Policies + Procedures — Governance + Compliance — Bucks Institutional Review Board

1.37 Bucks County Community College Institutional Review Board

I. Purpose

The Bucks County Community College (BCCC) Institutional Review Board (IRB) is charged with reviewing all research involving human subjects that is conducted at BCCC by BCCC students or employees, or by anyone who recruits subjects who are BCCC students, employees, or governing body members to ensure that the human subjects are protected and the research is consistent with the ethical principles in the Belmont Report and in compliance with Title 45, Part 46 of the Code of Federal Regulations (revised as of July 19, 2018).

II. Scope

All research involving human subjects proposed to be conducted at Bucks County Community College (BCCC) by employees or students or involving students, employees, or governing body members as participants or subjects must be reviewed and approved by the Bucks County Community College Institutional Review Board prior to initiating the research to ensure protection of human subjects, consistency with the ethical principles in the Belmont Report, and compliance with federal regulations (45 CFR 46. Revised as of July 19, 2018).

Definitions

For the purpose of the policy and procedures of the BCCC IRB, research involving human subjects refers to a systematic investigation that (1) is designed to develop or contribute to generalizable knowledge and (2) involves living persons about whom a researcher obtains (a) identifiable private information or specimens or (b) information or specimens through intervention or interaction with the person that they then use, study or analyze.

Consistent with 45 CFR 46, the following activities are not considered research involving human subjects: oral history, journalism, biography, literary criticism, legal research, and historical scholarship that focus directly on the specific individuals about whom the information is collected.

III. General

IRB Membership:

The Bucks County Community College (BCCC) IRB consists of at least 5 members appointed by the Provost. At least one member must be trained in natural or social sciences, at least one member must be a non-scientist, and at least one member must have no affiliations or family members with affiliations with BCCC. Collectively, the members of the IRB must possess the experience, expertise, and diversity necessary to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects and to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct. All members must provide evidence that they have completed training in the protection of the rights and welfare of human research subjects, such as that offered by the Department of Health and Human Services. In the course of the review of proposed research, the IRB may consult with individuals who have expertise related to the specific proposal if needed. Such consultants are not voting members of the IRB.

The IRB Administrator will maintain a current list of IRB members, including each member’s name, earned degrees, representative capacity, experience/certifications/licenses related to anticipated contributions to IRB deliberations, relationship to BCCC, and confirmation of training in protection of human research subjects.

IV. Procedures

The following procedures are intended to be consistent with Title 45, Part 46 of the Code of Federal Regulations (revised as of July 19, 2018). Any interpretation of these procedures should be consistent with the regulations.

I. IRB Initial and Continuing Review of Research

A. Exempt Research

Research eligible for exemption
1. Research conducted in educational settings that involves normal educational practices unlikely to adversely impact students’ opportunity to learn or to negatively affect assessment of educators.
2. Research that consists only of educational tests, surveys, interviews or observation of public behavior if the identity of human subjects cannot readily be ascertained OR disclosure of subjects’ responses would not be damaging.
3. Research involving benign behavioral interventions (brief, harmless, painless, unlikely to have a lasting impact, not physically invasive, and unlikely to be embarrassing or offensive) in conjunction with collection of information through verbal or written responses or audiovisual recording. The subject must agree prospectively. Either the identity of human subjects cannot readily be ascertained OR disclosure of subjects’ responses would not be damaging. If the research involves deception regarding the nature or purposes of the research, subjects must also agree prospectively to the fact that deception will be used in the study.
4. Use of identifiable private information or biospecimens if they are publicly available OR are recorded by the investigator in such a manner that the identity of human subjects cannot readily be ascertained and the researcher will not contact or re-identify subjects.
5. Research and demonstration projects conducted or supported by a Federal department or agency and designed to study, evaluate, improve, or otherwise examine public benefit or service programs (e.g., financial or medical benefits provided under the Social Security Act; social, supportive, or nutrition services as provided under the Older Americans Act).
6. Taste and food quality evaluation and consumer acceptance studies involving wholesome foods without additives or with ingredients, chemicals and contaminants at or below the level found to be safe by the FDA, EPA or USDA.
7. Secondary research (research using data collected for other research or non-research purposes) or storage or maintenance of identifiable private information or biospecimens for potential secondary research if broad consent was obtained in accordance with federal regulations AND documentation of consent or waiver of consent was obtained in accordance with federal regulations AND the research to be conducted is within the scope of the broad consent AND the investigator does not include returning individual research results to subjects in the research plan AND there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
Processes for Exempt Research

Determination of exemption will be made by the IRB Chair, based on a summary of the research procedures provided by the investigator. The investigator will be informed via email of the determination and instructed to inform the IRB of any changes to the protocol prior to its implementation. The IRB Chair will determine the level of review required for any changes submitted. Exempt research is not subject to annual review.

