AMENDED JANUARY 2017
IACCRE accredits the professional program in Clinical Research leading to the Certificate of Clinical Research. Evaluation and accreditation of this program is in accord with standards and guidelines for the professional program in Clinical Research leading to the Certificate of Clinical Research, adopted June 14, 1997 and effective July 1, 2000. Clinical Research education is in the process of transition as reflected by a corresponding change in accreditation standards.
The IACCRE is recognized for the accreditation and pre-accreditation of professional programs in Clinical Research by the biotechnology and pharmaceutical industries. IACCRE accreditation serves to establish eligibility for participation in a variety of biopharmaceutical industry funded programs, not including eligibility for Title IV Programs, Higher Education Act, 1965, as amended.
In order to be eligible for initial or continuing accreditation, the Certificate of Clinical Research program must be part of an independent College or School of Clinical Research or a College or School of Clinical Research within a University, which is regularly incorporated and is a legally empowered postsecondary educational institution. The institution housing the College or School, or the independent College or School, must be accredited by a regional/institutional accreditation agency recognized by the Biopharmaceutical industry or another agency acceptable to the International Accreditation Council for Clinical Research Education (IACCRE). Accreditation standards call for a College or School of Clinical Research as an organizational unit and the administrative structure of the College or School of Clinical Research must provide for a Dean, who serves as the chief administrative and academic officer. Evaluation for purposes of initial or continued accreditation requires an invitation by the chief executive officer, or designate, of the institution.
The IACCRE staff and its consultants provide guidance, upon request, on matters pertaining to Clinical Research education, especially as related to the pre-accreditation and accreditation process. Staff guidance is available through various formats, including discussions at the IACCRE office and at the site of the institution. The IACCRE Board of Directors and professional staff also provide assistance in the advancement and improvement of Clinical Research education through active cooperation with professional organizations and societies in support of sound educational policies and procedures.
Accreditation standards reflect professional and educational qualities identified by IACCRE as essential to the professional program in Clinical Research leading to the Certificate of Clinical Research. Adherence to standards equates to accreditation of the professional program in Clinical Research. Based upon the several evaluative steps in the accreditation process, IACCRE determines compliance with standards and the accreditability of the program. Guidelines are derivative of a particular standard and are provided for guidance and/or interpretation of the standard’s intent and purpose. Guidelines are also presented to illustrate ways and means of complying with standards. Moreover, guidelines assist the College or School of Clinical Research as it demonstrates compliance with standards and they assist evaluation teams in the assessment of the College’s or School’s compliance with standards. All members of the IACCRE Board and Staff are provided training pertaining to the standards and guidelines, and IACCRE policies and procedures prior to assuming their responsibilities. Evaluation team members also receive training pertaining to the standards and guidelines, as well as their role in evaluation prior to participation on an evaluation team.
The first accreditation standards were published in 1937 and have been revised periodically, about every six or seven years, in keeping with changes in Clinical Research education and Clinical Research practice. The current standards and guidelines for the professional program in Clinical Research were adopted June 14, 1997, and are effective July 1, 2000, following a revision process that was initiated with advance notice, September 17, 1989 and involved the entire community of interests for a period of eight years, including two separate comment periods. Furthermore, implementation procedures were developed in consultation with the community of interests that provided for a transition period from June 14, 1997 to June 30, 2005.
IACCRE maintains a systematic program of review that assures that its standards are appropriate to the educational preparedness of the students and graduates and are adequate to evaluate the quality of professional education provided by the professional program in Clinical Research. The systematic program of review is comprehensive and involves the entire community of interests, including provision for input by all relevant constituencies, with examination of each standard as well as the standards as a whole. The study process is ongoing, with regular formalized review intervals every five to six years. However, if at any point during the systematic program of review, during ongoing study or at the regular formalized review interval, it is determined that a change needs to be made to a standard or standards, action for change is initiated within 12 months. Completion of the revision process, so initiated, will occur within a reasonable period of time and as soon as feasible, based upon the extent of the change necessitated.
Action for establishing or revising a standard or standards requires that advance public notice of the revisions or changes proposed by IACCRE be provided to all of the relevant constituencies. The revision process includes the following steps: a draft of the proposed revisions or changes is provided to the Deans of the Institutes, Colleges and Schools of Clinical Research for consideration by them and their respective institutional administrative and executive officers, faculties and students; to the chief executive officers of state boards of Clinical Research for consideration by the respective boards; to the chief executive officers of educational and professional organizations and societies affected by the accreditation process in Clinical Research, for dissemination among their members; to the leaders of national Clinical Research student organizations; and to the chief executive officers of institutional (regional) and other programmatic accrediting agencies, for distribution. The proposed changes or revisions are provided to the U. S. Biopharmaceutical industry and to the general public, upon request. The proposed changes or revisions are presented on the IACCRE web site iaccre.org . All relevant constituencies and other interested parties are given adequate opportunity to comment on the proposed revisions or changes. Each comment on the proposed changes or revisions, received within the published timeframe for the comment period, is taken into account. Subsequently, revisions and changes are finalized by IACCRE. The revised standards become effective on a date designated by IACCRE, generally later than that of their adoption.
