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March 2012 BEAUMONT HEALTH SYSTEM BEAUMONT HOST TO ONLY MICHIGAN SITE OF PERRY INITIATIVE: Special Program Broadens Career Options for Area High School Girls RI Administration: David L. Felten, MD, PhD Medical Director Vice President, Research Tel: 248-55-17983 Email: [email protected] Mary Thill, RN, MSN Administrative Director Tel: 248-55-11105 Email: [email protected] Accounting: Jack DeChellis, CPA, MBA Tel: 248-55-12476 Email: [email protected] Education & Process Improvement: Barbara Higgins, RN, BSN, CCRC Tel: 248-55-11535 Email: [email protected] Grant Development: Pamela Sims, MBA Tel: 248-55-15071 Email: [email protected] Human Investigation Committee (HIC): Lynne Paul, RN, MSN Tel: 248-55-10653 Email: [email protected] Human Resources: Mary Thill, RN, MSN Tel: 248-55-11105 or Kim Andrews - RI HR Tel: 248-55-17946 Research Compliance, Patient Care Costs: Barbara Scott, BS, CCRP Tel: 248-55-17366 Email: [email protected] Research Computer Systems: Derrick Dugeon, BA, MSA, MCPD Tel: 248-55-13327 Email: [email protected] More women are entering medical and graduate schools, but women constitute only 12% of the academic faculty in orthopaedics (research and clinical) and only 7% of practicing orthopaedists, according to the American Academy of Orthopaedic Surgeons. Likewise, just 11% of engineering school faculty members are women. The Perry Initiative seeks to increase those numbers and on February 25, 2012, Beaumont’s department of Orthopaedic Surgery hosted the only Michigan-based Perry Initiative outreach program, with the goal of encouraging 38 high school girls to consider a career in orthopedic medicine or engineering. Beaumont’s version of the initiative was a one-day, hands-on event designed to inform and inspire participating students. The program ran from 8 am to 4 pm at the Applebaum Surgical Learning Center, Beaumont Hospital, Royal Oak. It included presentations from local orthopaedic surgeons and research engineers and participants’ interactive lab exercises. Students performed simulated surgical procedures like suturing, placement of metal rods and screws to repair injuries and even an anterior cruciate ligament (ACL) repair. “The focus of our program is to encourage 38 local young women to consider their future and a career in medicine or engineering,” explains Rachel Rohde, MD, Beaumont orthopaedic hand and upper extremity surgeon and onsite coordinator. “How better to judge if it might be a career fit than to spend a day here with professionals from those fields.” In addition to Dr. Rohde, many other Beaumont-affiliated professional women volunteered their time and expertise at the event including three orthopaedic surgery residents, a research engineer, a research intern, a physician assistant and an orthopedic surgery fellow. The event was featured in The Daily Tribune newspaper and on the Fox 2 weekend news broadcasts. The Perry Initiative program was founded in 2009 by Dr. Jenni Buckley, a mechanical engineer and Dr. Lisa Lattanza, an orthopaedic surgeon. The first Perry Outreach Program was held in the summer of 2009 in San Francisco. The program expanded nationwide the next year and the organization incorporated as a nonprofit in 2011. The program is named in honor of Dr. Jacquelin Perry, the first woman orthopaedic surgeon to graduate from the residency program at the University of California, San Francisco. Dr. Perry’s academic career has spanned 60 years and she has received numerous honors for her clinical and scholarly work. Learn more about the program at http://perryinitiative.org/ HIC Corner…... Frequently Asked Questions What are the Basic Elements of Informed Consent? The basic required elements of informed consent can be found in the HHS regulations at 45 CFR 46.116(a). OHRP has a tip sheet for informed consent at http:// www.hhs.gov/ohrp/policy/ictips.html. Federal regulations require each participant to be provided the following: 1. A statement notifying the participants the study involves research, an explanation of the purposes of the research and the expected duration of the participant’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental; 2. A description of any reasonably foreseeable risks or discomforts to the participant; 3. A description of any benefits to the participant or to others which may reasonably be expected from the research; 4. A disclosure of appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the participant; 5. A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained; 6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; 7. An explanation of whom to contact for answers to pertinent questions about the research and research participants’ rights, and whom to contact in the event of a research-related injury to the participant; and 8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled. The informed consent and authorization document is the legal agreement between the patient and Beaumont. There must be an executed consent with appropriate lines signed by the participant, consent provider and a witness. Policy 221 