Human Studies

Human Studies

1. The World Medical Association (Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects), which is available at http://www.wma.net/e/.
    
2. The Council for International Organizations of Medical Sciences (International Ethical Guidelines for Biomedical Research Involving Human Subjects), which is available at http://www.cioms.ch/.

JURISDICTION OF IRB

The jurisdiction of the IRB extends to all human research projects that fit either of the following:

 

1. Projects where the investigator conducts research activities as part of his or her role as an employee or agent of the University (normally, a faculty member). As such, the University is considered to be engaged in the research through the activities of the particular investigator. A significant factor to consider is whether the University provides compensation to the investigator because, at least in part, the investigator is performing research activities, regardless of whether the University receives grant or other revenue from external sponsors of the research to offset that compensation.
    
2. Projects where any research activity is conducted on or through the use of University property (including recruitment activities).

HUMAN PARTICIPANT and RESEARCH

The term “human participant” (also termed “human subject”) means either of the following definitions:

Common Rule (sometimes termed DHHS) definition: A living individual about whom an investigator (whether professional or student) conducting research obtains either:

1. Data through intervention or interaction with the individual, or
    
2. Identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the participant or the participant’s environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between the investigator and participant.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifable (i.e., the identity of the participant is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human participants.

FDA definition: An individual who is or becomes a participant in research, either as a recipient of the test article or as a control; or an individual on whose specimen a medical device is used.

The term “research” means either of the following definitions:

Common Rule (sometimes termed DHHS) definition: A systematic investigation (including research development, testing, and evaluation) designed to develop or contribute to generalizable knowledge. Any activity that meets this definition constitutes research, whether or not it is conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

FDA definition (also known as clinical research, clinical study, study, or clinical investigation): Any experiment that involves a test article and one or more human participants, and that either:

* must meet the requirements for prior submission to the FDA (i.e. any use of a drug other than use of an approved drug in the course of medical practice OR any activity that evaluates the safety or effectiveness of a medical device) OR

* need not meet the requirements for prior submission to the FDA, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit.

PRINCIPAL INVESTIGATOR

All research protocols must designate one individual as the Principal Investigator (PI). In addition to a PI, a research protocol may have one or more persons designated as a collaborative investigator or co-investigator (CI). The CI need not have a faculty appointment at the University but must have fulfilled the other required qualifications of a PI.

The PI shall comply with the University’s Human Research Protection Program and protect the rights and welfare of human participants. Some specific responsibilities include the following:

(1) Ensuring that all members of the research staff have received training and demonstrate knowledge of human participant research within the last 12 months that includes University policies, the applicable laws and ethical principles.

(2) Complying with requirements of the IRB, the applicable laws, and ethical principles.

(3) Developing and employing a scientifically sound study design.

(4) Establishing effective oversight mechanisms to monitor, timely receive, and appropriately respond to information that may affect the rights and welfare of the human participants and the scientific and ethical integrity of the research project (and especially providing greater oversight in projects involving greater than minimal risk). Such information includes data generated within the research project; information originating from outside the research project; and complaints, requests, or similar relevant communications.

(5) Ensuring that necessary resources are present before project initiation.

(6) Guaranteeing consistency between

(a) the protocol submitted to the IRB and

(b) the specifics contained in any written correspondence or agreement with the sponsor or government agency (such as a clinical trial agreement, sponsor agreement, and/or grant application).

(7) Assessing interests held by members of the research staff to identify any potential or apparent conflicting interests that may affect the rights and welfare of the human participants or the scientific and ethical integrity of the research project. Upon identifying a potential or apparent conflicting interest, the PI shall immediately disclose that interest to the IRB along with a proposed resolution that either effectively manages the conflict or results in a disqualification of the individual from performing those particular research duties that created the conflict situation.

(8) Obtaining compliance with other laws and University policies that apply.

(9) Assisting the University in the ongoing efforts to improve the Human Research Protection Program.

APPLICATION FOR REVIEW

For each research protocol involving human participants (including those that appear to meet the criteria of “exempt”) within the jurisdiction of the IRB, the PI shall complete, sign, and submit to the IRB Administration Office an application for review based on the type of review desired by the PI (whether it is initial review, continuing review, or reviewing a requested modification). PIs should seek guidance from the IRB Chair or his/her designee whether a particular project is research involving human participants as those terms are defined in University policy. When necessary or prudent, further assistance and guidance should be sought from the IRB.

