It is the policy of Eastern Michigan University to respect and safeguard the rights and welfare of all individuals who are involved in its activities, especially where human beings may be participating as subjects in research, experimental procedures in instruction, or other related activities. To this end, a University Human Subjects Review Committee has been established to review all research involving human subjects. It is the policy of the University to comply with the regulations of the United States Department of Health and Human Services, Office for Human Research Protections (Part 46 of Title 45 of the Code of Federal Regulations, as amended).
The University Human Subjects Review Committee (UHSRC) is responsible for developing and enforcing policies and procedures applicable to research wherein human beings may be at minimal risk(1) or greater as a consequence of participating in an investigation or experimental procedure.
Note that research using secondary data on human subjects must be reviewed by the UHSRC. In cases where an investigator begins a project for non-research purposes (e.g., a experiment done in the context of a class assignment), and then realizes that he or she might like to disseminate findings, the project must also be reviewed by the UHSRC. It is the investigator’s responsibility to seek UHSRC approval whenever considering dissemination of such findings beyond the classroom. When there is a question about whether an activity constitutes human subject research that is subject to UHSRC review, College or University-level HSRC member other than the investigator or research team verify and document that the activity qualifies for exemption from IRB review.
A. Implementation of the Policy
The Board of Regents of Eastern Michigan University delegates responsibility for the implementation and administration of the Human Subjects Policy to the Provost and Vice President for Academic Affairs. The Provost is responsible for appointing the members of the University Human Subjects Review Committee and giving them direction. The Provost is also responsible for promulgating and enforcing the procedures to be used in the implementation of this Policy.
B. Authority of the University Human Subjects Review Committee
The University Human Subjects Review Committee shall review and have authority to exempt, approve, require modifications in, or disapprove all research activities covered by the Human Subjects policy. It shall review proposed research at convened meetings at which a quorum of the members of the Committee are present, it may use an expedited review procedure if the research involves no more than minimal risk and meets one or more of the categories outlined in OHRP guidance document http://www.hhs.gov/ohrp/policy/expedited98.html or if it is reviewing minor changes in previously approved research during the period in which approval is authorized, or it may determine that research is exempt from federal regulatory requirements.
If during an expedited review any member of the expedited review group determines that there is greater than minimal risk, the proposal shall be referred to the full Committee for consideration. The UHSRC would be given 10 business days when University classes are in session to review the document(s) and discuss the protocol at their next monthly meeting.
The UHSRC may establish college-level committees to review Exempt research, using procedures approved by the UHSRC, when the volume, type or timing of research in a particular college necessitates it. If the study is initiated by a student, the student’s faculty advisor shall be considered the Principal Investigator and shall be responsible for obtaining the Exempt determination and for enforcing any conditions stipulated by the UHSRC or its appointees. The Principal Investigator or any of his or her research staff may not make an Exempt determination for his or her own study.
The University Human Subjects Review Committee shall conduct continuing review of research covered by the Policy at intervals appropriate to the degree of risk, but not less frequently than once per calendar year, and shall have authority to observe or have a third party observe the consent process and the research itself. The Committee shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with the Policy or that has produced unexpected serious harm to subjects. In cases where the Committee disapproves of research, notification will promptly be sent to the investigator, appropriate institutional officials and funding agency, if applicable, along with a statement of the reasons for the disapproval. The Committee may also recommend that the University impose sanctions upon any investigator who does not conform to this Policy.
Research covered by the Policy that has been approved by the University Human Subjects Review Committee may be subject to further appropriate review and approval or disapproval by officials of the University. However, those officials cannot approve the research unless the committee has also approved it.
C. Applicability of the Policy.
The Human Subjects review process applies to all research(2) involving the use of human subjects for one or more of the following criteria:
1. Whether funded or unfunded
2. Participated in, or directed by, any faculty, staff or students at Eastern Michigan University
3. Done on the property of, or using the facilities of, Eastern Michigan University
4. Using university personnel or students as subjects
All faculty and staff must, prior to the commencement of research, using procedures promulgated by the University Human Subjects Review Committee, submit research proposals for review by the Committee. Securing prior approval for research is the responsibility of the project director, principal investigator or similarly designated person who has responsibility for leading the project.
