IRB Policies and Procedures 10-2013 Approved.Pdf

DUQUESNE UNIVERSITY INSTITUTIONAL REVIEW BOARD FOR HUMAN SUBJECTS PROTECTION

POLICIES AND PROCEDURES

Date Revised: May, 2007 Revised October, 2013 Approved October 9, 2013

2

TABLE OF CONTENTS

Introduction ...... 4

Article I: IRB Administration ...... 4

A. Composition and Structure ...... 4 B. Responsibilities ...... 4

Article II: Rules of Order ...... 5

A. Meetings ...... 5 1. Regular ...... 5 2. Unscheduled ...... 5 3. Quorum ...... 6 4. Subcommittees ...... 6 B. Conflict of Interests ...... 6

Article III: Protocol Review ...... 6

A. Definition of Research ...... 6

1. Research Activities in the Classroom ………………………………………… 7 2. Faculty Serving as Co‐Investigator on External Study ……………….. 8 3. International Research ……………………………………………………………… 8 4. Protection of Children from Abuse Clearances …………………………. 8 5. Recruitment of Duquesne University Students by External Researcher ……………………………………………………………..8

B. Types of Review ...... 9 1. Exempt ...... 9 2. Expedited ...... 10 3. Full ...... 11

Article IV: Informed Consent...... 11

1. Elements of Informed Consent ...... 11 2. Child Assent ...... 12 3. Waiving Consent ...... 12 4. Documentation of Informed Consent ...... 13

Article V: Responsibilities ...... 14

Revised: October 14, 2013 3

1. Principal Investigator ...... 14 2. Faculty Advisor ...... 14 3. Primary Reviewer ...... 14 4. Secondary Reviewers ...... 14 5. External Reviewers ...... 14

Article VI: Continuing Review ...... 15

1. Annual Review ...... 15 2. Changes in Study Methodology ...... 15 3. Unanticipated Risks ...... 15

Article VII: Reports of Non‐Compliance ...... 16

Article VIII: Human Subject Protection Training ...... 16

Article IX: Procedures for Submitting Protocols ...... 17

Article X: Deadlines ...... 19

Article XI: Amendment ...... 20

Revised: October 14, 2013 4

INTRODUCTION

The Duquesne University Institutional Review Board (IRB) is responsible for ensuring compliance with federal regulations, university policies and professional standards guiding the conduct of research involving human subjects. Accountable to the Associate Academic Vice‐President of Research, the IRB ensures the protection of the rights of human subjects by assuring the University and federal regulating agencies that all research conducted by faculty, staff or students of Duquesne University conforms to the principles inherent in the Belmont Report that serve as the standard for research involving human subjects: respect, beneficence and justice. As such, all research conducted by faculty, staff or students of Duquesne University must be approved prior to data collection by the IRB in accordance with the policies and procedures set forth in this document.

The principle source for the policies and procedures set forth in this document is the Code of Federal Regulations Title 45, Part 46 which was published in 1991 by the U.S. Department of Health and Human Services, National Institutes of Health, and the Office for Protection from Research Risks (OPRR,) now reconstituted as the Office for Human Research Protections (OHRP.) The IRB shall require documentation or may waive documentation of informed consent according to terms specified in 46.117 of the code.

ARTICLE I: IRB ADMINISTRATION

Composition and Structure

The IRB membership includes faculty representatives from all schools in which human subjects research is customary and at least one non‐scientist member and one external member who has no direct relationship to the University. Federal regulations mandate a diverse committee in terms of gender and ethnicity. Depending on average IRB activity, some divisions within the university have two regular representatives and one alternate while others have one regular representative and one alternate member. With the approval of the Office of Research, members are assigned or appointed by deans of schools or heads of divisions. The board asks that members commit to serve no less than 3 years.

Responsibilities

Members are responsible for ensuring that protocols that are submitted for approval meet acceptable standards of scientific merit for the disciplines and federal standards for protection of the rights of human subjects. By accepting appointment to the IRB, members agree to maintain confidentiality, review protocols in a timely manner in accordance with acceptable standards of scientific merit for their disciplines and attend

Revised: October 14, 2013 5

meetings or to notify alternates to attend in their places. Failure to attend three consecutive scheduled meetings may result in termination of membership.