is an excellent reference for any questions regarding informed consent. Please join us in welcoming the following staff members to the Research Institute: Judith Berry, RN, BSN, Research Nurse Clinician, BioBank Tina Carter, Research Services Aide, Research Services Warren Reaves, RN, BSN, Research Nurse Clinician, Cardiology Research The following staff have been promoted within Research: Sarah Krueger, PhD, Research Associate II, Radiation Oncology Research Upcoming Educational Opportunities Human Investigation Committee Brown Bag Seminar Series: Session VII: How to Determine the Difference Between Waiver of Consent / Waiver of Consent Documentation April 11, 2012 11:00 am - 12:00 PM. Royal Oak ABW LL Classroom 1 and telecast to Troy-Hospital Administration Conference Room. Research Roundtable: Please join the Beaumont Research Institute and your colleagues for “Research Roundtable”, an informative presentation held each month from 12:00 - 1:00 PM, Surgical Learning Center, Classrooms 1 and 2. April 3, 2012 - Subramaniam Ganesan, PhD, Oakland University, will present “Development of Intelligent Agent Based Mobile Health Care Utilizing Cell Phones and iPads”. Policy Update A new HIC policy has been posted to the RI website - #256, titled Vulnerable Populations: Enrollment of Employees, Students or Trainees. A copy of the policy is also attached to this newsletter. The policy was developed to assure we recognize the potential for employees and students to feel obligated or coerced when considering research participation and the increased risk of invasion of privacy or loss of confidentiality than other research participants. Among the key points of the policy: ♦ Beaumont employees and students may not be required to participate in research conducted at Beaumont. ♦ Employees may not be directly (i.e., in person, via direct email or telephone) solicited by a member of their current department, an administrator, medical director or faculty to enroll in Beaumont research, regardless of the level of risk. ♦ In the event an employee, student or trainee asks about research opportunities within their own department, the researcher may provide the information requested. The researcher will be responsible to provide objective and complete information about the research and be especially careful not to influence the decision of the employee, student or trainee. ♦ Investigators or consent providers may not enroll employees, students or trainees who report directly to them. In the event an employee, student or trainee responds to an indirect solicitation to participate, someone other than a direct supervisor should administer the informed consent to limit the opportunity for coercion (intended or unintended). ♦ Whenever employees, students or trainees are the targeted research participants, regardless of level of risk or prospect of direct medical benefit, investigators must provide the HIC with specific plans for ensuring the privacy of these vulnerable populations will be respected. ♦ The use of monetary incentives for soliciting employee, student or trainee participation in research is only permissible when consistent with what other participants are offered and within the requirements of HIC Policy #220 Compensation and Incentives Offered to Research Participants. Questions regarding the recruitment of a Beaumont employee or student may be directed to Lynne Paul, HIC Manager at (248) 551-0653 or Barbara Higgins, Education and Audit Manager at (248) 551-1535. Subject No. Page VULNERABLE POPULATIONS: ENROLLMENT OF EMPLOYEES, STUDENTS OR TRAINEES 256 1 of 4 Prepared By Issue Date Human Investigation Committee PURPOSE Prior Issue Date 2/28/12 This policy provides guidelines for the recruitment of employees, students, fellows and trainees recruited as participants in research conducted within the Beaumont Health System (BH). SCOPE The policy applies to principal investigators, research staff, HIC members and staff, physicians, administrators and employees of BH and students or trainees in recognized educational programs or activities at BH. BACKGROUND Federal regulations governing human participant research do not provide specific guidance concerning the inclusion of employees, students or trainees as research participants in research conducted by the institution where they are employed or active as a student or trainee. The Office of Human Research Protections (OHRP) discusses employees under the heading of “Special Classes of Subjects” in its IRB Guidebook. OHRP advises attention be given to voluntariness, undue inducement, and confidentiality and recommends avoiding individual solicitations to participate in research. Ethical Considerations The central ethical concern with respect to employees, students or trainees participating in human research is the individual, under certain circumstances, may not feel free to decline. Employees, students or trainees may volunteer to participate out of a belief they will gain favor with physicians, administrators, supervisors or faculty (e.g., better work assignments, grades, recommendations, position, etc.), or failure