D. Student Research
In the case of research involving human subjects that is conducted by undergraduate or graduate students as part of a course assignment or thesis project, the instructor of the class or project investigator shall be responsible for having the research reviewed in accordance with this policy.
Undergraduate students are prohibited from conducting research in which there would be greater than minimal risk to human subjects. The student could participate in a study conducted by a faculty member and the faculty member would seek UHSRC approval.
E. Course-Related Activities
Course-related activities that use human subjects are exempt from review if the purpose of the activity is purely pedagogical and the results are intended solely for use within the classroom setting.
F. Cooperative Research
In the event that a research project's director or co-director is from another institution, the University Human Subjects Review Committee may cede review to the other institution. The EMU Principal Investigator must complete a Cooperative Research application for review by the UHSRC Chair.
If the Principal Investigator of a collaborative research project is a faculty or staff member of Eastern Michigan University, the Principal Investigator must submit a Cooperative Research Form in addition to the UHSRC Request for Human Subjects Approval form. The Eastern Michigan University Human Subjects Review Committee must review the project.
G. Independent Research
Research involving the use of human subjects that is conducted independent of the University is not covered by this Policy. However, to consider research as independent, the investigator cannot use his/her affiliation with the University, any University facilities, nor other University resources in the conduct of the research, nor may the research be pursued under University auspices in any way.
H. Use of Secondary Data
Research projects proposing to analyze secondary data fall under this policy and therefore require UHSRC approval. The term “secondary data” includes all forms of clinical records, medical charts, correctional institution records, personnel or human resource records, financial records, or records from educational institutions. Prior consent for medical treatment, psychological counseling, or other informed consent for treatment or service is neither a substitute for nor an a priori equivalent to UHSRC review. If information is to be obtained from medical records, the UHSRC HIPAA Summary Form must be completed, in addition to the Request for Human Subjects Approval.
I. Use of Technology (online data collection)
Researchers who use online data collection must explain in their protocol security precautions, data storage procedures, and anonymity issues relative to safeguarding sample identity.
If data are collected manually and subsequently converted to an electronic/digital format for storing and analysis, the researcher needs to explain in the protocol safeguards to protect data through such measures as encryption, password protection, de-identifying the data, deletion of file, etc.
J. Exempt Activities
As described in the Code of Federal Regulations (Title 45, Part 46, Protection of Human Subjects, Subpart A), research activities in which the only involvement of non-prisoner human subjects will be in one or more of the following categories may be determined to be exempt from human subject protections outlined in 45 CFR 46. All research studies conducted under the auspices of EMU are still subject to applicable portions of this policy as well as all other applicable EMU policies and procedures and state law.
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
a. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND
b. Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
NOTE: This exemption does not apply to research involving children, unless the investigator is a non-participant observer of behavior.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under Criterion 2, above, if:
a. The human subjects are elected or appointed public officials or candidates for public office; OR
b. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
a. Public benefit or service programs;
b. Procedures for obtaining benefits or services under those programs;
c. Possible changes in or alternatives to those programs or procedures; or
d. Possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies, if:
a. Wholesome foods without additives are consumed, or
b. A food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Data collected for the purpose of evaluation, review, and improvement of EMU academic and extra-curricular programs does not meet the federal definition of Research and will be designated as Not Human Subject Research unless these data are collected: a) for use beyond program review, and/or b) for publication beyond the review process for EMU programs administered by EMU, by its associated accrediting agencies, and by other related educational bodies. Program Review proposals that neither contribute to nor develop generalizable results do not need to be sent to the EMU UHSRC.