The IRB staff will review submitted applications for completeness. Applications that are incomplete will be returned to the PI, prior to review.

The PI will include supporting documentation to enable the appropriate level of review, including the following:

 

1. Conflict of Interest Disclosure Report: The IRB application includes a Conflict of Interest Disclosure provision and, depending on the circumstances, a copy of a Disclosure Report that was reviewed by the Conflict of Interest Committee, along with that committee’s determination, may be required. In addition, the PI shall require each individual involved in the design, conduct, or reporting of the research to complete a Conflict of Interest Program Disclosure Report: Employed Faculty – Research Form.
    
2. Research Protocol: A complete written description of and scientific rationale for the proposed research. For an application for continuing review of a previously approved project, a protocol summary may be submitted in lieu of the previously approved protocol only when there are no requested changes or modifications. The IRB Administration Office can provide guidelines addressing the required contents of a research protocol.
    
3. Informed Consent Document: The proposed informed consent document for initial review, the previously approved informed consent document for continuing review, or the previously approved document and the proposed modified document for cases in which modifications are sought. For exceptions to the informed consent documentation requirement, see specific policies on that subject.
    
4. Self-Assessment Report (only for applications for continuing review): A self-assessment and status report that contains the number of participants accrued, a summary of adverse events, any unanticipated problems involving risks to participants or others, any serious or continuing noncompliance with the policies, requirements, or determinations of the IRB, any withdrawal of participants from the research, any complaints about the research, interim findings of the research project, and recent relevant literature.
    
5. PI’s Research Staff Roster and dates of when each staff member completed recent (within past year) human participant research training (copies of completion certificates must be provided if they are not already on file in the IRB Office).
    
6. Investigator’s Brochure (when applicable).
    
7. Recruitment Materials (when applicable).

The deadline for submission of applications for review is three weeks prior to the scheduled IRB meeting date on which the PI desires the protocol to be reviewed. Earlier submission (one month prior) is encouraged. In determining the desired IRB review date, PIs should consider the possibility of IRB deferral during its initial review, especially for complex protocols, such as those requiring review by more than one committee or board.

Click here to access IRB Applications.

SCIENTIFIC VALIDITY COMMITTEE (SVC)

The SVC is a committee of the IRB designed to provide information to the IRB concerning scientific and statistical issues of the particular protocol in order to assist the full IRB perform its functions.

All protocols scheduled to receive full IRB review are initially reviewed by a SVC. Protocols scheduled to receive review other than full IRB review may undergo SVC review at the discretion of the IRB Chair.

The function of the SVC is to provide information to the IRB concerning scientific and statistical issues of the particular protocol in order to assist the full IRB perform its functions. The scientific and statistical issues would relate to:

a. the scientific qualifications of the PI and any other investigators;

b. the hypothesis or scientific question;

c. the research design; and

d. the benefits and risks involved.

 

FULL OR EXPEDITED IRB REVIEW

For each project undergoing full or expedited IRB review, For each project undergoing full IRB review (whether it is initial review, continuing review, or reviewing a requested modification), the topics of consideration include:

a. Risks to participants are minimized: (a) By using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk, and (b) whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.

b. Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result. Evaluation of the risk/benefit ratio is a major ethical judgment that often depends upon prevailing community standards and subjective determinations of risk and benefit. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies participants would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

c. Selection of participants is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. When some or all of the participants are likely to be from a vulnerable population, additional safeguards have been included in the study to protect the rights and welfare of these participants. Additionally, participant selection should include children and adults, male and female, and minority and majority populations unless such inclusion is inappropriate due to scientific or ethical reasons with due consideration given to the health of the participants and purpose of the research.

d. Informed consent will be sought from each prospective participant or the participant's legally authorized representative and will be appropriately documented.

e. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants. Monitoring techniques are to be employed as appropriate to protect the safety of human participants depending upon the specifics of the research project, including the element of risk involved. The techniques employed to monitor the data collected would, as appropriate, include activities of the research team and/or activities of another body (e.g. DSMB).