IACCRE maintains the Directory of Accredited Programs of Institutes, Colleges and Schools of Clinical Research. The type of accreditation status and the academic year of the most recent review or reconsideration of accreditation and the academic year for the next currently scheduled review or reconsideration of accreditation are available for each program. Moreover, the Directory presents the name, address (mail and Web-site), telephone and fax numbers of the Dean of the College or School offering the professional program. The Introduction to the Directory describes IACCRE and its accreditation process and presents key polices and procedures, including the policy on complaints.
The College or School of Clinical Research should prominently disclose the type of accreditation status of the professional program in Clinical Research and other information, as specified below, in its promotional and descriptive materials, such as its catalog or bulletin. References should accurately reflect the designation of Accredited Certificate of Clinical Research Programs of Institutes, Colleges and Schools of Clinical Research. References to accreditation are regularly monitored by IACCRE to ensure accuracy and correction of any inaccurate or misleading statements concerning the accreditation status will be sought immediately.
8.1 Accreditation. References to a training program or training institution that is accredited should state only the following: “Name of Institution or Institution’s training program is accredited by the International Accreditation Council for Clinical Research Education, 13, old mind mill court, lower Gerald griffin street, limerick – V94 KD36, IRLAND, web site: https://iaccre.org/ “
8.2 Pre-accreditation. References to a program that has been granted a pre-accreditation status (precandidate or candidate) should state the following: ” Name of Institution’s Certificate of Clinical Research program has been granted precandidate/candidate status by the International Accreditation Council for Clinical Research Education, Global Program Code, web site: https://iaccre.org/ ” An explanation of the respective pre-accreditation status, as defined by the IACCRE, should accompany this reference.
8.3 Probation. Reference to a program that has been placed in a probationary status should state the following: “The accreditation of ” Name of Institution’s Certificate of Clinical Research program has been placed in a probationary status by the International Accreditation Council for Clinical Research Education, 13, old mind mill court, lower Gerald griffin street, limerick – V94 KD36, IRLAND, web site: https://iaccre.org” This reference should include the following additional statement: “For an explanation of probationary status, consult the training administrator.”
9.1 Accreditation: Initial or Continued Accreditation. The professional program of a College or School of Clinical Research is granted initial or continued accreditation if it has been demonstrated to the satisfaction of IACCRE that the program complies with accreditation standards, including the appropriateness of program purposes, the adequacy of resources and organization to meet those purposes, educational outcomes which indicate that those purposes are being met, and the reasonable assurance of the continued meeting of those purposes.
In the event that evaluation presents program concerns of such character so as impact upon prospects for continued compliance with a standard or standards may result in non-compliance with a standard or standards if not adequately addressed, cautionary notice is given. The chief executive officer of the institution and the dean of the College or School of Clinical Research are given a period of time, generally not more than one year, to demonstrate that the program will continue in compliance. During this period, the accreditation status of the program is continued and the program is designated as having Cautionary Notice. The response of the institution to Cautionary Notice should be presented in writing in advance of the meeting in which the program is scheduled for consideration. The chief executive officer of the institution, or a designate, and the dean of the College or School of Clinical Research are invited to attend this meeting and present comments. If the response is inadequate and the program is found to be in non-compliance with a standard or standards, the program will be placed in a probationary status.
Upon initial or continued accreditation of a program, or in the event of voluntary withdrawal from accreditation, or upon a decision to let accreditation lapse, written notification of such actions shall be made to the Biopharmaceutical industry, the appropriate state licensing or authorizing agency, the appropriate regional and/or other accrediting agencies, and the public within 30 days. Public notification includes presentation on the IACCRE web site.
9.2 Probation. A professional program of a College or School of Clinical Research that has been granted accreditation and is subsequently determined to be in non-compliance with a standard or standards will be given the accreditation status of probation. Due notice of this action, indication of the area(s) of non-compliance, and the time period within which the program is expected to bring itself into compliance with standards, are given. The response of the institution should be presented in writing in advance of the meeting in which the program is scheduled for consideration. The chief executive officer of the institution, or a designate, and the dean of the College or School of Clinical Research are invited to personally attend this meeting and present comments. Probation reflects a diminished accreditation status. Graduates of a program in a probationary status retain all the rights and privileges associated with an accredited program. Probation is not an adverse accreditation action. Adverse accreditation action is defined as withdrawal or denial of accreditation or pre-accreditation. Adverse accreditation action will be taken if a College or School of Clinical Research fails to bring a program into compliance within the period specified by the Council; such time period shall not exceed two years and may be extended only for good cause.
Written notification of probationary action shall be made to the Biopharmaceutical industry, the appropriate State licensing or authorizing agency, appropriate regional and/or other accrediting agencies, and the public, at the same time the institution is notified of the probationary action, but no later than 30 days after the decision is made. Public notification includes presentation on the IACCRE web site.