Studies in which EMU is not Engaged
Human subjects research that is otherwise non-exempt does not require UHSRC review if it is determined that EMU is not engaged in the research, in accordance with the guidelines set forth by the U.S. Department of Health and Human Services Office for Human Research Protections (DHHS OHRP, 2008). In brief, EMU would not be considered "engaged" in a research study that might be conducted on campus, using EMU students, staff, property, or facilities, if:
1. EMU employee or agents perform commercial or other services for non-EMU investigators provided that all of the following conditions also are met:
a. the services performed do not merit professional recognition or publication privileges;
b. the services performed are typically performed by those EMU employees or agents for non-research purposes; and
c. the EMU employees or agents do not administer any study intervention being tested or evaluated under the protocol.
d. when appropriate, investigators from an institution engaged in the research retain responsibility for:
i. overseeing protocol-related activities; and
ii. ensuring appropriate arrangements are made for reporting protocol-related data to investigators at an engaged institution, including the reporting of safety monitoring data and adverse events as required under the IRB-approved protocol.
2. EMU employees or agents are involved only to the extent that they
a. inform prospective subjects about the availability of the research;
b. provide prospective subjects with information about the research (which may include a copy of the relevant informed consent document and other IRB-approved materials) but do not obtain subjects’ consent for the research or act as representatives of the investigators;
c. provide prospective subjects with information about contacting investigators for information or enrollment; and/or
d. seek or obtain the prospective subjects’ permission for investigators to contact them.
e. An example of this would be a clinician who provides patients with literature about a research study at another institution, including a copy of the informed consent document, and obtains permission from the patient to provide the patient’s name and telephone number to investigators.
3. EMU permits the use of their facilities for intervention or interaction with subjects by investigators from another institution. Examples would be if EMU allows investigators from another institution to conduct or distribute a research survey in the classroom; or EMU permits investigators from another institution to recruit research subjects on campus.
K. Ethical Standards for Research Involving Human Subjects
The decision to undertake research rests upon a considered judgment by the individual investigator. Having made the decision to conduct research, the investigator considers alternative directions in which research energies and resources might be invested on the basis of this consideration. The investigator carries out the investigation with respect and concern for the dignity and welfare of the people who participate and with cognizance of federal and state regulations, University policy and professional standards governing the conduct of research with human participants.
In order to approve research covered by this Policy, the University Human Subjects Review Committee shall determine that all of the following requirements are satisfied:
1. Risks to the subjects are minimized.
a. By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and
b. Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
2. Risks to subjects are reasonable in relation to anticipated benefits, and the importance of the knowledge that may reasonably be expected to result.
3. Selection of subjects is equitable(3) considering the purposes of the research, the setting in which the research will be conducted, and the population from which subjects will be recruited.
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative. The written informed consent statement shall be in language that is understandable to the subject or his/her representative and shall include a statement about a subject's right to withdraw from a study at any time without prejudice.
5. Informed consent will be appropriately documented.
6. Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of research subjects.
7. Where appropriate, the research plan makes adequate provision to protect the privacy of subjects and to maintain the confidentiality of data.
8. Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness, or persons who are economically or educationally disadvantaged, appropriate additional safeguards have been included in the study to protect the rights and welfare of these subjects.
1. The University Human Subjects Review Committee (hereafter UHSRC) shall be composed of a minimum of seven voting members.
a. No fewer than five members shall be selected from the ranks of the faculty. At least one person from each of the colleges shall be selected.
b. At least one person, such as a, lawyer, ethicist, or member of the clergy, shall be from professions or vocations that are in a non-scientific area. This person may be a member of the faculty if he or she meets the vocational requirement.
c. At least one person who is not otherwise affiliated with the institution or a part of the immediate family of one who is affiliated.
d. The Research Compliance Officer will serve as an Alternate member of the UHSRC. The Research Compliance Officer will not be permitted to vote at meetings except as a proxy if and only if required to maintain quorum.