Approved exemptions will be reported to the full IRB within 30 calendar days of approval. Such reports may be made electronically.

B. Expedited review

Research eligible for expedited review

Human subjects research meeting ALL of the following criteria is eligible for expedited review:
1. Risks to subjects are minimized.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects
  and the importance of knowledge that may reasonably be expected to result.
3. Selection of subjects is equitable so that it does not contribute to unjust social patterns
  in the overall distribution of the burdens and benefits of research among potential subjects. Those who are vulnerable, overly burdened, or not in the researcher’s favor must not be over-represented among those placed at risk in research nor under-represented among those benefiting from research. (For more information, see The Belmont Report)
4. Informed consent will be sought AND appropriately documented or a waiver of documentation is obtained from the IRB.
5. When appropriate, adequate provision is made for monitoring data collected to ensure safety of subjects.
6. When appropriate, adequate provisions are made to protect the privacy of subjects and maintain the confidentiality of data.
7. When some or all subjects are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons), additional safeguards are included to protect the rights and welfare of these subjects.
  
  Research consisting of storage or maintenance for secondary research is also eligible for expedited review if broad consent was obtained in accordance with federal regulations and is appropriately documented AND there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of the data if changes are made for research purposes in the way the identifiable private information or biospecimens are stored or maintained.
Processes for Expedited Review

Minor changes in previously approved research are also eligible for expedited review.

Human subjects research eligible for expedited review will be submitted to the IRB using the approved proposal forms. The IRB Chair will verify that the research qualifies for expedited review. The submitted materials will be distributed to the IRB electronically for comment. IRB members will be given no fewer than five business days to respond electronically with their vote (approve, request revisions, or disapprove) and comments on the proposal. Once the five business days have passed and at least three votes from IRB members (including the chair) received, the IRB Chair will compile comments received and inform the investigator via email of the IRB’s decision.

If the decision is to request revision, the same review procedure will be followed once revisions are received. If the decision is to disapprove, the proposal will be moved to full- board review. If the decision is to approve the research, the approval date will be the date the notification email is sent to the investigator. The investigator will be instructed to inform the IRB of any changes to the protocol prior to their implementation, of any unanticipated problems involving risk to human subjects within 72 hours, and of study completion within 30 calendar days. The IRB Chair will determine the level of review required for any changes submitted. Investigators will also be instructed to retain all study records and documentation for a minimum of three years after study completion.

Annual continuing review will be required and will use the expedited review process.

C. Full-board Review

Research requiring full-board review

Any human subjects research that does not qualify for exemption or expedited review will be processed via full-board review.
Processes for full-board review

Research requiring full-board review will be submitted to the IRB using the approved proposal forms. The IRB Chair will verify that the research requires full-board review. The submitted materials will be distributed to the IRB electronically for review prior to a convened meeting, which may be held face-to-face or electronically. Presence of a quorum (over half of IRB members, including at least one member whose primary concerns are in nonscientific areas) is required for a convened meeting. The IRB will discuss the research at the convened meeting and vote via simple majority to approve, request revisions, or disapprove. The investigator will be informed of the decision via email.

If the decision is to request revision, the same review procedure will be followed once revisions are received.

If the decision is to approve the research, the approval date will be the date the notification email is sent to the investigator. The notification email will instruct the investigator to inform the IRB of any changes to the protocol prior to their implementation, of any unanticipated problems involving risks to human subjects within 72 hours, and of study completion within 30 calendar days. Any changes submitted will be subject to full-board review. Investigators will also be instructed to retain all study records and documentation for a minimum of three years after study completion.

The IRB Chair will determine the frequency of continuing review for each approved study. For research posing minimal risk to participants, annual review will be required. If risk posed to participants exceeds minimal risk, more frequent review may be required. Review will follow the full-board review process.

D. Institutional Review

Once research has been determined to be exempt or approved, proposal materials will be sent to the Provost for institutional review and permission to conduct the research at Bucks County Community College. The Provost’s Office will inform the investigator of the decision and send a copy to the IRB.

An annual report detailing all proposals received and related IRB decisions will be submitted to the Provost by the IRB Administrator.

