This manual outlines the research protocols for human subject research at American Public University System



Download 190.54 Kb.
Page4/6
Date28.01.2017
Size190.54 Kb.
#9484
1   2   3   4   5   6

Annual Renewal


If the approved study will exceed the one year approved timeframe, the research must be renewed with the IRB before the one-year anniversary as indicated on the initial approval letter. Complete the Extension Request (Appendix G) form and submit that to the IRB prior to the expiration of the one year deadline.

Addition or Deletion of PERSONNEL OR Investigators


The IRB must be notified if investigators are added or removed from the research. Submission of a Protocol Amendment Form (Appendix E). If deemed necessary, additional documentation may be requested from the investigator(s). Approval of deletion or addition of personnel or investigators will be provided to all investigator(s) via email.

IRB COMPOSITION, PROCEDURES AND RESPONSIBILITIES


Composition of the IRB for research utilizing human subjects

The IRB Chair shall recommend APUS faculty or staff to fill any vacancies on the IRB. Nominations will then be acted upon by the Provost. Members of the IRB shall be appointed for a term of 2 years. Members wishing to serve another term may do so. No member of the IRB may participate in the IRB review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. In such instances the remaining IRB members will review submitted proposals.

One of these members shall be the IRB Chair (or their designee) and at least two members shall be graduate level faculty. The remaining positions shall be filled at the discretion of the IRB Chair and the Office of the Provost. Faculty members shall represent a diversity of Departments. The full board will always have one member who is not affiliated with APUS and one member from the field of science.

Full Board


The IRB consists of eight members. All eight members review applications requiring a full board review. A five member quorum is required for all full board IRB votes.

Expedited and Exempt Applications


A subcommittee of five members of the full board reviews applications that are expedited. The Director of Graduate Studies and the Assistant Provost for Graduate Studies review exempt requests.

Procedures for Review of Research


Consistent with applicable law and regulation, the IRB shall establish procedures for reviewing research proposals not exempt from review, to include procedures for continuing periodic review of research proposals initially approved. It is the University investigator's responsibility to comply with procedures established by the IRB and to keep the IRB informed of any proposed changes in the research that may affect risk to human subjects.

Committee Records


Documentation of IRB activities is maintained by the Office of the IRB Chair for at least three years following the completion of research and includes the following:

1. Copies of all research proposals reviewed, approved consent documents, etc.;

2. Documentation of actions taken through procedures of expedited review;

3. Minutes of meetings in sufficient detail to show attendance; actions taken; vote on these actions for, against, and abstaining; basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution;

4. Records of continuing review activities;

5. A list of IRB members as well as a copy of each member's professional vita.


UNIVERSITY POLICY ON ETHICAL CONDUCT IN RESEARCH, SCHOLARSHIP AND EDUCATIONAL ACTIVITIES


APUS supports and encourages full freedom, within the law, of inquiry, of research and publication, and of teaching. Members of the faculty and staff recognize that accuracy, forthrightness and dignity befit their association with APUS and their position as men and women with a shared commitment to the highest principles of learning.

Public trust in the integrity and ethical behavior of scholars must be maintained if research and other scholarly activities are to continue to play their proper role in our University and society. It is the policy of APUS that research and educational activities carried out by its faculty, staff and students be characterized by the highest standards of integrity and ethical behavior. It is further the policy of the University to inform fully all affected parties where research data or other information related to projects or programs sponsored by, or under the administrative supervision of, the University have been falsified or otherwise misrepresented. Finally, it is the policy of the University to protect to the maximum extent possible the positions and reputations of those persons who, in good faith, make allegations of scientific misconduct and of those persons against whom allegations of misconduct are not confirmed.

Each member of the APUS community has a personal responsibility for implementing this policy in relation to any scholarly work with which he or she is associated and for helping his or her associates in continuing efforts to avoid any activity which might be considered in violation of this policy. Failure to comply with this policy shall be dealt with according to the procedures specified herein and is considered to be a violation of the trust placed in the faculty, staff and student researchers.

Procedures


"Misconduct in research or educational programs" is defined as:

  1. Failure to secure IRB approval before conducting human subjects research.

  2. Serious deviation, such as fabrication, falsification, or plagiarism, from practices commonly accepted in the research community for proposing or carrying out research, or in reporting the results of research.

  3. Material failure to comply with Federal requirements affecting specific aspects of the conduct of research or educational programs. Examples include, but are not limited to:

    1. The protection of human subjects and the welfare of laboratory animals;

    2. Fabrication, falsification, plagiarism, or other serious deviation from accepted practices in proposing, carrying out, or reporting results.

  4. Retaliation of any kind against a person who reported or provided information about suspected or alleged misconduct and who has not acted in bad faith.

Anyone having reason to believe that a member of the faculty, staff member or student researcher has engaged in research misconduct should consult the IRB Chair.

Upon receipt of written allegations, the IRB Chair shall immediately report the concern to the Institutional Review Board



  1. Immediately upon receipt of the report, the Institutional Review Board shall conduct an inquiry, consisting of information-gathering and initial fact-finding to determine whether the charge warrants an investigation. The inquiry should normally be concluded within 30 days. If the judgment is made that the charge does not warrant an investigation, no further action is required.

  2. If no violation is found to have occurred, the research may continue.

  3. If the investigation finds a violation has occurred, the IRB Chair, in consultation with the Provost and the Institutional Review Board, shall (a) take appropriate action to preserve and protect the data and other records relevant to the charge, and (b) notify the individual of the initiation of the investigation and of his or her opportunity to appear on his or her own behalf before the IRB, and (c) take the appropriate steps to notify sponsors in accordance with applicable law and regulations. The IRB Chair may also suspend the individual accused from the project or activity in question. All data collected from human subjects without IRB approval must be destroyed and the research must stop immediately. Throughout the investigation the committee shall be sensitive to the effects of the proceedings on the individual, protecting his or her rights, and avoiding disclosure except to individuals who need to be involved in the investigation.

  4. Any breach of the APUS Responsible Conduct of Research (RCR )policy is a serious violation of professional standards and will result in sanctions. Sanctions may vary depending upon the severity of the infraction, but may include written warning, termination, expulsion, termination of research, and/or the destruction of research data. Actions taken by the IRB and the University also will be subject to Federal reporting guidelines.


Download 190.54 Kb.

Share with your friends:
1   2   3   4   5   6




The database is protected by copyright ©ininet.org 2024
send message

    Main page