Research Involving Human Subjects

Policy 209

Introduction

1.1 This policy provides authority to the Institutional Review Board (hereinafter “IRB”) to provide ethical and regulatory oversight for research involving human subjects conducted by Appalachian State University, its faculty, staff, students and visitors.

1.2 The University is committed to protecting the rights and welfare of human subjects participating in research projects. Therefore, the University has created an Institutional Review Board (“IRB”) to ensure protection of human subject rights and welfare during any research activity. The IRB acts according to policies set forth by the United States Department of Health and Human Services Public Health Service Act as amended. Compliance with these federal regulations not only safeguards human subjects and the institution sponsoring the research project, but also protects the Principal Investigator.

Scope

2.1 This policy applies to all faculty, staff and students of Appalachian State University involved in research involving human subjects.

Definitions

Anonymity

means that the identity of a subject cannot be matched to his/her response.

Confidentiality

refers to the treatment of individual information gathered during the conduct of the research. An individual discloses information to the investigator with the expectation that the information will not be divulged to others in a manner inconsistent with the understanding of the original agreement.

Data Collection

refers to any research procedure that is intended to elicit from or record the actions, reactions, attitudes, and/or behavioral manifestations of subjects participating in a research project.

Exempt Research

refers to human subject research activities that fall into one or more of the federally defined exempt research categories. Exempt research does not mean the research protocols are exempt from IRB review, only that the research may not require a full IRB review, and may not be subject to other IRB requirements, such as annual reviews or informed consent. It is strongly suggested that informed consent be used whether required or not.

Expedited Review

refers to the review by the IRB Chair or designate of research proposals which involve minimal risk or no-risk.

Full IRB Review

refers to the review of proposals conducted during an IRB meeting at which a quorum has been established.

Human Subject

refers to a living individual about whom a researcher obtains either identifiable private information, or data through intervention and/or interaction with the individual.

Informed Consent

refers to the voluntary agreement by an individual or an individual's legally authorized representative to participate in a particular study without any element of force, fraud, deceit, duress, or any other form of constraint or coercion. Valid consent requires voluntary action, competence, informed decision, and comprehension of terminology.

Minimal Risk

means that the probability and magnitude of harm(s) or discomfort(s) anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations.

Research

refers to a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. In other words, the IRB defines research as a systematic investigation (i.e. having or involving a system, method or plan) conducted to develop or contribute to knowledge about the human experience. It is understood that such research may be disseminated by publication or in a public or professional forum. In addition, based on the principle that the Appalachian IRB exists to protect the rights and safety of individuals who participate as research subjects in projects administered by university faculty, staff and students, the IRB will review protocols for projects involving interviews recorded for research purposes.

Vulnerable Populations

refers to subjects such as children, prisoners, pregnant persons, or any population that may be relatively or absolutely incapable of protecting their interests through the informed consent process.

Policy and Procedure Statements

The Institutional Review Board (IRB) and Its Actions

4.1.1 In reviewing research proposals, the IRB has the authority to approve, require modifications in, defer, disapprove or terminate any research involving human subjects conducted under Appalachian State University’s auspices.

4.1.2 If at any time, the Board becomes aware of:

1. unanticipated problems involving risks to subjects, or
2. other serious or continuing noncompliance with 45 CFR 46 or determinations of the Board, including ongoing human subject research which has not been reviewed by the Board,it may request a meeting with the PI and/or suspend the research until the problem can be further evaluated. Under these circumstances, the Authorized Institutional Official (the Dean of Graduate Studies and Research) must be made aware of the situation immediately, and he/she will be advised of any further sanctions subsequently recommended by the Board.

4.1.3 In these circumstances, the Board may impose sanctions on an individual by suspending the individual's right to conduct or supervise research involving human subjects, taking possession of the data collected by the non-compliant individual, withholding or revoking academic credit to a student researcher, and recommending discipline of a faculty member by the University. This list is provided by way of example only, and is not intended and should not be construed as exhaustive, in that individual situations may call for specific actions and remedies not identified herein.

