The High Point University Human Participants Institutional Review Board (IRB) safeguards the welfare and rights of human participants in research conducted by faculty, adjunct faculty, staff, and students. The IRB has authority to review and approve, require appropriate modifications to, or disapprove human participant research in accordance with 45 Code of Federal Regulations, Part 46 and High Point University policy. The University subscribes to the ethical principles of respect for persons, beneficence, and justice outlined in the Belmont Report and therefore elects to apply federal regulations to all of its human participant research regardless of source of support. Show
Determining Whether Your Project Requires IRB Oversight Research Federal regulations define “research” as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Activities that meet this definition constitute research for purposes of IRB review whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. The federal government has categorized the following activities not subject to IRB review:
Some teaching-related activities are sufficiently research-related that they raise questions for faculty about what does or does not come under the province of the IRB. As a general rule, if the activity results in public displays (e.g., Honors Day presentations, conference presentations) or publication (i.e., journals or books), the research is considered to contribute to generalizable knowledge. Please note if the activity does not require IRB approval, the results cannot ever be used outside the class for which they were collected. In other words, the IRB cannot retroactively approve a study for future use. If the activity does not require IRB approval, the faculty member should ensure risks to participants are minimized and reasonable in relation to anticipated benefits. In addition, identifying information from the participants should be kept private. Human Participants “Human participant” is defined as “a living individual about whom an investigator (whether professional or student) conducting the research
Application for Research Project Review Every research project review shall begin with the submission by the investigator of a completed Protocol Application Form, all required supporting documents (i.e., consent form, recruiting materials, instruments), and current reports of education in the responsible treatment of human participants for all investigators and personnel. If the primary investigator is a student or group of students, please have them read the Student Researcher’s Guide to the IRB. All student projects must be supervised by a faculty member. Please refer to the section on Faculty Mentor and Faculty Sponsor responsibilities. Length of Project An investigator may request a term for the project no less than 3 months and no more than 3 years. The IRB has the authority to determine the approval period based on the application. Exempt from Review (Level 1) The determination whether any particular research project qualifies as “exempt” must be made by the Chair of the IRB. Investigators do not have discretion to make this determination. Investigators who believe their research projects should be classified as “exempt” must secure written approval from the IRB. The following research activities normally fall under the exempt classification: REVISED JANUARY 21, 2019
*Broad Consent not currently adopted by HPU IRB To apply for Exemption status, investigators must submit a completed Protocol Application including the exemption form to the IRB office. The IRB office will verify the completion of all applications and materials before forwarding them to the IRB Chairperson, or designated Committee Member, for review (Limited Review). The IRB may approve, approve pending modifications, defer, or request that the study be reviewed through expedited procedures or by the Committee. Request for exemption must be approved in writing prior to initiation of the research or contacts with participants. . Any changes made to the approved exempt research must be submitted for review by the IRB prior to implementation. Expedited Review (Level 2) Expedited review does not mean “fast”; rather, certain research that meets the specified criteria may be reviewed by the IRB Chairperson and/or designated Committee Member, not at a convened Committee meeting. The IRB will provide expedited review for proposed research activities that (1) present no more than minimal risk to human participants, and (2) involve only procedures listed in one or more of the categories listed below as authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included. Inclusion on this list merely means that the activity is eligible for review through an expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human participants. New Research
Examples: (a.) hair and nail clippings in nondisfiguring manner; (b.) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c.) permanent teeth if routine patient care indicates a need for extraction; (d.) excreta and external secretions (including sweat); (e.) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f.) placenta removed at delivery; (g.) amniotic fluid obtained at time of rupture of the membrane prior to or during labor; (h.) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i.) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j.) sputum collected after saline mist nebulization.
