PRP 3990 - Institutional Review Board (IRB) for Human Subjects Research

Issued by: James Krause, Interim Provost and Vice President for Academic Affairs
Effective Date: Fall, 2019

NOTES: Amended by Institutional Review Board Fall, 2002 Reviewed by Graduate Council, January, 1994 BUCC approved April 13, 1994, Forum approved October 19, 1994 Reviewed by Graduate Council, December 6, 2002 BUCC approved April 16, 2003 Reported to Forum Nov. 17, 2004 Amended by Institutional Review Board, December, 2007, Endorsed by Graduate Council, December 7, 2007. Approved by BUCC February 6, 2008. Reported to Forum Feb. 27, 2008. Amended by Institutional Review Board, February, 2019. Endorsed by Graduate Council Feb. 27, 2019. Approved by BUCC April 27, 2019. Reported to Forum April 24, 2019.

The Final Rule to update the current regulations at 45 CFR 46, Subpart A - "Federal Policy for the Protection of Human Subjects" (the Common Rule) was published by the U.S. Department of Health and Human Services (HHS) on 19 January 2017 in the Federal Register. The general compliance date for all entities is January 21, 2019. This policy revision reflects changes to the Common Rule.

Feb. 27, 2008.

Introduction

Bloomsburg University recognizes its ethical and legal responsibilities to provide a mechanism to protect individuals involved as subjects in research conducted under the auspices of the University. Research, as defined by the by the Department of Health and Human Services, is the systematic inquiry/investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.. Human subject means a living individual about whom an investigator conducting research (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. Therefore, all research involving human subjects will be reviewed, prior to the initiation of the research, through the procedures set forth by the University and directed by the Institutional Review Board (IRB). Failure to submit research for review and approval is a violation of Bloomsburg University policy. The IRB is not able to approve a project retro-actively.

Key Definitions: See end of policy for key definitions.

Rationale

The University policy entrusts the investigator with the primary responsibility for protection of human subjects. The University assumes the responsibility for ensuring the conditions for protecting human subjects as required by the National Research Act, Public Law 93-348 and implemented by the Department of Health and Human Services (Title 45 CFR 46, Protection of Human Subjects, as amended and by other Federal agencies with appropriate jurisdiction.) The complete document can be reviewed online at the Health and Human Services Office for Human Research Protections.

The University assumes responsibility for encouraging research activities to benefit advancement of knowledge of human conditions and, at the same time, protecting the rights and welfare of human subjects, the investigators, and the University. This includes assuring the scientific validity of the research methodology as it relates to the protection of human subjects. University faculty, staff, and students conducting human subject research are responsible to comply with this policy and all federal regulations. The IRB reserves the authority to suspend or terminate approval of research that is not being conducted in accordance with the Bloomsburg University IRB policy #3990.

The University policy entrusts the investigator with the primary responsibility for protection of individual subjects. The University assumes the responsibility for ensuring the conditions for protecting human subjects as required by the National Research Act, Public Law 93-348 and implemented by the Department of Health and Human Services (Title 45 CFR 46, Protection of Human Subjects, as amended and by other Federal agencies with appropriate jurisdiction.) The complete document can be reviewed online at the National Institutes of Health Office of Human Subjects Research, Regulations and Ethical Guidelines.

Structure

The IRB has the responsibility and authority to approve, require modifications in, or disapprove research involving human subjects.

The IRB Administrator will direct all proposals to the IRB Committee members for review. Applications in the ‘Exempt Review’ category will be reviewed by a single assigned member of the Committee. If this initial reviewer determines that the proposal requires an expedited review, the application will then also be sent to a second IRB reviewer. Applications that are deemed to be more than minimal risk, or do not fit within an Exempt or Expedited review category, will be required to undergo Full Board review, in which case it is sent to all IRB committee members. The IRB Chair will then call a meeting to discuss the proposal.