2. The Provost and Vice President for Academic and Student Affairs shall Approve UHSRC membership, based on the recommendation of the Associate Provost and AVP for Research and the UHSRC Chair.
a. Candidates for faculty positions on the UHSRC shall be selected by the Chair from the lists of names recommended by the academic Deans in consultation with their constituent departments/schools and programs.
b. The selection of faculty to serve on UHSRC shall take into account such factors as the prospective member’s experience and expertise in matters that fall within the purview of the UHSRC, the degree to which the faculty member’s discipline involves research likely to be in the domain of the UHSRC, and representation from among the colleges.
c. The following additional criteria should be considered in selecting UHSRC membership.
i. The UHSRC shall be sufficiently qualified through the experience and expertise of its members, and the gender, professional, racial and cultural diversity of the members’ background to assure its sensitivity to such issues as community attitudes, and to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
ii. The UHSRC shall possess the professional competence necessary to review specific research activities.
iii. In order to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice, the UHSRC shall include persons knowledgeable in these areas.
d. There shall annually be public notice of vacancies on the UHSRC.
3. The UHSRC may, at its discretion, invite individuals with competence in special areas to assist in the review of complex issues that require expertise beyond that available on the UHSRC. These individuals may not vote with the UHSRC.
4. No member of the UHSRC may participate in the committee’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the UHSRC.
5. New members of the UHSRC, within the first semester of their appointments, shall obtain training in the protection of Human Research Subjects by completing online training provided by the Collaborative Institutional Training Initiative (CITI). If new members have received training prior to joining the Committee, the nature and extent of such training will be taken into consideration, and the training requirement may be waived or reduced. The UHSRC Chair and Research Compliance Officer will be responsible for communicating with committee members about training options and monitoring adherence to this policy. Members who do not complete such training or, for whatever reasons, are unable to provide informed reviews that address pertinent human subjects issues may be removed from the committee by the Chair.
B. Term of Service
1. The term of service on UHSRC shall be three years.
2. All new appointments shall become effective at the beginning of the calendar year.
3. Members who do not fulfill the training requirement in human subjects protection, who do not return protocol review documents in a timely fashion, or who do not regularly attend the Committee meetings will be removed and replaced by the Chair if there is the consensus of the UHSRC. Additionally, if reviews indicate a lack of comprehension about important human subjects’ considerations, the member may be removed and replaced by the Chair.
C. Officers of the UHSRC
1. There shall be one Chairperson for the UHSRC: a faculty member of the UHSRC who shall serve as executive and signature authority for the Committee.
2. There shall be a Vice-Chairperson for the UHSRC: a faculty member of the UHSRC who shall serve as a secondary executive and signatory authority for the Committee. The Vice-Chair shall take on primary executive and signatory duties at the request of the Chair.
Except when an Expedited review procedure is used, the UHSRC shall review proposed research at meetings at which a majority of the members of the UHSRC are present, including at least one member whose primary concerns are in non-scientific areas. In order for the research to be approved, it must receive the approval of a majority of those members present at the meeting. All documents that require consideration for a vote at the meeting of the full committee shall be distributed at least two weeks in advance of the meeting.
E. Research Approval and Oversight
1. Only research approved by the means set forth in this document shall be considered authorized.
2. To be considered for review, investigators must submit a completed UHSRC Request for Approval application. All applicable supplemental documents that also must be submitted and reviewed include:
Consent forms and scripts/assent forms and scripts/information sheets
Recruitment and screening materials
Questionnaires, surveys, interview questions, and other assessments or measures
Grant application or research proposal
3. UHSRC Review
The UHSRC shall notify investigators in writing of its decision to approve or disapprove the proposed research activity, or of the modifications required to secure UHSRC approval. If the UHSRC decides to disapprove a research activity, it shall include in its notification a statement of the reasons for its decision and shall give the investigators an opportunity to respond to the Committee in person or in writing. The Chair or Research Compliance Officer will also notify the Provost and the Associate Provost/AVP for Research of any proposal that has been disapproved.
Requirement for Review of Research by the IRB at Convened Meetings: Projects that are greater than “minimal risk” must undergo Full Board review at a convened meeting. The UHSRC can also review studies that are deemed not greater than minimal risk at its discretion. Each project will be reviewed and voted upon separately to ensure that members with a conflicting interest related to a particular study do not participate in the continuing review of that study, except to provide information requested by the UHSRC. Materials to be reviewed by the Full Board must be provided to UHSRC members at least two weeks prior to the date of the convened meeting. Full Board meetings will be scheduled for September through May, inclusive. During summer months (June, July, August), a convened meeting may take place if necessary due to imminent funding and if quorum can be obtained.