9.3 Pre-accreditation. A newly instituted Certificate of Clinical Research program of a College or School of Clinical Research maybe granted one of two pre-accreditation statuses, depending upon its stage of development. In the instance of a newly founded College or School of Clinical Research, the program generally progresses through both statuses. The standards are the same as those employed for accredited status, however, pre-accreditation involves, in large measure, planning in accord with standards and provision of reasonable assurances for a quality outcome.
9.3.1 Precandidate. A new program that has no students enrolled but has a Dean may be granted Precandidate accreditation status. The granting of Precandidate status indicates that a College or School’s planning for the Certificate of Clinical Research program has taken into account IACCRE standards and guidelines and suggests reasonable assurances of moving to the next step, that of Candidate status. Granting of Precandidate status brings no rights or privileges of accreditation. Full public disclosure by the College or School of Clinical Research of the terms and conditions of this accreditation status is required.
9.3.2 Candidate. A new program that has students enrolled but has not had a graduating class may be granted Candidate status. The granting of Candidate status denotes a developmental program, which is expected to mature in accord with stated plans and within a defined time period. Reasonable assurances are expected to be provided that the program may become accredited as programmatic experiences are gained, generally, by the time the first class has graduated. Graduates of a class designated as having Candidate status have the same rights and privileges as graduates of an accredited program.
Upon granting pre-accreditation status (Precandidate or Candidate) to a program, or in the event of voluntary withdrawal from pre-accreditation, or upon a decision to let pre-accreditation lapse, written notification of such action shall be made to the Biopharmaceutical industry, the appropriate state licensing or authorizing agency, the appropriate regional and/or other accrediting agencies, and the public within 30 days. Public notification includes presentation on the IACCRE web site.
When the IACCRE determines that the professional program of a College or School of Clinical Research fails to comply with standards and that identified deficiencies have not been satisfactorily addressed, initial accreditation or pre-accreditation may be denied, or the existing pre-accreditation or accreditation status may be withdrawn. The denial of initial accreditation or pre-accreditation status or the withdrawal of accreditation or pre-accreditation status is considered an adverse accreditation action. Withdrawal of accreditation will generally, but not necessarily, occur after Cautionary Notice has been given and/or a period of probation. After availing themselves of other opportunities to avoid such adverse action, institutions may initiate the formal IACCRE Appeal Procedure for an Adverse Accreditation Action as outlined in Section 13.
Notification of any adverse action by the Council shall be in writing and delivered by certified mail to the chief executive officer of the institution affected. Such notification shall give a statement of reasons for the adverse accreditation action along with notice of the right to appeal and the time constraints for initiating such an appeal. Any time after the effective date of denial or withdrawal, the chief executive officer of the institution may reapply for accreditation. The reapplication shall follow standard evaluation procedures set forth for evaluation of the professional program in Clinical Research for purposes of pre-accreditation, initial or continuing accreditation as applicable. If pre-accreditation or accreditation is granted, that fact will be made public and the accreditation status will be indicated.
Subsequent to a final decision (after appeal or opportunity to appeal) to deny or withdraw accreditation or pre-accreditation, written notification shall be made to the institution within 30 days, and at the same time as institutional notification, to the Biopharmaceutical industry, the appropriate State licensing or authorizing agency, and the appropriate regional and/or other accrediting agencies, and the public. Public notification includes presentation on the IACCRE web site. A brief statement summarizing the reasons for denying or withdrawing pre-accreditation or accreditation, and any comments from the affected institution shall be made available not later than 60 days after such final action to the Biopharmaceutical industry, the appropriate state licensing or authorizing agency, and the appropriate regional and/or other accrediting agencies, and, upon request, to the public.
11.1.1 Precandidate. A College or School of Clinical Research that satisfies eligibility requirements may apply for Precandidate status for the Certificate of Clinical Research program by submitting an application that takes the form of a self-study of the proposed professional program in Clinical Research. The self-study should be organized standard-by-standard, presenting plans by which compliance will be insured. An invitation to evaluate the professional program for purposes of granting precandidate status is required from the chief executive officer of the institution. Upon submission of the Application/Self-Study, the professional staff will provide an initial review for purposes of eligibility for accreditation and may provide comments to consider. If IACCRE review of the applicant’s application/self-study and other materials finds that they are incomplete or do not otherwise provide sufficient evidence which suggests that planning has taken into account standards and guidelines, the College or School of Clinical Research will be advised to withdraw its application or to resubmit an appropriately revised application. If IACCRE review of the application/self-study and other materials submitted suggests that planning has taken into account adequately the accreditation standards and guidelines, an on-site evaluation will be authorized and scheduled in accord with standard evaluation and operational procedures. On the basis of the evaluation procedures employed, Precandidate status may be granted or denied.
