IRB, the Provost, and to the responsible Deans or Directors.

Duration of SU IRB Approval and Termination of Research
SU IRB approval of research is always for a limited period of time not to exceed one year from the date of the SU IRB meeting at which the research was approved. The duration of approval will be stated in the approval letter from the SU IRB to the Principal Investigator. If the study is to continue beyond the period of approval stated by the SU IRB, then continuing review and approval of the project is required as indicated. If continuing review information is not received in time for SU IRB review prior to the end of the period of approval then a request for renewal must be submitted to the IRB chair..
Termination of Approved Research by Investigator
Normally research terminates at the time when the period of SU IRB approval expires. If for unusual circumstances such as new information about adverse events or efficacy, or a decision by the sponsor of the research, the research is to be terminated before the end of the approval period, the Principal Investigator should notify the SU IRB and provide information regarding the reasons for the termination.
Suspension of Approved Research by the SU IRB
The SU IRB has the authority to suspend approval of any type of SU IRB approved research protocol. Suspension of a protocol shall be by majority vote of members present at a convened meeting of the SU IRB. The Principal Investigator shall be notified of the suspension, and of the reasons for the action, in writing, and shall have the opportunity to respond to the SU IRB in writing or in person at a convened meeting of the SU IRB. The SU IRB Chairperson shall notify the Institutional Official who shall notify the OPRR of any suspension of research by the SU IRB. The Institutional Official shall also notify other officials of the Institution as appropriate. In addition the Institutional Official shall notify the FDA of any suspension of research by the SU IRB or noncompliance with SU IRB requirements when the investigation is an FDA regulated study.
Monitoring Adverse Events

Reporting Requirement

It is mandated by Federal regulations that every adverse event which occurs during the course of research involving human subjects must be reported, in writing, to the SU IRB within 72 hours (three business days) of its occurrence. Reporting is required regardless of whether the adverse event is serious or minor, was anticipated or unanticipated, was study related or unrelated. In addition, in a multicenter study, it is required that the investigator provide copies of the reports of adverse events occurring at other study sites to the SU IRB within 72 hours (three business days) of receiving the report.

Procedure for Reporting Adverse Events

Any adverse event occurring during the course of research involving human subjects must be reported in writing within 72 hours to the SU IRB Chair via electronic submission to Sitero. If the possibility of the particular adverse reaction was not considered in the original protocol submission and was not included in the informed consent, the investigator should discuss whether they had expected this adverse reaction and the implications of the adverse reaction for the continuation of the project and should consider submitting an appropriately revised "informed consent."

Procedure for SU IRB Review of Adverse Event Reports

All reports of adverse events, whether originating from Shenandoah University or from other study sites, will be reviewed by the Executive Committee. The committee shall determine if additional information is required from the investigator and will assess whether changes are required in the protocol or consent form. The committee shall inform the investigator of its determinations in writing when additional information or changes are required. They will also inform the full SU IRB at its next convened meeting of adverse events which are deemed to be serious or repetitive as well as those for which the committee recommends changes in the protocol and/or informed consent document. Recommendation by the executive committee of the suspension of a protocol shall be presented to the convened SU IRB at its next meeting and will be discussed and voted upon by the convened SU IRB. The investigator shall be notified of the SU IRB's decision in writing.

Research Involving Human Subjects Which is Exempt from Review by the SU IRB

Federal regulations [45 CFR 46.104] precisely define several categories of research involving human subjects that are exempt from the requirement for SU IRB review because they entail little or no risk to the research subjects.
If the Principal Investigator believes that their research project should be exempt from review by the SU IRB then they must submit a summary of the proposed research project to the SU IRB and indicate the applicable exemption category within 45 CFR 46.104, along with required SU IRB forms. Any applicable surveys or attachments should also be submitted with these forms. The request will be reviewed by the Chairperson of the SU IRB or their designee who will make the determination as to whether the work is exempt from SU IRB review and will notify the Principal Investigator of the determination in writing.

Research Involving Human Subjects Which Requires Expedited Review

An expedited review procedure may be used for certain kinds of research involving no more than minimal risks and for minor changes in approved research (45 CFR 46.110).
If the Principal Investigator believes that the research that they are proposing to conduct involving human subjects is appropriate for expedited review, they will submit the required documents electronically via Sitero Mentor. Two members of the SU IRB will conduct the review of the research. The SU IRB reviewers shall confirm that the research is in a category appropriate for expedited review and that the research involves no more than minimal risk for the research subjects. In their review of the proposed research the SU IRB reviewers may exercise all of the authorities of the SU IRB except that they may not deny approval of the research. If the SU IRB reviewers believe that the research should be denied approval then they shall refer the research proposal for review at a convened meeting of the SU IRB and the research shall then be reviewed in a manner consistent with the SU IRB's usual review procedures as described above. If the SU IRB reviewers approve the research (initially or after revision) they shall provide written notification to the Compliance Coordinator who will contact the Principal Investigator of their action and of the duration of the approval. Approval shall be effective as of the date of the letter of approval.
The SU IRB reviewers shall report their actions taken in regard to research proposed for expedited review to the SU IRB at its next convened meeting. A copy of the research proposal and consent document shall be present at the SU IRB meeting so that members may review it if they desire.