f. When appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data. When private information linked to individuals will be recorded as part of the research design, the protocols must provide for adequate precautions to safeguard the confidentiality of that private information. Private information includes any information the participant would not want to be released to the general public for any reason, including a desire to avoid psychological, social, or economic harm. The IRB should also be aware of the available provision for waiving documentation of consent when a signed consent form would itself constitute a risk to the participants. The IRB is not required to review and approve HIPAA Privacy Rule authorizations or otherwise enforce HIPAA Privacy Rule compliance. Further information about the HIPAA Privacy Rule and research is available from the Office of Compliance and the federal government at http://privacyruleandresearch.nih.gov.

g. The investigators are qualified to conduct the research.

(1) The investigator’s professional experience, expertise, and potential conflicting interests, should be considered and compared to the specifics of the research project, to include its complexity, risk to human participants, and skill sets.

(2) For cases in which a conflict of interest is identified, IRB approval will be withheld pending completion of the Conflict of Interest Committee Evaluation and the IRB’s independent review the management plan. The IRB has independent authority to decide whether the particular conflict is effectively managed as part of the IRB’s responsibility regarding approval of research.

(3) In addition, the investigator will be deemed to be not qualified if that investigator as listed as an excluded party, debarred, disqualified, or restricted on federal government lists. Those lists include:

(a)  http://epls.arnet.gov/ is the federal “Excluded Parties List System” (EPLS).

(b) http://oig.hhs.gov/fraud/exclusions.html is the HHS (OIG) list with more specific info on particular persons (the same names should be on EPLS but this list contains more detailed info when the excluding agency is HHS).

(c) http://www.fda.gov/ora/compliance_ref/bimo/dis_res_assur.htm has disqualified and restricted investigators.

(d) http://www.fda.gov/ora/compliance_ref/debar/default.htm has debarment list.

h. The review schedule for renewal of approval is appropriate to the degree of risk, but at least annual. All approved projects require a review at intervals appropriate to the degree of risk, but at least annually.

VULNERABLE POPULATIONS AS HUMAN PARTICIPANTS

Vulnerable participants are those who, due to some characteristic, condition, or status, are likely to have either diminished decisional capacity or diminished sense of voluntariness (i.e. the exercise of free will relating to whether to give or withhold consent). As a matter of law or University policy, the following are deemed vulnerable participants:
 

1. pregnant women, human fetuses, neonates or fetal material;
    
2. prisoners;
    
3. children;
    
4. cognitively impaired persons;
    
5. economically or educationally disadvantaged persons;
    
6. University students and University employees;
    
7. any other person, as determined by the IRB, to meet the above definition (the IRB must consider whether human participant has a pre-existing relationship with the PI or sponsor that involves significant authority, dependence, or fiduciary duties, such as physician-patient, institution-resident, employer-employee, or teacher-student).

The PI and IRB must assess the participant selection criteria and other information to determine whether the research involves vulnerable participants. If so, additional affirmative safeguards must be included in the protocol (usually in the recruitment phase but often in other phases as well) to specifically address the participant’s:
a. diminished capacity and/or

b. diminished sense of voluntariness.

In addition, protocols for research involving cognitively impaired persons must describe:
a. the process used to determine whether the individual lacks decisional capacity and any reassessments made to ascertain a change in capacity;

b. the process used to identify the appropriate legally authorized representative;

c. the process used to solicit the human participant’s assent or an explanation of why no such assent will need to be sought.

University students and/or employees should be recruited through general announcements or advertisements, rather than through individual solicitations. Individual solicitations increase the likelihood that participation will be the result of undue influence and coercion.

a. In cases of individual solicitations (i.e. anything other than a general announcement or advertisement located in a common area) of a University student or students:

             (1) the PI may not personally engage in the individual solicitation of that PI’s own students or be present during that individual solicitation (this includes any recruitment or informed consent activities).

             (2) The Dean of the school in which the student is enrolled will review the protocol and provide written comments and recommendations to the IRB prior to IRB review (these written comments will be delivered by the investigator as part of the application submission).

 b. In cases of individual solicitations (i.e. anything other than a general announcement or advertisement located in a common area) of a University employee or employees:

             (1) the PI may not personally engage in the individual solicitation of employees that are supervised by that PI or be present during that individual solicitation (this includes any recruitment or informed consent activities).