No expedited review shall be available if identification of the participants or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections are implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. Investigators should remember that even though research may be eligible for expedited review it still remains subject to the requirements of informed consent. Every expedited review shall be conducted by the IRB Chairperson, or by one or more experienced Committee Members designated by the Chairperson, in accordance with 45 CFR 46. In reviewing the proposed research, the reviewers may exercise all of the authorities of the IRB, except that they may not disapprove the research. A research activity may be disapproved only after the full IRB review. Proposed research shall be deemed approved by the IRB when it is approved by the Chairperson and the designated Committee Member(s). Investigators shall receive an electronic notification of approval. For student investigators, faculty supervisors shall be copied on all electronic communication. No human participants may be enrolled or recruited prior to receipt of written final approval of the application from the IRB. Expedited approval actions shall be summarized in writing by the Chairperson or the designated Committee Member. Summaries and communication between the IRB and investigators will be kept electronically on a secure server that can be accessed by IRB members at any time for review. Any IRB member may request a full IRB review and reconsideration of any expedited review action. Full Committee Review (Level 3) The standard review requires one or more experienced primary reviewers, designated by the Chairperson to conduct an in-depth examination of the Protocol Application Form, all required attachments submitted by the investigator, and any additional documents submitted by the investigator at the request of the primary reviewer(s). These materials shall fully disclose any risks to participants or others and any risks of noncompliance. The primary reviewer(s) shall then write memos to the IRB summarizing the proposed research and appraising the risks involved. The memos shall contain a recommendation that the IRB approve the research, approve the research provided that certain modifications are made in the protocol or in the proposed informed consent process, or disapprove the research. The reviewer memos, the Protocol Application Form, the proposed informed consent document, and any other documents specified by the primary reviewer, shall then be submitted to all IRB members at least five business days prior to a regular monthly or specially scheduled IRB meeting. At such an IRB meeting, at which a majority of the IRB members are present, (an IRB quorum), the IRB shall fully consider the proposed research and the recommendation of the primary reviewers. Proposed research shall be approved by a majority vote of the IRB quorum. Should the quorum fail during the meeting (e.g., loss of a majority through recusal of members with conflicting interests or early departures), the IRB shall not take further action or votes unless the quorum is restored. The deliberation, action, and vote on each proposed research by the IRB quorum shall be recorded in the meeting minutes. The recorded vote shall include the number of members voting for, against, and abstaining. Proposed research shall be deemed approved by the IRB when it is approved by the IRB quorum. Investigators shall receive an electronic notification of approval. For student investigators, faculty supervisors shall be copied on all electronic communication. No human participants may be enrolled or recruited prior to receipt of written final approval of the application from the IRB. Umbrella Review (Level 4) As part of a research course (for example, PSY 4100, SOA 3210), students may conduct individual research projects involving human participants. Due to the nature of these courses, the IRB will allow faculty teaching these courses to apply for an umbrella review that covers all projects under one protocol. The application form is a summary for all projects. However, a separate description, short methodology, and materials should be included for each project. Sample applications are available; contact the IRB Chairperson. All student investigators must complete the required CITI training courses. Once the course is finished, the faculty member must submit a Study Closure form. Modifications to Approved Research Minor Modifications If changes to the protocol do not affect the rights and welfare of study participants, do not have the potential to increase risk to study participants, and do not involve significant changes in the study procedures (e.g., research assistants, recruitment advertisements, informed consent documents), the protocol modification form can be submitted and an expedited review process may be used to approve the changes. The Chairperson or the designated Committee Member will review the changes and assess the risk. Major Modifications Each revision to a research protocol shall be incorporated into the written protocol, to assure that there is only one complete protocol, with revisions highlighted in the form itself, revision dates noted on each revised page, and on the first page of the protocol itself. IRB project approvals shall advise investigators that any proposed material changes in research activity must be promptly reported to the IRB and that such changes may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to participants. IRB project approvals shall also advise investigators that they should report promptly to the IRB any unanticipated or undisclosed problems involving risks to participants or others, or any serious or continuing noncompliance with the protocol or with the requirements or determinations of the IRB. The IRB has the authority to suspend or terminate approval of research that has been associated with noncompliance to Federal regulations, ethical principles outlined by the Belmont Report, University policy, or unexpected serious harm to participants or others. When the IRB takes such action, it is required to provide a statement of reasons for the action and to promptly report this action to the Investigator and the Provost. Cooperative Research Cooperative research projects are those covered by Federal regulations that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with Federal regulations. Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. The following research is not subject to this provision:
For research not supported by or conducted by Federal department or agency, HPU will enter into joint review arrangements, reliance agreements with another qualified IRB, or make similar arrangements to avoid duplication of effort on a case-by-case basis. Completion Report A Protocol Completion Report must be submitted to the IRB Office no later than the expiration date for all protocols (unless applying for continuation of protocol). Reporting Unanticipated Problems and Adverse Events In accordance with Federal regulations and OHRP policies, an Unanticipated Problem is defined as:
An Adverse Event is a physical or psychological “risk” to participants that ultimately results in harm to the participant or others. Adverse events most commonly occur in the context of biomedical research, but on occasion they can occur in social and behavioral research. Adverse Event reports must be filed when any of the following occur:
Reasonable judgment must be used when determining what constitutes an unanticipated problem. Researchers must consider psychological, emotional, economic, and social harms, not merely physical harms. When in doubt, it is best to err on the side of reporting the event or contact the IRB Chairperson for guidance. Unanticipated problems and adverse events must be reported within 5 business days of the occurrence or within 5 business days from the date in which the Principle Investigator learned of the occurrence. The Principle Investigator or a Co-Investigator must submit the Unanticipated Problem/Adverse Event form to the IRB Chairperson electronically. Federal regulations require that research participants be informed of all significant new findings identified during the course of research. A significant new finding may affect the willingness of participants to continue to participate in research. Significant findings almost always involve necessary changes to the Protocol Narrative and Consent Form. If the unanticipated problem involves significant findings, in addition to submitting the Unanticipated Problem/Adverse Event form, the protocol must also be modified (see section on minor vs. major modifications for instructions). The IRB will review the Unanticipated Problem/Adverse Event Report in a timely manner and confirm whether the submission constitutes an unanticipated problem involving risk to participants or others. The IRB will consider a range of possible corrective actions such as:
The IRB will report any unanticipated problems to the appropriate University officials and Federal regulatory authorities. The IRB has the authority to suspend or terminate approval of research that has been associated with unexpected serious harm to participants. When the IRB takes such action, it is required to provide a statement of reason for the action and to promptly report this action to the Principal Investigator, the Provost, and any other appropriate agency. Data Breaches A data security breach involving identifiable data almost always involves an unanticipated problem. If this occurs submit an Unanticipated Problem Report within 5 business days of the occurrence or within 5 business days from the date in which the Principle Investigator learned of the occurrence. Compliance Policy Reminders Primary investigators will receive a reminder via email approximately one month prior to the due date for a protocol expiration. If a continuation application or study completion report is not received by the due date, a written warning is sent to the primary investigator and the protocol is now lapsed. Likewise, research personnel as well as primary investigators, will receive an email approximately one month prior to the expiration of CITI human participant training. If renewed training (or modification form to remove personnel) is not received by the due date, a written warning is sent to the primary investigator and the protocol is now lapsed. Lapsed Protocol If the primary investigator fails to submit a continuation application or study closure within one month following the protocol expiration date, then the lapsed study will be classified as noncompliant. Once a study is declared noncompliant all research-related activity must immediately cease, except for those necessary for the welfare of the human participants. A written notice of this status will be sent to the primary investigator and his or her supervisor. For CITI training, if renewed training is not submitted within two months following the expiration date, then the lapsed study will be classified as noncompliant. Once a study is declared noncompliant all research-related activity must immediately cease, except for those necessary for the welfare of the human participants. A written notice of this status will be sent to the primary investigator. Noncompliant Protocol If a protocol is classified as noncompliant, the primary investigator’s research privileges are suspended. The investigator may not continue any research-related activity or submit protocol applications for review. If a protocol is classified as noncompliant for more than three months, the department to which the primary investigator belongs will be suspended. Members of the department may not continue any research-related activity or submit protocol applications for review. If the primary investigator wants to continue a noncompliant protocol, then the investigator must submit a new application for re-review by the IRB and must receive approval prior to resuming research under the protocol. Upon receipt of these materials, the IRB will review the suspension of the investigator and, if appropriate, the department. If the primary investigator wants to close the noncompliant protocol, then the investigator must submit the study closure form along with a final report. Upon receipt of these materials, the