The IRB Chair serves in an administrative capacity to provide the approval for exempt, expedited and full review protocols as well as quality improvement/program evaluation projects. The Chair is responsible for reviewing all protocols, ensuring compliance with federally mandated standards and with the policies and procedures of the IRB. The Chair coordinates the review process, chairs the meetings, provides a mechanism for orienting new members and is responsible for records. The Chair ensures that records and minutes are maintained in accordance with federally mandated standards.

Faculty members of the IRB are appointed by the Associate Academic Vice‐President for Research upon the recommendation of the Deans of their respective Schools. The Chair is appointed by the Associate Academic Vice‐President for Research with the approval of the Provost and Vice‐President for Academic Affairs. Any member may recommend new members for appointment to the IRB. Nominations are submitted to the Chair to forward to the Associate Academic Vice‐President.

In addition to the Committee and Chair, a third person serves to oversee human subjects’ protections. The Human Protections Administrator (HPA) is the University official charged with serving in a liaison role between the University and the federal regulating agencies, primarily the department of Health and Human Services. The HPA ensures accountability of the Duquesne IRB and reports to the Associate Academic Vice‐ President for Research in this capacity.

The Associate Academic Vice‐President for Research serves as the University official responsible for research compliance and safety and reports to the Provost and Academic Vice‐President. The HPA and IRB Chair are accountable to him for the research compliance functions, as are the animal subjects committee and biohazard committee.

ARTICLE II: RULES OF ORDER

Meetings

Regular

Regularly scheduled meetings are held bimonthly (September, November, January, March, May and July) or more frequently as needed. Meetings are canceled at the discretion of the Chair at the deadline date for receipt of IRB protocols. The deadline for protocols requiring full review is two weeks prior to the meeting for the IRB representatives from each School or the College to review. Dates will be posted on the web annually.

Revised: October 14, 2013 6

Unscheduled

Unscheduled meetings may be called at the discretion of the Chair, typically when a violation has been reported.

Quorum

A quorum is defined as a simple majority of voting members. Alternate members vote in place of but not in addition to voting members. Action on motions may be deferred until the next meeting if a quorum is not present.

Subcommittees

Subcommittees may be appointed by the Chair to address specific issues, for example, orientation of new members.

Conflict of Interests

Members may not participate in reviews in which they have a vested interest. For example, if a voting member from a School or the College plans to serve as the PI or plays a role in a study (such as dissertation advisor), the alternate member will review and vote on the protocol for the study. If the IRB Chair is the PI or has a role in the study, the HPA will issue approval and/or serve as the Chair for that portion of the meeting.

ARTICLE III: PROTOCOL REVIEW

Definitions of Research and Research Subjects

Duquesne University defines research according to the Office for Human Research Protection (OHRP), which states in 46.101 Section d that

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities, which 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. For example, some demonstration and service programs may include research activities.

In Section f, the OHRP defines human subject as a living individual about whom an investigator obtains data through intervention or interaction with the individual or identifiable private information. In qualitative research, it is customary to refer to the subject as participant or cultural informant, but for the purposes of the IRB all participants will be called subjects. Private information is that in which the person

Revised: October 14, 2013 7

reasonably expects that no observation or recording is taking place or information the person would not expect to be made public (e.g. medical records, school grades, psychotherapy notes.)

A researcher who obtains aggregate data without personal identifiers or links to identifiers does not need to undergo IRB review. In addition, if a researcher receives individual data but cannot discover the identity of individuals because the repository does not have it or forbids access, the research does not need to undergo IRB review. The representative from the local division determines whether data from a repository involves possible identifying links requiring IRB review, conferring with the chair at the representative’s discretion.

Research Activities in the Classroom

Although all human subject research requires prior institutional approval, not all data gathering by students constitutes human subject research. To be research, an activity must be designed with the intent to develop or contribute to “generalizable knowledge.” Clearly, some classroom activities are designed to teach research techniques and have no such intent. Simulations of human experimentation an course‐ assigned data collection do not constitute human subjects research if the activities are designed for educational purposes only; and, the data will not be generalized outside the classroom or university setting (reporting of data within the class or the university setting is acceptable because the activities were performed solely for teaching purposes); and, the data will not result in a master’s thesis, doctoral dissertation, or poster session, abstract, or other publication or presentation disseminated off campus; and, the student volunteers or other participants are clearly informed that the activities are an instructional exercise, and not actual research. If an instructor however determines that there is a possibility that a student’s proposed research project may result in a formal presentation or publications, the instructor should recommend that t6he student submit the project for IRB review before beginning the study. There may be instances when a student or instructor wishes to use data for research that was previously collected for educational purposes. In this case, an application should be submitted to the IRB when a student or instructor wishes to analyze the data with the intent of contributing to generalizable knowledge. Therefore, there are some types of classroom activities may be mandated for approval by the IRB. The criterion for mandatory IRB review is that the activity meets the federal definition of research as specified in 46.101 Section d. In the case of any question as to whether or not a classroom activity should be reviewed by the IRB as research, the person should contact either the IRB Chair or the representative for the School or College. The IRB reserves the right to fulfill its mandate by reviewing any activity it deems to be research according to the federal definition in 46.101 Section d.

