FAQ

Anyone who is collecting data or involved with the research process must be listed on the proposal. The PI may not be a student, but students may be listed as CIs.

The WTAMU IRB reviews proposals every two weeks, on the 1st and 15th of each month before 2:00 PM, with the exception of May 1st and the full month of December.

1. Scholarly and journalistic activities (e.g. Oral history, journalism, biography, literarycriticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
   
   
2. Public health surveillance activities, including the collection and testing of information or bio-specimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
   
   
3. Collection and analysis of information, bio-specimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
   
   
4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

AR-EHS sends the revisions to the IRB Chair and the IRB Chair makes a determination, using Designated Member Review.

If you are involved in collaboration work, you must submit a Reliance Agreement to AR-EHS.
Contact AR-EHS@wtamu.edu for further instructions.

Noncompliance is a failure (intentional or unintentional) to comply with applicable federal regulations, state or local law, the requirements or determinations of the IRB (including failure to follow approved protocol), System policies or regulations, university rules or procedures in the conduct of human subjects research. Noncompliance can result from action or omission.

Noncompliance may be non-serious (minor) or serious, and may also be continuing (see below).

Non-serious or minor noncompliance is noncompliance that does not increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the human subjects protection program. Examples of minor noncompliance may include, but are not limited to: lapses in continuing IRB approval, failure to obtain exempt determination before exempt research involving human subjects is conducted, minor changes in or deviations from an approved protocol, or administrative errors.

Serious noncompliance is noncompliance that a reasonable investigator should have foreseen would increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the human subjects protection program. Examples of serious noncompliance may include, but are not limited to: conducting or continuing non-exempt human subjects research without IRB approval; lack of legally effective informed consent from research participants; failure to report or review serious adverse events, unanticipated problems, or substantive changes in research; or inappropriate oversight of the research to insure the safety of human subjects and the integrity of the research/data.

Continuing noncompliance is noncompliance (serious or non-serious) that is a pattern of repeated actions or omissions taken by an investigator that indicates a deficiency in the ability or willingness of an investigator to comply with human subjects protection requirements that may affect research participants or the validity of the research and suggest the potential for future noncompliance without intervention. Examples of continuing noncompliance may include, but are not limited to: repeated failures to provide or review progress reports resulting in lapses of IRB approval, inadequate oversight of ongoing research, or failure to respond to or resolve previous allegations or findings of noncompliance.

An Unexpected Problem refers to any incident, experience, or outcome that meets all the following criteria:

1. unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are  described   in  the  protocol-related  documents,  such   as  the   IRB-approved   research protocol   and   informed   consent   document;  and   (b)  the   characteristics   of   the  subject population  being studied;
   
   
2. related or possibly related to a subject's participation in the research; and
   
   
3. suggests that  the  research  places  subjects  or  others  at  a greater  risk  of  harm  (including physical, psychological, economic, or social harm) related to the research than was previously known or recognized.

An adverse event  is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory  finding), symptom,  or  disease, temporarily  associated  with  the  subject's  participation  in  the  research,  whether  or  not considered  related  to  the  subject's  participation  in  the  research. 

Adverse  events  encompass  both physical and psychological  harms and occur  most  frequently  in the context  of biomedical research, although  they can  occur  in the context  of social and  behavioral  research.

Investigators must report the following events or issues to the IRB as soon as possible but within seven (7) working days after the investigator first learns of the event to AR-EHS.  If investigators are uncertain but believe that the event might represent an UAP, a report should be submitted.

Upon receipt of the Event Report, the IRB Chair pre-reviews the submission and, if needed, contacts the investigator for corrections or additional information. If the report came from someone other than the investigator verbally, by email, or by other means, came from someone other than the investigator verbally, by email, or by other means, the IRB Chair or AREHS Director will develop a written report summarizing the available information. If the information provided suggests that subjects may be at risk of harm without immediate intervention or that research misconduct may have occurred, the AREHS Director, IRB Chair, and, when appropriate, the IO, will be notified so that they can take any necessary steps to ensure the safety of subjects or investigate the matter.

The IRB Chair or designated reviewer receives and reviews the report and makes an initial determination as to whether the event represents noncompliance, and, if so, if the noncompliance may be serious or continuing. If needed, the reviewer may request additional information from the investigator or others. When circumstances warrant, the AREHS Director    or IRB Manager may bypass this step and assign the report for convened board review.

If the reviewer determines that the event or issue is not noncompliance, or is noncompliance but not serious or continuing, they will review any proposed corrective and preventative action plans and determine if the plan is acceptable as proposed or if modifications to the plan or additional actions are required. As warranted, the reviewer may refer the matter to the convened IRB for review. The results of the review will be recorded in the electronic system and communicated to the investigator.

If the reviewer determines that the event or issue may be serious or continuing noncompliance, the report will be referred for review by the convened IRB. The convened IRB will determine whether the event is serious or continuing noncompliance. The IRB will review any proposed corrective and preventative action plans and determine if the plan is acceptable as proposed or if modifications to the plan or additional actions, such as those outline below, are necessary to ensure the protection of human subjects. If needed, the IRB may request additional information from the investigator or others. The results of the review will be recorded in the IRB minutes and communicated to the investigator.

When the IRB determines that an event is serious or continuing noncompliance, the IRB may take any of the following actions, or others, to ensure the protection of human subjects:

1. Requiring modifications to the protocol or research plan
2. Revising the continuing review timetable
3. Modifying the consent process
4. Modifying the consent document
5. Providing additional information to current participants (e.g., whenever the information may relate to the subject’s willingness to continue participation)
6. Providing additional information to past participants
7. Requiring additional training of the investigator and/or study staff
8. Requiring that current subjects re-consent to participation
9. Monitoring the research
10. Monitoring consent
11. Reporting or referral to appropriate parties (e.g., the IO, Compliance, Risk Management, Privacy)
12. Suspending IRB approval
13. Terminating IRB approval
14. Other actions as appropriate given the specific circumstances

When the IRB determines that an event is serious or continuing noncompliance, the IRB staff will follow the procedures for reporting to regulatory agencies, sponsors, and organizational officials. When appropriate, a preliminary report may be submitted while more information is obtained to inform the determination or actions.