Human Research Review Procedures

All of the College of Charleston’s (College) human research participant activities are guided by the ethical principles in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and governed by the policies and procedures of the College.  Further the College adheres to applicable federal, state and local laws.

The College has established the Institutional Review Board for the Protection of Human Research Participants (IRB) which functions in accordance with the Terms of the Federalwide Assurance (FWA) for Institutions within the United States.  For all research conducted or supported by any federal department or agency that has adopted the Common Rule, the College adheres to the applicable provisions of 45 CFR 46 and its sub-parts and any additional human participant regulations and policies as required by the funding agency.  The Common Rule and its sub-parts serve as guidance for the College’s written procedures for human participant research that is not federally funded.

The purpose of the IRB is to protect the rights and welfare of individuals recruited to participate in research activities conducted under the auspices of the College of Charleston.

The IRB has the authority to approve, require modifications in, or disapprove all research activities involving human participants that fall within its jurisdiction as specified by both the federal regulations and local institutional policy.

Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the institution.  However, those officials may not approve research if it has been disapproved by the IRB.

Research that has been reviewed and approved by the IRB is subject to continuing IRB review and must be reevaluated at least annually or more frequently if specified by the IRB.

IRB Membership

The IRB is comprised of at least nine (9) regular voting members with varying backgrounds, including a community representative who is not affiliated with the College of Charleston, at least one member representing a non-scientific discipline and one from a scientific discipline.   Every effort will be made to ensure that the IRB members represent the disciplines with the most frequent IRB applications and have a sufficient knowledge of the local research context.  The IRB Administrator of the Office of Research & Grants Administration (ORGA) serves as a non-voting ex-officio member.

In July of each year, the Chair of the IRB and the IRB administrator submits to the President a slate of individuals recommended to replace outgoing IRB members and alternates.  The President will appoint the new members and alternates.

An IRB Chair and an IRB Vice-Chair are elected from the regular voting membership by the regular voting members for a one-year term at the first IRB meeting of the academic year, with re-election possible.

The IRB may solicit ad hoc reviewers with specific expertise to assist in protocol reviews on a case-by-case basis.  Ad hoc reviewers may participate, but not vote, in the designated reviews.

IRB Chairperson

The IRB Chairperson is elected at the first meeting of the academic year and serves for a one year term.  There is no limit to the number of terms which may be served.

Responsibilities:

1. Chairs the IRB meetings.
2. Serves as expedited reviewer for continuation applications with no modifications or minor modifications, or designates another IRB member (usually the Vice Chairperson) to serve as the reviewer.
3. Serves as expedited reviewer for minor modification applications.
4. Advises the IRB administrator and provides consultation questions related to the assignment of applications for expedited and/or full board review.
5. Provides consultation to the Exemption Reviewer as needed.
6. May not review his/her own applications.

IRB Vice Chairperson

The IRB Vice Chairperson is elected at the August meeting and serves for a one year term.  There is no limit to the number of terms which may be served.  It is anticipated that the Vice Chairperson will succeed an outgoing Chairperson.

The Vice Chairperson is responsible for the duties of the Chairperson in his/her absence or the event of a conflict of interest.  The Vice Chairperson may carry out other duties as delegated by the Chairperson, but may not review his/her own applications.

IRB Administrator

The IRB Administrator reports to the Assistant Vice President for Research and manages the Human Research Participant Program.

Responsibilities:

1. Schedule IRB Meetings and prepare agendas.
2. Maintain IRB section of the ORGA website and the IRB eForm system.
3. Attend IRB meetings and prepare minutes.
4. Receive all applications for exemption and IRB review, including External Requests to Recruit and Reliance Agreements.
5. Refer all applications for exemption to the Exemption Reviewer.
6. Pre-review all applications for expedited or full board review.  Post applications for review on the IRB “members only” section of the eForm system.
7. Serve in an advisory capacity to the IRB on matters of regulatory compliance.
8. Notify researchers of IRB actions on expedited and full board protocols, including requested revisions.
9. Provide verification of research deemed Non-human Subjects Research to the researcher. 

