Institutional Review Board Procedures
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 PointUniversity 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.
Federal regulations define “research” as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” “Human participant” is defined as “a living individual about whom an investigator (whether professional or student) conducting the research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”
Faculty Teaching vs. Research Related Activities
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. The following guidelines are based on the federal definition of research as “a systematic investigation (i.e. the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.” 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.
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 a current certificate 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. If a project is approved beyond a one-year limit, an annual report must be completed (unless research classified as exempt).
Exempt from Review (Level 1)
Federal guidelines and University policy permit certain types of research to proceed without IRB approval. The determination whether any particular research project qualifies as “exempted” must be made by the Chair of the IRB usually after consultation with at least one member of the IRB. Investigators do not have discretion to make this determination. Investigators who believe their research projects should be classified as “exempted” must secure written approval from the Chair of the IRB. The following research activities normally fall under the exempt classification:
Research that is conducted in established or commonly accepted educational settings, involving normal educational practices (e.g., curricular changes, teaching styles).
Research that involves the use of educational tests, survey procedures, interview procedures, or observation of public behavior, and the information taken from these sources is recorded in such a manner that the participants cannot be identified either directly or indirectly. (This category does not include personality tests.)
Research that is not exempt under above, but whose human participants are elected or appointed public officials or candidates for public office; or federal statue(s) require (s) without exception that the confidentiality of the personally identifiable information is maintained throughout the research and thereafter.
Research that involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. These are from sources that are publicly available, or the information in them is recorded in such a manner that the participants cannot be identified either directly or indirectly.
Research that is designed to study, evaluate, or otherwise examine a public benefit or service program.
Research that involves taste and food quality evaluations or consumer acceptance studies in which only wholesome foods without additives are consumed; or if a food is consumed that contains an additive food ingredient or an agricultural chemical or environmental contaminant, these are at or below levels considered safe by the Food and Drug Administration, the Environmental Protection Agency, or the U.S. Department of Agriculture.
To apply for Exemption status, investigators must submit a completed Application citing the reason for exempt status 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. 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. With exempt approval, the study is not subject to continuing review requirements.
Any changes made to the approved exempted research request 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. All expedited protocols must be reviewed by the IRB annually. 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.
1. Clinical studies of drugs and medical devices only when condition (a.) or (b.) is met.
(a.) 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.)
(b.) 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.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a.) 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
(b.) 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.
3. 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.
4. 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)
5. 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).
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7. 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.
Minor Modifications to Approved Research
In some cases the expedited review process may be used to approve minor changes to previously approved protocols, informed consent documents, recruitment advertisements, or researchers (other than principal investigators). This is only possible if the changes 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. Any revision that entails increased risk or discomfort to the participants, or which substantively changes the study design or study procedures, must be reviewed by the full IRB at a convened meeting.
Continuing Review, Interim Reports, and Completion Reports
Except those approved by the IRB as exempt, Federal regulations require periodic review of all research involving human participants at an interval appropriate to the level of risk, but not less than annually. The IRB determines the interval of Continuing Review during initial evaluation. Continuing Review conducted 365 days or less from the most recent project approval will be expedited.
Interim Reports and Completion Reports may be reviewed using the expedited review process only if:
- The research is permanently closed to the enrollment of new participants, all participants have completed all research-related interventions, and the research remains active only for long-term follow-up of participants; or
- No participants have been enrolled and no additional risks have been identified; or
- The remaining research activities are limited to data analysis; or
- For research not conducted under an investigational new drug application or investigational device exemption where the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified; or
- The research initially qualified for expedited review and there have been no changes that would increase the risk.
Research Approved Elsewhere
The Chair of the IRB may waive review requirements that ordinarily would apply to a proposal when the investigator has already secured approval for the particular project from an IRB at another institution that operates according to 45 CFR 46. Investigators seeking a waiver under this provision must submit evidence of prior formal IRB review and approval to the Chair of the IRB.
