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New Mexico State University
IRB Principles & Procedures

NEW MEXICO STATE UNIVERSITY
PRINCIPLES AND PROCEDURES FOR THE CONDUCT OF RESEARCH INVOLVING HUMAN SUBJECTS
October 2007

INTRODUCTION
New Mexico State University (NMSU) recognizes research as essential to the vitality of the university and as an important component of every academic activity. NMSU further recognizes that research involving human subjects is an important and necessary activity of the university and that it must be conducted in an ethical manner. NMSU complies with the ethical principles set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. In addition, NMSU complies with federal regulations (45 Code of Federal Regulations [CFR] Part 46) concerning research involving human subjects regardless of the source of funding.

NMSU has established the Institutional Review Board (IRB) to administer the following principles and procedures for the conduct of research involving human subjects. These principles shall apply equally to all research involving human subjects or data related to human subjects, whether carried out solely with NMSU resources or with the assistance of external funds from federal, state, or public, or private sources.

1. NMSU and the individual members of its faculty, staff, and student body recognize their responsibility to assure that all research and sponsored projects involving human subjects are conducted in an ethical manner and that NMSU complies with government regulations for research involving human subjects.

2. Appropriate professional attention and facilities shall be provided to insure the safety and well being of human subjects. All research involving humans as subjects must at all times protect the subjects safety, privacy, health, and welfare.

3. All research involving human subjects must protect the subjects from unreasonable risk and the benefit of the research must outweigh the risk to the subjects. This determination shall only be made by the Institutional Review Board.

4. In all research involving human subjects, the subjects and/or their representative shall give informed consent, except where such consent is waived by law. (*Eighteen years of age in New Mexico; for the legal age elsewhere, contact the individual state.) The subjects informed consent shall be documented by the researcher and shall contain the elements of informed consent as established by the federal government (45 CFR 46.116).

5. Participation of all human subjects shall be voluntary and subjects may withdraw from the research at any time without any penalty. All requests by any subject to withdraw from a research activity shall be honored promptly without penalty or loss of benefits to which the subject is otherwise entitled, within the limits of the research.

6. Researchers shall protect the confidentiality of private information obtained from the human subjects during the conduct of a research activity, to the extent permitted by law.

7. In no case shall human subjects involved in research activities surrender their rights by participating in research.

8. Research involving children as research subjects shall comply with the additional protections provided in Subpart D of 45 CFR 46 titled, ?Additional Protections for Children Involved as Subjects in Research."

9. Research involving prisoners as research subjects shall comply with the additional protections provided in Subpart C of 45 CFR 46 titled, ?Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects."

10. Research involving pregnant women, human fetuses and neonates as research subjects shall comply with the additional protections provided in Subpart B of 45 CFR 46 titled, ?Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research.?

ADMINISTRATIVE RESPONSIBILITIES
Office of the Vice President for Research

It is the responsibility of the Office of the Vice President for Research, Graduate Studies, and International Programs (OVPRGSIP) to assure that the policies and procedures concerned with research involving human subjects are conducted in accordance with federal regulations. The Associate Vice President for Research and Administration (AVPRA) serves as the Institutional Official for the IRB. The AVPRA is responsible for:

1. oversight of the human subjects protection program and the IRB, and

2. oversight for ensuring compliance with 45 CFR 46 and applicable federal regulations.

Office of Compliance
The Office of Compliance (OC) provides support to the IRB and all principal investigators conducting research activities involving human subjects. The OC is responsible for the day-to-day activities and operations of the IRB. The OC is responsible for:

1. receiving all IRB applications from researchers conducting research involving human subjects;

2. reviewing all applications for completeness prior to providing them to the IRB Chair or members of the IRB for review;

3. disseminating information and answering questions about policies and procedures pertaining to research involving human subjects; and

4. maintaining all IRB records such as originals of each application submitted for IRB review, copies of IRB agendas and minutes, copies of all correspondence between the IRB and the researchers as required by 45 CFR 46.115(a)(4); a list of IRB members as required by 45 CFR 46.103(b)(3); and written procedures for the IRB as required by 45 CFR 46.103(b)(4) and 45 CFR 46.103 (b)(5).