to participate will negatively affect their relationships (i.e., seen as uncooperative, not committed to department goals, not part of the scientific community). The pressure may be subtle, for example, when a culture of expectations emerges in a work group that reinforces and encourages employees to participate in research. Alternatively, the pressure may be more overt, with individuals fearing their employment may be adversely affected if they do not participate. Another ethical concern is employees, students and trainees may be more at risk of invasion of privacy or loss of confidentiality than other research participants. Co-workers of employees, students or trainees participating in research may have access to research data and may obtain and share personal information about research participants inappropriately. Research involving the collection of data on sensitive subjects such as mental health, sexual activity, or the use of illicit drugs or alcohol presents risks to participants of which they should be made aware and from which they should be protected, to the greatest extent possible. DEFINITIONS Employee For purposes of this policy, employee refers to an individual employed by BH or serving as a volunteer/intern/observer at BH. Research Administration Disclaimer: User must ensure that any printed copies of this policy/procedure are current by checking the policy and procedure web page before use. Subject No. Page VULNERABLE POPULATIONS: ENROLLMENT OF EMPLOYEES, STUDENTS OR TRAINEES 256 2 of 4 Prepared By Issue Date Human Investigation Committee Student Prior Issue Date 2/28/12 For purposes of this policy, student refers to an individual who is approved to participate in activities at BH as part of a formal and recognized educational affiliation. Trainee For purposes of this policy, trainee refers to an individual in the process of being formally trained by a Beaumont mentor. POLICY Under no circumstances may a BH researcher coerce or impose undue influence on an employee, student or trainee to participate in research. All Beaumont employees, students, and trainees enrolled as participants in research will be treated in a manner commensurate with their special status. Such individuals are vulnerable to coercion. Additional safeguards must be implemented to protect their rights and welfare (45 CFR 46.111(b) and 21 CFR 56.111(b)), as described below. Prohibition on Required Enrollment An employee may not be required to enroll in employer-initiated research as a condition of employment. Similarly, a student may not be required to enroll in Beaumont research as part of a course requirement. Enrollment Solicitation Employees may not be directly (i.e., in person, via direct email or telephone) solicited by a member of their current department, an administrator, medical director or faculty to enroll in Beaumont research, regardless of the level of risk. Acceptable recruitment methods include the posting of HIC-approved flyers and the placement of HIC-approved advertisements. Personal solicitations increase the likelihood participation will be the result of undue influence, either because of the relationship between the recruiter and the prospective participant, or methods of communication employed by the recruiter which may act to persuade prospective subjects to participate, thus compromising the voluntariness of the agreement to participate. In the event an employee, student or trainee asks about research opportunities within their own department, the researcher may provide the information requested. The researcher will be responsible to provide objective and complete information about the research and be especially careful not to influence the decision of the employee, student or trainee. Investigators or consent providers may not enroll employees, students or trainees who report directly to them. In the event an employee, student or trainee responds to an indirect solicitation to participate, someone other than a direct supervisor should administer the informed consent to limit the opportunity for coercion (intended or unintended). Minimal Risk Research - Enrollment in research activities designated “minimal risk” by the HIC is open to all Beaumont employees, students, or trainees, subject to the solicitation restrictions above. More-than-Minimal Risk Research - Beaumont employees, students or trainees may not enroll in non-therapeutic research designated by the Research Administration Disclaimer: User must ensure that any printed copies of this policy/procedure are current by checking the policy and procedure web page before use. Subject No. Page VULNERABLE POPULATIONS: ENROLLMENT OF EMPLOYEES, STUDENTS OR TRAINEES 256 3 of 4 Prepared By Issue Date Prior Issue Date Human Investigation Committee 2/28/12 HIC as “more-than-minimal risk” IF they are directly supervised by an investigator of the research, or if their direct supervisor reports to an investigator of the research. Confidentiality Whenever employees, students or trainees are the targeted research participants, regardless of level of risk or prospect of direct medical