IRB will review the suspension of the investigator and, if appropriate, the department. Audit Policy The IRB has the responsibility and authority to observe ongoing research projects and the consent process, including audits of research records. The purpose of the research audit is to ensure that research is carried out according to the highest standards of scientific integrity and ethical behavior. The IRB will select approximately 5% of active nonexempt IRB protocols to be monitored each year. Selection may be random, for cause, or based on compliance records of the investigators. Principal Investigators whose projects are selected for monitoring will be contacted by the IRB to schedule an appointment at least 5 business days prior to their visit. Other IRB members may accompany the auditor. Monitoring and/or auditing activities may include, but are not limited to examination of records, including copies of signed consent forms, observation of the informed consent process, review of advertisements and other recruiting materials and methods, and examination of procedures to verify that changes have not been implemented without IRB approval. Following the audit, a report will be drafted and forwarded to the Principal Investigator and the IRB Chairperson stating findings. If deficiencies, problems, or concerns are identified, the IRB may temporarily halt subject recruitment, require additional oversight, or recommend other corrective actions as deemed necessary. If deficiencies, problems, or concerns are identified, the Principal Investigator is required to respond to the IRB Chairperson in writing stating corrective actions taken. The IRB may suspend or terminate research if the audit/monitoring indicates that human subjects were exposed to unexpected risk or harm, or that federal regulations or IRB policies were not adhered to. Funded Research Federally Funded Research Investigators seeking federal funding must submit an application for “Approval of Sponsored Research Involving Human Participants.” IRB approval shall be received prior to the start of the project and release of funds, except in cases where the sponsor requires IRB approval prior to proposal submission or to award acceptance. Research Funded by Off-Campus Sources Investigators seeking research support from non-federal, off-campus sources must submit an application for “Approval of Sponsored Research Involving Human Participants.” IRB approval shall be received prior to the start of the project and release of funds, except in cases where the sponsor requires IRB approval prior to proposal submission or to award acceptance. High Point University Funded Research Investigators seeking research support from the University must submit an application for “Approval of Sponsored Research Involving Human Participants.” IRB approval shall be received prior to the start of the project and release of funds, except in cases where the sponsor requires IRB approval prior to proposal submission or to award acceptance. FERPA/PPRA Guidelines Schools that receive federal funding from the U.S. Department of Education must comply with the Family Education Rights and Privacy Act (FERPA) and the Protection of Pupil Rights Amendment (PPRA), which is designed to protect the privacy of student education records. When accessing student educational records for research purposes at the University or any federally-funded school (e.g., public schools), investigators are responsible for complying with FERPA laws (including exempt research). This includes records accessed for the purpose of identifying and recruiting potential research participants and/or conducting analysis. If a researcher intends to conduct research at a school, he/she must obtain written assurance of FERPA compliance from the school. This assurance must be provided by a school administrator and delivered on school letterhead. This must be included with the protocol application. Student educational records are defined as information directly related to a student and maintained by an educational agency or by a party acting for the agency or institutions. Records may be recording in any way, including, but not limited to, handwriting, print, computer media, video or audio tape, film, microfilm, and microfiche. Student records may be accessed by researchers and disclosed to the public under the following conditions:
The US Department of Education indicates that “A document containing only non-personally identifiable data, even when originally taken from student’s Education Record, is not a part of the student’s Education Records for purposes of FERPA.” Information that must be removed include:
FERPA allows schools to disclose certain items of information as “directory information”, such as a student’s name, address, telephone number, date and place of birth, honors and awards, and dates of attendance. Each educational institution designates what information is considered directory information. FERPA requires that students be given the opportunity “opt out” and therefore prevent the release of directory information. Therefore, data files containing directory information for students delivered to a researcher will not contain information pertaining to students who have “opted out”. Conflict of Interest No IRB member shall participate in the IRB’s initial or continuing review of a project in which the member has a conflicting interest, except to provide information requested by the IRB. Unless requested by the IRB to be present to provide information, IRB members with conflicting interests must be absent themselves from the meeting room when the IRB reviews research in which they have conflicting interests. Their absence shall be reported in IRB meeting minutes. Reporting The IRB Chairperson shall ensure prompt reporting, within 30 days, to the IRB, appropriate University officials, the Office for Human Research Protections of the U.S. Department of Health and Human Services and any other appropriate entities of any unanticipated problems involving risk to participants or others, or any serious or continuing noncompliance with 45 CFR, Part 46, or the requirements or determinations of the