The Office of Compliance is also responsible for promptly reporting to the IRB, appropriate institutional officials, the Office for Human Research Protections (OHRP) and any other sponsoring federal department or agency head any:

1. injuries to human subjects or other unanticipated problems involving risks to subjects or others;

2. serious or continuing noncompliance with the regulations or requirements of the IRB; and

3. suspension or termination of IRB approval for research activities involving human subjects.

Institutional Review Board
The Institutional Review Board (IRB) is responsible for reviewing all proposed research involving human subjects. The IRB may conduct the review through an expedited review procedure as allowed by 45 CFR 46.110, or at a convened meeting at which a majority of the members are present. At least one member whose primary concerns are in nonscientific areas must be present at any convened meeting. A majority of those IRB members present at the convened meeting must approve the research. (See 45 CFR 46.108)

The IRB shall:

1. review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities;

2. require that information given to subjects as part of informed consent is in accordance with 45 CFR 46.116 (the IRB may require that additional information be given to the subjects when in its judgment the information would meaningfully add to the protection of the rights and welfare of the human subjects);

3. require documentation of informed consent or may waive documentation in accordance with 45 CFR 46.117;

4. notifiy the researchers and NMSU, in writing, of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity (if the IRB disapproves a research activity, its written notification shall include a statement of the reasons for its decision and shall give the researcher an opportunity to respond in person or in writing);

5. conduct continuing review of all approved research at intervals appropriate to the degree of risk, but not less than once per year;

6. have the authority to observe or have a third party observe the consent process and the research;

7. have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects (any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, the Office of Compliance, and appropriate institutional officials);

8. provide advice and guidance to investigators regarding the protection of the rights and welfare of human subjects;

9. ensure that investigators have been certified in the ethical principles of using human subjects in research

Responsibilities of the Researcher/Principal Investigators
The researchers or principal investigators (PIs) are responsible for the conduct of the research and for ensuring that the rights and welfare of human subjects are protected. It is the responsibility of the PIs to maintain the consent documents signed by research subjects and all complete records of all documentation pertaining to the research in a designated on-campus location (or alternate storage facility) approved by the IRB. All documentation pertaining to the research must be retained for at least three (3) years after completion of the research.

All documentation must be accessible for inspection and copying by authorized officials of NMSU, the Office of Compliance, the IRB, appropriate regulatory agencies, and/or funding agencies.

Principal Investigators shall:
1. disclose, in writing, to the IRB and research subjects any significant new findings developed during the course of the research which may related to the subjects willingness to continue their participation in the research activity, as required by 45 CFR 46.116(b)(5);

2. report the progress of the research to the Office of Compliance as often as and in the manner determined by the IRB, but no less than once per year;

3. request, in writing, any proposed changes/modifications in a research activity during the period for which IRB approval has already been given to the IRB through the Office of Compliance before they are implemented (changes/modifications shall not be implemented without IRB review and approval, unless necessary to eliminate apparent immediate hazards to the human subject) (when this occurs, the IRB must be notified as soon as possible through the Office of Compliance)(See Modification Request Form);

4. promptly report, in writing, to the IRB, through the Office of Compliance, any serious or continuing non-compliance with NMSU's policies and procedures or the determinations of the IRB;

5. promptly report, in writing, to the IRB, through the Office of Compliance, any injuries to human subjects or any unanticipated problems which involve risks to human subjects or others participating in research activities.

To facilitate the review of research and the protection of the rights and welfare of human subjects, principal investigators may be asked to attend a meeting with the IRB Chair (if their protocol is under expedited review) or a convened IRB meeting(s) should IRB members have any concerns regarding their protocol(s).

