Institutional Review Board

Institutional Review Board

Contact Information:

Institutional Review Board
C/O Diane Basta
133 North River Street
Wilkes-Barre, PA 18711
Phone: 570-208-5900 ext: 5429
Fax: 570-208-6024

IRB Chair
Robert Butler
570-208-5900 ext. 5674

  • When is submission to the IRB required?
    • Anytime King's College faculty, students, and staff are planning to conduct research with human participants, submission to the IRB is required prior to beginning any advertising, recruitment, or research procedures.
    • Some activities that involve human subjects may not be considered research and may be exempt from submitting a full protocol. Even when a project is exempt from review, the primary investigator must file the correct exempt form with the IRB.
  • Is my study classified as Human Subjects Research?
    • Human Subject research is defined by federal guidelines and regulations and determined by the chair of the IRB. It is always appropriate to contact the IRB for help with determining if your study is classified as human subject research.
    • To help clarify this question researchers may want to visit the following website.
    • http://grants.nih.gov/grants/policy/hs/faqs_aps_hsr.htm#347
    • If you determine that your study is not human subjects research and/or exempt from review, you must complete the appropriate exempt form (see exempt section for forms).
  • Who has to do ethics training and how long is it valid?
    • Researchers and other key personnel (research assistants) must complete NIH training available through the following link and submit their documentation of completing the training to the IRB. The IRB will keep this certificate on file. The training must be renewed on a bi-annual basis (every two years). http://phrp.nihtraining.com/users/login.php
  • Can I submit electronically?
    • Protocols may be submitted electronically or in paper version. Both versions must be typed. Handwritten proposals will not be accepted.
      • To submit electronically the forms must be e-mailed to dianebasta@kings.edu as either a PDF or Word document. If submitted electronically, the form must include electronic signatures from the investigators OR the investigators must also submit pages requiring signatures to the IRB.
      • To submit a paper version of your IRB please submit one copy with original signatures and the number of copies specified below.
        • For full board review, submit 6 copies.
        • For expedited review, submit 3 copies.
        • For exempt determination, submit 2 copies.
        • Institutional Review Board
      • Paper versions and signature pages should be sent to Diane Basta

    Institutional Review Board
    C/O Dianne Basta
    133 North River Street
    Wilkes-Barre, PA 18711