Revised: October 14, 2013 8

Faculty Serving as Co‐Investigator on External Study

A faculty member at Duquesne University serving as a co‐investigator on a research study that has been approved by another IRB (that is, the PI is affiliated with another institution within the United States) does not need to seek approval from Duquesne University’s IRB unless the PI’s institution is from outside of the United States.

International Research

Researchers conducting international research, regardless of their role on the research team, should submit an application for review by Duquesne University’s IRB to ensure that human subjects outside of the United States who participate in research projects receive the same level of protections as research participants inside the United States. The researcher should contact either the IRB Chair or the representative for the School or College should that person have any question as to whether or not a research study should be reviewed by Duquesne University’s IRB. The IRB reserves the right to fulfill its mandate by reviewing any activity it deems to be research according to the federal definition in 46.101.

Protection of Children from Abuse Clearances

All individuals who may interact with children as part of an IRB approved protocol are required to have the Protection of Children from Abuse clearances as follows: 1) Pennsylvania Department of Public Welfare Child Abuse Clearance History; 2) Pennsylvania State Police Criminal Report Check; and, 3) FBI Criminal Background Check. It is the responsibility of the Principal Investigator to ensure that all members of the research team including faculty and students have these clearances prior to any interaction with children. Interact refers not only to face‐to‐face meetings, but also includes communication via phone, text messaging, or internet. A participating investigator or support staff member who does not have personal contact with children (e.g., statistician or laboratory personnel) does not need to obtain clearances.

Recruitment/Participation of Duquesne University Students by External Researcher

We often receive requests from researchers outside of the university who may want to recruit Duquesne University students. The researcher must submit a written request to the Chair of the IRB that outlines the details of the study and includes all pertinent documents such as the recruitment flyer and consent form if applicable. The Chair of the IRB will review the request and discuss with the Executive Vice President of Student Life prior to issuing an approval letter. In addition, specific requirements must be met prior to recruitment of Duquesne University students including: 1) the research proposed must be consistent with the Mission of the University; 2) the study must provide

Revised: October 14, 2013 9

students with a genuine benefit for their participation; and, 3) the study must have IRB approval from another institution. Types of Review

The investigator is responsible for carefully reviewing the criteria for exempt, expedited, and full‐review studies as defined in the Code and listed here. However, the IRB ultimately determines the category of approval. All research involving human subjects must be reviewed by the IRB.

Exempt (according to 46.101 of the Code)

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special educational instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b) (2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

5. Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those

Revised: October 14, 2013 10

programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if 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.

Note: Ordinarily exemptions do not apply to categories of vulnerable populations.

Expedited

Expedited review approval may be given if the study involves no more than minimal risk and falls within one of the expedited categories as described in the Code, which is subject to review and change:

1. Clinical studies of drugs and medical devices only when the drugs or devices have been approved for marketing and are used as prescribed.

2. Collection of blood samples by finger stick or venipuncture from non‐ pregnant healthy adults in amounts less than 550 ml in an eight‐week period and no more than twice per week.

3. Prospective collection of biological specimens by non‐invasive means (e.g. hair and nail clippings, extracted teeth, excreta and external secretions, uncannulated saliva, placenta removed at delivery, amniotic fluid obtained at rupture of membrane prior to or during delivery, dental plaque and calculus, mucosal and skin cells collected by swab and sputum collected after saline mist nebulization.)

4. Collection of data through non‐invasive procedures routinely employed in clinical settings, excluding x‐rays or microwaves (e.g. physical sensors that do not shock or invade the subject’s privacy, weighing or testing sensory acuity, magnetic resonance imaging, EEG, EKG, moderate exercise or strength testing with healthy non‐pregnant subjects.)