IRB Membership

The IRB shall be appointed by the Provost and Senior Vice President for Academic Affairs. Federal guidelines indicate that members should possess a sufficient background to be able to look at ethical issues, and that the committee should reflect members of varying backgrounds and diversity, including gender. A committee comprised of the current IRB Chair, the Director of the Office of Research and Sponsored Programs, and the Assistant Vice President and Dean of Graduate Studies and Research, in consultation with the appropriate college dean, will determine the faculty to be recommended to the Provost to fill the five federally required roles. College representatives will be selected by each college dean from the faculty and recommended to the Provost.

All those considered for membership will have a demonstrated record of research/scholarly activity and/or previous IRB experience, and agree to participate fully in the work of the IRB committee. In compliance with federal guidelines, voting members will be appointed to fill the five federally required roles of (1) science representative, (2) non-science representative, (3) ethicist, (4) diversity issues representative, and (5) a representative from outside the university. In addition to those five mandated positions, one voting representative from each of the four Colleges, the College of Business, College of Education, College of Science and Technology, and College of Liberal Arts, will be appointed. Thus the IRB membership roster will consist of 9 voting positions.

As allowed by the federal guidelines, an alternate will be appointed for each position, bringing the IRB membership list to a total of 18 individuals. These alternate members are encouraged to participate fully in the work of the IRB committee and are eligible to review all - proposals. Alternates will vote on occasions when a voting member is absent or when the area of expertise needed for the review is closer to that of the alternate than the voting member. All members must complete the CITI IRB Members Training Course before being eligible to vote.

The term of office will be staggered two-year terms, with terms being renewable. The Assistant Vice President and Dean of Graduate Studies and Research and the Director of the Office of Research and Sponsored Programs, will serve as ex officio, non-voting, members. The Chair will be elected yearly by and from among the voting members of the IRB, and may be renewed yearly for no more than three consecutive years. All IRB Committee Members may nominate a member of the IRB for consideration. It shall be known that the IRB Chair nomination shall first go to a tenured faculty person. In cases where a tenured faculty is unable to serve, the IRB may vote to elect any member of the IRB Board they feel has sufficient experience to serve.

If the IRB Committee is unable to elect a member from the current IRB Board, then a committee comprised of the current IRB Chair, the Director of the Office of Research and Sponsored Programs, and the Assistant Vice President and Dean of Graduate Studies and Research shall make an outside member recommendation to the Provost, who shall review and approve/disprove.

Administration

The University official responsible for carrying out or delegating executive functions is the Provost and Senior Vice President for Academic Affairs. The executive functions include developing and modifying policy to conform to laws and regulations; providing continuing education for personnel with respect to policy; and providing administrative support and legal assistance to the IRB.

Procedures

Investigators must describe their proposed research to the IRB in enough detail that the potential adverse effects and benefits to human subjects can be evaluated. The IRB forms and procedures provide a means for researchers, subjects, the University, and community to communicate clearly and responsibly about the risks and benefits of research involving human subjects and informants. Copies of all IRB forms and corresponding documentation will be stored by the Office of Research and Sponsored Programs and will be available to the IRB Chair, the Assistant Vice President and Dean of Graduate Studies, the Provost and Vice President for Academic Affairs, relevant federal agencies, and others approved by the Provost and Vice President for Academic Affairs. Three principles guide the review process:

• Subjects must give their informed consent to participate in research;
• Investigators must protect subject confidentiality;
• Potential risks to subjects must be balanced by potential benefits of the research.

The review process uses the concept of minimal risk to decide the extent to which subject interests warrant formal and extensive review of research proposals. Minimum risk is defined as "the risks anticipated in the proposed activity, are not greater than those ordinarily encountered in daily life or during performance of routine physical or psychological tests." Risks to subjects are minimized (1) by using procedures which are consistent with sound research design and which do not unnecessarily expose the subjects to risk, and (2) whenever appropriate, using procedures already being performed on subjects for diagnostic purposes.

The IRB classifies research into three categories based on the need to ensure that research conforms to the above principles. These categories are Full Review, Expedited Review, and Request for Exemption from Review. These review categories are discussed in detail in the Guidelines for Human Subject Research.