  • How do I determine which level of review is necessary?
    • Exempt
      • Review of exempt research must be completed by the IRB chair or IRB member as designated by the chair.
      • In all cases the research must meet the following conditions.
        • Deception will not be used
        • The research is minimal risk meaning that subjects are not exposed to discomfort or harassment beyond levels experienced in everyday life.
        • The researcher will not ask any questions related to suicidal or homicidal ideation, intent, or plan.
        • The researcher certifies that they have thoroughly reviewed the federal guidelines for what qualifies as research and what qualifies as a human subject and their project does not qualify as research OR it does not include human subjects (Designation for federal guideline: 45 CFR 46.101(b)). Use this website to make this determination. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102
      • The Principle Investigator must complete one of the five forms below.
      • Unlike a full board review, the IRB member reviewing the protocol may contact the primary investigator directly.
      • Exempt forms are generally reviewed and determination is given within two weeks of receipt.
      • Although federal guidelines do not require informed consent for exempt research, it is standard practice at many research institutions to do so in some cases. Therefore, in some select circumstances the IRB has discretion to request that such measures are taken in the form of an information sheet.
      • In no case will an exempt submission be rejected. Rather the reviewer can determine that an expedited or full-board review is required.
      • The primary investigator will be notified by e-mail or letter as the determination of the review.
      • Proposals that receive exempt status are valid for three years at which time resubmission is required.
      • An IRB staff member will review the submission for completeness of documentation prior to sending it to the IRB. If the staff member determines that required information is missing the staff member may return the IRB form requesting further information prior to the form being submitted to the IRB. This review will not be based on content.
    • Expedited
      • The primary investigator(s) must submit a completed IRB form.
      • Expedited research must meet the federal standards for minimal risk research. This means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during performance of routine physical or psychological examinations or tests (45 CFR 46.102(i)).
      • Two members of the IRB must review the exempt protocol.
      • Unlike a full board review, the IRB members reviewing the protocol may contact the primary investigator directly.
      • In no case will an expedited submission be rejected. Rather the reviewer can make one of the following three determinations.
        • Approved: This indicates that the reviewers concluded that the protocol and consent forms meet federal criteria for approval.
        • Conditional Approval: This indicates that the reviewers concluded that the protocol may meet criteria for exempt review and further information or corrections are needed prior to a determination. This does not indicate that a project will receive approval upon resubmission. Upon receiving a conditional approval, the primary investigator will be given a list of items needed to be addressed. The primary investigator must send a revised protocol and a memo outlining how each item on the list was addressed. The revised materials will be reviewed by at least one member of the IRB.
        • Full Board Review Required: The reviewers have determined that a full review by the IRB is necessary.
      • An IRB staff member will review the submission for completeness of documentation prior to sending it to the IRB. If the staff member determines that required information is missing the staff member may return the IRB form requesting further information prior to the form being submitted to the IRB. This review will not be based on content.
      • Proposals that receive approval are valid for one year at which time a renewal form must be completed. Renewal forms for expedited research must be reviewed by at least one IRB member. This IRB member can request another IRB members review.
      • Any time the primary investigator wishes to modify the original protocol approved by the IRB, they must submit a protocol modification form. Modification forms for expedited research must be reviewed by at least one IRB member. This IRB member can request another IRB members review. They can make the same determinations as above.
      • At the conclusion of the study a final report must be submitted to the IRB.
      • To access the form for an expedited review please access the form for the full-board review in the full board review section. They are the same document.
    • Full Board Review
      • Research that does not qualify for either exempt status or expedited review necessitates a full board review.
      • The principle investigator must complete the full IRB form.
      • An IRB staff member will review the submission for completeness of documentation prior to sending it to the IRB. If the staff member determines that required information is missing the staff member may return the IRB form requesting further information prior to the form being submitted to the IRB. This review will not be based on content.
      • The IRB chair will review the document and determine if it does not qualify for either the exempt or expedited status.
      • If the IRB protocol is for a grant, copies of the grant application must also be submitted.
        • In the case of a protocol being accompanied by a grant proposal, one member of the IRB will be assigned to review the protocol and grant application to insure that the two documents are congruent. This member of the IRB will notify the rest of the committee if there is any incongruence.
      • A minimum of five members of the IRB will review the research protocol.
      • The protocol will be reviewed on the following criteria.
        • The IRB must find that risks to subjects are minimized.
        • Risks are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result from the research.
        • Selection of subjects is equitable.
        • Informed consent will be sought from each prospective subject or the subject's legally authorized representative and appropriately documented in accordance with, and to the extent required by the DHHS, FDA, or VA regulations.
        • When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
        • When appropriate, 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, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
      • Any member of the IRB can request further information from the primary investigator. However, unlike in other reviews, the reviewers may not directly contact the investigators. All communication will take place through either IRB staff or the IRB chair.
      • In no circumstance is an investigator to contact the members of an IRB reviewing their protocol directly. All communication is to be directed to IRB staff or the IRB chair. Failure to comply will result in the protocol being DISAPPROVED.
      • The IRB can make any of the following determinations.
        • Approved: This indicates that the reviewers concluded that the protocol and consent forms meet federal criteria for approval.
        • Conditional Approval: This indicates that the reviewers concluded that the protocol may meet criteria for approval and further information or corrections are needed prior to a determination. This does not indicate that a project will receive approval upon resubmission. Upon receiving a conditional approval, the primary investigator will be given a list of items needed to be addressed. The primary investigator must send a revised protocol and a memo outlining how each item on the list was addressed. The revised materials will be reviewed by at least two members of the IRB. Either of these members can request a full board review of the revisions.
