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REVISED FORMS AVAILABLE RIGHT SIDE BAR (PDF NOT CURRENTLY AVAILABLE)

REVISIONS TO FEDERAL REGULATIONS (COMMON RULE) IMPLEMENTATION BEGINS JANUARY 21, 2019

 

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.

 

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:

  • Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
  • Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products).
  • Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
  • Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

 

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

  • obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  • obtains, uses, studies, analyzes, or generated identifiable private information or identifiable biospecimens”.

 

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

 

  1. Research, conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
    1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot be readily be ascertained, directly or through identifiers linked to the subjects;
    2. Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
    3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
  3. Research involving benign behavioral interventions (benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing (deceiving the subjects may not be used in this category)) in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
    1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot be readily be ascertained, directly or through identifiers linked to the subjects;
    2. Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
    3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
  4. Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
    1. The identifiable private information or identifiable biospecimens are publicly available;
    2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
    3. The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CRF 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
    4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et. seq.
  5. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
    1. Each Federal department of agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal website or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
  6. Taste and food quality evaluation and consumer acceptance studies.
    1. If wholesome foods without additives are consumed, or
    2. If 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.
  7. Storage or maintenance for secondary research for which broad consent* is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).
  8. Secondary research for which broad consent* is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary. research use, if the following criteria are met:
    1. Broad consent* for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtain in accordance with §46.116(a)(1) through (4), (a)(6), and (d);
    2. Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
    3. An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and  makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and
    4. The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

*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

 

  1. Clinical studies of drugs and medical devices only when condition (a.) or (b.) is met.
    • Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
    • Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

 

  1. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
    • from healthy, nonpregnant adults who weigh at least 110 pounds. For these participants, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
    • from other adults and children, considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

 

  1. Prospective collection of biological specimens for research purposes by noninvasive means.

 

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.

 

  1. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. (HHS for examples)

 

  1. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for nonresearch purposes (such as medical treatment or diagnosis).

 

  1. Collection of data from voice, video, digital, or image recordings made for research purposes.

 

  1. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

 

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:

  1. Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or
  2. Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.

 

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:

  1. Unexpected (in terms of nature, severity, or frequency) given
    • the research procedures that are described in the protocol-related documents, such as the IRB-approved protocol and informed consent document; and
    • the characteristics of the subject population being study; and
  2. Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
  3. Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

 

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:

  1. Death
  2. Unanticipated “risk” requiring treatment, hospitalization, or prolongation of existing hospital stay
  3. Any suspicious findings that may have relationship to the study
  4. Adverse pregnancy outcome before, during and at the time of delivery
  5. Birth defects or congenital anomaly
  6. Loss of research records that contain identifiable information
  7. Overdose of drug
  8. Unusual frequency or intensity of expected effects described in the informed consent document or trends in one type of AE event toward within a protocol (serious or not)
  9. Breach of confidentiality
  10. Unanticipated problems involving risks to “others” (Example:  A nurse in a research study is inadvertently stuck by a needle containing a hazardous agent)
  11. Abnormal test results that is critical to evaluate the “risk” or “safety” of subjects
  12. Unexpected – any adverse experience that is not identified in nature, severity or frequency in the consent form and is not due to a disease process

 

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:

  • Suspend or terminate the research
  • Notify current participants when such information might be related to their willingness to continue to take part in the research (e.g., reconsenting participants)
  • Require modifications to the protocol and/or consent documents
  • Provide additional information to past participants (e.g., long-term risks have been identified that could affect them)
  • Require or increase frequency of continuing review
  • Impose additional monitoring requirements
  • Require additional training of research personnel

 

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:

  1. Obtaining consent:

 

FERPA and IRB requirements are usually met if an eligible student (e.g., a student who has reached 18 years of age or is attending an institution of postsecondary education) or, if the student is a minor, their parent signs a consent form to participate in a research study and authorizes disclosure of the specified personally identifiable education records for research purposes.

 

Requirements for Informed Consent Form

  • Must be signed or dated by eligible student or parent (in case of minor not enrolled in secondary education).
  • Must provide an explanation of the purpose for disclosure of the education records.
  • Must identify the party or class of parties to whom the records may be disclosed.

 

  1. Accessing records without obtaining consent:
    • Removal of all personally identifiable information (PII)

 

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:

  1. Student’s name and other direct personal identifiers, such as the student’s social security number or student identification number.
  2. Indirect identifiers, such as the name of the student’s parent or other family members; the student’s or family’s address, and personal characteristics or other information that would make the student’s identity easily traceable; date and place of birth and mother’s maiden name.
  • Biometric records, including one or more measurable biological or behavioral characteristics that can be used for automated recognition of an individual, including fingerprints, retina and iris patterns, voiceprints, DNA sequence, facial characteristics, and handwriting.
  1. Other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable certainty.
  • Disclosure of directory information

 

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:

  • an emancipated minor (married minor, emancipated by order of court, serving in armed forces, NC Gen. Stat. 90-21.5(b))
  • a minor parent can provide consent for his/her own child (NC Gen. Stat. 90-21.5 (b))