Basic features of each category are:

1. Full Board Review - A Full Board Review occurs for all other studies that cannot be reviewed and approved at an Exempt or Expedited category. . Full Board Reviews are conducted for proposed research that involves more than minimal risk or where very careful evaluation of risks and benefits is appropriate, minors or vulnerable populations are subjects, or where adverse impact on subjects may occur due to research activities. For example, research exposing subjects to threats to dignity, physical or emotional injury or discomfort, legal liability or arrest, damage to financial or social standing, or procedures in which subjects experience stress or have their behavior, attitudes or beliefs manipulated by researchers must undergo a Full Board Review. A Full Board Review usually involves research that is greater than minimal risk, but also includes minimal risk research that does not meet one or more of the Expedited Review Categories.

In cases where a Full Board Review is necessary, the IRB application is forwarded to all members of the IRB Committee for review, including non-voting members. The IRB Committee then meets to discuss and evaluate the impact on human subjects. The investigator is invited to attend the Full Board meeting to provide an overview of the proposed study, and to answer any questions. The Investigator will then be excused. No individual involved in the conduct and/or supervision of the research project is to participate in its review, except to provide information to the IRB.

After review, and once the Investigator is excused, all IRB Board members discuss the protocol concerns. Once discussion is complete, the IRB voting members, or the appropriate alternate, vote to: 1) approve the protocol “as is”, 2) approve the study with minor conditions/revisions, 3) defer until substantial revisions are made, or 4) disapprove the research. Approval is by majority vote in all cases, with a quorum of members and at least one member whose primary concerns are in nonscientific areas.

2. Expedited Review - Expedited Review occurs when at least two members of the IRB, designated by the IRB Administrator, review the proposal and independently indicate 1) the protocol is approved “as is”, 2) approve with certain conditions, 3) require revisions to be resubmitted. Researchers are not required to meet with reviewers. Reviewers frequently give written comments advising the researcher on ways to enhance the protection of human subjects. Reviewers may ask for more information or require changes in procedures to enhance the provisions for informed consent, confidentiality and risk/benefit balance. Expedited research involves minimal risk to subjects, but involves procedures with potential impact on subjects; such as the collection of body samples or physiological data, video or voice recordings, or studies involving vulnerable populations or sensitive issues. Expedited Reviewers may exercise all authorities of the IRB, except that they may not disapprove the proposed research. A study can only be disapproved at a full board/convened IRB meeting. If an expedited reviewer determines that a protocol that would fall under an expedited review category poses more than minimal risk, the reviewer can override that presumption, and request that it be reviewed by the full board; however, the reviewer must document their rationale. Applications determined to be expedited will be approved for a one year period, and require an annual check-in to extend the research from year to year.

3. Exempt Review - Exempt research may involve research on effectiveness of or the comparison among instructional techniques, curricula, or management methods, the use of educational tests, or the study of existing data. Applications determined to be exempt will be approved for a one year period, and then require an annual check-in to extend the research from year to year.
i. Limited Review- Is a new condition that applies to some exempt applications. This limited review condition sometimes applies to exempt research in exempt categories 2 and 3, but is always required for exempt research falling under exempt categories 7 and 8. The limited review is required to ensure “there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data”.

Student Research

Student research activities are governed by both the requirements of good research and the regulations of the Bloomsburg IRB. Student research is any systematic data collection and recording process done by students that is subject to interpretation and dissemination to solve a problem or advance understanding of a discipline. Dissemination occurs whenever information goes beyond registered students or assigned faculty or supervisors for the course. Examples of student research include the collection of data for a thesis, honors paper, or departmental paper or data collected for publication, distribution, presentation, or that is publicly available beyond the course environment. It is the responsibility of faculty members overseeing student research activities to ensure that the students meet the professional standards of the discipline and also conform to Policy 3990 and IRB procedures. In cases of student research, a Bloomsburg University faculty member must be listed as the Principal Investigator on the application, and is responsible for compliance and oversight of the research, and conforming to this Policy 3990. All students listed on a protocol must also complete the CITI Human Subjects Training most applicable to the proposed research.