The Review Process

4.2.1 The IRB reviews protocols for research in accordance with federal regulations governing research with human subjects. The Board may also apply such codes of professional ethics as it deems appropriate. These additional codes may or may not be addressed in federal documents. It is the policy of Appalachian State University that in order for any research protocol to be approved, the Board must determine that all of the following requirements are satisfied:

1. Risks to subjects are minimized and are reasonable in relation to anticipated benefits of the research,
2. Selection of subjects is equitable given the purposes and the setting of the research,
3. Appropriate informed consent will be sought from each subject or the subject's legally authorized representative, and such consent will be appropriately documented (see Informed Consent Guidelines below),
4. The research plan makes appropriate provision for monitoring the data collected to insure the safety of subjects,
5. Appropriate provisions are made to protect the privacy of subjects and to maintain the confidentiality of data, and
6. Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, appropriate additional safeguards have been included to protect the rights and welfare of these subjects.

4.2.2 The IRB may process a protocol in one of three ways:

1. By exemption certification
2. By expedited review
3. By full review

4.2.3 Any research protocol which does not fall under the category definitions of exempted or expedited research as outlined below, or any protocol as specifically requested by the Board, shall undergo full review.

4.2.4 Upon review by the Board, the office of the IRB Administrator shall notify the PI by letter and/or email of the Board’s decisions, and conditions which must be met, if approval is to be awarded. Approval will not be granted until all specified conditions are met. The letter shall also

1. Advise the PI to notify the IRB if there are any subsequent changes proposed in the research protocol. No changes may be initiated without IRB review and approval.
2. Indicate the period for which approval is valid (1 year, in most cases).
3. Require the PI to make an application for annual review should the study extend beyond the initial approval expiration date.
4. Direct that during the course of the research, should an adverse event occur which threatens the health, safety or emotional well-being of a participant, or which increases the risks to subjects from that described in the approval documents for the project, the PI must suspend the research immediately and report the incident to the IRB Administrator. The IRB Administrator will investigate and determine the course of action to follow.

Categories of Review

Exempt Research

a. Certain categories of research protocols may be exempt from review. Only the IRB Administrator or IRB Associate Administrator is authorized to determine which protocols may be subject to limited review or may be exempt from review by the Board. Investigators who believe that their research meets the following criteria may request exempt status for their study when it is submitted to the Board, and list the justification. The IRB reserves the authority to require proposal modifications regarding human subject protection before approving the research as exempted from the requirements of the Common Rule.

b. Note that the exemption DOES NOT APPLY when the research activities include:

1. Prisoners, fetuses, pregnant women or human in-vitro fertilization.
2. The review of medical records when the information is recorded in such a way that subjects can be identified, directly or through identifiers linked to the subjects.
3. Techniques which expose the subject to more than minimal risk.
4. The deception of the subject.

c. The federal categories of research eligible for exemption certification are as follows:

1. Research conducted in established or commonly accepted educational settings, involving normal education practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), surveys, interviews or observation of public behavior, unless: (i) information obtained is recorded in such a manner that participants can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of an individual’s response(s) outside of the research setting could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. Surveys or interviews which include minors as subjects are not included in this exempt category.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), surveys, interviews, or observations of public behavior that are not exempt under (2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personal identifiable information will be maintained throughout the research and thereafter.
4. Research involving the collection or analysis of existing data, documents, records, pathological specimens, or diagnostic specimens, if such sources are a matter of public record or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of, department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under such programs; (iii) possible changes in or alternatives to such programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under such programs.
6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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.