Approval of research is by a majority vote of the quorum as described in 45 CFR 46.108(b). Should the quorum fail during a meeting (e.g., loss of a majority through recusal of members with conflicting interests or early departures, or absence of a nonscientist member), the IRB may not take further actions or votes unless the quorum can be restored.” The date of initial approval for projects discussed at convened meetings is the meeting date, unless approval is granted with conditions and the UHSRC decides that one member of the UHSRC can review the Principal Investigator response in lieu of the committee. Under this scenario, further review by the UHSRC at a subsequent convened meeting is not necessary for the initial approval to become effective; the effective date of the initial approval is the date on which the UHSRC Chair (or any other individual(s) designated by the UHSRC) has reviewed and accepted as satisfactory all changes to the protocol or informed consent documents, or any other responsive materials, required by the UHSRC from the investigator.
Expedited studies do not require approval at a convened meeting. Expedited reviews are conducted by at least one (usually two) members of the UHSRC. The Expedited reviewers will send their reviews to the UHSRC Chair. After reviews are received, the UHSRC Chair or a UHSRC member who has been designated by the Chair may issue approval through a letter; the approval date is the date that the letter is sent. Reports of all Expedited approvals will be included in the UHSRC monthly and annual reports.
An expedited review may be conducted for research in which all research activities can be described by at least one of the nine categories delineated by the Office of Human Research Protection and involving no more than minimal risk. “Minimal Risk” is defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” Classified research cannot be approved under Expedited review.
Expedited reviewers will review applications in accordance with regulations and guidelines specified in 45 CFR 46 and all other application federal, state, local, and institutional regulations and policies. Expedited reviewers can approve, approve with conditions, or defer a study. Expedited reviewers cannot disapprove a study. If Expedited reviewers decide that a study should be disapproved, they must recommend it for Full Board review.
Research projects that consist of program review/quality improvement or meet the specifications defined in 45 CFR 46.101(b) may qualify for Exemption. These studies are not subject to federal regulations specified in 45 CFR 46 but are subject to all other applicable federal laws and regulations, state law, local law, and university policy. Research involving prisoners and FDA-regulated research that does not qualify under Exempt Category 6 may not be Exempt. Similarly, research involving surveys, interviews, or public observation of children may not be Exempt except for public observation research involving public observation of children in which the investigator does not participate in the activities being observed.
All Exempt research will be reviewed by College Level committees (see below). The Research Compliance officer or one of the officer’s designees will inform the Chair of the appropriate College Level committee when an Exempt study is received. The Chair will designate a reviewer from the committee to make an Exempt determination. The reviewer will then send his or her review to the College Level committee Chair, who will send out the Exempt determination letter.
Exempt research will be reviewed according to the following ethical criteria:
The research presents no greater than minimal risk to subjects.
Subject selection, if applicable, will be equitable.
If identifiable data are recorded, confidentiality will be protected. If subject identity will be disclosed in publication, the subject will be adequately informed and given the opportunity not to be identified.
If there are interactions with subjects, the following information will be disclosed to subjects prior to enrollment:
That the investigator is a researcher conducting a research study
All study procedures involving the subject
Any risks that may be involved with participation
How data will be kept confidential. If the investigator wishes to identify subjects in publication, each subject will individually be given the option to remain anonymous
That participation is voluntary
That at any point, the subject can refuse to participate or go “off the record” during the study
If the reviewer decides he or she needs additional information, the reviewer will contact the College Level committee Chair who will then send an information request email to the investigator. Once that information has been received and the reviewer is satisfied, the reviewer will inform the College Level committee Chair that an Exempt determination can be made and the Exempt type/category. The College Level committee Chair will send the Exempt determination letter to the principal investigator.