Course Research Assignments Involving Human Subjects (previously PRP 3991)

Student research conducted within an academic course may be categorized as either a course assignment or disseminated research. If the student research is categorized as a course assignment, the data collection and interpretation is for pedagogical purposes only, and is contained wholly within the course environment. Such data is gathered without the intention of disseminating it beyond the instructor and students of the course. Disseminated research occurs whenever information is formally presented (eg. poster, oral or written) to any audience beyond the course. If a course research assignment moves outside of the classroom for data collection, the research must be reviewed by the IRB. If the faculty/student believes they may wish to present or publish their work at a future point, an IRB application must be submitted. The IRB is not able to provide approval for projects after the fact.

Disseminated research must be reviewed by the Bloomsburg IRB. All research course assignments must still be planned and carried out with a due consideration of the University's ethical and legal responsibility to protect individuals involved as the subjects of these activities, and should be designed to pose no more than minimal risk. Student research which involves vulnerable populations as subjects is always considered to be more than minimal risk. (Minimal risk is defined as "the risks, anticipated in the proposed activity, are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or test.")

It is encouraged that faculty teaching research methods and overseeing course research assignments complete the CITI Human Subjects Training.

Role of faculty in supervising student research categorized as a course assignment:

A. It is the responsibility of faculty to determine, prior to giving an assignment, whether a project falls within the area of course assignment or disseminated research. Disseminated research must be reviewed under Policy 3990. Student research originally conducted as a course assignment may not later become disseminated research. No IRB (Institutional Review Board) approval will be given after the fact.

B. It is the responsibility of the faculty to discuss research ethics with the class in the context of the assignment prior to the initiation of data collection.

Vulnerable Populations:

Vulnerability refers to subjects that are “vulnerable to coercion and undue influence, in recognition that coercion or undue influence refers to the ability to make an informed decision about participating in research” (Final Rule Preamble). Vulnerable populations require utmost care, specific ancillary considerations and augmented protections in research. The vulnerable person’s freedom and capability to protect themselves from intended or inherent risks is considerably shortened due to decreased freewill and inability to make informed choices (Shivayogi, 2013). Vulnerable populations are individuals with impaired decision- making ability, including, but not limited to children, prisoners, or economically or educationally disadvantaged persons.

Bloomsburg University Students as Research Subjects:

When Bloomsburg University students are proposed as subjects of a research study, the Investigator should carefully review and understand the concepts of Coercion and Undue Influence. Participation of students in research must be voluntary, and students should not be used as a population of convenience for faculty/staff research. In any proposed study that involves recruiting for research through classrooms, or other student groups, a clear explanation or justification should be provided as to why those students are the most appropriate participants for the study.

If using students as research subjects, reasonable levels of extra credit or rewards may be offered for participating in research. If extra credit or rewards are offered for participation, students must be provided with and informed of non-research alternatives involving comparable time and effort to obtain the extra credit in order for the possibility of undue influence to be minimized. However, if participation in research is a course requirement, students must be informed of non-research alternatives involving comparable time and effort to fulfill those requirements in order for the possibility of undue influence to be minimized. Moreover, students must not be penalized for not participating in research.

In cases where faculty propose to conduct research with students in their own classrooms or students that they directly oversee, the potential for coercion or undue influence increases and additional protections are required. In many cases, the involvement of a co-investigator or neutral third party may be an effective way to address perceived coercion or undue influence. The Bloomsburg IRB considers all of the following factors in support of proposed enrollment of subjects with potential status relationships with the researcher(s):
i. The research presents no more than minimal risk to subjects.
ii. The research represents a potential educational opportunity for participants.
iii. The recruitment/consent language contain clear statements to address and minimize coercion and undue influence.
iv. The recruitment and/or consent process will be conducted by someone who does NOT have a status relationship with the potential subjects.
v. If the research is conducted within the classroom setting, the instructor is blinded to the identity of participants - at least until grades are posted.