Expedited Review

a. Federal regulations permit an expedited review procedure for protocols that meet certain eligibility requirements. Such reviews may be carried out by the Chair of the IRB or by one or more experienced reviewers from among the members of the Board. In performing expedited reviews reviewers may exercise all of the authorities of the Board with the exception of disapproval. A research project may be disapproved only after full Board review as described in the next section. The Board shall be informed of all expedited reviews at its next full meeting.

b. Research activities that present no more than minimal risk (see glossary) to human subjects, and involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure. The activities detailed below should not be deemed to be of minimal risk simply because they are included on this list. Inclusion merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

c. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, or reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

d. The expedited review procedure may not be used for classified research involving human subjects. The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review used by the IRB — expedited or full. The categories in this list apply regardless of the age of subjects, except as noted. Categories one 1-7 pertain to both initial and continuing IRB review.

Expedited Categories

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
   1. 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.)
   2. 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:
   1. From healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, 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
   2. From other adults and children, taking into consideration the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed 5 ml, or 3 ml per kg, whichever is less, in an 8-week period, and collection may not occur more frequently than 2 times per week.
3. Collection of data through noninvasive procedures, i.e., not involving general anesthesia or sedation, routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, nor are studies of approved medical devices being considered for new indications.)
4. Prospective collection of biological specimens for research purposes by noninvasive means.
5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research 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.
8. Continuing review of research previously approved by the full IRB as follows:
   1. When (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects.
   2. When no subjects have been enrolled and no additional risks have been identified.
   3. When the remaining research activities are limited to data analysis.
9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but 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.

Full Board Review

Full board review must take place for all protocols that do not qualify as “exempt” or “expedited”, or as otherwise specified by the Board.

Procedures to Initiate Review

4.5.1 Prior to the execution of any research involving human subjects, investigators shall have completed the mandated education described at the beginning of this document, and they shall have completed and submitted to the IRB Administrator copies of the protocol form along with copies of the proposed informed consent statement. The protocol form must provide the following information:

1. Name(s) and department(s) of investigator(s)
2. Title of the study
3. Signature of responsible faculty member
4. Whether or not external funding is proposed
5. Purpose of the study
6. Description of subjects
7. Description of methodology, including a copy of any instruments used
8. Potential benefits and risks to the subject
9. Anticipated beneficial knowledge resulting from the study
10. Qualifications of investigator(s), e.g. a CV or experience in the specific research area
11. Description of any deception
12. Procedures for protecting the anonymity/confidentiality of subjects
13. A copy of any recruiting materials or scripts.
14. Method for insuring informed consent, including a copy of the proposed informed consent statement.

Informed Consent Guidelines

4.6.1 Informed consent constitutes the very essence of protecting the rights of subjects. Obtaining the informed consent of a potential human subject (or the subject’s legally authorized representative) for participation in non-exempt research is a federally mandated safeguard to ensure the protection of the rights and welfare of all individual subjects. The IRB will carefully review the proposed method for obtaining informed consent and the content of the document prepared for participants’ signatures. For research that is not exempt from IRB review, the informed consent form must include the following information:

1. The title of the study, information on the purpose(s) of the research, a description of the method(s) and procedure(s) to be followed, including the intention to publish or disseminate the results of the study, and the amount of time the subject will spend in actual project participation.
2. A description of any reasonably foreseeable risks or discomforts to the subject, including expected total time of participation. If disguised or deceptive procedures are to be used, a plan to debrief participants must be explained to the IRB.
3. A description of any benefits to the subject or to others as a result of the information obtained from the research.
4. A disclosure of appropriate alternative procedures that may be advantageous to the subject when making an informed decision whether or not to participate in the research (this pertains primarily to medical research and drug trials).
5. A description of the measures to be taken to insure the confidentiality of data and the anonymity of individual subjects, if applicable, as well as any circumstances under which confidentiality CANNOT be guaranteed.
6. The name and phone number of a contact person(s) who will be available to answer any questions the subject or his/her legally authorized representative may have regarding the research (student investigators must include the name, address, and phone number of his/her faculty supervisor), and "Questions regarding the protection of human subjects may be addressed to the IRB Administrator, Research and Sponsored Programs, Appalachian State University, Boone, NC 28608, (828) 262-2130, [email protected].”
7. A clear explanation that participation is voluntary and that no penalty or loss of benefits to which the subject is otherwise entitled will occur should the subject either refuse to participate or decide to discontinue participation (at any time).
8. Disclosure of costs to the subject, if any, because of his/her participation in the research; disclosure of compensation/reward to the subject, if any, for his/her participation in the research.
9. For projects of more than minimal risk to subjects, a statement must be included that describes how the costs of medical care or other therapies required as a result of injury or mishap incurred while participating in the research will be handled. The Consent Form should also include information about the availability and extent of on-site medical treatment should an injury occur.
10. The approval and expiration date for the consent form once approval of the project has been granted.
11. The consent form must not include a statement releasing the investigator, sponsor, institution or its agents from liability or negligence.