IRB, or any suspension or termination of IRB approval. Timetable The IRB meets regularly during the academic year (September through May) and as needed during the summer months of June, July, and August. Other meetings may be called at the discretion of the Chairperson. Exempt and Expedited reviews do not require a meeting. Average turn-around-time for approval (including request for additional documents or modifications of submitted documents) is approximately 2 weeks. Training The Office for Human Research Protections (OHRP) requires that all members of the University’s Human Participants Institutional Review Board and any individual conducting and/or supervising federally-funded research involving human participants complete a program of instruction on the responsible treatment of human participants. All Investigators, Students, and Faculty Mentors who are conducting human participants research are required to complete the Collaborative Institutional Training Initiative Program (CITI) on-line training course prior to submitting a research application protocol. Required courses include: Basic/Refresher Human Subjects Research Responsible Conduct of Research Information Privacy Security Conflicts of Interest Completion Reports must be submitted to the IRB Office. Certificates for all Faculty are valid for three years. Certificates for Students must be renewed annually. CITI On-Line Course: https://www.citiprogram.org/ Records of the IRB IRB records must be retained for at least three years, and records relating to conducted research shall be retained for at least three years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the Department of Health and Human Services at reasonable times and in a reasonable manner. Informed Consent The Belmont Report provides Investigators with basic ethical principles for conducting research. The principle of “respect for persons” incorporates two ethical convictions. First, individuals should be treated as autonomous agents; and second, persons with diminished autonomy are entitled to protection. An autonomous individual is capable of establishing personal goals and completing actions toward those goals. Others may respect an individual’s autonomy by taking into consideration an individual’s opinions and choices while refraining from obstructing those actions unless the actions are harmful to self or others. In regards to research participation, respect for autonomy is addressed by giving an individual a choice to enter research voluntarily after being presented with adequate information. This is the premise of informed consent. For individuals who may have diminished autonomy as a consequence of age, maturity, or psychological state, Investigators must assure that additional protections are in place (e.g., permission from legally authorized representative). The Federal regulations provide additional guidance on including participants with diminished autonomy (e.g., children, cognitively impaired). Informed consent is a process whose goal is to respect the research participant’s dignity. The process does this by attending to the participant’s right to deliberate and to make a knowing decision whether to cooperate with the Investigator’s research interest. High Point University requires that every researcher (faculty, staff, or student) secure the informed consent of any human participant used in research before involving that participant in the research project (except under very specific conditions, see next section on Waivers of Informed Consent). Every potential participant who is a physically and mentally able adult must provide consent to participate in the research prior to the initiation of the actual research. Federal regulations define an adult as anyone at least 18 years old. The ideas of mental and physical normalcy revolve around the ability of the participant to provide truly informed and voluntary consent. If a person varies from this norm due to age or disability, special safeguards, described later, are required. Researchers must ensure that the circumstances under which consent is sought will provide the participants (or their representatives) with sufficient opportunity to consider whether or not to participate in the proposed research. The circumstances must minimize the possibility that the participants will experience coercion or undue influence. The situation of the participants may, in certain cases, be inherently coercive; i.e., their freedom of choice may be restricted by the nature of their employment, age, associations with others, place of residence (prisons, mental hospitals) and mental or physical capacities. Participants in these categories need not be excluded from research; rather, researchers must make a special effort to ensure that potential participants are given every opportunity to exercise free choice in consenting to participate in a research project. The informed consent document communicates to the prospective research participant the purpose, procedures, risks and benefits of the study; the participant’s rights in participating in the research; and the freedom to decline to participate without penalty. The consent document also allows the participant to obtain further information and answers to questions related to the study. The consent form, therefore, serves as a written summary of the proposed research and provides a reference for both the participant and the researcher. The informed consent document requires a notice about whether participants’ information or biospecimens collected as part of the research will be stripped of identifiers and used for other research in the future, or that this will not happen. Additional notices that if applicable must be included: participants must be notified if research results will involve commercial profit; participants must be notified if clinically relevant research results will be provided to them; and participants must be notified whether research activities will or might include whole genome sequencing. Please see examples posted on the IRB website. A copy of the Informed Consent must be given to each participant Minors Minors are persons who have not yet attained the legal age of consent under North Carolina law. In North Carolina, a person under the age of 18 is considered a minor and cannot consent to medical or surgical treatment, or participation in research without authorization from a parent, guardian, or custodian, or any person standing in loco parentis to the minor (NC Gen. Stat. 90-21.1). Situations in which minors may consent to medical treatment or research participation for themselves or others in North Carolina include:
Assent / Consent “Consent” involves the act of the will, based upon legal rights of the consenter, which requires the individual to be 18 years of age or older. Individuals who have appropriate decisional capacity and legal empowerment can give their informed consent. Consent embodies judgments about proposed interventions and, more importantly, consent (literally “to feel or sense with”) expresses something for one’s self: a person who consents responds based on unique personal beliefs, values, and goals. “Assent” means a child’s affirmative agreement to participate in research. It is an act signifying understanding (recognizing that the minor has not reached full legal age). Mere failure to object by the child should not, absent affirmative agreement, be construed as assent. While children may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent to or dissent from participation. Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research, particularly if the research: (1) does not involve interventions likely to be of benefit to the participants; and (2) the children can comprehend and appreciate what it means to be a volunteer for the benefit of others. The IRB must determine for each protocol – depending on such factors as the nature of the research and the age, status, and condition of the proposed participants – whether all or some of the children are capable of assenting to participation. Obtaining Assent If the participant is a minor, an assent form must be signed by those participants capable of reading and understanding a simplified version of the consent form to be signed by the parent or guardian. A copy of this assent form must accompany the protocol. For participants too young to read, but who are capable of understanding an oral explanation of the procedures, a copy of the oral explanation to be given must accompany the protocol. The age, maturity, and psychological state of the participants must be taken into account by the researcher when creating an assent form or an oral presentation to obtain assent from minors. Adolescent’s Written Assent: For junior high or middle school aged children, a child’s written assent is needed (in addition to parental or guardian consent), because children in this age group usually can read and comprehend a well-constructed assent form (see sample). The researcher should use supplementary verbal explanations as needed. Child’s Assent: For elementary school age children, the researcher should obtain, in addition to parental or guardian consent, the child’s assent to participate. The explanation to the child should contain elements of consent expressed in a form the child can understand. A conversational question/answer setting is often the most useful form of communication. If the child is old enough to provide a signature, student researchers are required to obtain a signed assent. Very Young Children: Researchers should give explanations that match the level of understanding for children below school age (infants, toddlers, preschoolers). In many instances, the child’s nonresistant behavior may be interpreted as assent, but the researcher must use special care to discontinue the participation of any child who appears to experience undue stress from the research procedure. A verbal script must be submitted as part of the protocol as well as a written consent form to be signed by parents or guardians. Parental Consent: All research participants under the age of 18 must provide written parental (or guardian) consent in order to participate in University-sponsored research projects. Active/Passive Parental Consent Active and passive consent methods differ in important ways. A passive consent procedure typically involves distributing a letter to the children’s parents or guardians explaining the nature of the study and providing a method to retract permission. In an active consent procedure, the introductory letter explains the nature of the study and provides a method to document permission. The important distinction between these two procedures is that the passive consent procedure assumes that the parent or guardian has consented unless some action is taken, whereas the active consent procedure requires the parent or guardian to signify in writing their permission for the minor to participate in the study. Parental passive consent will only be approved in situations that meet all of the following criteria:
Special Populations: Besides children, numerous other types of participants require special attention when obtaining informed consent. In all cases, the guiding principle is respect for the rights of the potential participant. Federal regulations consider prisoners, the mentally disabled, and pregnant women to be “special populations,” and as such, are entitled to extra protection under the law. Other groups, such as racial minorities, the elderly, substance abusers, the economically disadvantaged, the very sick and the institutionalized are described as “vulnerable populations” and are extended similar protection when used as research participants. Researchers wishing to use these populations as research participants must contact the IRB Chair prior to protocol submission in order to determine what, if any, additional restrictions may be imposed in order to assure the protection of participants falling in the special/ vulnerable populations category. HIPAA Guidelines The Health Insurance Portability and Accountability Act of 1996 (HIPAA) set forth regulations to safeguard and protect personal health information (PHI) through the establishment of the Privacy Rule and the Security Rule. All “covered entities” are subject to HIPAA regulations. High Point University