Research Involving Human Subjects Which Requires Full Review

All research that does not meet above definitions for either exempt or expedited review must undergo full review by the SU IRB.
If the Principal Investigator believes that their research project should need full review by the SU IRB, then they must submit a proposal and consent document of the proposed research project to the SU IRB. The proposal will be considered at the next SU IRB meeting and reviewed in a manner consistent with the SU IRB's usual review procedures as described above. The SU IRB will make the determination as to whether to approve or disapprove the proposal. If the committee decides to approve the proposal (initially or after revision) they shall provide written notification to the Principal Investigator of the committee’s action and of the duration of the approval. Approval shall be effective as of the date of the letter of approval. If the SU IRB believes that the research should be denied approval then they shall provide written notification to the Principal Investigator of the committee’s action in writing of the denial and the reasons for it. The Principal Investigator or their representative may respond to the SU IRB in writing or in person at a convened meeting of the SU IRB.

IV. Notification and Reporting

Notification of Investigations of Determinations or Requests of the SU IRB
All official notification of SU IRB actions shall be in writing and sent to the individual listed as the ‘Principal Investigator’, along with a copy to the faculty advisor on the proposal.
Institution and Departmental Review of Research
Research involving human subjects that has been approved by the SU IRB may be subject to prior or further review and approval or disapproval by divisional, departmental, or institutional officials or committees. These officials or committees may not override SU IRB disapproval of or restrictions on research proposals.
Reporting of SU IRB to Institution

The Compliance Coordinator will distribute the following:

Minutes and official documents to the institutional official within 10 working days.
Other publications approved by the SU IRB to the institutional official within 10 working days.
Minutes are confidential and may not be shared with other than committee members.

V. Guidelines for Submission of Research Proposals to the SU IRB

Definitions

HUMAN SUBJECT
An individual about whom an investigator (whether professional or student) conducting research obtains:

Data through intervention or interaction with the individual, or
Identifiable private information.

INFORMED CONSENT
An agreement between an investigator and freely participating subjects that informs the subjects of their role, the procedures, and potential hazards or risks of the study and describes all activity features that might reasonably be expected to influence their willingness to participate.

Note that, for minor subjects or other subjects who cannot give their consent, a parent, legal guardian, or other person legally in charge of the subject's welfare must give their written consent. If a minor subject can understand the consent procedure, their assent should also be obtained.

A sample of an approved informed consent format and the necessary elements of the explanation of the study can be found on the SU IRB website. Note that, in the case of written consent, a copy of the informed consent document and the explanation of the study must be given to each subject.

The SU IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds either:

That the only record linking the subject and the research would be the consent document and the principal risk would be the potential harm resulting from a breach of confidentiality, or
That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
In the event that written consent is not required, a copy of the explanation of the study (including the rights of the subject) must be given to each subject. This situation arises most often in the cases of mailed questionnaires, telephone interviews, or similar situations. If this is not practical or feasible, the investigator should justify the omission.

MINIMAL RISK
The risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

VI. Overview of SU IRB Forms

All SU IRB forms discussed here are available for download on the SU IRB website.

Submission Checklist

A Checklist to assist in the preparation of material for submission to the SU IRB.

Form C

Request for extension or notification of changes to a proposal already approved by the SU IRB.

Consent Form Templates

Multiple templates for developing an informed consent document for use in various contexts.

Assent Form Template

A template for developing an assent form document to be used in conjunction with a Consent Form template. Assent should be given by minors or other human subjects who are unable to provide consent. In this case, consent should be provided by the subject’s legally authorized representative.

Electronic Equipment Safety Check Memorandum

Used to document that electronic equipment used in the research project is inspected and determined to be electronically safe for use in human research.

VII. Selecting Your Review Category

No Review

No forms need to be filed when the proposal does not constitute human research. Human research is defined by 45 CFR 46.102(i) as “a systematic investigation designed to develop or contribute to generalizable knowledge.” If in doubt, consult any member of the SU IRB committee or IRB Compliance Coordinator.

Common proposals within SU that do not need to be submitted to the SU IRB include:

Institutional evaluations of departments, curriculums, or programs.
Standard student clinical or teaching situations that do not involve collection of data for publication.
Student classroom projects that do not involve collection of data for publication.
Case reports (three or fewer participants) from standard clinical practice.

Exemption Requested Review

The following types of research may be exempted from committee review if proper procedures to assure confidentiality and informed consent are evident and subjects are exposed to no more than "minimal risk" (see definitions) under 45 CFR 46.104. These include:

Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

The identifiable private information or identifiable biospecimens are publicly available;
Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

Taste and food quality evaluation and consumer acceptance studies:

If wholesome foods without additives are consumed, or
If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).
Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:

Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);
Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

Expedited Review

The categories of research eligible for expedited review authorized by 45 CFR 46.110 and 21 CFR 56.110 are:

Clinical studies of drugs and medical devices only when condition (i) or (ii) is met.

Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.
Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
from other adults and children2, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

Prospective collection of biological specimens for research purposes by noninvasive means.

Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)

Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
Continuing review of research previously approved by the convened IRB as follows:

where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
where no subjects have been enrolled and no additional risks have been identified; or
where the remaining research activities are limited to data analysis.

Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

D. Full Committee Review

Any research not covered by the conditions of Exemption or Expedited Review, including research which involves more than "minimal risk," or which could not be approved using other review categories, will require a full review.

VIII. Required Documentation by Category

If Exemption Requested Review is selected, the principal investigator must submit the following items:

Explanation of Protocol via Application Sections on Sitero Mentor
Informed consent document(s)
Letter of approval from each cooperating organization's institutional review board or assurance (conditional)
Recruitment materials
Surveys, guided interview questions, or any further supplemental materials

If Expedited or Full Review is selected, the principal investigator must submit the following items:

Explanation of Protocol via Application Sections on Sitero Mentor
Informed consent document(s)
Letter of approval from each cooperating organization's institutional review board or assurance (conditional)
Electrical equipment safety check memo (conditional)
Recruitment materials
Any further supplemental materials

IX. Electronic Submission – Sitero Mentor IRB System

Investigators should submit completed applications to the Sitero Mentor IRB System. Once submitted, the Compliance Coordinator will assign a unique project number to the application and initiate the review process. All subsequent correspondence about your protocol should go through Mentor and include the project number to avoid confusion.
If data collection is planned at a site not owned by Shenandoah University (SU), the investigator must send a copy of the SU IRB application to each additional facility for independent review. After the review has been completed by the participating institution(s), an administrative representative of the site(s) must send a signed letter of approval on organization letterhead to the SU Compliance Coordinator. Simultaneous review by all involved institutions should result in fewer processing delays. Initial SU IRB approval can only be granted for data collection on SU campuses. Supplemental approval by the SU IRB and participating site(s) must be obtained in writing prior to data collection at the new site(s).
Investigators should request the type of review most appropriate for their study (see Checklist for help).
All protocols are reviewed by the SU IRB (full review) or committee member(s) (exempt or expedited). In the event that the Chair or a member of the SU IRB disagrees with the investigator's selection of a review category, the Compliance Coordinator will contact the investigator to explain the reasons for disagreement and to inform the investigator of the need for any additional information to continue the review process. Investigators are encouraged to contact the Compliance Coordinator prior to the submission of their protocol if they have any questions about the eligibility of their study for a particular type of review.
All information requested must be complete, follow the prescribed format, and be typed.
Investigators must submit all information electronically through Sitero Mentor using University-approved forms (see Checklist for explanation). Do not change the default fonts or margins of the online forms because this will require extensive reformatting of the finished documents.

X. Timeline

The approximate times for completion of the review process are:

Exempt Review: 2-4 weeks
Expedited Review: 3-6 weeks
Full Review: 6-8 weeks

This timeline may lengthen if revisions and additional information are required by the SU IRB in order to make an informed decision. Investigators should submit information well in advance of the anticipated date to begin data collection.
The committee's actions, comments, and recommendations will be sent to the investigator by the Compliance Coordinator, along with instructions and forms necessary to complete the review process. The primary reviewers remain anonymous to the applicant.
After compliance with each SU IRB recommendation, conditional approval for use of human subjects in research on Shenandoah campuses will be granted in writing. In the event that the SU IRB does not approve the protocol, the investigator has the right to an appeal. Notify the Compliance Coordinator of the request for an appeal by email within two weeks of receiving notification of denial of approval. The hearing will then be arranged at the earliest possible date convenient to all parties involved.

XI. Communication with the Committee

Communication between the Committee and the Principal Investigator occurs through the IRB Compliance Coordinator. The Compliance Coordinator may be reached at:

IRB Compliance Coordinator

c/o Office of the Provost

1460 University Drive

Winchester, VA 22601

Phone: (540) 535-3593

sucomply@su.edu

XII. Compliance with state and local laws and organizational policies

In addition to complying with the federal law embodied in these policies and procedures, investigators are expected to comply with all applicable state and local laws, and the policies of Shenandoah University. In addition, when research is conducted at external organizations, investigators will comply with all of the organization’s applicable policies and procedures.

XIII. International Research Policy

Research conducted in countries other than the United States by Shenandoah University personnel, which includes faculty, staff, and students, is subject to Shenandoah University IRB policies. Requests for a waiver of any of these policies as a result of conflict with legal or standard cultural practices of the country in question must be approved by the board and be in compliance with United States federal regulations. To apply for a waiver, researchers must provide an explanation of the specific issue they are requesting to be waived along with evidence of site compliance.

(January 22, 2007)