Institutional Official

The Assistant Vice President for Research serves as the Institutional Official for Human Participant Research.

IRB meetings

Meetings of the IRB will be held during the following months: August, September, October, November, January, February, March, April, May, and June.  A scheduled meeting may be canceled if no applications for full review are received by the deadline for that meeting.  Meetings may also be held in December or July if warranted.  Meetings may be held by teleconference or video conference.  Any member of the IRB may call for a convened meeting by notifying the Chair.   A meeting will be scheduled within one week of the request.

Meeting dates and correspondence deadlines is made public to the College at the beginning of each semester.

A simple majority constitutes a quorum and must include at least one regular voting member whose primary concerns are in nonscientific areas. When a quorum of regular members is not present, the IRB Chair may delegate full responsibilities of membership (including voting privileges) to an alternate member for the duration of the meeting.  Should the quorum fail during a meeting (e.g., loss of a majority through recusal of members with conflicting interests, early departures, or absence of a nonscientist member), the IRB may not take further actions or votes unless the quorum can be restored.   For review of federally funded research, quorum must also include the community representative, or other persons as required under federal regulations.

To facilitate the review of research and the protection of the rights and welfare of research participants, research investigators are encouraged to attend IRB meetings when invited by the IRB.

Protocols for review at an IRB meeting are distributed to the IRB members at least one week prior to the scheduled meeting.  Other documents for review are distributed in a timely manner to facilitate review.

Actions of the IRB

Protocols reviewed by the IRB may be 1) returned to the researcher with recommendations for substantive revision (revision may qualify the protocol for expedited review or require review at a convened meeting); 2) approved with stipulations, i.e., revisions deemed minor by the IRB contingent which require only administrative approval; 3) approved; or 4) disapproved.

IRB Records

IRB records are retained in ORGA for at least 3 years, in accordance with federal and state regulations and College of Charleston policy.  Records of federally funded research are accessible for inspection and copying by authorized representatives of DHHS and the funding agency at reasonable times and in a reasonable manner.

IRB records comprise:

1. The minutes of IRB meetings document:
   • Attendance at the meetings.
   • Actions taken.
   • Vote on the actions including the number of members voting for, against, and abstaining; members absenting themselves during review of research in which they have a conflicting interest.
   • Findings related to individual protocol review, specifically those dealing with
     • a consent procedure which does not include, or which alters, some or all of the required elements of informed consent or when waiving the requirement to obtain informed consent,
     • a procedure which waives the requirement for obtaining a signed consent form,
     • research involving human fetuses, or neonates,
     • research involving prisoners, or
     • research involving children.
   • The basis for requiring changes in or disapproving research; and
   • A written summary of the discussion of issues and their resolution.
2. General IRB business correspondence.
3. The Federalwide Assurance.
4. Annual reports to the Office of Human Research Protections (OHRP) are prepared by the Research Protections & Compliance manager and signed by the institutional official.
5. The membership list which identifies all IRB members by name, earned degrees, representative capacity, employment relationship, indication of experience contributing to the IRB (such as College Department).
6. Written procedures which outline the procedures that the IRB will follow for conducting initial and continuing reviews and reporting its findings and actions; determining which protocols require review more often than annually and/or need verification from sources other than the investigator concerning protocol changes; and ensuring prompt reporting to the IRB of proposed changes to approved research.
7. A copy of every research protocol whether reviewed as exempt, expedited, or full IRB is maintained in the Office of Research and Grants Administration.  The protocol file consists of the
   • Human Research Review Application,
   • Conflict of Interest statement, if applicable,
   • Approved consent documents,
   • Approved recruitment materials,
   • Questionnaires, interview scripts, and other research instruments,
   • Approval letters from non-College of Charleston research sites,
   • Technical section from grant applications if externally funded,
   • Continuing reviews (if required),
   • Modifications,
   • Correspondence,
   • Reports of unanticipated problems or injuries to participants, and
   • Final report (if required).