4. Continuing Review of Research Projects
UHSRC approval lasts up to, and no longer than, one year in accordance with 45 CFR 46.109(e). Continuing review must be conducted before the expiration date of the previous UHSRC approval, even if the research activity began some time after the UHSRC approval date. Continuing review must be conducted according to criteria outlined in 45 CFR 46.111. Continuing review will be conducted in the same way as the original approval unless the study was approved at a convened meeting and one of the following two situations applies:
1. Continuing review of research previously approved by the convened UHSRC as follows:
a. Where the research is
i. permanently closed to the enrollment of new subjects
ii. all subjects have completed all research-related interventions, AND
iii. the research remains active only for long-term follow-up of subjects; OR
b. Where no subjects have ever been enrolled and no additional risks have been identified; OR
c. Where the remaining research activities are limited to data analysis
2. Continuing review of research, not conducted under an investigational new drug application or an investigational device exemption where categories 2 through 8 do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risks and no additional risks have been identified.
Principal Investigators are required to submit the Continuing Review form.. Annual reviews may be processed using the Continuing Review form for two years after the initial review (i.e., a total of three years of research activity). If a project is being renewed for a fourth year of data collection, it should be submitted using the full Request for Human Subjects Approval form, including all attachments listed on the last page of that form.
Research projects deemed to be Exempt at the time of initial review do not require continuing review. When continuing review of research is conducted under an Expedited review procedure, the review must be conducted by the UHSRC Chair or one or more of the UHSRC Chair designees. The date of continuation approval for Expedited projects is the date on which the approval email/letter is sent to the Principal Investigator.
No UHSRC member may participate in the initial or continuing review of research in which the member has a conflicting interest, except to provide information requested by the UHSRC.
Research on non-exempt, non-expedited (i.e., Full Board) studies undergoing continuing review will be evaluated and discussed at a convened meeting. The Continuing Review form and supporting documentation will be distributed to the Committee at least two weeks prior to the meeting. Each project will be reviewed and voted upon separately to ensure that members with a conflicting interest related to a particular study do not participate in the continuing review of that study, except to provide information requested by the UHSRC. The meeting minutes will reflect any conflicts of interest and the outcome of the vote on each continuing review. The date of continuation approval for projects discussed at convened meetings is the meeting date, unless approval is granted with conditions. Under this scenario, further review by the UHSRC at a subsequent convened meeting is not necessary for the continuation approval to become effective; the effective date of the approval is the date on which the UHSRC Chair (or any other individual(s) designated by the UHSRC) has reviewed and accepted as satisfactory all changes to the protocol or informed consent documents, or any other responsive materials, required by the UHSRC from the investigator.
If a project is not continuing beyond the one-year approval period, the protocol can be closed by completing and submitting the Closure Form to the UHSRC. A protocol can be closed when all research activities including participant/subject recruitment, enrollment, intervention, interaction, and follow-up have been completed and data have been sufficiently de-identified (anonymized) with all links to identifiers destroyed. The Principal Investigator may continue data analysis and dissemination of findings. Documents are retained by the UHSRC for three years post study closure.
If the Principal Investigator does not submit for continuing review prior to lapse of UHSRC approval, the UHSRC administrator will send a notice to the Principal Investigator that UHSRC approval has lapsed, the Principal Investigator must submit a Continuing Review form as soon as possible, and all study activity must cease until approval has been granted again. If the UHSRC does not receive a Continuing Review form within 60 days of the expiration date, the study will be administratively closed.
5. Event Reporting
a. Adverse Event Reporting
An adverse event is defined as any negative outcome experienced by the subject that has taken place during the course of a research project. Note that the adverse event does not necessarily have to be caused by research participation Adverse events must be reported to the UHSRC at continuing review.
b. Serious Adverse Events, Unanticipated Problems, and Deviations
Serious Adverse Events (SAE) are serious negative outcomes experienced by a subject and include death, life-threatening outcomes, hospitalizations (initial or prolonged), disability or permanent damage, congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage (as in with a device), or other important medical or psychological events. Unanticipated Problems (UP) are any events that are unexpected, related or possibly related to the research, and may increase risk to subjects or others. Deviations are all instances where the UHSRC-approved protocol has not been followed, whether intentionally or unintentionally.
