RESEARCH MISCONDUCT

Research subjects have a right to bring to bear a concern (e.g., allegation), complaint, or question and to be assured that the concern, complaint, or question is taken seriously and resolved in a timely manner. 

The Chief Academic Officer (CAO) or designee, with "as needed" assistance from Legal Counsel, is responsible for investigating concerns, complaints, and questions from subjects and any improprieties involving investigators or their staff.

The CAO or designee handles these issues in a timely manner to assure protection of human subjects. Moreover, the IRB holds any violators accountable to the applicable regulation. To this end, a research subject (past, current, or prospective) or anyone with a concern about a human research study may raise concerns, complaints, or questions about a research project in writing to the CAO or designee. 

When a human subjects concern/complaint is brought to the CAO's attention, the CAO or designee takes the following steps to inquire about the complaint and take protocol‐specific and/or systemic corrective action steps, as appropriate. Corrective steps will vary depending on the nature of the concern/complaint. 

1. Investigate
   
   

2. Correct as appropriate

Depending on the nature of the event or circumstances, the CAO or designee may take the following actions, including but not limited to:

• Halt (any further) data collection;

• Administrative action to suspend or terminate the protocol;

• Forward details and recommendations to the Department Chair and/or Dean for action as appropriate; or

• Other actions as deemed appropriate, based on the severity and seriousness of the findings.
  
  

3. Document/Close

1.  A research subject with a concern, complaint, or question regarding a research study involving human subjects may raise the concern, complaint, or question with the Chief Academic Officer (CAO) or designee. 

2. Upon receipt of a concern (e.g., allegation), complaint, or question, the CAO or designee gathers the following information from the Subject (or complainant) as appropriate: 

   •  Subject's (or complainant's) name, address, and phone number. This information is NOT MANDATORY, and an individual may report an incident anonymously, but the CAO or designee should advise the individual that a thorough review may not be possible and that, without this information, follow‐up responses to the individual are not feasible. 

   • Study protocol title and the name of the Primary Investigator (PI).

   • Date(s) of concern, complaint, or question.

   • An explanation of the concern, complaint, or question.

3. The CAO or designee assures the subject (or complainant) that he/she will inquire into the circumstances and that the IRB will take appropriate measures to address the issue. Moreover, the CAO or designee informs the subject (or complainant) that a response will be forthcoming as rapidly as possible provided that contact information is given (e.g., if possible, within 2 to 3 weeks, if the issue is a complaint). The CAO or designee also explains to the individual the limits to confidentiality.

4. The CAO or designee handles the concern, complaint, or question in a confidential manner to the extent possible; that is, the CAO or designee limits access to information concerning the contact to employees with responsibilities that require knowledge of the concern, complaint, or question.

5. The CAO or designee investigates the concern, complaint, or question; evaluates the alleged impropriety on a case‐by‐case basis; and makes every effort to correct the issue(s) at the administrative level. The investigation may include the following steps:

   • A thorough paper review of the protocol in question

   • An inquiry to the IRB Coordinator/Staff involved in the pre‐screen and review facilitation of the protocol in question

   • An inquiry to the IRB or members of the IRB involved in the review of the protocol in question

   • An inquiry to the PI of the study at issue; the CAO or designee conveys the information regarding the concern, complaint, or question to the PI of the study at issue in a timely and confidential manner (i.e., consistent with Step 3)

   • If appropriate, a notice to Legal Counsel and CTL Director about the concern, question, or complaint; depending on the complaint, the CAO or designee may request Legal Counsel's review and evaluation of the IRB-approved protocol documentation, the complaint and request assistance in articulation of corrective actions steps.

6. If the alleged impropriety involves a serious issue (i.e., potential harm to human subjects or others), the CAO or designee notifies the IRB for immediate action pending formal inquiry. As noted in Step 5, the CAO or designee reports concerns, complaints, or questions involving serious issues immediately to the CTL Director and if appropriate, Legal Counsel.

7. The CAO or designee manages the inquiry, preparing related correspondence, and maintaining documentation of the review from completion of the inquiry or close out of the IRB file, whichever is longer. 