             (2) The Dean or Vice President of the employee will review the protocol and provide written comments and recommendations to the IRB prior to IRB review (these written comments will be delivered by the investigator as part of the application submission).

Additional requirements for research involving the following are addressed separate policies:

a. pregnant women, human fetuses, neonates, or fetal material.

b. prisoners.

c. children.

INFORMED CONSENT PROCESS

Human participants, to the degree that they are able, ought to be given the opportunity to choose what will or will not happen to them through a consent process. This consent process consists of three elements: information, comprehension, and voluntariness.

The extent and nature of information to be supplied to the prospective human participant ought to be that which a reasonable volunteer would want to know before making a decision whether to participate in the furtherance of knowledge, fully understanding that the research is neither necessary for their well-being nor perhaps fully understood.

Because the information is useful only if it is comprehended, the presentation of such information ought to be adapted to the prospective participant’s capacity and competence.

Any agreement to participate ought to be voluntary (i.e. completely free of coercion and undue influence).

For a participant who is incompetent or otherwise lacks decisional capacity, issues relating to consent (including the informed consent discussion and documentation) will involve a legally authorized representative of the participant. A “legally authorized representative” means an individual or entity authorized under applicable law of the jurisdiction in which the research will be conducted to consent to the treatments or procedures involved in the research on behalf of the human participant because the human participant lacks either competency or decisional capacity to consent.  Applying that definition to research conducted in Illinois, a parent is a legally authorized representative for that person’s minor child (see also Human Research Program 112.13 entitled Vulnerable Participants - Children).  Other applications of that definition to research conducted in Illinois are that a legally authorized representative includes the following:

1.  a court-appointed guardian of the person, to the extent the court appointment authorizes the guardian to give consent to the treatment or procedures involved in the research and the guardian complies with the court appointment.

2.  an “agent” identified in a written Power of Attorney for Health Care document created pursuant to the Illinois Power of Attorney for Health Care Law (755 ILCS 45/Art. IV) is a legally authorized representative of the principal (sometimes termed “patient”) who lacks decisional capacity to the extent the written Power of Attorney for Health Care document authorizes the ability to give consent for the treatments or procedures involved in the research and to the extent the agent is complying with the written Power of Attorney for Health Care document and Illinois Power of Attorney for Health Care Law.   

3.  a “surrogate decision maker” identified by the attending physician pursuant to the Illinois Health Care Surrogate Act (755 ILCS 40) is a legally authorized representative for a patient who lacks decisional capacity to the extent the surrogate decision maker is complying with the Illinois Health Care Surrogate Act.

Note: Legal advice from the General Counsel or other legal counsel representing the University should be sought regarding the application of this definition to research conducted in other jurisdictions and/or for further clarifications of the above.

Click here for the Informed Consent Document Template.

Click here for a List of Policies that includes Informed Consent.

IRB DETERMINATIONS AFTER FULL OR EXPEDITED IRB REVIEW

The IRB may make one of the following determinations:

1. Approval. A determination of approval may be made when the research has been reviewed, all criteria in IRB Full or Expedited Review topics of consideration are fulfilled, and the research may be conducted within the constraints set forth by the IRB and by University and government requirements. In order for the research to be approved, it must receive such a vote by a majority of those members present at the meeting. A mere plurality, even in cases of a member or members abstaining, is not sufficient for an IRB determination of approval.
    
2. Conditional Approval. A determination of conditional approval may be made when the research would meet the criteria for approval upon fulfillment of a specified list of conditions and the PI would be required to show fulfillment of those conditions to the Chair of the IRB and receive written final approval from the IRB Chair before initiation of the protocol. The “conditions” will be expressly listed on the written letter to the PI, will be capable of being accomplished without the exercise of judgment or discretion; and will be capable of being easily determined to have been either fulfilled or not fulfilled. Examples of appropriate conditions are correcting typographical errors and making specific wording changes. Examples of inappropriate conditions (because these changes should receive full IRB review) are requirements to submit a document that itself should be a matter of review by the IRB and requirements to make changes to the informed consent document but allowing discretion and judgment in the selection of wording (e.g. “make it easier to understand” or “include comments about privacy”). In order for the research to receive a determination of conditional approval, it must receive such a vote by a majority of those members present at the meeting. A mere plurality, even in cases of a member or members abstaining, is not sufficient for an IRB determination of conditional approval. In order for the protocol to receive final approval from the Chair of the IRB, the PI must show, in writing, the fulfillment of the conditions and receive the approval of the Chair.
    