        • Deferred: The committee is unable to review due to the limitations of Kings college. As a small liberal arts college we do not have the appropriate make-up and insurances to conduct certain categories of research (this is especially the case in medical research). In these cases the IRB is indicating that the research may meet federal guidelines, but the primary investigator must submit the protocol to another institution for determination.
        • Disapproved: The IRB determined that the risk of the procedures outweighs any benefit to be gained or if the proposed research does not meet the federal guidelines for IRB approval. A protocol will also be disapproved if the protocol contains misleading information or if the researchers engage in any activity such as recruitment or data collection prior to receiving approval from the IRB.
      • Proposals that receive approval are valid for one year at which time a renewal form must be completed.
      • Any time the primary investigator wishes to modify the original protocol approved by the IRB, they must submit a protocol modification form. Modification forms for full board research must be reviewed by at least two IRB members. These IRB members can request a full board review. They can make the same determinations as above. A full board IRB is required for Deferred or Disapproved status.
      • At the conclusion of the study a final report must be submitted to the IRB.
  • How long does review take?
    • When referring to a week, this refers to 10 days in which the college is officially open excluding summer.
    • Expedited and Exempt reviews can expect a response within two weeks.
    • Full-Board reviews can expect a response within three weeks.
    • Summer Approvals: The IRB does not meet regularly during the summer.
      • Exempt and Expedited research can expect a response within three weeks.
      • Full Board reviews seeking approval for the beginning of fall semester must be submitted by the last day in June. Investigators can expect a response by the first day of the fall semester.
  • How do I modify an already approved form?
    • Any time the primary investigator wishes to modify the original protocol approved by the IRB, they must submit a protocol modification form. Responses to Modification forms can be expected in two weeks.
  • Renewal
  • Unanticipated Problems and Adverse Events
    • An adverse event encompasses physical harm, psychological harm, and breaches in confidentiality.
    • The IRB must determine if it was anticipated or unanticipated as outlined by federal guidelines with the help of the primary Investigator.
    • All adverse effects must be reported to the IRB.
    • For serious adverse events, a report must be filed within 2 days of the discovery of the event.
    • For all other events, a report must be made within 5 days of the discovery of the event.
    • To report, the primary investigator must complete the Unanticipated Problems and Adverse Events form.
  • Research Completion
    • At the conclusion of the study a final report must be submitted to the IRB.
    • Failure to submit completion reports will result in no further research being reviewed by the IRB until such reports are submitted.
  • Protocol Deviation and Noncompliance
    • If a researcher fails to follow established protocols outlined on this web page, conducts research without approval, or misrepresents their information the following sanctions will be taken. Depending on the seriousness of the violation and if the entire IRB committee concurs, the first step in sanctions may be skipped.
      • Violation #1:
        • The faculty member responsible for research will redo the NIH training.
        • The faculty member will submit a letter outlining how they violated ethical standards and how they can remedy the violation. Two IRB committee members will review the letter and determine if the faculty member in violation has remedied the problem, if the faculty member has not demonstrated an understanding into why their actions were in violation of ethical standards the IRB will provide further training and the faculty member can resubmit the letter.
      • Violation #2:
        • All actions for violation 1 will be repeated.
        • The faculty members human subject research will be supervised by another faculty member for a one year period or until the faculty member has submitted one protocol for a full-board IRB review, whichever occurs later.
      • Violation #3:
        • All actions for violation 1 will be repeated.
        • The faculty members human subject research activities will be suspended for a one year period.
        • The faculty members human subject research will be supervised by another faculty member for a five year period or until the faculty member has submitted one protocol for a full-board IRB review, whichever occurs later.
      • Violation #4:
        • All human subjects research rights will be suspended for the remainder of ones career at Kings College.
  • Informed Consent
    • To protect participants, informed consent must be collected.
    • Informed Consent is the process through which a possible research participant is educated about the research project including both the possible benefits and detriments. The individual then consents or agrees to participate in the research study.
    • What is the difference between formal informed consent and an information sheet?
      • Formal informed consent is when an individual or their guardian signs a form consenting to the research study (or other procedure). An information sheet provides the same information as a formal informed consent, but no signature is obtained.
      • Information sheets can be used in some cases of minimal risk research. Specifically, they are preferred when collecting a participants signature increases the risk to the participant by introducing the possibility of a breach in confidentiality.
    • The difference between consent and assent.
      • Frequently researchers are interested in studying populations that cannot legally consent to being research participants (for example minors and those with intellectual disabilities). In these cases, it is necessary to obtain informed consent from guardians. However, it is also considered standard practice to obtain assent from individuals who can understand the study, but cannot legally consent to the study. For example, research participants who are 17 years old can assent to a study, but their guardian has to give consent (except in rare circumstances).
    • Requirements for informed consent
    • Templates for and Information Sheet and Consent Sheet are below. Examples of assent forms and consent forms for parents are available online through various resources. Whatever template you use. Please make sure that the federal guidelines listed in the link above are followed.
  • Record Retention
    • According to federal regulations, investigators are required to maintain research records for three years beyond the completion/termination of the study.
    • Deidentified data may be kept indefinitely.
  • Special Populations
    • Protected populations are any group or individual afforded special consideration in regards to research. These include, but are not limited to prisoners, minors, individuals with diminished capacity, mentally or physically challenged, pregnant. To learn more about these populations and requirements visit the below website.
    • Using Kings College students
      • As with all participants, participation must be voluntary and free from coercion. Students should not be asked to participate in research that will interfere with their academic success. A students decision to participate or not cannot have bearing on grades awarded by the instructor. Therefore, if extra credit is to be used as an incentive to research, other comparable activities must be made available that are worth the same amount of extra credit. These may include: short papers, special projects, book reports, brief quizzes on additional readings, research seminars, or completing a similar project. These should be similar in time commitment and educational benefit to the research study.
  • Forms
© King's College • 133 North River Street, Wilkes-Barre, PA 18711 • 1-888-KINGS-PA Contact Us | Site Index