Informed Consent:

Potential participants must be provided with information about the research project that is understandable and that permits them to make an informed and voluntary decision about whether or not to participate in the study. The amount of information and the manner of presentation will vary, depending on the complexity and risk involved in the research study. The Investigator must describe their process for obtaining informed consent for participation in human research. It is important to understand that implied consent is not informed consent. Revised regulations state that key information must receive priority by appearing at the beginning of the consent form, and be presented first in the consent discussion. A concise description of the following five elements at the beginning of the consent form, and informed consent process, would encompass the required key information:

1. The fact that consent is being sought for research and that participation is voluntary.
2. The purpose of the research, expected duration of the prospective subject’s participation, and procedures to be followed in the research.
3. The reasonably foreseeable risks or discomforts to the prospective subject.
4. The benefits to the prospective subject or others that may reasonably be expected from the research.
5. Appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the prospective subject.

Recruitment and Study-Related Materials:

All recruitment and study related materials must be reviewed and approved by the IRB prior to any materials being seen or heard by prospective participants. Recruitment materials include, but are not limited to the following: media advertisements, letters, website advertisements, social media advertisements, online recruitment, phone-screen scripts, newsletters, and pre-screening scripts. All recruitment materials must include the approved study number. Study related materials include, but are not limited to, subject instructions, questionnaires, survey instruments, interview scripts, and any information sheets.

Key Personnel:

All research personnel listed on the IRB application must complete the CITI Human Subjects Training applicable to their field of study, and attach a copy to their application. A refresher course is required every three years. All persons who will have contact with human subjects or their identifiable data, in association with the research project (i.e. students, collaborators, and other research staff), are required to be listed on the IRB application. Once the IRB application is approved, an Investigator is required to submit a Key Personnel Change form to add or remove Key Personnel from the Study.

Modifications:

Investigators are responsible for ongoing requirements in the conduct of approved research. This includes obtaining prior approval from the IRB for any modifications of the previously approved research, before implementing the proposed modifications. To request a modification, the researcher should complete and submit a modification request. Modification requests will generally be reviewed at the same level of review in which the study was first reviewed (exempt, expedited, full board review), however, the modification may increase the risk, thus increasing the necessary level of review.

If the Investigators change the research in order to eliminate apparent immediate hazards to subjects without prior IRB approval, they should report those changes promptly to the IRB via an unanticipated event form.

Reporting Unanticipated/Adverse Events and Protocol Deviation Report:

An unanticipated problem is an occurrence that negatively affects one or more research participants that is related or possibly related to the research, but was not expected based upon available data or experience. This includes any anticipated adverse event that has greater severity of harm or frequency among participants than originally anticipated. Any protocol deviations should also be submitted via the unanticipated event form within the IRB Manager System. Unanticipated events are required to be reported to the IRB within 7 calendar days of the event. If the adverse event requires emergency response, it is the responsibility of the Investigator to ensure the appropriate emergency response. Any emergencies should also be submitted directly to the IRB Chair and Assistant VP and Dean of Graduate Studies and Research via a high priority email.

Unanticipated events will be forwarded to the IRB Chair for review, who will then make one of the following decisions: 1) to review and approve, or 2) to forward to the full board review for discussion. The full board will discuss, and may vote for actions outlined below:

1. No action;
2. Modification of the research protocol;
3. Modification of the information disclosed during the consent process;
4. Additional information provided to past participants;
5. Notification of current participants (required when such information may relate to participants’ willingness to continue to take part in the research);
6. Requirement that current participants re-consent to participation;
7. Modification of the continuing review schedule;
8. Monitoring of the research;
9. Monitoring of the consent;
10. Suspension or termination of the research;
11. Confiscation of data;

If no action is required, a letter of acknowledgement will be sent to the Investigator, and a copy of the letter filed in the research file. If the IRB takes any actions or imposes any requirements, the actions and requirements are documented in the minutes and in a letter to the Investigator.