MEMBERSHIP OF IRB
The administrative authority for the protection of human subjects at NMSU has been delegated by the University President to the Vice President for Research, Graduate Studies, and International Programs (VPRGSIP). The VPRGSIP has designated the Associate Vice President for Research and Administration as the Institutional Official. The members of the IRB are nominated by Director of the Office of Compliance in consultation with representatives from the colleges and departments most concerned with research involving human subjects and appointed by the Institutional Official on behalf of the University President. The IRB is considered a standing committee of NMSU and is administratively responsible to the Associate Vice President for Research and Administration. In order to assure complete and adequate review of research activities involving human subjects, the IRB will be composed of sufficient members with varying backgrounds, experience, and expertise. The IRB will be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to experience and expertise, the IRB will also be able to determine the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB is primarily comprised of representatives from the colleges and departments most concerned with projects involving human subjects. The IRB includes at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. The IRB also includes an individual from outside the University who is not affiliated with NMSU and who is not part of the immediate family of a person who is affiliated with NMSU. The Associate Vice President for Research and Administration and the Director of the Office of Compliance are ex-officio non-voting members of the IRB. A representative from NMSU's General Counsel will serve as a non-voting consultant to the IRB as necessary.

If the IRB regularly reviews research protocols that involve a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disable persons, the IRB will include one or more individuals whose background is in protecting the welfare of these subjects.

The IRB will not consist entirely of men or entirely of women, or entirely of members of one profession. The IRB will not have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB, The IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

REVIEW PROCEDURES
The IRB must review and approve all research activities, including all interventions or interactions with a living individual, before those interventions or interactions can occur given that these research activities are intended to result in the collection of data about living individuals. An intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject?s environment that are performed for research purposes. An interaction includes communication or interpersonal contact between investigator and subject, e.g., obtaining informed consent.

While the IRB will usually make its determinations based on information provided by the principal investigator, the IRB may, in some cases, determine that a research protocol shall require monitoring from sources (to be identified by the IRB) other than the researcher. The criteria the IRB may use to determine that a research protocol requires monitoring from other sources may include, but is not limited to:

1. complex studies involving unusual levels or types of risks to subjects;
2. Studies conducted in a foreign country;
3. studies conducted by researchers who previously failed to comply with applicable regulations or institutional or IRB requirements;
4. studies where concerns have been raised by subjects and/or their legally authorized representatives;
5. Studies where concerns about possible material changes occurring without IRB approval have been raised subjects, IRB members, or other university personnel.

Federal regulations have established the following three categories of IRB review of proposed research activities involving human subjects: (1) Expedited Review, (2) Full Board Review, and (3) Exempt Review. An authorized staff member of the Office of Compliance shall make an initial determination of whether the research protocol meets the criteria necessary for designating Expedited Review, Full Board Review, or Exempt Status. In making this determination, this staff member will consult with the IRB Chair and/or IRB members as necessary. In some cases, it may be determined that the research is not human subjects research as defined by 45 CFR 46. In such cases, the principal investigators will receive notification of this determination.

Exempt Review
Studies which fall under any exempt category as defined by 45 CFR 46.101(b) may qualify for an exempt review. An exemption cannot be granted for research that uses prisoners and for research with children that involves survey or interview procedures or observation of public behavior, unless the research involves observations of public behavior when the investigator(s) does not participate in the activities being observed. If the IRB finds the study is not exempt, it must go through an expedited or full board review.
While research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from the 45 CFR 46 regulations, they must still be submitted to the IRB for their review and approval.

Categories of Exempt Research Activities
1. Educational Practices
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
a. research on regular and special educational instructional strategies, or
b. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2. Surveys, Questionnaires, Interviews, Observational Studies
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior unless:
a. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
b. any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

3. Educational Tests
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, if:
a. the human subjects are elected or appointed public officials or candidates for public office; or
b. federal statue(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4. Existing Data or Specimens
Research involving the collection or study of existing data documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

5. Research and Demonstration Projects
Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate or otherwise examine:
a. public benefit or service programs;
b. procedures for obtaining benefits or services under those programs;
c. possible changes in or alternatives to those programs or procedures; or
d. possible changes in methods or levels of payment for benefits or services under those programs.

6. Taste and Food Quality and Consumer Acceptance
Taste and food quality evaluation and consumer acceptance studies,
a. if wholesome foods without additives are consumed, or
b. 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.