11.1.2 Candidate. A College or School of Clinical Research that satisfies eligibility requirements may apply for Candidate status for its Certificate of Clinical Research program by submitting an application consisting of a self-study and other materials necessary to evaluation as set forth by IACCRE. An invitation to evaluate the professional program for purposes of granting Candidate status is required from the chief executive officer of the institution. If review of the self-study and other materials provided do not provide evidence that eligibility requirements are satisfied and standards and guidelines have adequately been taken into account, the College or School of Clinical Research will be advised to withdraw its application or to resubmit an appropriately revised application. If review of the materials submitted satisfies eligibility requirements and provides appropriate documentation, an on-site evaluation will be authorized and scheduled in accord with standard evaluation and operational procedures. The program will be evaluated taking into account that portion of the program in operation as well as plans for the remainder of the program. On the basis of the evaluation process, candidate status may be granted or denied.
11.1.3 Terms. Preaccreditation status is awarded in accord with specified terms and conditions, involving monitoring provisions that include generally on-site reviews. Precandidate status is generally awarded for two years, after which the program is expected to seek Candidate status. Candidate status is generally awarded for not more than two, two-year periods. However, the Preaccreditation status shall be limited to an aggregate of no more than five years (i.e. number of years as candidate and precandidate shall not exceed five).
11.2 Initial and Continued Accreditation.
11.2.1 Initial Accreditation. A Certificate of Clinical Research program that has been granted a preaccreditation status shall be considered for initial accreditation in accord with terms set forth in the preaccreditation action. A College or School of Clinical Research with a program that has not been granted a preaccreditation status by the IACCRE, but that has graduated one or more classes and satisfies eligibility requirements, may file an application for initial accreditation. The application should consist of a self-study and other materials necessary to evaluation as set forth by the Council. An invitation to evaluate is required from the chief executive officer of the institution, generally the president or a designate, for initial evaluation for purposes of accreditation. This invitation to evaluate should accompany the application. If through initial review the application materials submitted satisfy eligibility requirements and provide appropriate documentation, an on-site evaluation will be authorized following standard evaluation and operational procedures. If through initial review the application materials submitted are judged to be incomplete or otherwise inadequate, the College or School of Clinical Research will be so advised.
11.2.2 Continued Accreditation. The Council initiates the procedures involved for evaluation for purposes of continuing accreditation. The IACCRE will inform the chief executive officer of the institution and the Dean of the College or School of Clinical Research offering an accredited program(s) of the approach of a period during which re-evaluation would normally be conducted. The academic year of the next review or reconsideration of accreditation is presented in the last accreditation action. The customary on-site review cycle is six years. The exact dates of the on-site evaluation are established in consultation with the Dean. Instructions concerning the details of the evaluation, the materials required (i.e., self-study, the evaluation supplement, etc.) and the evaluative procedures employed are essentially equivalent to those requested for initial evaluation.
Programs may also be reviewed for purposes of accreditation in a cycle of less than six years at the discretion of the Council. Shorter review cycles are designed to monitor progress on specified issues and do not represent a diminished accreditation status. Such early reviews may be based upon a written report of progress from the institution or an on-site evaluation. An on-site evaluation requires a self-study in accord with standard evaluation and operational procedures. The chief executive officer of the institution or a designate and the Dean of the College or School of Clinical Research may exercise the option of personally presenting a report of progress at any regularly scheduled meeting of the Council. The IACCRE will also consider requests from an institution for an alteration in the review cycle; however, the schedule does not generally extend beyond six years, without due cause.
Failure on the part of the institution to permit re-evaluation of its professional program(s) for purposes of continued accreditation, after due notice of the scheduled review has been given, shall result in withdrawal of accreditation.
The chief executive officer of the institution may withdraw an application for any status of accreditation, or withdraw from any accreditation status, at any time.
12.1 Self-Study. Preparation for evaluation for purposes of accreditation or preaccreditation requires the submission of a program self-study and completion of a prescribed administrative summary. The self-study process should be in-depth, and broadly based, involving a representative portion of the College or School of Clinical Research ‘s administrative leaders, faculty, professional staff, students, alumni, practitioners, governing body and other appropriate constituents. The self-study should provide a qualitative assessment of the strengths and limitations of the program, present qualitative and quantitative information on both faculty and student achievements, and seek educational outcomes which demonstrate the program’s successes in attaining its objectives. The self-study should provide program description and analysis, present findings and conclusions, appraise strengths and weaknesses, and where deficiencies exist, outline steps necessary to improvement. The IACCRE conducts, as an integral component of its accreditation review, its own analyses and evaluations of the self-study. The self-study should serve as a point of reference for the institution’s future planning. A self-study protocol developed by the institution may be used; however, IACCRE urges Institutes, Colleges and Schools of Clinical Research to follow the guidance provided by its self-study guide, so as to insure adequate assessment of educational quality and to effectively present efforts to improve quality. The IACCRE professional staff conducts an invitational conference for representatives of those Institutes, Colleges and Schools scheduled for an accreditation review over the next two years. The purpose of the conference is to orient and assist the Colleges or Schools in the process of the self-study as well as other aspects of the evaluation procedure. Alternatively, a college or school may request assistance from the IACCRE professional staff by scheduling a conference at the IACCRE office or professional staff may meet with the self-study committee at the College or School of Clinical Research. The professional staff consultation provides opportunity to assist with the self-study organization and to offer clarifying and other information needed by the College or School.