Continuing Review, Annual Check-In, and Closeout

Continuing Review is the process by which the IRB re-evaluates whether the research is being conducted in compliance with the criteria for approval applied during the initial review. Continuing reviews for full board reviews will take place at least annually (unless specified differently by the IRB), or unless the research has progressed to the point where only data analysis remains. The Investigator will be notified at time of approval regarding the dates for continuing review. For new applications approved on or after January 21, 2019, continuing reviews will no longer be required for exempt or expedited reviews, per revisions to the Common Rule. An IRB reviewer may require an Investigator to submit a continuing review for exempt or expedited research, but will be required to document their rationale. In this scenario, the Investigator will be notified of this requirement upon approval of their research.

Annual Check-In. Expedited and Exempt research no longer requiring continuing review will submit an Annual Check-In to inform the IRB of the continuing research. This Check-In is required to be submitted annually to the IRB, at least 30 days PRIOR to the 1 year anniversary of the previous approval.

Closeout. If all research-related interventions or interactions with participants have been completed and collection and analysis of identifiable private data or linked (coded) data, as described in the IRB-approved research, are finished, the study should be closed with the IRB. If the approved research expires, or the IRB does not receive a continuing review/annual review, the research will be administratively closed by the IRB.

Maintaining Records

The Bloomsburg University IRB will maintain IRB documents for a period of at least three years from completion of the research. The investigator is required to retain documentation of informed consent of the subjects, and either the signed informed consent form or the short form and written research summary. These must be maintained for a period of 3 years after completion of research, unless the IRB waived the requirement for informed consent or the requirement of documentation of informed consent. If an investigator should leave the University, the informed consent documents must be provided to the BU IRB for maintaining the records.

Procedures for Appeal and Reporting Non-Compliance with IRB Policy

Procedures for noncompliance - Investigators are admonished to remember that the university policy entrusts the investigator with the primary responsibility for protection of human subjects. It is the individual investigator's responsibility to be in compliance with this policy. The IRB is the only body authorized to take action when a researcher is in noncompliance with PRP #3990. Noncompliance includes:

• Failure to submit applicable research involving human subjects for review and approval to the IRB;
• Failure to conduct research according to the approved protocol as it relates to the protection of human subjects;
• Failure to immediately notify the IRB when research activity results in an unexpected adverse impact on the subjects.

Allegations of noncompliance (either written or oral) should be directed to the chair of the IRB. The IRB will investigate allegations of noncompliance, maintaining confidentiality in all matters. Allegations may also be submitted via the anonymous tipline on the Bloomsburg University IRB website. Only voting members will participate in the investigation. In the event that allegations are substantiated, the IRB will terminate approval of the research and recommend to the Assistant Vice President for Graduate Studies and Research that the research be terminated. These decisions will be communicated to the Investigator and the appropriate federal agency or funding agency, if appropriate, by the Assistant Vice President of Graduate Studies and Research. A decision to terminate research may be appealed to the IRB within 15 days of notification.

Key Definitions

Research: The systematic inquiry/investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Human Subject: A living individual about whom an investigator conducting research (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

CITI Human Subject Protection Training: Human Subject Protection Training is completed through Collaborative Institutional Training Initiative (CITI), a web-based ethics training program for those conducting or reviewing research with human subjects.

Key Personnel: Persons who have contact with human subjects or their identifiable data, in association with the research project.

Continuing Review: The process by which the IRB re-evaluates whether a protocol is being conducted in compliance with the criteria for approval that are applied during initial review.

Vulnerable Populations: Individuals with impaired decision-making ability, including, but not limited to children, prisoners, or economically or educationally disadvantaged persons.

Limited IRB Review: This is an additional review requirement under the revised regulations (in the Common Rule) for studies otherwise qualifying for exempt review, but working with identifiable information or identifiable biospecimens. In these circumstances, an IRB member must conduct a limited IRB review to determine that the research design includes adequate provisions to protect participant privacy and maintain confidentiality of data.