The College of Charleston IRB requires completion of online CITI Program training for all IRB members, researchers and research staff (including students) who will have direct and substantive involvement in proposing, performing, reviewing, or reporting the research. Training must be updated every five years, or when a protocol is submitted which requires additional training modules beyond those originally completed. Additional modules are required when the previous training has been only for exempt applications and the new protocol requires expedited or full IRB review.

Appropriate training must be completed before a researcher may submit an application.

Principal Investigator

The Principal Investigator has the primary responsibility for protecting human participants in the research project, and must be knowledgeable about the requirements of the Federal regulations, applicable state law, their institution’s policies and procedures, and the Code of Ethics of their profession.

Effective Janaury 1, 2024: The Principal Investigator must be a faculty member (roster or adjunct), matriculated graduate student, staff member, or administrator of the College of Charleston. Undergraduate students may serve as the Principal Investigator on applications submitted and approved prior to January 1, 2024. After that date, Undergraduates may not be the Principal Investigator, hoever, they may serve as the Co-PI or Research Associate. 

Responsibilities:

1. Complete IRB recognized training in human participant research and renew certification as required.
2. Submit an application to ORGA through the eForm system for every research project involving human participants.
3. Complete and file appropriate paperwork with the Controller’s office for all participants to be paid (check, cash, gift certificate) for their participation.
4. Submit applications and gain approval for modifications prior to instituting those changes.
5. Submit an application for continuation of the protocol if needed at least 30 days prior to the expiration of the current approval and gain approval before continuing the research, as necessary for research involving more than minimal risk.
6. Submit a final report within 30 days after the end of the protocol, as necessary for research involving more than minimal risk.

Research Advisor

Student principal investigators must have a faculty, staff, or administrator as a Research Advisor who is responsible to assure that the student has completed all requirements for IRB submission and approval, including the submission of the application to the IRB and the final report.  The research advisor has full access to his/her students’ protocols through the eForms system, and can make changes to the students' application, request revisions, and provide feedback. Instructions for use of the eForm system will be made available on the IRB website. 

(Effective January 1, 2024) Undergraduate students may serve as a Co-Principal Investigator or Research Assistant on a project conducted by their Research Advisor (also called Faculty Sponsor). The Research Advisor must be the PI of the IRB application, and the Research Advisor must initiate and submit the protocol application in the eForm system. The undergraduate student researcher may be listed as a Co-PI, and may be given full edit access to contribute to the application. The Research Advisor for undergraduate students assumes all the responsibilities of a Principal Investigator and must complete the required CITI training. 

The IRB Administrator serves as the first and primary contact point for inquiries and submissions to the IRB. Instructions for use of the eForm application system are available on the IRB website. 

Application

The Human Participants (IRB) webpage on the ORGA website has links to the Human Research Review eForms.  eForms are submitted electronically to Research Protections & Compliance.  The forms detail all information required for review and help the principal investigator determine the level of review anticipated.

The Research Protections & Compliance manager initially screens all applications and notifies reviewers.  Applications may be returned to the principal investigator if additional information is needed or corrections are required.

Types of Review

• Administrative Review:  Applications qualifying under an exemption category are reviewed by the Exemption Reviewer within 5 days of receipt.
• IRB Review:
  • Expedited Review:  Applications qualifying for expedited review are sent to reviewers on a rolling basis within 5 days of receipt.
  • Full IRB Review  Applications requiring full IRB review must be submitted at least two weeks (14 calendar days) prior to a scheduled meeting.  Meeting dates and application deadlines are posted on the ORGA website and in the eForm system at the beginning of each academic year.

Notification

Following review, the IRB Administrator shall communicate the results within 5 days to the Principal Investigator via e-mail with a copy to the IRB Chair.