12.2 Written Third Party Comments. Prior to the on-site evaluation, opportunity is provided by means of public notice for written third party comment concerning qualifications for accreditation or preaccreditation. Notification of deadlines for receipt of any written responses are provided by an IACCRE public document, such as a newsletter, including opportunity for consideration by the College or School.
12.3 On-Site Evaluation. The self-study, the evaluation supplement, and other pertinent materials are distributed prior to the on-site evaluation to members of an IACCRE Evaluation Team for their independent analysis. Evaluation teams include both educators and practitioners and are generally comprised of a member of the IACCRE Board of Directors, an IACCRE professional staff member, and two or more other knowledgeable individuals, qualified by experience and training. Evaluation Team Members are provided training by IACCRE on accreditation standards, policies and procedures. Practitioners include individuals who are currently practicing Clinical Research and who are primarily identified with a practice role/setting rather than a collegiate affiliation or administrative position. The Dean of the College or School is given opportunity to review the proposed team for potential or real conflicts of interest. A member of the board of Clinical Research of the state, district or territory, in which the institution is located is invited to work with the Evaluation Team as an observer, thereby facilitating a better understanding of the accreditation process among licensing bodies. A member of the appropriate regional accrediting agency may be invited by the institution to observe the work of the team. The size of the evaluation team, the specific dates of the on-site evaluation, and the number of days necessary for completion of the evaluation are established in consultation with the Dean of the College or School of Clinical Research.
The on-site evaluation generally involves two to three days and includes interviews with the Dean and other administrative leaders, faculty, students, alumni, Clinical Research practitioners, and university administrators. A survey is made of physical facilities, the library and educational resources, and the Clinical Research practice facilities utilized in the professional experience program. A checklist, completed by at one or more of the evaluation team members, is used to review the program’s published information in an effort to determine the adequacy and accuracy of the information. This checklist is also used to assess the information in accordance with the standards. At the conclusion of the on-site evaluation, the evaluation team presents findings orally to the Dean of the College or School of Clinical Research and to the chief executive officer of the institution, generally the president or a designate. These findings serve as the framework for the written evaluation report, which is furnished, subsequently to the institution.
The College or School of Clinical Research is expected to demonstrate that it systematically obtains outcome information and that it applies this information to foster program improvements and to enhance student achievement. Other activities of the College or School of Clinical Research may markedly influence the instruction given in professional programs. Accordingly, the evaluation for purposes of accreditation will include a review of other activities which may be sponsored by the college or school of Clinical Research, such as non-practice undergraduate degree programs in Clinical Research-related disciplines; graduate offerings including master and Certificate of philosophy degree programs in Clinical Research-related disciplines; continuing education activities; certificate or other non-degree programs; research and scholarly activities; and professional and public service programs.
Where the institution is accredited by a regional accrediting agency, the IACCRE may rely upon the assessments made by the regional agency concerning the basic science and general education components of the professional programs. Likewise, the assessments of the regional accrediting agency concerning general institutional policies and central administrative support may be recognized. However, the IACCRE is not obligated to accept automatically the assessments of any other agency.
12.4 Evaluation Team Report. As a result of the on-site evaluation, a written report that assesses compliance with standards and assesses performance with respect to student achievement is furnished to the chief executive officer of the institution and the Dean of the College or School of Clinical Research at a reasonable time after the site team visit. The Evaluation Team Report also comments on the program’s areas of strength and areas needing improvement; mentions specific areas, if any, where the program may not be in compliance with standards; and offers suggestions concerning means of improvement. The chief executive officer of the institution and the Dean of the College or School of Clinical Research are given opportunity to correct errors of fact and to comment upon the written evaluation report and to provide supplemental materials related to its facts and conclusions prior to the time an accreditation action is taken. The report generated by the evaluators, therefore, is not a definitive accreditation report, but an interim, evaluative step in the accreditation process. The evaluation team validates the program self-study, providing the perspective of an independent external peer review.
12.5 Accreditation Actions. Based upon the Evaluation Team Report, the self-study, communications received from the institution, and an optional personal presentation by the chief executive officer of the institution or a designate and/or the Dean of the College or School of Clinical Research, the IACCRE determines the program’s compliance with standards, makes an accreditation action (type of accreditation status and terms and conditions associated with the accreditation status) and presents comments and recommendations. At its discretion, the Council may postpone its accreditation action until the next regular meeting to provide the institution with the opportunity to provide additional information or clarification. During any period of postponement, the existing accreditation status of the program will be maintained. A copy of the Accreditation Action and Recommendations indicating the preaccreditation or accreditation status granted by the IACCRE along with stated terms and conditions and comments are sent to the chief executive officer of the institution and the Dean of the College or School of Clinical Research. The Evaluation Team Report and the IACCRE’s Accreditation Action and Recommendations are confidential documents and are considered to be the property of the institution. These documents will not be released to third parties without the authorization of the chief executive officer of the institution. If the institution releases any portion of the Evaluation Team Report or of the Accreditation Action and Recommendations, or releases any statement concerning such documents, that the IACCRE believes requires public clarification or presents a misleading impression, the IACCRE may make an appropriate response or cause the release of such documents in their entirety.