II. IRB Review Process and Criteria

A. Criteria for IRB Approval of Research

To be approved, the IRB must determine that the proposed research meets ALL of the following requirements:

Risks to subjects are minimized by use of procedures that do not unnecessarily expose subjects to risk.
Risks to subjects resulting from the research are reasonable in relation to anticipated benefits of the research, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
Selection of subjects is equitable. The subjects recruited are appropriate to answer the scientific question.
Informed consent is sought and documented from each prospective subject or the subject's legally authorized representative.
When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

B. Requirements for Informed Consent, Broad Consent, and Documentation of Consent

Informed Consent
1. Before involving a human subject in research, the investigator must obtain the
  legally effective informed consent of the subject or the subject's legally authorized
  representative.
2. When consent is sought, there must be an opportunity for the subject or the
  subject’s legally authorized representative to discuss, consider whether or not to
  participate, and ask questions.
3. The possibility of coercion or undue influence to consent must be minimized.
4. The consent form or information must be in language understandable to the subject or the subject’s legal representative.
5. The consent form or information must include information and detail that a reasonable person would want to have in order to make an informed decision about whether to participate, including the reasons why one might or might not want to participate in the research.
6. The consent form or information must not include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
Required elements of informed consent form or information

The informed consent form or information provided to subjects must include at least the following elements:
1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, identification of any procedures that are experimental, and indication of the approximate number of subjects who will be involved in the study.
2. A description of any reasonably foreseeable risks, discomforts or costs to the subject and, if appropriate, a statement that the treatment or procedure used in the study may involve risks to the subject that are currently unforeseeable.
3. A description of any benefits to the subject or to others that may reasonably be expected from the research.
4. If appropriate, a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
6. For research involving more than minimal risk, an explanation as to whether there will be any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
7. Instructions to contact the IRB Chair with questions, complaints, problems or concerns about the research and research subjects' rights or in the event of a research-related injury to the subject.
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled, along with instructions for how to discontinue participation. If appropriate, a description of anticipated circumstances under which the subject's participation may be terminated by the investigator should be included.
9. One of the following statements, for any research that involves the collection of
  identifiable private information or biospecimens:
  1. A statement that identifiers will be removed from the identifiable private
    information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative.
  2. A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
10. A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject and, if appropriate, a statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
11. If appropriate, a statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
12. For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
Broad consent for the storage, maintenance, and secondary research use of identifiable private information or biospecimens.

For the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens (collected for either research studies other than the proposed research or non-research purposes), broad consent, allowing the investigator to obtain data or biospecimens in association with a current study that can be used in future research without having to re-consent the subject, rather than study-specific consent, may be sought.
1. Before involving a human subject in research, the investigator must obtain the legally effective informed consent of the subject or the subject's legally authorized representative.
2. When consent is sought, there must be an opportunity for the subject or the subject’s legally authorized representative to discuss, consider whether or not to participate, and ask questions.
3. The possibility of coercion or undue influence to consent must be minimized.
4. The consent form or information must be in language understandable to the
  subject.
5. The consent form or information must include information and detail that a
  reasonable person would want to have in order to make an informed decision about whether to participate, including the reasons why one might or might not want to participate in the research.
6. The consent form or information must not include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
7. The broad consent form or information must include at least the following:
  1. A description of any reasonably foreseeable risks or discomforts to the
    subject.
  2. A description of any benefits to the subject or others that may reasonably
    be expected from the research.
  3. A statement describing the extent, if any, to which confidentiality of
    records identifying the subject will be maintained.
  4. A statement that participation is voluntary, refusal to participate will
    involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
  5. If appropriate, a statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
  6. For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
  7. A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted.
  8. A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens.
  9. A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite).
  10. Unless the subject or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject's identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies.
  11. Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject.
  12. An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.
Assent

In cases in which a legal representative is consenting to a subject’s participation in a study, assent must be sought from the subject if possible. All of the required elements of informed consent that can be presented to the subject in a manner that the subject can understand must be presented, and the subject’s assent must be documented in the same manner as consent. If obtaining assent is possible then assent must be obtained prior to including the subject in the research.
Documentation of Informed Consent

Informed consent must be documented by the use of a written or electronic informed consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. The form must be read by or to the subject or the subject’s legally authorized representative prior to signing in writing or electronically. A written or electronic copy must be given to the person signing the informed consent form.
Waiver of Documentation

An investigator may request and the IRB may waive the requirement for the investigator to obtain a signature on the informed consent or assent form for some or all subjects under any one or more of the following circumstances:
1. The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality.
2. 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.
3. The subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects, and there is an appropriate alternative mechanism for documenting that informed consent was obtained.
  
  In cases in which the documentation requirement is waived, the investigator must provide subjects or legally authorized representatives with a written or electronic statement containing all of the required elements for informed consent (detailed above).
Waiver of Consent

In order for the IRB to waive consent altogether, the IRB must find and document ALL of the following:
1. The research involves no more than minimal risk to the subjects.
2. The research could not practicably be carried out without the requested waiver or
  alteration.
3. If the research involves using identifiable private information or identifiable
  biospecimens, the research could not practicably be carried out without using such
  information or biospecimens in an identifiable format.
4. The waiver will not adversely affect the rights and welfare of the subjects.
5. Whenever appropriate, the subjects or legally authorized representatives will be
  provided with additional pertinent information after participation.