 

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:

  • The project takes place in an accredited educational facility during regular education hours.
  • A teacher employed by the school will be present during the study.
  • The principal or director of the school has been informed about the study and provides permission for parental passive consent.
  • The research activity is consistent with regular educational activities (e.g., take a test, view educational materials, or engage in a discussion about an age relevant topic).
  • The activity could reasonably be assumed to take place without research as its goal (e.g., fill out questionnaires or take a quiz).
  • Parents are provided full and complete information in a timely manner.
  • The school is able to contact all parents about the project rather than rely on the students to notify the project. Mechanism could include email, website announcements, robo-calls, or mailings.
  • The minors have the intellectual capacity to understand the project and provide informed assent.
  • The minor should be given an explanation of the proposed research procedures in a language that is appropriate to the child’s age, experience, maturity, and condition. This explanation should include a discussion of any discomforts and inconveniences the child may experience if he or she agrees to participate.
  • All cooperating institutions allow passive consent (The Department of Education now requires active parental consent for surveys, analyses, and evaluations they fund).

 

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:

  1. The use or disclosure of the PHI involves no more than minimal risk to the privacy of individuals based on, at least, the presence of the following elements:
    • An adequate plan to protect health information identifiers from improper use and disclosure.
    • An adequate plan to destroy identifiers at the earliest opportunity consistent with conduct of the research (absent a health or research justification for retaining them or a legal requirement to do so).
    • Adequate written assurances that the PHI will not be reused or disclosed to (shared with) any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of the PHI would be permitted under the Privacy Rule.
  2. The research could not practicably be conducted without the waiver or alteration.
  3. The research could not practicably be conducted without access to and use of the PHI.

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:

  1. The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
  2. The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

 

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.

 

  1. Waiver for Research Activities Designed to Study Certain Aspects of Public Benefit or Service Programs.  The IRB may approve a consent procedure which does not include, or which alters, some of all of the elements of informed consent or waive the requirements to obtain informed consent entirely provided the IRB finds and documents that:
    • the research or demonstration project is to be conducted by or subject to the approval of State or local government officials and is designed to study, evaluate, or otherwise examine public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternative to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs.
    • the research could not practically be carried out without the waiver or alteration.
  2. Waiver for Minimal Risk Studies. Additionally, the IRB may approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent, or waive the requirement to obtain informed consent entirely provided the IRB finds and documents that:
    • the research involves no more than minimal risk to the participants.
    • the waiver or alteration will not adversely affect the rights and welfare of the participants.
    • the research could not practically be carried out without the waiver or alteration.
    • whenever appropriate, the participants will be provided with additional pertinent information after participation.

 

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:

 

  1. That the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.
  2. That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.
  3. If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to the subjects, and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

 

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.

  1. For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal website that will be established as a repository for such informed consent forms.
  2. If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal website (e.g., confidential commercial information), such Federal department or agency may permit or require redactions to the information posted.
    1. The informed consent form must be posted on the Federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.

 

 

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:

  • Anonymous data: Data are anonymous is no one, not even the researcher, can connect the data to the individual who provided it. No identifying information is collected from the individual, including direct identifiers such as name, address, etc.

 

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.

 

  • Confidential: There is a link between the data and the individual who provided it. Researchers are obligated to protect the data from disclosure outside the research according to the terms of the research protocol and the informed consent document. Methods to reduce the risk of inadvertent disclosure include:
    • Storing the subject’s name and/or other identifiers separately from the research data.
    • Replacing the subject’s name and other identifiers with a unique code and using this code to refer to the subject data. Note this does not make the data anonymous.
    • Storing the code key separately from the subject’s identifiers.

 

  • De-Identified: Investigator cannot readily ascertain the identity of the individual. Direct or indirect identifiers or codes linking the data to the individual subject’s identity are stripped and destroyed.

 

  • PHI: Protected Health Information (as defined by the HIPAA Privacy Rule 45 CFR 164 § 501)

 

  • PII: Personally Identifiable Information “(1) any information that can be used to distinguish or trace an individual’s identity, such as name, social security number, date and place of birth, mother’s maiden name, or biometric records; and (2) any other information that is linked or linkable to an individual, such as medical, educational, financial, and employment information.”

 

  • Sensitive Research Data: Data is considered sensitive when disclosure of identifying information could have adverse consequences for participants or damage their financial standing, employability, insurability, or reputation.

 

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.

Contact Us

Chair of the IRB: Dr. Kimberly Wear

kwear@highpoint.edu
(336) 841-9246

Forms

Complete each section of the appropriate form (no handwritten forms). Email the form and any supporting documentation necessary to kwear@highpoint.edu. Signatures should be scanned and included as part of the electronic submission if possible.

The PDF versions of these forms are best viewed with Internet Explorer. If the content in the form does not load, please save the file to your computer and open it with Adobe Reader.

Consent Templates