SAEs, UPs, and Deviations must be reported to the UHSRC soon as possible, but no later than 24 hours after the PI learned of the event (see Event Report form). The Research Compliance Officer is responsible for immediately sending a copy of this report to the University’s attorney. If the research is being funded by an external agency, the PI must also report the event to the Director of the Office of Research Development, whose responsibility it is to inform the agency in conformance with agency rules or regulations.
The UHSRC Chair will review the Event Report form and determine what actions might be necessary to protect human subjects and continue the study, if risks can be adequately managed. The UHSRC may suspend the research or take other appropriate action as necessary.
6. Protocol Changes
PIs are responsible for notifying the UHSRC when there are changes to their research protocol. For minor changes, use the Minor Modification to Research Protocol form. Minor modifications would include items such as the addition or deletion of researchers or research partners, change in source of sample but type of source is the same (e.g., different high school), change in contact information on informed consent, minor changes to the language of the survey instrument or interview questions, etc. When the changes are more substantial (e.g, address sample composition to include special populations or when data collection procedures change) use the Request for Human Subjects Approval form checking the modification section. All changes, whether major or minor, must be accompanied by a modified protocol (with changes highlighted or otherwise tracked) and all modified supplemental documents (with changes highlighted or otherwise tracked).
Approval of all changes must be obtained in advance of implementation.
All changes will be reviewed in the same manner of original approval. If the change increases the risk to subjects so that it no longer meets the “not greater than minimal risk” threshold, the changes will be reviewed at a convened meeting. All changes are subject to the criteria outlined in 45 CFR 46.111, 46.116, and 46.117.
Changes to Exempt research must be submitted to the UHSRC as email correspondence. The changes will be reviewed by the appropriate College official to determine that the study remains Exempt. If the change causes the study to no longer qualify for exemption, the entire study will be reviewed by the UHSRC, either under Expedited review or at a convened meeting, whichever is deemed appropriate.
7. Ongoing Research Not Approved by the UHSRC
Research otherwise falling under the purview of the UHSRC but that has not been approved by the UHSRC shall not be conducted at the University or under its auspices. When such research becomes known to the committee, the UHSRC Chair shall immediately notify the investigators, the Research Compliance Officer, the Associate Provost/AVP for Research, the Provost and Vice President for Academic and Student Affairs, and the University Attorney in writing that if the research is not halted, the Provost and the Vice President for Academic and Student Affairs shall notify the investigator and University’s attorney of the continuing infraction of the University Policy and shall specify the disciplinary actions that the University has at its disposal. Should the research not be halted, the Provost shall take appropriate action in consultation with the University’s attorney to resolve the matter.
8. Suspension or Termination of Research
The UHSRC shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the UHSRC’s requirements, that has resulted in unexpected serious harm to subjects, where new information indicates an increase in the level of risk to subjects, or in instances of serious and/or continuing non-compliance. Any suspension or termination of approval shall include a statement of the reasons for the UHSRC’s action and shall be reported promptly to the PI, the dean, the department head/school director, the Research Compliance Officer, the Associate Provost/AVP for Research, the Provost, the Office of Human Research Protection, and if the study is funded, the Director of the Office of Research Development and the funding agency. Should compliance with a notice of suspension or termination not occur immediately, the Provost will take appropriate action in consultation with the University’s attorney to resolve the matter.
F. College-Level Review Committees
The UHSRC will grant authority to college-level permanent committees to conduct review of all Exempt research. Such college-level committees will be approved when the following conditions are met:
1. The college-level committee is composed of at least two faculty who are thoroughly conversant with all guidelines and procedures of the UHSRC (committee composition should meet the protocol volume of the college);
2. The UHSRC will be notified of the chairs and current membership of the college-level committees;
3. All members must show evidence of prior or current human subjects training.
Committees will annually report their activities to the UHSRC. The Research Compliance Officer will regularly supervise the College-Level Committees to ensure appropriate review procedures, compliance with this policy, and current training.