3. Deferral with comments. A decision of deferral with comments means the project is not approved but will be reviewed further to address certain areas as designated by the IRB. This option may be appropriate when the IRB concludes that further information must be submitted for review and the protocol has the potential for approval.
    
4. Disapproval. A decision of disapproval is when the project is not approved and is not scheduled for further review.

Before commencing any research activity involving human participants, the PI must have received written approval from the IRB.

Note: IRB approval addresses human research protection issues. It is not an assurance of compliance with other applicable requirements or laws. It is the responsibility of the PI to identify and comply with those other requirements and laws (e.g. HIPAA Privacy Rule).

MODIFICATIONS OF PROTOCOL

The PI must seek and obtain approval from the IRB of any changes or modifications, however minor, to the approved research protocol before initiation of those changes or modifications except when modification is necessary to eliminate an apparent and immediate hazard to the participant or others, in which case the PI shall notify the IRB promptly of the modification made and its rationale.

Click here to access IRB Applications.

RENEWAL OF APPROVAL OR TERMINATION OF PROJECT

All approvals (whether review was full IRB, expedited, exempt, or cooperative) will expire on a predetermined date. The PI must apply in a timely fashion either to continue the project through a renewal of approval or to voluntary terminate the project such that action by the IRB will occur prior to expiration of the existing approval.
 a. For continuing review, the PI and IRB shall follow the same polices used for initial review of research proposals.

 b. For termination of a research project, the IRB may approve an application for project termination when it determines that:

             (1) the cessation of all research activities will not itself create a harm to the welfare or safety of the human participants and
             (2) further IRB oversight is not warranted.

Continuing review is as important as initial review. It involves the same criteria as initial review plus a review of any new, relevant information obtained since initial review.

The failure to obtain approval of the application for either continuing review or termination of the research project prior to the expiration date of the existing approval will result in a lapse in approval. In such cases:
 a. the IRB will treat the matter as one of noncompliance with policies and/or IRB requirements in accordance with University policies;

 b. the PI must cease recruitment and all other research activities, other than those that are necessary to protect the rights and welfare of the human participants, during the period of lapse of approval; and
 c. PIs must immediately apply for continuing review or to terminate the research project.

Click here to access IRB Applications

EVENT REPORTS TO THE IRB

Without delay and no later than 7 days, the PI must make a written report to the IRB Chair or his/her designee (e.g. Safety Monitor) of eachinternal situation that is either:

a. a serious adverse event or

b. an unanticipated problem involving risk to human participants or others.

Internal. Situations that relate to the human participants that were enrolled pursuant to the approval of the IRB at RFUMS.

Serious adverse event. An “adverse event” is any undesirable effect upon a human participant occurring during or within a reasonable time after the conduct of research activities (i.e. the process of intervention or interaction with a human participant and/or the process of collection of identifiable private information about a human participant). An adverse event is “serious” when the undesirable effect is:

a. a physical harm or injury characterized as death, life-threatening condition, in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, requires medical or surgical intervention to prevent any of the aforementioned physical harms; or

b. a psychological, social, or economic harm or injury of similar magnitude.

Unanticipated problem involving risk to human participants or others. The phrase means any incident, experience, or outcome that meets all of the following criteria:

a. unexpected in terms of its nature, its severity, or its frequency (required considerations are what was disclosed during the recruitment process and what was described in the protocol-related documents);

b. related or having a reasonable possibility of being related to the participation in the research (required considerations include whether the sole cause can be identified and what is the natural progression of any pre-existing disease, disorder, or condition); and

c, suggests a greater risk of harm for human participants or others (in terms of its nature, severity, or frequency of either physical, psychological, economic, or social harm).