Submission and Review Process
Principal Investigator(s) whose research studies fall into one of the exemption categories should submit the Application for Exempt Research to the Office of Compliance for review by the IRB. Along with the application, researchers should include a copy of the questionnaire, interview questions, survey outline, the cover/information letter, written description of any verbal instructions, and any other documentation that will be used.

Research which qualifies for exempt status does not require a signed informed consent form. It does require a written cover letter or information letter which informs the participants (human subjects) of what is expected of them. The cover letter or information letter should include the elements of informed consent.

The determination of an exempt status can be made by the IRB Chair or designee identified by the IRB Chair. In the IRB Chair?s absence, the designee will be identified by the Director of the Office of Compliance. Applications for exempt studies, posing minimal risk to human subjects, will be reviewed within 1 to 2 weeks from the date received in the Office of Compliance.

Researchers will receive initial notification of IRB approval by email. A hard copy letter will be sent to the principal investigator. If the PI is a student, the hard copy letter will also be sent to the faculty advisor. An IRB number will be assigned by the Office of Compliance to all approved protocols. The IRB number and the category or categories of exempt research will be provided in the hard copy letter. The IRB number is to be used to identify the protocol in all future communication.

A listing of applications which have been determined to be exempt will be provided to all IRB members and will be included in the IRB agenda of a convened IRB meeting. All applications will be held on file by the Office of Compliance.

Expedited Review
Research activities involving no more than minimal risk and in which the only involvement of human subjects will be in one or more of the following categories may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list.

Classified research involving human subjects may not be reviewed using the expedited review procedure. 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, 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.

Minor changes in previously approved research may be reviewed using the expedited review procedure during the period for which approval has been authorized. The IRB may also use the expedited review procedure to review modifications and amendments to an approved study that contain only insignificant changes from the approved protocol.

Categories of Expedited Review
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 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
(b) From other adults and children*, considering 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 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.

*Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." (45 CFR 46.402(a)). In New Mexico, the legal age for consent to treatments or procedures involved in the research is 18 years of age.

3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples include:
(a) hair and nail clippings in a 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 the time of rupture of the membrance 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; and
(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. 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, including studies of cleared medical devices for new indications.) Examples include:
(a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy;
(b) weighing or testing sensory acuity;
(c) magnetic resonance imaging;
(d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; and
(e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

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). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.

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. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

8. Continuing review of research previously approved by the convened IRB as follows:
(a) where (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; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where 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.

Submission and Review Process
Principal Investigator(s) whose research studies fall into one of the above categories should submit the Application for Permission to Use Human Subjects in Research to the Office of Compliance for review by the IRB. Along with the application, researchers should include a copy of the questionnaire, interview questions, survey outline, the cover/information letter, written description of any verbal instructions, and any other documentation that will be used.

The standard requirements for informed consent (or its waiver, alteration, or exception) shall apply to all research activities regardless of the type of review - expedited or convened full board review.

An expedited review shall be conducted by the IRB Chair or by one or more of the experienced IRB members designated by the IRB Chair from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110. The IRB member conducting the expedited review may exercise all of the authorities of the IRB except that the reviewer may not disapprove the research. The reviewer shall refer any research protocol which he/she would have disapproved to the full IRB for review. Either the IRB Chair or the designated IRB member may refer any research protocol to the full IRB whenever they believe a full IRB review is necessary.

The expedited review procedures may be used for continuing review of research previously approved by the convened IRB when: (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; (iii) the research remains active only for long-term follow-up of subjects; (iv) no subjects have been enrolled and no additional risks have been identified; or (v) the remaining research activities are only limited to data analysis.

Applications for expedited studies, posing minimal risk to human subjects, will be reviewed within 2 to 4 weeks from the date received in the Office of Compliance. Review time will be dependent on the clarity of the information provided in the application submitted and the researchers? responsiveness to the IRB?s questions and/or concerns.