C. General IRB Review Process

Forms and templates for expedited or full-board review

The IRB will approve forms and templates to be used by investigators requesting IRB review of their human subjects research. The IRB Administrator will maintain these forms and related templates, which will be accessible to the BCCC community via Sharepoint and by request.

These forms will request at least the following information from the investigator:
1. Level of review being requested (Expedited Review or Full-Board Review). To request expedited review, an explanation of how the research meets each of the criteria for expedited review listed above must be included.
2. An explanation of how the research meets each of the criteria for IRB approval of research listed above.
3. A copy of any informed consent and assent form(s) or information that will be used to obtain and document consent.
4. A detailed description of the process that will be used for selecting and recruiting subjects and obtaining voluntary and informed consent. This may include a request and justification for a waiver of the requirement to document consent.
5. An indication of whether the study involves subjects who are likely to be vulnerable to coercion or undue influence and, if so, the safeguards included in the research protocol to protect the rights and welfare of these subjects. This includes research involving children, prisoners, pregnant women, human fetuses and neonates, as well as other vulnerable categories.
6. Qualifications of the principal investigator and study staff, including documentation of training received regarding protection of the rights and welfare of human subjects and confirmation that the investigator and staff have no history of failure to comply with the policies and procedures of an IRB.
7. Copies of any data collection tools that will be used in the study, such as questionnaires, surveys, interview or focus group questions, etc.
8. Copies of any materials or messages that will be used to recruit subjects.
Submission of forms

The principal investigator can obtain the approved forms from the IRB Chair, Administrator, or any IRB member. All required materials must be submitted to the IRB Administrator in electronic form via email before the review will be initiated.
Requests for clarification

The IRB Chair or Administrator may request clarification of information from the Principal Investigator via email prior to initiating the review.
Confirmation of level of review

The IRB Chair will confirm that the level of review requested is appropriate prior to initiating the review. A justification will be provided to the investigator if a determination is made that a study for which expedited review is requested is determined not to be eligible for expedited review.
Initiation of review

Once the level of review requested has been confirmed as appropriate, the review will be initiated by distributing all submitted materials to IRB members. The review will then proceed according to the process appropriate to the level of review, as described above.

III. Unanticipated Problems, Noncompliance, Suspension or Termination, and Complaints

A. Unanticipated Problems

Unanticipated problems involving risk to human subjects must be reported in detail by the principal investigator to the IRB Chair within 72 hours. The full IRB will be informed within 72 hours thereafter, review the details, and make a determination of whether it is necessary to suspend or terminate approval of the research within 3 business days. The determination will be made via majority vote of a quorum. If a decision is made to suspend or terminate approval, the IRB Chair will immediately notify the Provost, investigator, and any federal funder and provide the reasons for the IRB's action.

B. Noncompliance

The investigator is required to report noncompliance with IRB policy or procedures to the IRB Chair within 72 hours. If noncompliance with IRB policy or procedures is reported or otherwise discovered, the IRB Chair will inform the full IRB within 72 hours of the discovery and will make a determination of whether it is necessary to suspend or terminate approval of the research within 3 business days. The determination will be made via majority vote of a quorum. If a decision is made to suspend or terminate approval, the IRB Chair will immediately notify the Provost, investigator, and any federal funder and provide the reasons for the IRB's action.

C. Complaints

Investigators and human subjects will be instructed to direct any complaints, problems, concerns, or questions about the IRB, IRB decisions, the rights and protection of human subjects, or related issues to the IRB Chair.

IV. IRB Records and Registration

IRB contact information, policy, procedures, forms and templates will be available to the BCCC community via Sharepoint and by request made to the IRB administrator, IRB Chair, or other member of the IRB.
The IRB administrator will maintain copies of correspondence with investigators, research proposals, protocols, consent forms, data collection tools, progress reports, reports of unanticipated problems or noncompliance, completion reports, and other records pertaining to human subjects research submitted to the IRB for review.
The IRB Administrator will maintain a record of proposals received as well as IRB decisions and decision dates, continuing review dates and decisions, and closing dates for all studies.
The IRB Administrator will prepare and maintain the minutes of all convened IRB meetings. Minutes shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
All records will be retained for a minimum of three years after study completion.
Records will be electronic and stored on an internal BCCC shared drive with limited access.
The IRB Administrator will complete paperwork to ensure that the IRB’s registration with DHHS and Federalwide Assurance are up to date.