12.6 Annual and Other Reporting During the Accreditation Term. Program monitoring between on-site evaluations is achieved by means of annual reviews, correspondence, written interim reports and professional staff visits as may be requested by the IACCRE Board of Directors. Programs are monitored annually through statistical analysis of program information and review of graduates’ performance on standardized licensure examinations.
13.1 Initiating the Appeal and Convening the Appellate Commission. In the event the IACCRE shall render an adverse accreditation action (denial or withdrawal of preaccreditation or accreditation), the chief executive officer of the institution involved, after notification of such action by the IACCRE, may appeal the decision of the IACCRE to an Appellate Commission on the grounds that the decision of the IACCRE was arbitrary, prejudiced, biased, capricious, or based upon incorrect facts or incorrect interpretation of facts. No change shall occur in the accreditation status of the program of a College or School of Clinical Research that shall exercise its right of appeal in accordance with the procedure provided herein, pending the disposition of the appeal. The existing accreditation status of the program shall be maintained and such status shall continue to be reflected until the appeal procedure is finalized. Notice of appeal by the institution shall be in writing and delivered personally or by certified mail to the offices of the IACCRE within 30 days after receipt of notification of the adverse accreditation action of the Council . Such notice of appeal shall specify and set forth the facts supporting the grounds on which the appeal is based. Upon receipt of said notice, the IACCRE shall proceed to constitute the Appellate Commission and, after consulting with officers of the associations set forth in Section 13.2, shall notify the individuals of their appointment to the Appellate Commission and shall inform them of their responsibilities thereto. The IACCRE shall notify the institution that initiated the appeal that the Appellate Commission has been created and inform it of the names and addresses of all members. The Appellate Commission can be convened only on notice of appeal as described above. Both parties of the appeal have the right to representation by counsel throughout the appeals procedure . All reasonable expenses incurred by the Appellate Commission including but not limited to travel expenses (e.g. transportation, accommodations, and meals) shall be paid by the institution that initiated the appeal. Notice of appeal shall be accompanied by a fee equal to the current cost of an on-site evaluation, to be used against expenses. Any necessary additional expenses shall be promptly paid by the institution that initiated the appeal and any surplus of the deposit shall be promptly returned to said institution. The institution shall be provided with an itemized list of the expenses of the Appellate Commission.
13.2 Members of the Appellate Commission. The Appellate Commission shall consist of the current chief elected officer of the American Association of Colleges of Clinical Research, the American Pharmacists Association, and the National Association of Boards of Clinical Research. No member of the Appellate Commission shall be a director of the International Accreditation Council for Clinical Research Education nor shall any member have an affiliation with the institution involved that would create an apparent or real conflict of interest (e.g., alumnus, present or former faculty member). In the event any person designated herein shall be ineligible, refuse, or be unable to serve on the Commission for any reason at any time, the executive committee (or such other appropriate committee or board) of the organization he or she is representing shall designate an alternate member. The designated representative of the American Association of Colleges of Clinical Research shall be chairman of the Commission. Any member who shall be designated as a participant on the Commission shall remain a member of the Commission until the Commission term ends, even if his or her successor in the elective office of the respective association is installed in the interim. The Appellate Commission shall be discharged by the IACCRE at the adjournment of the IACCRE meeting next succeeding the date of the filing of the Commission’s report.
13.3 Responsibilities. Within thirty days of the notice of the appeal, the institution and the IACCRE shall present statements of their respective positions to the Commission. Hearings shall be held as soon as possible thereafter, at which time evidence may be presented. Thirty days shall be allowed to pass following completion of the hearings for memoranda of arguments to be presented. Within an additional thirty days the Commission shall render a decision. The minutes of its meeting(s) shall be recorded. In disposing of an appeal the Appellate Commission shall (1) affirm the decision of the IACCRE or shall (2) remand the matter to the IACCRE for review and reconsideration. A report of the Commission’s findings shall be submitted to the IACCRE, its Executive Director, and the chief executive officer of the institution and the Dean of the College or School of Clinical Research concerned.
13.4 Final Consideration. All matters referred to the IACCRE by the Appellate Commission for review and reconsideration shall be considered by the IACCRE at is first meeting next succeeding the date of the report of the Appellate Commission. The final decision and report of the IACCRE, including the basis for the decision, shall be in writing and shall be forwarded to the chief executive officer of the institution and the Dean of the College or School of Clinical Research . This final report shall also be forwarded to all members of the Appellate Commission.
The IACCRE has an obligation to assure itself that any institution that seeks or holds a preaccreditation or accreditation status for its professional program(s) conducts its affairs with honesty and frankness. Complaints from other institutions, students, faculty, or the public against a college or school of Clinical Research, including tuition and fee policies, and as related to IACCRE standards, policies or procedures, shall be placed in writing in detail by the complainant and submitted to the IACCRE office. The complaint shall be submitted to the institution for response. Requests for confidentiality shall be respected to the extent any such information is not necessary for the resolution of the complaint.