5. Research involving data, documents, records or specimens collected for non‐research purposes, such as medical records.

Revised: October 14, 2013 11

6. Collection of data from audio or visual recordings.

7. Research on individual or group characteristics when considering the subject’s own behavior (including perception, cognition, motivation, identity, language, communication, socio‐cultural beliefs, practices or behavior) or research employing survey, interview, oral history, focus group or program evaluation measures for purposes of research.

Note: Expedited category excludes research on children, vulnerable persons or sensitive content.

Full Review

A full review is conducted when research procedures pose risks to subjects or when subjects, as a group, belong to a vulnerable population. The IRB is particularly concerned with research involving the following:

1. Subjects under the age of 18; 2. Pregnant subjects; 3. Frail elderly subjects; 4. Incarcerated subjects or persons under a correctional sentence (parolees); 5. Mentally impaired subjects; 6. False or misleading information to subjects; 7. Withholding information such that subjects’ consent is in question; 8. Procedures for debriefing subjects; 9. Biomedical procedures; 10. Procedures that are novel or not accepted practice; and, 11. Risky procedures or harmful effects, including discomfort, risk of injury, invasive procedures, vulnerability to harassment, invasion of privacy, controversial information, or information creating legal vulnerability.

ARTICLE IV: INFORMED CONSENT

Elements of Informed Consent

Imperative in conducting research is that the investigator obtains legally effective informed consent of the subject or the subject’s legal guardian. Inherent in the process of obtaining informed consent is that the subjects have sufficient opportunity to consider whether or not to participate and that all questions have been answered to the satisfaction of the subject. The informed consent process must indicate no coercion, undue influence to participate or exculpatory language in which subjects are asked to

Revised: October 14, 2013 12

waive their rights. Basic elements of informed consent as defined in Section 46.116 of the federal code must be described in all protocols:

1. Statement of the purpose of the research, duration of subject’s participation, procedures and identification of any experimental procedures; 2. Foreseeable risks or discomforts; 3. Reasonable benefits to the subject or others; 4. Alternative procedures; 5. How confidentiality will be maintained; 6. Compensation, including whether and what type of medical treatment is available in case of injury; 7. Names, credentials and phone numbers of persons to contact for clarification about the research, the subject’s rights and whom to contact in case of injury; and, 8. Statement that participation is voluntary, refusal to participate involves no penalty and that subject may withdraw at any time without penalty.

Additional elements of informed consent that may be appropriate for certain types of studies:

1. Statement that the treatment may involve risks to subject or fetus if pregnant subject or may become pregnant during study; 2. Circumstances under which subject may be dropped from study without regard to subject’s consent; 3. Additional costs to subject from participating in study; 4. Consequences of subject’s decision to withdraw from study and procedures for orderly termination; 5. Statement that significant new findings of the study which might affect subject’s willingness to continue will be provided to the subject; and, 6. Approximate number of subjects in study.

Child Assent

In cases in which the research subject or participant is a child (defined as under the age of 18) the researcher shall obtain the consent of the parents or guardian and the assent of the child. Assent is the agreement of the child to participate. The process for obtaining assent should follow the procedures for obtaining consent by the parents, with the form for assent written in age‐appropriate language and sufficient attention given to explaining the study and answering the child’s questions.

Waiving Consent

Revised: October 14, 2013 13

The IRB may waive some or all of the elements provided there is documentation that the research is to be conducted by or subject to approval by state or local government officials. In addition, it is possible to waive consent when the following conditions apply:

1. Risk is minimal; 2. No adverse effects on the rights of subjects; 3. Research could not practically be carried out; and, 4. Subjects would be provided with additional pertinent information after participation.

Documentation of Informed Consent

Written consent signed by the subject or guardian is necessary for most studies. The consent form must have all appropriate elements specified in the IRB Instructions to Researchers. Consent forms and assent forms must be submitted for IRB review. The first page of forms should be on Duquesne University letterhead. When the forms are approved, the IRB Office will stamp them with an approval date and a one‐year expiration date. If researchers still need to utilize the forms after one year, they need to resubmit the forms for a new one‐year approval.

There are two consent/assent forms with original signatures, one for the subject and one for the researcher.

Adequate time to read and ask questions must be given to the subject prior to asking for the signature. In cases in which an oral consent is requested, the administration of the oral consent must be witnessed and a written form signed by the witness with a copy provided to the subject.