Researchers will receive initial notification of IRB approval by email. A hard copy letter will be sent to the principal investigator. If the PI is a student, the hard copy letter will also be sent to the faculty advisor. An IRB number will be assigned by the Office of Compliance to all approved protocols. The IRB number, the type of review, the approval date, and the expiration date will be provided in the hard copy letter. The IRB number is to be used to identify the protocol in all future communication.

In accordance with 45 CFR 110(c), a listing of applications which have been approved by expedited review will be provided to all IRB members and will be included in the IRB agenda of a convened IRB meeting. The list will include the IRB number, the researcher(s)? name(s), title of the project, approval date, expiration date, and faculty advisor, if researcher is a student. All original protocols will be available to all IRB members at a convened IRB meeting. Any member may request that a protocol which has been approved under the expedited review procedure be reviewed by the IRB in accordance with non-expedited procedure. When such a request is made, the IRB members shall vote on the request. A majority of the votes shall decide. All applications will be held on file by the Office of Compliance.

Full Board Review
All research which does not qualify for either exempt or expedited review must be reviewed by the Full IRB. The full IRB review is conducted for studies that pose greater than minimal risk to human subjects. All protocols requiring review by the full IRB shall be reviewed at convened meetings which will be held at timely intervals. If an emergency meeting is necessary in order to comply to any aspect of the federal regulations, such a meeting will be called by the IRB Chair. The principal investigator may be invited to attend a convened meeting at which their protocol is to be reviewed. In such cases, the IRB reserves the right not to review the research study if a representative of the research team knowledgeable about the study design is not present.

The Director of the Office of Compliance and/or a staff member shall generally attend full IRB meetings.

Submission and Review Process
Principal Investigator(s) whose research studies fall into one of the exemption categories should submit the Application for permission to use human subjects in research to the Office of Compliance for review by the IRB. Applications must contain all the information necessary for reviewers to make informed judgments about the impact of the research on the human subjects.

Along with the application, researchers should include a copy of the questionnaire, interview questions, survey outline, the cover/information letter, written description of any verbal instructions, and any other documentation that will be used. Letters of permission shall be required when the research is conducted at an off campus location.

When a convened full IRB review is to be used, the standard requirements for informed consent (or its waiver, alteration, or exception) shall apply to all research activities. Informed consent will be obtained from each potential human subject or the subject?s legally authorized representative and appropriately documented, in accordance with, and to the extent required by 45 CFR 46.116 and 45 CFR 46.117.

For new research protocols, IRB members receive a copy of the application, as well as any supplemental materials, submitted for the protocol approximately 1 week prior to the scheduled convened IRB meeting. For research protocols undergoing a continuing review, the members will receive a copy of the continuing review form and any supplemental materials submitted by the researcher(s). The application and supplemental materials will also be distributed to consultants or experts 1 week prior to the scheduled convened meeting when it is determined that such consultants or experts are required to advise the IRB in its review of a research protocol.

Applications will be reviewed in the order in which they are received in the Office of Compliance. Incomplete applications will not be reviewed until they are complete.

Criteria for IRB Approval of Research
In order to approve research activities, the IRB shall determine that the following basic considerations outlined by 45 CFR 46.111 are satisfied:

1. Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

3. Selection of subjects is equitable. In making this assessment, the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

4. Informed consent will be sought from each prospective subject or the subject?s legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.116.

5. Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117.

6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons, the IRB shall ensure that the research study includes additional safeguards to protect the rights and welfare of these subjects.

Meeting Quorum and Voting
In order for official IRB business to be conducted, a majority of the total membership must be present. At least one IRB member whose concerns are primarily in non-scientific areas must be present at a convened meeting before the IRB can conduct any review of research. All IRB members shall be responsible for reviewing all research protocols on the agenda for a convened IRB meeting. No IRB member shall be involved in either the initial or continuing review of a research activity in which he/she has a professional responsibility, except to provide information requested by the IRB. No IRB member shall vote on any activity in which he/she has a conflicting interest.

In order for a research protocol to be approved, a majority of those IRB members present at the convened meeting must approve it. In instances where the research activities were initially approved under expedited review procedures and subsequently reviewed by non-expedited review procedures, the decisions reached by the convened IRB shall supersede any decisions made through the expedited review procedure.