G. Informed Consent
No investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the appropriate informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek informed consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language at an appropriate understandable level to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence. Copies of the UHSRC-approved informed consent form with approval and expiration dates must be used by the investigator to obtain consent, and these records must be maintained throughout the life of the project.
In conducting research with children, procedures must be in place for obtaining both the informed consent of the parent or legal guardian and the assent of the child, obtained in a developmentally appropriate fashion.
In seeking informed consent, the following information shall be provided to each subject:
1. A statement that the study involves research, an explanation of the purpose of the research and expected duration of the subject’s participation, a description of the procedures to be followed, identification of any procedures that are experimental, that may result in public dissemination;
2. A description of any reasonably foreseeable risks or discomforts to the subject;
3. A description of any benefits to the subject or to others that may reasonably be expected from the research;
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that may be advantageous to the subject;
5. A statement describing the extent to which confidentiality of records identifying the subject will be maintained and how participant confidentiality will be maintained in the dissemination of results;
6. A statement describing the extent to which the subject’s privacy will be maintained.
7. For research involving more than minimal risk, information must be made available regarding medical treatments, counseling or other personal assistance that will be provided should personal injuries or problems occur;
8. A list of contacts who can answer pertinent questions about the research and research subject’s rights, and whom to contact in the event of a research-related physical or psychological injury to the subject;
9. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time;
10. Statements of significant new findings developed during the course of the research that may relate to the subjects’ willingness to continue participation will be provided to all subjects.
A waiver of signed informed consent may be requested if either of the following two conditions apply.
1. The only record linking the subject and the research would be the consent document AND the principal risk is potential harm resulting from a breach of confidentiality
2. The research presents no more than minimal risk of harm to subjects AND involves no procedures for which written consent is normally required outside of the research context.
Regardless of whether informed consent is obtained on a signed document or more informally, the above-delimited elements of informed consent must be in place.
H. Record Keeping
The UHSRC shall maintain records of all reviews, correspondences related to reviews, and decisions. These shall be retained for at least three years after the completion of the research, and the records shall be accessible for inspection and copying by authorized representatives of the University at reasonable times and in a reasonable manner. These records shall include:
1. Copies of all research proposal reviews, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of adverse events;
2. Minutes of UHSRC meetings, which shall be in sufficient detail to show attendance at the meetings, actions taken by the UHSRC, the vote on these actions including (the number of members voting for, against, and abstaining) the basis for requiring changes in or disapproving research, and a written summary of the discussion of controversial issues and their resolution;
3. Records of continuing review activities;
4. Copies of all correspondence between the UHSRC and the investigators;
5. A list of UHSRC members as required by federal guidelines;
6. Written procedures which the UHSRC will follow for (a) conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (b) determining which projects require review more often than annually and which projects need verification from sources other than investigators that no material changes have occurred since previous UHSRC review; (c) reporting changes that have occurred since previous UHSRC review; (d) ensuring prompt reporting to the UHSRC of proposed changes in research activity, and for ensuring that changes in approved research, during the period for which approval has already been given, may not be initiated without UHSRC review and approval except where necessary to eliminate apparent immediate hazards to the subjects; and (e) ensuring prompt reporting to the Secretary of Health and Human Services of unanticipated problems involving risks to subjects or others.
Conclusion. The intent of EMU policy and related review procedures is to assure the minimization of research-related risks to human beings and to provide for informed and voluntary participation by subjects, while complying, as an institution, with Federal regulations. The goal of the review process is to work with faculty and students to promote research that protects all participants, including the investigators. When investigators conduct or supervise research that has been approved by the UHSRC or one of its sanctioned review committees, their personal liability is limited in the same way that it is when one is teaching in the classroom (or conducting other activities associated with the terms and conditions of his or her employment).
Notes: (1) - Minimal risk means that the risk of harm anticipated in the proposed research is not greater, considering probability and magnitude, than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (2)- "Research" is defined in this policy to mean a systematic investigation designed to develop or contribute to generalizable knowledge (3)- The term "equitable" is defined to mean that there is no discrimination in the selection of subjects and no over-selection of vulnerable subjects.