The IRB may waive the requirement for a written signed consent in either of the following cases:

1. The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from breach of confidentiality. In this case the subject shall be asked whether he or she wants to sign a consent form.

2. The research involves no more than minimal risk and involves no procedures for which written consent is normally required outside the research context. (Example would be a questionnaire in which consent is implied by the fact of the subject returning the questionnaire.)

In either case, the researcher should provide the subject with a written description of the study that includes the elements of informed consent.

Revised: October 14, 2013 14

ARTICLE V: RESPONSIBILITIES

Principal Investigator

The role of the principal investigator (PI) is to document to the IRB that the study for which approval is requested has sufficient merit according to the standards of the discipline; that the IRB protocol is complete and accurate; that assurance is given the IRB that rights of human subjects are protected in accordance with the principles of the Belmont Report; and, that there is compliance with all Duquesne University IRB policies and procedures.

Faculty Advisor

If the PI is a student, the faculty advisor (dissertation chair or other faculty member) shall be responsible for ensuring that the student’s protocol meets the standards. The faculty advisor shall indicate that he or she is fully aware of the human protection considerations of the study by indicating their approval of the protocol prior to its submission to the IRB representative. In addition, the advisor must complete the Collaborative Institutional Training Initiative (CITI) Training Program required of the student. See article VIII.

Primary Reviewer

The primary reviewer is generally the voting member or alternate member of the IRB from the PI’s School or College. The primary reviewer ascertains that the protocol is submitted in the proper format and meets the criteria for the type of review for which it is submitted. The primary reviewer works with the PI and/or faculty advisor to make any obvious revisions needed prior to their approval. Once all revisions as requested by the IRB representative/reviewer are met and the reviewer has indicated their approval, the protocol will be returned to the researcher/PI. The PI is responsible for submitting the approved protocol to the IRB Chair for final approval. Protocols that require exempt or expedited reviews require the approval of the primary reviewer and the Chair of the IRB.

Secondary Reviewers

A second IRB representative reviews the protocol for full‐board submissions. In exempt and expedited cases, the primary reviewer or chair may request a secondary review, but it is not required by policy.

External Reviewers

Revised: October 14, 2013 15

In some cases, the IRB might wish to consult outside experts in the field of study. These individuals submit a written review of the protocol to the IRB, but do not vote. External reviewers are not necessarily employed by Duquesne University. (Two examples of use of the outside reviewer are when a study uses a controversial methodology unfamiliar to the members of the IRB or any other faculty or when the study involves a culture or requires expertise in a topic unfamiliar to IRB members.

ARTICLE VI: CONTINUING REVIEW

The IRB is required to review studies periodically to ensure that the protective conditions under which approval was given initially remain true. There are two conditions under which the IRB reviews protocols on a continuing basis: 1) annual review of all studies approved by the IRB; and, 2) review of studies in which there are changes to the protocol after approval in which case an amendment form must be submitted along with appropriate documents.

Continuing Review for Follow up of Subjects in Research Protocols.

HHS regulations at 45 CFR 46.109(e) state that an IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year. HHS regulations at 45 CFR 46.102(f) define human subject as 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. Even where (i) the research is permanently closed to the enrollment of new subjects; and (ii) all subjects have completed all research‐related interventions, continuing review is required as long as the research remains active for long‐term follow‐up of subjects and continues to involve non‐exempt human subjects’ research. Furthermore, continuing IRB review of research is required where the remaining research activities are limited to data analysis of individually identifiable private information.

Annual Review

Approximately 11 months after initial approval is granted, the PI will receive an email reminder to update the IRB on the status of the study. This is done to comply with the federal mandate to conduct annual reviews. An update of all expedited and full board reviews is provided to IRB members at board meetings. An annual review is not required of an exempt study. In cases that previously involved full‐board approval, any significant changes or developments are discussed by the full board. Compliance is expected in a timely fashion. If the PI does not comply by submitting an annual review in a timely manner, all recruitment and data collection procedures must stop until an annual review form is received and approved.

Revised: October 14, 2013 16

In addition, all PIs regardless of the type of review that was required must complete and submit the annual review form at the end of the study indicating that the study was completed or terminated. In addition, an abstract of the findings should be submitted.