For both new applications and for continuing protocols, the IRB shall assess whether a research study is appropriately categorized as more than minimal risk, thereby requiring review by the convened full board. If the IRB members determine a research study falls under a category of research eligible for expedited review under 45 CFR 46.110, they may vote to defer review to the expedited review procedure. In such cases, a majority of the members must approve such a decision.

The IRB has the authority to make the following determinations regarding a research study:

1. Grant approval as submitted.
Researchers may initiate the research study upon receiving a written approval letter from the Office of Compliance on behalf of the IRB. The approval period will be from the date of the convened IRB meeting until 364 days after the date of the convened meeting. If the approved submission is an amendment, there will be no change to the original expiration date of the protocol.

2. Require modifications to the protocol in order to secure approval.
The IRB approves the research study with specific conditions that must be met by the principal investigator prior to starting the research. The IRB Chair or a staff member of the Office of Compliance will send the principal investigator a list of required modifications within 1 week of the convened IRB meeting. The required changes must be submitted to the Office of Compliance, which will coordinate the review of the changes. As part of its deliberations, the IRB shall indicate whether the required modifications are considered minor or substantial and what type of review will be required ? expedited or convened full IRB meeting.
If the modifications are minor, the IRB Chair may approve the research study upon receipt of the satisfactory revisions. Modifications shall be considered minor if they will not change the risk to the human subjects regardless of the response. In such a case, the expiration date of the research study shall be 364 days from the date of the convened IRB meeting.
Modifications shall be considered to be substantial if the research study does not meet the basic considerations outlined in 45 CFR 46.111. Modifications that have been determined to be substantial shall be reviewed at a convened IRB meeting.

3. Disapproved.
The IRB does not approve the research study because the concerns are of such significance that the IRB members feel approval of the research study to be unwarranted. A researcher has the right to appeal the disapproval of the research study to the IRB and to have the decision reconsidered. The researcher must submit his/her appeal in writing to the Office of Compliance to the attention of the IRB Chair. Researchers may resubmit a revised study to be considered as a new application requiring review by the convened IRB.

In the event of harm to human subjects or if a project is not being conducted in accordance with the IRB?s requirements and/or conditions, the IRB has the authority to terminate or suspend its approval of the research study.

The Office of Compliance shall notify researchers in writing of the IRB?s decisions, conditions and requirements regarding their research protocols. If the IRB does not have enough information to review the research study, the research study can be tabled. The researchers shall be notified of the IRB?s determination by the Office of Compliance or by the IRB Chair. Such notification may initially be made via email, but will be followed by a hard copy letter sent by the Office of Compliance. If the researcher(s) is a student, notification will also be sent to his/her faculty advisor. Researchers may submit a revised application to be considered independently.

Once a research study is approved, the researcher will be notified of the approval. Such notification may initially be made via email, followed by a hard copy of the approval letter. If the researcher(s) is a student, notification will also be sent to his/her faculty advisor. An IRB number will be assigned by the Office of Compliance to all approved protocols. The IRB number and the type of review conducted will be provided in the hard copy letter. The IRB number is to be used to identify the protocol in all future communication.

Meeting Minutes
Provisions shall be made for taking written minutes or recordings of all convened IRB meetings. The minutes or recordings shall include the date and time of the meetings; IRB members present or absent from the meetings; an accurate description of all actions proposed, discussed or taken; and the names of the IRB members who proposed a motion, where applicable. The minutes or recordings shall also identify all applications discussed, the name of the principal investigator and/or representative of the research team invited to attend the meeting to discuss their protocol, and the action taken regarding the statements and materials presented. A listing of all applications reviewed by the IRB Chair or member of the IRB using the expedited and exempt review procedures shall be included in the minutes or recordings. All minutes will be held on file by the Office of Compliance for at least 3 years after completion of the research addressed in the minutes and which is conducted. All records shall be accessible for inspection and copying by authorized representatives of a regulatory or funding department or agency at reasonable times and in a reasonable manner.