is designated a “hybrid entity” because only selected areas of the university are covered by HIPAA. Covered components of the university include those areas that meet the definition of “health care provider” in the Privacy Rule. A health care provider is “any person or organization who furnishes, bills, or is paid for health care in the normal course of business” and who electronically transmit health information. Researchers who create or access PHI for studies in covered areas of the University must comply with HIPAA regulations. Researchers in non-covered areas of the University that receive PHI from covered entities outside of the University (e.g. physician) must provide evidence that the covered entity complies with HIPAA regulations. Examples of research in which investigators have legitimate reason to use, access, or disclose PHI are 1) studies that involve review of existing medical records and 2) studies that involve the creation of new medical information because a health care service is being performed as part of the research. PHI is physical or mental health information that is individually identifiable and created, maintained, or disclosed in the course of providing a health care service such as health history, provision of care, or payment for care. There are 18 PHI identifiers. Once the identifiers are removed, the information is no longer considered PHI and is not under the Privacy Rule. To comply with HIPAA, researchers intending to use PHI can acquire authorization from subjects or apply for (and be granted) a waiver or partial waiver of authorization or apply for alteration of authorization. They may also use PHI if certain PHI identifiers are removed and a data use agreement is established between the covered entity and the PHI recipient. The 16 PHI identifiers that must be removed can be found here. Authorization is similar to informed consent, but is a separate process and is provided in addition to informed consent. If it is determined by the Privacy Board (IRB) that study participants must provide authorization, then use the High Point University HIPAA Authorization Form. The participant or authorized representative must be given a signed copy, and researchers must maintain a signed copy for six years. A participant may revoke his/her authorization in writing at any time. The requirement to obtain Authorization may be waived if all of the following criteria are met as outlined by the National Institutes of Health:
If researchers are using PHI to identify and contact potential participants to recruit for a research study, a partial waiver may be granted by the Privacy Board (IRB). As outlined by the NIH: For activities involved in preparing for research, covered entities may use or disclose PHI to a researcher without an individual’s Authorization, a waiver or an alteration of Authorization, or a data use agreement. However, the covered entity must obtain from a researcher representations that (1) the use or disclosure is requested solely to review PHI as necessary to prepare a research protocol or for similar purposes preparatory to research, (2) the PHI will not be removed from the covered entity in the course of review, and (3) the PHI for which use or access is requested is necessary for the research. The covered entity may permit the researcher to make these representations in written or oral form. Alterations of Informed Consent An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject’s legally authorized representative, if either of the following conditions are met:
Waivers of Written (not Oral) Informed Consent There are two types of waivers or alterations to informed consent to consider when making a request to the IRB. Process Waiver Under this approval, the Investigator would not obtain informed consent from the participant. There would not be an informed consent document reviewed and approved by the IRB. However, research must meet certain conditions to be granted waiver.
Documentation Waiver Under this approval, informed consent is obtained. However, the requirement to obtain a signature from the participant is waived. These circumstances are very limited. The IRB must find either:
Waiver of written consent procedures does not imply waiver of the researcher’s responsibility to obtain consent from the participant. In all cases, the researcher must provide the participant with a statement describing the research that includes all relevant elements of informed consent. The IRB requires that when the use of written informed consent is waived, a cover letter be given to the participants outlining the purpose and procedures of the project. Oral Consent If oral consent is necessary (e.g. due to limited literacy) the participant or their legal representative will be asked to sign a short form stating that the basic consent form elements have been orally presented. Both the short consent form and the oral presentation must be approved by the IRB. The IRB may require that a witness must also be present for this presentation and must sign both the short form and a written summary of the oral presentation. The participant or their legal representative must receive a copy of both signed documents. Posting of Clinical Trial Consent Forms The term “clinical trial” refers to research studies in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of the intervention on biomedical or behavioral health-related outcomes.
Data Security Federal regulations require IRBs to determine the adequacy of provisions to protect the privacy of subjects and to maintain the confidentiality of their data. To meet this requirement, federal regulations require researchers to provide a plan to protect the confidentiality of research data. The Principal Investigator is responsible for ensuring that research data is secure when it is collected, stored, transmitted, or shared. All members of the research team should receive appropriate training about securing and safeguarding research data. Definitions:
Be aware that collecting indirect identifiers (i.e., information regarding other unique individual characteristics) might make it possible to identify an individual from a pool of subjects.