AMENDMENTS TO APPROVED STUDIES

Any significant changes to the methodology or key personnel must be approved by the IRB in writing prior to their initiation. Researchers proposing to change any aspect of an approved study should contact the IRB Chair to determine if the changes require approval of an amended protocol. If they do require review, the Chair will designate a representative or representatives to act as reviewers. Usually these are individuals in the same capacities as the reviewers of the original protocol. The proposed amendment should include all pertinent sections of the protocol, with explanations of how and why the researcher requests to amend the original methodology. In addition, all pertaining documents must be submitted along with the amendment form. For example, any changes related to recruitment activities/recruitment flyer or to the consent form must be included.

The IRB may request verification from sources other than the investigator that no significant changes have occurred since previous IRB review. This decision will be made by the IRB chair or board on a case‐by‐case basis, depending on the likelihood that the investigator cannot offer an adequate verification.

Unanticipated Problems

If unanticipated risks or hazards are discovered during the course of the research, the PI shall immediately suspend research activities and notify the IRB chair in writing. The Chair will consult with the original IRB reviewer or reviewers to determine what actions to take. The researcher may not continue research activities until receiving permission from the IRB Chair.

ARTICLE VII: REPORTS OF NON‐COMPLIANCE

Non‐compliance with human subject protections is considered a serious infraction of research ethics and places the University at risk for federal sanctions. Failure of the PI to comply with the protocol that was approved or with human subject protections in general may result in suspension of IRB approval. The IRB is required to report suspensions to the federal Office of Human Research Protections. In addition, suspensions are reported to funding agencies and to the Duquesne University Associate Academic Vice President for Research.

ARTICLE VIII: HUMAN SUBJECTS’ PROTECTION TRAINING

Revised: October 14, 2013 17

The IRB requires that Principal Investigators and Co‐Investigators who submit protocols provide documentation of completion of the federal OHRP training for protection of the rights of human subjects in research. Documentation is in the form of the training certificate issued by the training site. At Duquesne University we require all Principal Investigators, Co‐Investigators, other members of the research team, student researchers and their faculty advisors to complete the Collaborative Institutional Training Initiative (CITI) Training Program. The CITI certificate for all members of the research team must be uploaded to Mentor IRB software program when submitting a protocol. IRB Protocols will not be reviewed without evidence of training. CITI training must be renewed every three years. Members of the research team will receive notification of this at least one month prior to expiration and expected to comply. The CITI training is linked with the Duquesne University IRB site. NIH training certificates will not be accepted after March 15, 2014. All IRB members are expected to take the CITI training for IRB members by March 15, 2014.

ARTICLE IX: PROCEDURES FOR SUBMITTING PROTOCOLS

1. Prior to development of an IRB protocol, the PI should review the Office of Research IRB web site or Mentor via www.dori.duq.edu for the latest policies, procedures and forms since updates are made on a regular basis and complete the CITI training modules as specified on the site. Questions about policies and procedures should be directed to the school committee member or IRB Chair. The PI should determine whether he or she believes the protocol qualifies as exempt, expedited or full based upon the policies and request that type of review when submitting their IRB Protocol via Mentor. PIs are also encouraged to use the decision tree located on Mentor to determine the type of review required.

2. As of the beginning of the Spring Semester 2014, all faculty, students and staff are required to submit their IRB protocols through a software IRB tracking system called Mentor. Several documents are available on Mentor that will assist the researcher. Specific forms for the Protocol Summary, consent, amendment, annual review, etc. are available on Mentor and must be used accordingly.

3. Mentor is accessed through www.dori.duq.edu by clicking on the IRB icon. The PI (faculty, student or staff) must first create an account and thus, log in to Mentor. The first page is the information page and should be reviewed by all researchers. To submit a protocol, the researcher should click on My Protocols that is found on the left hand side of the page. Then click, Create New Protocol. Several fields must be completed such as name of PI, co‐investigators, School/College, and advisor’s name if appropriate. In addition, the researcher must determine the

Revised: October 14, 2013 18

type of review required and answer several required questions such as whether the protocol has been submitted to another IRB; subject compensation; HIPAA; and whether or not biomedical procedures will be employed. At the end of the form, the researcher can upload the IRB Protocol Summary Form that can be accessed via Mentor Information Page or via the IRB Documents tab. Please note that all forms are also available on the Office of Research website under IRB.