4.6.2 These requirements are not intended to preempt applicable federal, state, or local laws which require additional information to be disclosed in order to be legally effective. The consent form shall document that the subject understands the information contained therein, and has had an opportunity to have any of his/her questions answered.

4.6.3 The IRB may approve a consent procedure which does not include, or which alters some or all of the elements of informed consent set forth above, or waives requirements to obtain informed consent provided that the IRB finds and documents:

1. The research involves no more than minimal risk to the subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. The research could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

4.6.4 When a consent form requires the signatures of research subjects and/or their parents or legal guardians, a copy of the signed form must be given to the subject/parent/guardian and a copy must be retained by the researcher for a minimum of three years after completion of the project. The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects as described in 45 CFR Part 46.117.

4.6.5 For exempt research, the researcher is expected to provide information to prospective subjects about the research. This information should include:

1. A statement of the purpose of the research
2. An explanation of the procedures of the study
3. Details of any foreseeable risks, benefits and compensation
4. A clear explanation that participation is voluntary and that no penalty or loss of benefits to which the subject is otherwise entitled will occur should the subject either refuse to participate or decide to discontinue participation (at any time).
5. Contact information for the investigator and faculty advisor if the investigator is a student.

4.6.6 In some cases, it may not be practical to provide this information to prospective subjects. In these cases of exempt research, investigators should provide an explanation of why it is impractical to provide this information to potential subjects to the IRB Administrators.

Investigator's Right of Appeal

4.7.1 It is the policy of Appalachian State University that the final decision regarding approval or disapproval of all protocols rests with the IRB. In accordance with federal regulations, no research involving human subjects may be conducted under Appalachian State University's auspices without the prior and continuing approval of the Board. Any investigator who disagrees with a decision of the Board may request a hearing before the duly-convened IRB to appeal its decision. Relevant arguments and/or witnesses may be presented on behalf of the investigator. The investigator may also request that the Authorized Institutional Official be informed of the appeal. However, final decision rests with the Board.

Continuing Review of Research

In addition, federal regulations require that the Board conduct continuing review of approved expedited and full Board approved proposals at least once per year. Exempted protocols require no continuing review. It is the principal investigator’s responsibility to initiate the request for continuation, which must include a summary of the protocol and a status report on the progress to date. In summary, the following must be submitted:

1. The number of subjects accrued.
2. A summary of any adverse events or unanticipated problems involving risk to subjects, and of any withdrawal of subjects or complaints about the research since the last review.
3. A summary of findings, and any amendments or modifications to the study.
4. A copy of the current informed consent document

Certain protocols may be reviewed more often than yearly, e.g.:

1. Where protocols are considered to involve high risk, or have a high risk/benefit ratio.
2. Where studies are complex involving unusual levels or types of the risks.
3. For projects conducted by investigators who previously failed to comply with the requirements of the IRB.
4. For projects where information has come to the attention of the IRB that protocol changes have been made without IRB approval.

IRB Membership

The Board shall consist of a minimum of five members, including:

1. One member whose primary concern is in a scientific area
2. One member whose primary concern is in a nonscientific are
3. One member who has no affiliation with Appalachian State University
4. Additional members to insure ethical treatment of subjects
5. IRB Administrator, ex officio

Revision Dates

Approved 5/18/2010