• Notification of clarifications or revisions requested for further review shall include all items requested by the expedited reviewers or the IRB members.
• Notification of approval shall include:
  • Effective dates of approval,
  • The requirement that all modifications to the procedure must be approved by the IRB prior to instituting the change,
  • The terms of continuation review if required, and
  • The terms of a final report if required,.
• Notification of denial of approval shall include the reasons that the application has not been approved.

A copy of the notification of approval or disapproval shall  be sent to the Principal Investigator’s Department Chair or Program Director.

The IRB Administrator refers all new applications for exemption from IRB review to the designated Exemption Reviewer who has the authority to approve such requests request further information or clarification, or refer the application for IRB review.  If the reviewer is uncertain whether exemption should be granted, the request may be forwarded to the Chair for consultation.

Exemption Categories

Research activities that present no more than minimal risk to human subjects, and  meet one of the following criteria qualify for administrative review (i.e., exempt from IRB review).

Category 1. Evaluation/Comparison of Instructional Strategies, Techniques or Curricula

Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Category 2. Educational Tests, Surveys, Interviews or Observations

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; or

(ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.

Note:  This category may include anonymous surveys which deal with sensitive aspects of the research participants' own behavior such as illegal conduct, drug use, sexual behavior or use of alcohol if participants are advised in the consent form of the sensitive nature of the research and information about contact persons if the participant becomes distressed are included in the consent form and the questionnaire.

Category 3. Benign Behavioral Interventions

Benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; or

(ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.Note: If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Category 4. Secondary Research for which Consent is Not Required.

Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

(i) The identifiable private information or identifiable biospecimens are publicly available;

(ii) Information, which may include biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;

(iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is for the purposes of ‘‘health care operations’’ or ‘‘research’’ or for ‘‘public health activities and purposes’’ (as defined in the federal regulations; or

(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with federal regulations.

Category 5. Research and Demonstration Protocols Conducted or Supported by a Federal Department or Agency

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

Category 6. Taste, Food Quality Evaluation, and Consumer Acceptance Studies

Taste and food quality evaluation and consumer acceptance studies:

(i) If wholesome foods without additives are consumed, or

(ii) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the EPA or the USDA Food Safety and Inspection Service.

Notification

Within 5 days, the IRB Administrator shall notify the Principal Investigator via e-mail that either:

• The protocol does not meet the definition of research or the definition of human subject and therefore does not require review;
• Further information or clarification is required in order to make a determination.
• The research has been exempted from IRB review.  Notification shall include the exemption category and the end date of the protocol and will be copied to the IRB Chair and the Principal Investigator’s Department Chair.
• The research does not meet the criteria for exemption and must be revised and resubmitted for IRB review.

Categories of Research Which May Receive Expedited Review

Research activities that present no more than minimal risk to human subjects, and involve only procedures listed in one or more of the following categories, may qualify for expedited review.  The categories in this list apply regardless of the age of subjects, except as noted.

1. Clinical studies of drugs and medical devices (only when certain conditions are met, see OHRP Guidance).
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture (subject to certain age, health status, body weight, sample volume, and sampling frequency limitations).
3. Collection of biological specimens for research purposes by noninvasive means (subject to certain conditions of collection).
4. Collection of data through non-invasive procedures, such as application of physical sensors to the surface of the body, weighing, testing sensory acuity, and moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual
5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes.
6. Collection of data from voice, video, digital, or image recordings made for research purposes.   (Note:  For research that is not federally funded, this category may qualify for exemption under certain circumstances as described in the section on Exemption.)
7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.   (Note:  For research that is not federally funded, this category may qualify for exemption under certain circumstances as described in the section on Exemption.)
8. Continuing review of protocols which were approved by the Full IRB, but which have been documented in that approval to present no more than minimal risk to the participants.
9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories 2 through 8 do not apply, but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
10. Review of revisions specified in a convened review of a protocol when the revisions do not affect the risk level of the research.
11. Revisions affecting the level of risk or revisions not adhering to those prescribed in the convened meeting must be returned for review at a convened meeting.  This category may not be applied to federally funded research.