Records for IRB approved research projects must be stored in some form (paper and/or digital form) in secure locations on HPU property. For research performed off-campus, the data should be secured and returned to HPU property as soon after collection as it is practical. Access to data should be limited to only those individuals listed on the research protocol and registered with the IRB. Paper records must be stored in a secure location on HPU property. If the Principal Investigator is a student, the Faculty Supervisor is responsible for the storage and security of paper records. Access to files should be restricted to key personnel and supervised by the Principal Investigator/Faculty Supervisor. Locked file cabinets should be used and preferably in secured locations (i.e., locked office or laboratory). Signed informed consent forms must not be used as the identifying link to the research data and must not contain participant ID numbers nor be filed with other research data files. Digital records must be stored in password protected files on HPU hard drives, servers, or University approved cloud-based sites (OneDrive) with regular and secured back-up plans. Sensitive data should also be encrypted, stored, and securely erased when appropriate according to Federal guidelines for protecting Personally Identifiable Information (PII). Tapes and other media-supporting devices used for audio and/or video recordings should be stored in the same secure manner as paper records and erased as soon as information has been transcribed or coded and is no longer needed for research. If it is necessary to use portable devices for initial data collection, the data files should be encrypted and any identifiers moved to a secure system as soon as possible. The portable device(s) should be locked up in a secure location when it is not in use. The Principal Investigator should consult with the IRB and the IT department to discuss how to correctly configure laptops or other devices for safe use in the collection and storage of research data. Portable devices (i.e., USB) may be used only for data transfer, not long-term storage. Identifiers must be coded and/or removed and data must be password protected. No sensitive human subjects research data, protected health information (PHI), or personally identifiable information (PII) can be stored on a portable device long-term. For any protocol involving electronic data collection, the Electronic Data Collection form should be submitted with the Protocol Application. Survey/Questionnaire Software The University has a site license for the Qualtrics survey system. This cloud-based research tool has been vetted and authorized by the HPU IRB. If you use any online collection tool other than Qualtrics, you must submit the Electronic Data Security form along with the Protocol Application form. Faculty Mentor Responsibilities All student research projects must be supervised by a High Point University faculty member. The faculty mentor shares responsibility with the student for the design and execution of a research study that complies with University policies and procedures. Faculty mentors must complete the University IRB training requirements. The training can be found at https://www.citiprogram.org/. Completed training reports must accompany the protocol application. Faculty certification is valid for three years from the date of completion. Faculty mentors assist student researchers in design of the project and determining whether IRB review is required. Faculty mentors provide supervision, guidance, and oversight for the entire duration of study as well as ensuring that all required reporting to the IRB is completed (protocol application and completion report). Faculty mentors must complete the Faculty Mentor Assurance portion of the application prior to submission. Faculty mentors should ensure risks are minimized for research participants and the student researcher (i.e., safe research environment, researcher training in possible problems that may arise during data collection). Faculty Sponsor Responsibilities Researchers not affiliated with High Point University must be sponsored by a High Point University faculty or staff member. The Faculty sponsor shares with the non-affiliated researcher the responsibility for the execution of a research study that complies with University policies and procedures. Faculty sponsors must complete the University IRB training requirements. The training can be found at https://www.citiprogram.org/. Completed training reports must accompany the protocol application. Faculty certification is valid for three years from the date of completion. Faculty sponsors provide guidance, and oversight for the entire duration of study as well as ensuring that all required reporting to the IRB is completed (protocol application and completion report). Faculty sponsors must complete the Faculty Sponsor Assurance portion of the application prior to submission. Which of the following is an additional regulation that governs research in private and public schools if they receive federal funds?However, the Family Educational Rights and Privacy Act (FERPA) is a comprehensive law that applies broadly to information collected in public agencies or schools that receive federal education funds.
Which federal regulation or law governs how researchers can obtain data about subjects disciplinary status in school from academic records quizlet?Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records? The Family Educational Rights and Privacy Act.
What is PPRA quizlet?The Family Educational Rights and Privacy Act. PPRA. The Protection of Pupil Rights Amendment (PPRA) is a federal law that affords certain rights to parents of minor students with regard to surveys that ask questions of a personal nature.
Which example of research with prisoners would be allowable under the regulations?Which example of research with prisoners would be allowable under the regulations? Examining age at first arrest as a predictor of adult criminal history. Examining age at first arrest is the correct answer.
|
Which of the following types of information may Schools disclose without consent from the parent or student to a researcher at a local university Citi?
zusammenhängende Posts
Urheberrechte © © 2024 paraquee Inc.