benefit, investigators must provide the HIC with specific plans for ensuring the privacy of these vulnerable populations will be respected. These plans must take into account and adequately address the special concerns raised by the workplace context. Participation Incentives The use of monetary incentives for soliciting employee, student or trainee participation in research is only permissible when consistent with what other participants are offered and within the requirements of HIC Policy #220 Compensation and Incentives Offered to Research Participants. Investigator Guidelines Investigators enrolling employees, students or trainees in research must: • Engage in recruitment and consent activities outside of the presence of the employee, student or trainee’s supervisor(s), faculty or advisors whenever possible. • Ensure the employee, student or trainee understands they may choose not to participate in the research and their decision will not affect their employment, grade or performance evaluation. • Outline procedures to ensure the employee, student or trainee will not be subject to undue influence or coercion and to ensure each employee, student or trainee’s privacy will be respected. • Ensure steps are taken to avoid informing supervisors, administrators or faculty of individuals who decline participation. • Conduct the research procedures out of sight of other employees, students or trainees whenever possible. For example, surveys or questionnaires could be given to employee, student or trainee participants to complete at home and mail back to the investigators instead of asking the individual(s) to convene in a room on-site, which could identify them as research participants to their superiors, instructors, co-workers or fellow students or trainees. • Ensure all data given to the employer or faculty (when applicable) is either in the aggregate or is stripped of all identifiers so the employee, student or trainee participant’s identity is protected. • The subject’s employment status must be documented in the research record as soon as it becomes known. • The nature/category of the subject’s vulnerability and special protections instituted by the investigator and consent provider must be described in the consent process documentation/note in the medical/research record. Additional Guidance for Student Participants Investigators enrolling the institutions’ students or trainees in research must: Research Administration Disclaimer: User must ensure that any printed copies of this policy/procedure are current by checking the policy and procedure web page before use. Subject No. Page VULNERABLE POPULATIONS: ENROLLMENT OF EMPLOYEES, STUDENTS OR TRAINEES 256 4 of 4 Prepared By Issue Date Prior Issue Date Human Investigation Committee 2/28/12 • Ensure students understand they may choose not to participate in the research and their decision will not affect their grade/class standing. • Avoid using class time to recruit or engage in the research. • Outline procedures in the research protocol to ensure the students will not be subject to undue influence or coercion and to ensure the student’s privacy will be respected. • Identification of the participant as an employee/student/trainee and special protections instituted by the investigator and consent provider must be described in the consent process documentation/note in the medical/research record. When the participant’s status as an employee, student, fellow or trainee is unknown to the consent provider or the investigator until after the enrollment, prospective extra protections are not possible. However, the research records should reflect consideration of precautions once the participant’s status is known, when appropriate. Students or Employees as Subjects of non-Beaumont Research External investigators conducting research projects that do not involve Beaumont investigators but involve recruitment targeted specifically at members of the Beaumont community as a defined group, must obtain approval from the appropriate official responsible for the group to be recruited. Review by the Beaumont HIC is not required when Beaumont is determined not be engaged in the research as defined in HIC Policy #120 Institutional Engagement in Research. Recruitment of non-Beaumont Students or Employees Beaumont investigators targeting students or employees from another institution for participation in Beaumont research must respect the institution’s policies or practices with regard to such recruitment and seek appropriate institutional permission before initiating recruitment activities. APPLICABLE REGULATIONS 45 CFR 46 DHHS: Protection of human subjects 21 CFR 50 FDA: Informed Consent 21 CFR 56 FDA: IRB review and approval REFERENCES OHRP IRB Guidebook “Special Classes of Subjects” RI Policy # 120 Institutional Engagement in Research HIC Policy #220 Compensation and Incentives Offered to Research Participants HIC Policy #221 Informed Consent and Authorization in Research Original Revision or Review Research Institute Compliance Committee Review Date: Corporate Administration Approval:_____________________________________ Date: VP of Research or Chief Medical Officer Research Institute Board Approval:___________________________ Date: Research Administration Approval:_____________________________________ Date: Administrative Director Research Administration Disclaimer: User must ensure that any printed copies of this policy/procedure are current by checking the policy and procedure web page before use. Epic Integrated Medical Record – What Researchers Must Know Integrated electronic medical records (EMR) systems where hospital, clinic and physician’s record clinical information in a common system accessible by many providers has numerous benefits. For example, an EC nurse may look up the patient’s last office visit to determine medications being taken, or the outpatient physical therapist may view the patient’s most recent therapy regimen prior to discharge. This type of information sharing benefits both patients and providers. In addition to the benefits of an integrated medical record, there are other aspects of which researchers must be aware. HIPAA allows access to protected health information for providing care, billing, and healthcare operations (QA activities, internal and external reporting, nutritional services, etc.). However, for researchers there are an entirely different set of rules. First among them is researchers may not access a patient’s protected health information without either research informed consent provided by the patient or a waiver of consent granted by the HIC. The authority of the HIC to grant a waiver of consent for Beaumont medical records, does not extend to the records of private practices and clinics which may be using Beaumont Epic EMR. How does this affect researchers? Researchers may not access private practice (non-Beaumont owned) office records when developing a research protocol (preparatory to research), screening for participants or conducting chart review studies under an HIC- granted waiver of consent. Unfortunately, when viewing records available in the chart, it is not apparent which are “Beaumont” records and which are private practice records. To assist researchers in maintaining compliance, attached is a list of non-Beaumont private practices using Epic as their EMR, along with their Epic department abbreviation. The list will be posted on the Research Institute website and updated as needed. Please refer to this list when screening for research participants or conducting chart review/data collection studies to assure you do not access records from any of these practices unless research informed consent has been obtained. Once a patient has consented to allow access to their records for research, their consent will apply to all records in Epic. 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NNPC SERVICES NOSP AMB NPHC 12 MILE NPHC12 AMB NPHC MAIN NPHCM AMB NPHC SFLD NPHCS AMB NPHC TROY NPHCT AMB ODWG HW ODWGHW AMB ODWG SCS ODWGSCS AMB ODWG TROY ODWGTR GASTROENTEROLOGY MN OGAP GASTROENTEROLOGY RO OGAP GASTROENTEROLOGY WB OGAP GRP OMIMG AMB PRIMARY CARE ASSOC PCAPC AMB CHARLES MD PCIM AMB PAMILA DIWAN MD PDMD AMB PED HEALTHCARE PEDHC AMB PREMIER ORTHOPEDICS POSM JULIE L HENRY MD PC HOSEY FOOT AND ANKLE CENTERS HOSEY FOOT AND ANKLE CENTERS HOSEY FOOT AND ANKLE CENTERS HOSEY FOOT AND ANKLE CENTERS HOSEY FOOT AND ANKLE CENTERS HURON MEDICAL CENTER PC HURON MEDICAL CENTER PC HEMATOLOGY ONCOLOGY CONSULTANT HEMATOLOGY ONCOLOGY CONSULTANT HEALTHY WOMEN PLLC JEFREY RA FISHMAN MD JEFREY RA FISHMAN MD JAMES A HEINSIMER MD PC JAMES A HEINSIMER MD PC JOSEPHINE ISKANDER MD PLLC KARMA INTERNISTS PC T.N. KAKISH MD PC KENNETH J. 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As a result, we are required by the Corporate Compliance Office to establish an action plan to assure improved compliance for the 2012 mandatory education. The completion deadline for all staff of the Research Institute has been moved to October 31, 2012. New students, interns, volunteers or employees to your department must complete the Research Compliance Plan module within two weeks of their start date. Research managers will be responsible for submitting a departmental Mandatory Education Completion report to the Research Compliance office no later than Friday November 2, 2012. Failure to ensure completion of the mandatory education may be reflected in performance evaluations. Remember – the most common problem is remembering to complete the Research Institute Compliance Plan module, because it is not pre-assigned to you. You must go in on your own to enroll in this module. See enrollment instructions below. Our advice to you? Avoid the rush – get it done now. Enrolling in a session-based learning unit (classroom course, webinar, department specific mandatory's, etc.) ♦ Under My Performance select Beaumont Student Center. ♦ Click Browse Learning button. ♦ Select List from drop down menu. ♦ Search for the Course: you may type in the text box the course code or the title. Click on search. ♦ Select the Course by clicking on the Title Name. ♦ Click Enroll button. ♦ Press OK button when finished. ♦ The Course had been added to your development plan.