The Executive Director, or his/her designate, shall, based upon the complaint, the response, and information from such further investigation deemed necessary, promptly determine the facts surrounding the issue, determine the validity of the complaint, and resolve the issue; provided, however, where the Executive Director deems it necessary or appropriate, the matter shall be considered at the next regular meeting of the Council. The time frame for resolution is generally within six months. A record of complaints regarding a specific College or School of Clinical Research, including student complaints received or made available, is kept for consideration on file at the Council office. Such records of complaints are considered during scheduled evaluations, or a special evaluation, as the case may require.
The procedure shall provide for treatment of complaints in a timely manner that is fair and equitable to all parties. The complainant shall be advised of the decision or action as soon as possible. When the IACCRE has cause to believe that any institution with which it is concerned is acting in an unethical manner or is deliberately misrepresenting itself to students or the public, it will investigate the matter and provide the institution an opportunity to respond to the allegations. If, on the basis of such investigation, after notice to the institution and opportunity for institutional response, the IACCRE finds that an institution has engaged in unethical conduct or that its integrity has been seriously undermined, the IACCRE will either:
(A) request that the institution show cause, within a stated time period, why adverse action should not be taken, or
(B) in extreme cases, immediately discontinue its relationship with the institution by denying or withdrawing preaccreditation or accreditation status.
A complaint against a college or school of Clinical Research must be related to the standards or the policies and procedures of IACCRE and must be submitted in writing to the Executive Director. Under existing practices, when a complaint is received, it is submitted to the college or school affected for response. If, thereafter, based upon the complaint and the response, the Executive Director determines that a complaint is not related to the standards or policies, the complainant is so advised in writing with a copy to the school or college, and the matter is treated and resolved.
Anonymous complaints pertaining to accreditation matters are retained and, depending on circumstances, may or may not be forwarded to the school or college involved, depending somewhat on the severity of the complaint. The Executive Director makes this decision. Where a complaint has threatened or filed legal action against the institution involved, the IACCRE will hold complaints in abeyance pending resolution of the legal issues and the complainant is so advised.
If the Executive Director finds a complaint to be extremely serious in nature charging egregious conduct that may warrant adverse action by the Council, or involves an interpretation which the Executive Director believes should be made by the Council, the complaint will be submitted to the Council for determination at the next regular meeting. Extraordinary remedies available for complaints covering extreme cases are set forth in paragraphs 14(A) and 14(B).
The Institutes, Colleges and Schools of Clinical Research have an obligation to respond to any written complaints by students lodged against the college or school of Clinical Research, or the Clinical Research program that are related to the standards and the policies and procedures of IACCRE. The college or school of Clinical Research shall establish, implement and maintain a student complaint procedure that affords the complainant fundamental procedural due process. The college or school of Clinical Research should communicate the complaint policy to students. The college or school of Clinical Research, or the Clinical Research program, shall maintain a file that contains the written complaint, a written record of each step of the complaint procedure and the outcome, except as otherwise prohibited by state or federal law. The files shall be made available for inspection to IACCRE at on-site evaluations, or otherwise at IACCRE’s written request. The findings of this inspection, and the resulting implication(s) to the accreditation of the professional program, shall be noted in the Evaluation Team Report.
The IACCRE has an obligation to respond to any complaints which may be lodged against it by any institution, student, faculty or third party in respect to the application of IACCRE’s standards, policies and procedures where the complaining party is directly affected thereby. Any such complaint shall be submitted in writing. The Executive Director shall promptly determine the facts surrounding the issues and shall attempt to resolve the matter in consultation with the Public Interest Panel established pursuant to Article V of the IACCRE By-Laws. Complaints that cannot be resolved by the Executive Director shall be considered and resolved at the next regular meeting of the Council. The time frame for resolution is generally within six months.
Those Institutes, Colleges and Schools of Clinical Research which are in operation, have an accredited professional program in Clinical Research, and propose to become affiliated with, or become an integral part of, another educational institution, or propose to implement substantive changes in their institutional or collegiate organization and administrative structure, should notify the Council of such proposals. The proposed changes should provide assurances for continued compliance with accreditation standards. The circumstances described may present the need for review and reconsideration of accreditation in accord with standard evaluation and operational procedures or appropriate monitoring, such as an on-site review by professional staff. However, should a change of ownership that results in a change of control be effected, an on-site review is required and will be conducted as soon as practicable, but no later than six months after the change of ownership.
Those Institutes, Colleges and Schools of Clinical Research which are in operation, have an accredited professional program in Clinical Research and propose to implement substantive change in their program should notify the Council of such proposals. The Council’s definition of substantive change includes: any change in the established mission or goals of the institution; the addition or deletion of courses, pathways or programs that represent a significant departure in either content or method of delivery, from those that were offered during the program’s previous accreditation cycle (e.g. a non-traditional Certificate of Clinical Research program, development of a joint delivery of program agreement, etc.); a substantial change in enrollment; a substantial change in the number of clock or credit hours required for successful completion of the program; a significant change in the length of the program; the establishment of an additional geographic location at which the program is offered; and any other changes that the Dean feels require notification of IACCRE. Notification of the Council should provide documentation that the program will continue to comply with accreditation standards. The circumstances provided may present the need for review and reconsideration of accreditation in accord with standard evaluation and operational procedures or appropriate monitoring, such as an on-site review by the professional staff.