Expedited Review by Review Team

A team of two IRB members (either two full members or one full member and one alternate) serve as the expedited reviewers for all new research protocols and for some modifications and continuations.  Within two weeks of notification that an application is ready to review, the expediting team shall determine that the application should be:

• Returned to the researcher with revision.
• Returned to the researcher as “approved with stipulations” which are deemed non-substantive administrative verification by Research Protections & Compliance.  When a protocol is approved with stipulations, the effective date of approval is the date when the approval was issued, not when the stipulated revisions or documents were received.
• Approved.
• Referred for full IRB review.  Expedited reviewers may not disapprove an application.

Expedited Review by the Chair of the IRB or Designee

The IRB chair, or designee, may serve as the sole expedited reviewer for:

• Minor (non-substantive) modifications.
• Continuing reviews with no modifications or non-substantive modifications.

Within one week of notification that an application is ready for review, the Chair or designee shall determine that the application for continuation and/or modification should be:

• Returned to the researcher with recommendations for revision.
• Returned to the researcher as “approved with stipulations” which are deemed non-substantive administrative verification by Research Protections & Compliance.  When a protocol is approved with stipulations, the effective date of approval is the date when the approval was issued, not when the stipulated revisions or documents were received.
• Approved.
• Referred for review by a Review Team.
• Referred for full IRB review.  (Expedited reviewers may not disapprove an application.)

Applications which do not qualify for exemption or expedited review must be reviewed at a convened meeting of the IRB.  Approval or denial of approval must be voted by a majority of IRB members present.  In its review, the IRB may determine that protocol will require review more often than annually based on the risk level of the protocol, or concerns about an individual Principal Investigator.

Actions

Protocols reviewed by the IRB may be:

• Returned to the researcher with recommendations for substantive revision which will require review at a convened meeting.
• Returned to the researcher as approved with stipulations which are deemed non-substantive by the IRB and require either expedited review or administrative verification by Research Protections & Compliance.  When a protocol is approved with stipulations, the effective date of approval is the date when the approval was issued, not when the stipulated revisions or documents were received.
• Approved.
• Disapproved.

Terms of Approval

The IRB will specify the term of approval which may be shorter than the full term of the research protocol.  The IRB may, also specify terms for continuing review and final report.

All modifications to a research protocol whether reviewed as exempt, expedited, or full IRB must be submitted by the Principal Investigator in the Amendment section of the eForm for review and approval prior to instituting the change.

The Research Protections & Compliance manager shall determine whether the review of the modification request will be conducted as Expedited or Full IRB and shall notify the reviewers.

Non-Substantive (minor) Changes:

This type of change may be approved by the IRB Chair or designee.  A change is considered to be non-substantive if it:

• does not have the potential to increase the level of risk, AND
• is a change in the:
  • number of subjects;
  • investigator contact information in the informed consent information and written consent document;
  • title that does not change purpose;
  • personnel, including Principal Investigators or research assistants;
  • wording (i.e. corrections) of the informed consent or other documents that are provided to the participant that do not alter intent or meaning of the documents; and/or
  • participant population within non-vulnerable categories.

Substantive (major) Changes:

This type of change may qualify for review by an expediting or the full IRB.  A change is considered to be substantive if it:

• Alters the approved informed consent process or documents that in a way that changes the essential elements of consent as prescribed by federal regulations or waivers as originally approved;  (This does not include investigator contact, title, or wording corrections that do not alter intent or meaning of the document.)
• Increases the level of risk;
• Results in a different participant population within vulnerable categories or includes vulnerable populations not originally approved;
• Introduces potential for conflict of interest; AND/OR
• Introduces an element of potential coercion (e.g., using Principal Investigator’s own students).

Changes to Exempt Protocols:

Changes which result in the protocol not meeting the exemption criteria will require revision and resubmission of the protocol for expedited or Full IRB Review.