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 both an e-mail and hardcopy notification of approval, and faculty supervisors shall be promptly notified by e-mail. 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. These summaries shall be delivered to all IRB members prior to each IRB meeting (held monthly during the academic year), at which time 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 Application and Protocol 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 Application and Protocol 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 both an e-mail and hardcopy notification of approval, and faculty supervisors shall be promptly notified by e-mail. 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 3100), students may conduct individual research projects involving human participants. Due to the nature of the course and time constraints, the IRB will allow faculty teaching these courses to apply for an umbrella review that would describe the methods most likely to be used in the students’ research projects. These methods may be based on past experience with students in these courses. The protocol can be submitted prior to beginning the course. Protocols should be submitted each time the course is taught. Any student who designs a study that deviates from this umbrella protocol will be required to submit a separate and complete protocol for approval. Once the course is finished, investigators must submit a Continuing Review/Study Closure form.
Major Protocol Changes
Each revision to a research protocol shall be incorporated into the written protocol, to assure that there is only one complete protocol, with 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 Vice President for Academic Affairs.
Primary investigators will receive a written reminder approximately one month prior to the due date for protocol expiration or continuing review. If an application for renewal or study closure notice is not received by the due date, a written warning is sent to the primary investigator and the protocol is now lapsed.
A lapsed protocol is one for which the approval period has expired prior to renewed approval by the IRB. If the primary investigator fails to submit the materials for continuing review or study closure within one month 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 subjects. A written notice of this status will be sent to the primary investigator and his or her department chair.
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.
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.
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
(a.) Must be signed or dated by eligible student or parent (in case of minor not enrolled in secondary education).
(b.) Must provide an explanation of the purpose for disclosure of the education records.
(c.) Must identify the party or class of parties to whom the records may be disclosed.
2. Accessing records without obtaining consent:
(a.) 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 includes:
- Student’s name and other direct personal identifiers, such as the student’s social security number or student identification number.
- 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.
- 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.
(b.) 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”.
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.
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.
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. In addition, all Investigators, Key Study Personnel, Students, and Faculty Mentors must maintain a current education certificate on file with the IRB office. Certificates for all Investigators and Faculty Mentors are considered 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.
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 PointUniversity 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. Please see examples posted on the IRB website.
A copy of the Informed Consent must be given to each participant.
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:
(a.) an emancipated minor (married minor, emancipated by order of court, serving in armed forces, NC Gen. Stat. 90-21.5(b))
(b.) a minor parent can provide consent for his/her own child (NC Gen. Stat. 90-21.5 (b))
“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 subjects; 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 subjects – whether all or some of the children are capable of assenting to participation.
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:
(a.) The project takes place in an accredited educational facility during regular education hours.
(b.) A teacher employed by the school will be present during the study.
(c.) The principal or director of the school has been informed about the study and provides permission for parental passive consent.
(d.) 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).
(e.) The activity could reasonably be assumed to take place without research as its goal (e.g., fill out questionnaires or take a quiz).
(f.) Parents are provided full and complete information in a timely manner.
(g.) 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.
(h.) The minors have the intellectual capacity to understand the project and provide informed assent.
(i.) 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.
(j.) All cooperating institutions allow passive consent (The Department of Education now requires active parental consent for surveys, analyses, and evaluations they fund).
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.
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:
(a.) An adequate plan to protect health information identifiers from improper use and disclosure.
(b.) 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).
(c.) 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.
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.
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.
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:
- 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.
- 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.
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.
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.
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/. Chose both the Basic Course and Responsible Conduct of Research Course that is appropriate (biomedical researcher or social and behavioral researcher). Create an account and select High Point University as the participating university. Completed training certificates 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, interim reports, 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/. Chose both the Basic Course and Responsible Conduct of Research Course that is appropriate (biomedical researcher or social and behavioral researcher). Create an account and select High Point University as the participating university. Completed training certificates 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, interim reports, completion report). Faculty sponsors must complete the Faculty Sponsor Assurance portion of the application prior to submission.