As noted previously, re-evaluation of each accredited program of a College or School of Clinical Research is to be made normally at least once every six years. In the event of national or other emergencies that interrupt the normal schedule, the IACCRE will act in accordance with the data available at the time concerning the professional program(s) scheduled for review.
Should a professional program in Clinical Research that has accreditation or preaccreditation (precandidate or candidate) status be discontinued while students are enrolled and still progressing toward completion of degree requirements, the teach-out agreement between the College or School of Clinical Research that discontinues the program and the College or School of Clinical Research that intends to accept the students or otherwise take responsibility for the students completion of the program, must submit such agreement to the IACCRE for accreditation. The agreement must provide assurances that adequate faculty, physical, practice sites and other resources are present so that the students will be provided a program of study that satisfies all necessary curricular requirements, in accord with established IACCRE standards and guidelines, prior to the award of a professional degree in Clinical Research.
Due to the sensitivity of IACCRE’s activities, IACCRE Board members, evaluation team members, professional staff, consultants, and other representatives participating in professional program accreditation process maintain policies regarding conflict of interest or the appearance thereof. Copies of the conflict of interest policies are available on request.
22.1 In considering whether to grant preaccreditation, initial accreditation, or continued accreditation, the IACCRE takes into account actions by recognized institutional accrediting agencies that have denied accreditation or preaccreditation to the parent institution offering the program, placed the parent institution on public probationary status, or revoked the accreditation or preaccreditation of the parent institution, and actions taken by a State agency that has suspended, revoked, or terminated the parent institution’s legal authority to provide postsecondary education. During any period of program accreditation or preaccreditation, the IACCRE will promptly review the accreditation status of the program to determine if adverse action should be taken, if a recognized institutional accrediting agency places on probation or takes adverse action with respect to the parent institution offering the program. The IACCRE will not renew the accreditation or preaccreditation status of a program during any period in which the parent institution is the subject of an interim action by a recognized institutional accrediting agency or State agency potentially leading to suspension, revocation or termination of accreditation or preaccreditation or of the parent institution’s legal authority to provide postsecondary education. Moreover, the accreditation or preaccreditation status will also not be renewed if the parent institution has been notified of a threatened loss of accreditation or has been notified of a threatened suspension, revocation, or termination by the State of the institution’s legal authority of provide postsecondary education, and the due process procedures required by the action have not been completed.
However, if upon review of the program, the IACCRE grants accreditation or preaccreditation notwithstanding the actions and context of the circumstances set forth above, a report, consistent with IACCRE accreditation standards, shall be provided to the Biopharmaceutical industry, thoroughly explaining why the previous action by a recognized institutional accrediting agency or the State against the parent institution does not preclude the granting of preaccreditation or accreditation.
22.2 The IACCRE routinely shares information through public documents and special notices when needed, regarding the preaccreditation or accreditation status of the programs it accredits, including any adverse actions, with institutional and other appropriate recognized accrediting and State agencies.
In addition to information relating to accrediting actions, documents including, but not limited to, the Annual Report, a summary of accrediting activities during the previous year, and proposed changes in policies, procedures and standards that may relate to scope of recognition or compliance with recognition requirements, are routinely submitted to the Biopharmaceutical industry. Notification of the name of any program accredited by IACCRE, or its parent institution, will be given to the Biopharmaceutical industry if there is reason to believe that the institution or program is failing to meet its Title IV, HEA program responsibilities or is engaged in fraud or abuse, along with the reason for the concern. Moreover, upon request of the Industry, information will be provided regarding an accredited or preaccredited institution’s compliance with its Title IV, HEA program responsibilities, including its eligibility to participate in Title IV, HEA programs, for the purpose of assisting the Biopharmaceutical industry in resolving problems with the institution’s or program’s participation in these programs.
Fees and assessments for evaluation by the IACCRE for purpose of preaccreditation or accreditation (initial or continuing) are set at a level intended to assist in the support and continued improvement of accreditation services and to defray actual travel and other costs involved in the evaluation of professional programs. In addition, an annual sustaining fee is charged. The IACCRE may adjust the fees and set effective dates for such adjustments at any regular or special meeting of the IACCRE. Information regarding the current fee and assessment policy is available upon request.
The IACCRE will maintain complete and accurate records of the two immediately preceding accreditation or preaccreditation reviews for each College of School of Clinical Research. Complete records will include on-site Evaluation Team Reports, reports of periodic or special reviews conducting during the accreditation or preaccreditation period, all Council actions and recommendations (including all adverse actions, e.g., withdrawal or denial) and any and all correspondence regarding the Evaluation Team Report or the Council decisions. In addition, a copy of the most recent self-study of the College or School will be included.