If an IRB approved research protocol is expected to continue beyond the approval period, the Principal Investigator shall submit an Annual Report in the eForm system at least 30 days before the end of the IRB approval period.  Ongoing IRB approval shall be maintained during the data analysis phase as well as active involvement with the human participants.  If a request for continuation is not received, the protocol file shall be closed and no further participants may be recruited.

The IRB, at the time of approval shall determine whether the continuing review (if r required) will be conducted as expedited or full IRB.

Review and determination shall proceed in accordance with procedures set forth above under IRB Review - Expedited or Full IRB Review.

In addition, the expedited reviewers or the convened IRB may determine that the protocol needs verification from sources other than the investigators that no material changes have occurred since the previous IRB review based on the following:

• randomly selected protocols;
• complex projects involving unusual levels or types of risk to subjects;
• projects conducted by investigators who previously have failed to comply with the requirements of the HHS regulations or the requirements or determinations of the IRB; or
• protocols where concern about possible material changes occurring without IRB approval have been raised based upon information provided in continuing review reports or from other sources.

Continuing review is not required for a protocol that has been deemed minimal risk under an expedited or exempt category, unless otherwise specified by the IRB at the time of approval. Protocols that do not require continuing review can be extended administratively by the IRB Administrator following notification from the researcher.

Continuing Review is required when one of the following criteria are met: 

• Federally funded/supported research
• FDA-regulated research
• Research involving more than minimal risk
• Protocols which were initially approved prior to February 10, 2017 (adoption of internal Flexibility Policy)
• When requested by the IRB at the time of approval

The final report (if required) should be submitted by the principal investigator using the Annual Reporting section in the eForm system within 30 days after the end of the protocol.

If the principal investigator is a student who has left the College before completing the final report, the research advisor is responsible for completing a final report.  

A final report is not required for a protocol that has been deemed minimal risk under an expedited or exempt category, unless otherwise specified by the IRB at the time of approval. Protocols that do not require a final report can be extended administratively by the IRB Administrator following notification from the researcher.

The application will be reviewed either administratively for exemption or by expedited or full IRB process as appropriate.  All applications not approved by a jurisdictional IRB may not be administratively reviewed for exemption.

Recruitment may be approved for a period up to the expiration date of the jurisdictional IRB approval, or one year for projects which do not have jurisdictional IRB approval.

The researcher must use the recruitment and consent materials as approved by the College of Charleston IRB.

The IRB reserves the right to grant or deny permission to external investigators to recruit subjects on campus. The decision of the IRB to deny permission for participant recruitment by an external investigator may not be reversed by any other College of Charleston authority.

Decisions made by the IRB to grant permission to an external investigator to recruit research participants on campus may be reversed by the Board of Trustees of the College or by the President of the College, acting on their behalf, if it is in the best interests of the College to do so.

Unanticipated problems or adverse events involving risk or injury to research participants include:

1. Events that are related, or possibly related, to the research but were not expected based upon available data or experience.
2. Any adverse events that have greater severity or frequency than originally anticipated.

An Adverse Event report should be completed and submitted to ORGA through the eForm system as soon as possible and in no case later than two working days after the adverse event occurs. ORGA will notify IRB members, administrators, and sponsoring/regulatory agencies as necessary and will assist the investigator in developing the best course of action.

As part of its mandate to ensure that all human research is conducted in accordance with the highest ethical standards, the College of Charleston IRB reviews, approves, and monitors research activity carried out under its auspices for conformance with all applicable laws, regulations, policies, and procedures.

Definitions

Allegation – Any written or oral statement or other indication of possible human research misconduct or non-compliance made to a College official.

Research Noncompliance – Acts that directly impact the physical, social or psychological welfare of human research participants, including failure of the investigator involved in human participant research to follow applicable laws, regulations, policies, procedures, approved protocols, and/or directives of the IRB.