4. The PI completes the IRB Protocol Summary Form in WORD and uploads the document to Mentor via My Protocols. Consent forms and demographic data forms must also be submitted in WORD. Instruments/questionnaires may be submitted in PDF. Mentor will generate an email notification to alert the School or College IRB representative that a protocol is ready for review. If the IRB protocol is submitted by a student, Mentor will generate an email notification to the advisor who will need to login to Mentor and respond with an email indicating that they approve the student’s IRB Protocol. The School or College IRB representative will review the IRB Protocol and either approve it or return it to the researcher for revisions via Mentor. Once the School or College IRB representative indicates their approval of the IRB Protocol, Mentor will generate an email notification to the IRB Chair for final approval.

5. For exempt and expedited reviews, one primary review is required prior to the final review by the IRB Chair. However, if the primary reviewer wishes, a second IRB representative may be asked to review prior to sending to the IRB Chair’s final review. The Chair may also request a second review if deemed advisable. For full board cases, two IRB representatives review the protocol before it is reviewed at the full board meeting.

6. The IRB Chair reviews the protocol for compliance with the standards and approves the study’s status. In exempt and expedited cases, the Chair either approves the proposal or communicates the need for revisions within two weeks of receipt but longer periods may be necessary due to vacations or difficulty reaching the PI. In cases of full review when revisions are satisfactory to the two reviewers and the Chair, the Protocol Summary will be reviewed at the next scheduled Full Board IRB meeting. A schedule listing the dates for full board meetings is available on the IRB Office of Research website and on Mentor. Due dates to IRB representatives and for full board review must be adhered in order for the researcher to have their Protocol reviewed by the full board at the next available meeting date.

7. In exempt and expedited cases, the Chair reviews the proposal, requests revisions if needed, and when the protocol meets IRB requirements, issues a letter to the PI. Researchers may not begin contact with subjects, soliciting them or collecting data, until after receipt of the approval letter from the Chair of the IRB.

Revised: October 14, 2013 19

8. For full review, the IRB meets to discuss the study and vote as a group that human subject protections are adequate. It is acceptable for the PI to be available outside the room or via phone for questions, but this is not necessary. The primary reviewer presents the study and the secondary reviewer may also comment. After discussion, the vote is taken. The Chair issues the approval letter after the vote or informs the PI of required revisions. Communications about changes to protocols for student research will be copied to the faculty advisor. If the IRB requires further revisions or does not approve the research, the IRB Chair shall communicate with the PI as soon as possible after the meeting.

9. All official approvals are issued by the IRB Chair. The PI may not collect data before receiving official approval from the Chair. Every attempt will be made to review protocols in a timely yet thorough manner. Ordinarily the PI will receive notification of the decision within two weeks in exempt and expedited cases and within two weeks after board meetings in full‐review cases.

10. It is the responsibility of the PI to inform the Chair of termination of the study or changes in methodology or personnel prior to annual review, and it is the responsibility of the PI to promptly respond to annual review inquiries. Annual review forms and Amendment Forms are available on Mentor.

11. It is also the responsibility of the PI to inform the Chair of any adverse reactions that may occur as a result of the protocol. This form is available on Mentor and must be completed along with a plan to prevent future adverse reactions. In addition, all recruitment and data collection procedures must come to a stop until the Chair reviews the adverse reactions and the plan of action submitted by the researcher to prevent further adverse reactions. The Chair may consult with other IRB representatives and may also deem it necessary for the full board to review prior to the researcher restarting recruitment and data collection procedures. Once a decision is made, the Chair will notify the researcher. If this is a student’s study, both the student and the advisor will be notified.

ARTICLE X: DEADLINES

Protocols for Exempt and Expedited reviews are accepted by the IRB Chair at any time via Mentor submission process. Although every attempt will be made to provide a quick review, PIs should expect an approval decision within two weeks from the time an email notification was sent by the school/college reviewer to the Chair of the IRB unless revisions are requested by the Chair of the IRB. Protocols for Full review will be assigned to the next scheduled Board meeting. The deadline for receipt of all complete, revised protocols requiring a full board review must be received at least seven (7)

Revised: October 14, 2013 20

business days prior to the scheduled meeting. Please see IRB calendar including due dates on Mentor or the Office of Research IRB website.

ARTICLE XI: AMENDMENTS

Amendments to this document may be made whenever federal regulations change or at the direction of the Associate Academic Vice‐President for Research or the Chair of the IRB. Procedures will be reviewed on a regular basis consistent with the spirit of continuous improvement.

Revised: October 14, 2013