8. The CAO or designee ensures an appropriate response to each concern, complaint, or question and reports the action(s) taken to the IRB.  If the complaint, concern, or question is of a minor nature (e.g., payment of incentive), the CAO or designee may resolve the issue without bringing it forth an IRB committee vote.  The CAO or designee refers major issues such as a failure to obtain signed informed consent from potential subjects (if required) to the IRB committee, and the IRB votes on any actions the IRB takes. All actions taken are by the IRB and are appropriate for the circumstances, with the final course of action contingent on the nature, severity, and seriousness of the findings.

Depending on the nature of the event or circumstances, the CAO or designee may take the following actions, but is not limited to:

• Halt (any further) data collection

• Administrative action to suspend or terminate the protocol

• Details and recommendations forwarded to the appropriate Department Chair and/or Dean for action as appropriate

• Other actions as deemed appropriate

In some instances where a human subjects' concern/complaint is brought to bear , the IRB office may implement systemic corrective actions, if appropriate, rather than just protocol‐specific corrective actions. Systemic corrective steps may typically include, but are not limited to:

• • Addressing the concern/complaint/question with the appropriate representatives of the institutional group/unit with which the investigator is affiliated.

  • Reviewing relevant documents/processes of the institutional group/unit with which the investigator is affiliated.

  • Determining what corrective information, if any, is needed to prevent future concerns/complaints/questions and sharing appropriate information.

  • Other actions as deemed appropriate

Unless otherwise noted, all documentation related to human subjects' concerns can be found in the Continuous Improvement folder on the IRB SP site.

This procedure catalogues the resolution of non‐compliance incidents with the Purdue Global IRB Process, including breaches of the PG Legal Agreement. 

When an incident of non‐compliance is brought to the IRB office's attention, the IRB office contacts the investigator to inquire about the incident and request the investigator's assistance in taking corrective steps. These corrective steps will vary depending on the incident in question.

• 1. Investigate 

  2. Correct

  3. Document 

     • • • All documentation related to the address and resolution of follow‐ups on legal agreement compliance is retained in the investigator's folder on the IRB or FRGP SP site, as applicable. Unless otherwise noted, all documentation related to Failure to Submit a protocol can be found in the Continuous Improvement folder on the IRB site.

Breaches of the PG Legal Agreement, corrective steps may typically include, but are not limited to:

• • Retract disclosure, if possible, of the Purdue Global name (as the source of the data for the project) in any past dissemination of the research findings.

  • Provide an updated copy of the manuscript (i.e., having removed reference to the Purdue Global name as the source of the data).

  • Comply with the stipulations in the Legal agreement in any prospective dissemination of the research findings.

  • Confirm understanding of and willingness to comply with the aforementioned corrective action steps.

For incidents where an investigator Fails to Submit a protocol, corrective steps may typically include, but are not limited to:

• • Halt (any further) dissemination of the research findings.

  • If the investigator intends to continue dissemination, then he/she must submit findings for IRB review before further dissemination occurs.

  • If the investigator does not intend to continue dissemination of findings, the investigator must prepare and submit a statement, for the IRB's records, acknowledging the noncompliance incident and defining the protections the investigator has put in place for the collected data from the unapproved research project.  The investigator should communicate the following in his/her statement:

    1. Acknowledgement of the failure to submit protocol incident;

    2. Explanation of the circumstances that may have contributed to the incident;

    3. Description of what the study involved (i.e., research question(s) and methodology, with an emphasis on the processes used to collect data).  In lieu of this, we will also accept an abstract; and

    4. Articulation of assurances for how the investigator is protecting the data that he/she has already collected, with an emphasis on the steps he/she has taken to minimize risks to confidentiality and potential disclosure of the collected information that could place the subjects at risk of criminal or civil liability

In some instances where an incidence of non‐compliance is discovered, the IRB office may implement systemic corrective actions, if appropriate, rather than just protocol‐specific corrective actions.   Systemic corrective steps may typically include, but are not limited to:

• • Addressing the incident with the appropriate representatives of the institutional group/unit with which the investigator is affiliated.

  • Reviewing relevant documents/processes of the institutional group/unit with which the investigator is affiliated.

  • Determining what corrective information, if any, is needed to prevent future incidents and sharing appropriate information