Administrative Noncompliance – Acts that do not directly impact the physical or psychological welfare of human research participants, including, but not limited to, such acts as failing to complete and submit reports and other paperwork in accordance with IRB procedures and timelines, failing to follow administrative instructions, and failing to adhere to other related guidelines and practices. Administrative infractions are most commonly identified by ORGA and are dealt with directly by the IRB as part of its regular business, as opposed to being addressed through a preliminary review and investigation process.

Sanction – Any penalty or coercive action taken by the IRB to help ensure compliance with applicable regulations, policies, and procedures for the care and use of animals in research and instruction.

Respondent – The person against whom an allegation of non-compliance is directed or the person whose actions are the subject of a preliminary review and/or investigation. There can be more than one respondent in any preliminary review or investigation.

Reporting Non-Compliance

Any faculty member, student, or staff member who suspects noncompliance with regulations and policies governing human participant research at the College of Charleston has a legal and ethical obligation to report the suspected activity.  Report may be made to the IRB Administrator or any faculty member, staff member, dean or other College official.  Allegations may be submitted anonymously.  The person receiving the allegation shall report it to the IRB Chairperson with a copy to the IRB Administrator.

If the alleged noncompliance involves externally sponsored research or other activities, the IRB Chair will first inform the Senior Vice President for Academic Affairs, and then, if required by the sponsoring agency, will report the impending investigation to the agency according to its rules and regulations. (The sponsoring agency may reserve the right to initiate an investigation of its own.) The IRB may also consult with General Counsel of the College to develop and initiate any other procedures appropriate to the circumstances.

Procedures

Procedures for addressing allegations of non-injurious noncompliance have been designed with recognition that determination of why, or even if, noncompliance has occurred may be difficult and that the process of review and/or investigation must be sufficiently flexible to be terminated when it becomes clear that charges are unjustified or that the issue can be resolved appropriately by other means. It is understood that persons conducting the preliminary review and/or investigation must possess the special knowledge necessary to judge the situation but must also have no immediate personal interest in the case.

When an allegation of mistreatment noncompliance is received, the IRB Chair shall conduct a preliminary review.  Should a conflict of interest arise, any full voting member of the IRB may serve in his/her stead.

If the preliminary review indicates sufficient evidence and justification for additional study of the matter, an investigation will be conducted. The purpose of the investigation is to determine if noncompliance has occurred and, if so, to recommend appropriate sanctions. The investigation will begin immediately and will be completed as soon as practicable but will not exceed more than thirty (30) business days. At the request of any involved party, with appropriate documentation of extenuating circumstances, and with approval of the IRB, the period of time for the investigation may be extended.

The IRB Chair will promptly notify in writing the respondent, his/her cognizant administrators (generally the department chair and/or program director, and the dean), and as appropriate, the respondent’s immediate supervisor of the initiation of the investigation. At that time, all additional necessary administrative actions will be taken by the IRB, on behalf of the College, to ensure the welfare of the animals, the integrity of the research or instruction, the observance of legal requirements and responsibilities, and the continued protection of the rights and confidentiality of the informant and the respondent.

Throughout the investigation, the respondent will be advised of the progress of the investigation and will be afforded the opportunity to respond and to provide additional information. At all times, diligent effort will be made to maintain confidentiality of deliberations.

Actions

Actions may take the form of recommendations for changes in research protocols, additional training of investigators or other personnel, changes in procedures, sanctions, or referral to the Institutional Official for consideration under the policy on Misconduct in Research and Scholarship.

Sanctions will be determined on a case-by-case basis. Factors that will be considered include the seriousness of the offense, the past record of the investigator, and the level of cooperation that the investigator exhibits during the preliminary review and investigation. The IRB may impose sanctions that include, but are not limited to, the following:

• Written warning (may or may not be entered into official personnel file)
• Written reprimand (may or may not be entered into official personnel file)
• Training requirements before research can continue
• Requirement to add research staff
• Suspension or termination of any or all of the investigator’s protocols

Should the IRB determine that the noncompliant behavior warrants further action, the matter will be recommended for review under the policy on Misconduct in Research and Scholarship or the Student Honor Board.