Note: A situation that amounts to an unanticipated problem to human participants or others would normally warrant modifications to the research in order to protect the rights and welfare of the human participants or others. Examples of modifications could relate to changing inclusion or exclusion criteria; changing monitoring procedures; suspending research or enrollment; changing informed consent disclosures and documentation; providing additional information to enrolled participants; shortening the term of IRB approval; suspending or terminating IRB approval; and/or referral to other University offices, committees, or boards.

The PI must report other events if and as described in the IRB approval letter and those reports will be addressed in order to protect the rights and welfare of the human research participants. For example, these other reports might include:

a. Events that occurred at sites and involving human participants beyond the oversight of the IRB at RFUMS but nonetheless relate to activities of a particular protocol under the jurisdiction of the IRB at RFUMS (i.e. multi-site clinical trial projects).

b. Quarterly compilation and summary of events, including events previously reported.

The IRB will determine whether other action is appropriate in order to protect the rights and welfare of human research participants and, if so, take such action in accordance with the relevant policies..

Click here to access Event Report Form.

SAFETY MONITOR

For research involving more than minimal risk to the participants, the IRB will appoint by name an IRB Safety Monitor to:
  1. receive and review reports (as described above) and

  2. conduct other oversight of the progress of the research (e.g. recruitment, enrollment, data collection, or data storage and analysis), as described by the IRB.

The IRB Safety Monitor will be qualified by education and/or experience to competently review the notifications sent to the IRB and to conduct the oversight measures of the particular research activities being conducted. This may require the IRB Safety Monitor in some projects to be a credentialed physician, dentist, or other healthcare provider. The IRB Safety Monitor may not be part of the research team but may be a member of the IRB.

The IRB Safety Monitor has the authority to take immediate action to suspend IRB approval of research activities on behalf of the IRB as necessary to protect the safety and well-being of research participants until the full IRB can assess the situation.

NONCOMPLIANCE

Without delay and no later than 7 days, the PI must make a written report to the IRB Chair or his/her designee of each situation that the PI determines is “serious” or “continuing” noncompliance with policies or IRB requirements.

Noncompliance with policies or IRB requirements. Any act or omission that:

 1. is a violation of the human research protection program policies and procedures, federal regulations regarding human research (e.g. the Common Rule or FDA regulations), or written requirements or determinations of the IRB; and
 2. has the potential to adversely affect the rights and welfare of human participants.

Continuing. As the term relates to noncompliance with policies or IRB requirements, continuing means a situation involving all of the following criteria in sequence:
  1. an act of noncompliance with policies or IRB requirements;

  2. written notice of the noncompliance provided by the IRB to the PI;

  3. the passage of a reasonable time period to allow corrective action or avoidance of further noncompliance; and

  4. a subsequent and substantially similar act of noncompliance.

Serious. As the term relates to noncompliance with policies or IRB requirements, it is an act or omission that is a willful violation and that involves either:

  1. knowingly providing false information to the IRB;

  2. the development of a clear increased risk of a serious adverse event; or

  3. is simply determined by the IRB to be serious.

The IRB will determine whether other action is appropriate in order to protect the rights and welfare of human research participants and, if so, take such action in accordance with the relevant policies.

Research Misconduct (formerly known as misconduct in science or scientific misconduct). Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. It does not include honest error or honest differences in interpretations or judgments of data. Although the IRB may have a need to know the actions underlying any allegation of research misconduct in performing its functions relating to the protection of human participants, the procedures regarding to the institutional responsibilities regarding research misconduct are addressed in other University policies and involves the University Research Committee.

SUSPENSION OR TERMINATION OF APPROVAL

The IRB has authority to suspend or terminate its approval of research.

Suspension of approval means an action taken by the full IRB during the time period in which IRB approval is in effect and that fulfills all of the following criteria:

 1. is based on a determination that involves either:

             (a) serious or continuing noncompliance with policies or IRB requirements; or

             (b) unanticipated problem involving risk to participants or others;

 2. implements a cessation of approval to conduct research activities other than that necessary to protect the rights and welfare of the human participants as defined by the IRB; and
 3. contemplates a potential for approval to be granted upon the occurrence of some event or passage of time as expressed in the IRB determination letter.

Termination of approval means an action meeting the criteria of “suspension of approval” except that the action does not contemplate approval will be granted in the future (i.e. cessation of approval is permanent).