Researchers shall be notified in writing of the IRB?s decisions, conditions and requirements regarding their research protocols by the Office of Compliance. In cases where the IRB does not have sufficient information to review the research study, the study can be tabled and the researchers will be notified of the IRB?s decision by the IRB Chair or the Office of Compliance.

INFORMED CONSENT

No researcher may involve a human individual as a subject in any research activities unless the researcher has obtained the informed consent of the subject or the subject?s legally authorized representative. Informed consent is defined as a person?s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in a research activity. Researchers must ensure that the human subjects, or their legally authorized representatives, are provided sufficient opportunity to consider whether or not to participate and must seek to minimize the possibility of coercion or undue influence. The information that is provided to the subject or representative shall be in language understandable to the subject or the representative. No informed consent, whether written or oral, may include any exculpatory language through which the subject or the legal representative is made to waive or appear to waive any of the subject?s legal rights, or releases or appears to release the researcher, the funding source, the institution or its agents from liability for negligence (45 CFR 46.116). It is the responsibility of the IRB to evaluate the informed consent process.

Basic Elements of Informed Consent
As outlined in 45 CFR 46.116(a), the following information shall be provided to each human subject when seeking informed consent:

1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject?s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

2. A description of any reasonably foreseeable risks or discomforts to the subject;

3. A description of any benefits to the subject or to others which may reasonably be expected from the research;

4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects? rights, and whom to contact in the event of a research-related injury to the subject; and

8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

When appropriate, one or more of the following elements of information shall also be provided to each subject:

1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;

2. Anticipated circumstances under which the subject?s participation may be terminated by the investigator without regard to the subject?s consent;

3. Any additional costs to the subject that may result from participation in the research;

4. The consequences of a subject?s decision to withdraw from the research and procedures for orderly termination of participation by the subject;

5. A statement that significant new finds developed during the course of the research which may relate to the subject?s willingness to continue participation will be provided to the subject; and

6. The approximate number of subjects involved in the study.

The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
1. 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:

(i) public benefit or service programs;
(ii) procedures for obtaining benefits or services under those programs;
(iii) possible changes in or alternatives to those programs or procedures; or
(iv) possible changes in methods or levels of payment for benefits or services under those programs; and

2. The research could not practicably be carried out without the waiver or alteration.

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 in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that: 

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;
4. whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Researchers are responsible for obtaining informed consent and for ensuring that no human subjects are involved in the research prior to obtaining their consent. Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject?s legally authorized representative, unless the research meets the criteria for waiver of documentation of consent. The written consent document must include the elements of informed consent required by 45 CFR 46.116. The researcher must give either the subject or the subject?s legally authorized representative adequate opportunity to read the document before it is signed. In some cases, a short form written consent document stating that the elements of informed consent have been read orally to the subject or the subject?s legally authorized representative may be used. The IRB must approve a written summary of what will be said to the subject or the subject?s legally authorized representative. When the short form is used, a witness to the oral presentation must be present. While only the short form is to be signed by the subject or their representative, the witness must sign both the short form and a copy of the summary. The person actually obtaining consent must also sign the copy of the summary. A copy of the summary and the short form must be given to the subject or the subject?s legally authorized representative.

The IRB may approve a waiver of documentation of informed consent in cases where:
1. The principal risks are those associated with a breach of confidentiality concerning the subject?s participation in the research and the consent document is the only record linking the subject with the research (e.g., studies on sensitive topics such as drug abuse or sexual deviance); or
2. The research presents no more than minimal risk and involves procedures that do not require written consent when they are performed outside of a research setting.

In cases in which the documentation of informed consent is waived, an informational cover letter shall be required. .

Unless otherwise authorized by the IRB, researchers are responsible for ensuring that legally effective informed consent in accordance with 45 CFR 46.116 shall (1) be obtained in writing from the subject or the subject?s legally authorized representative; (2) be in language understandable to the subject or his/her representative; (3) be obtained under circumstances that offer the subject or his/her representative sufficient opportunity to consider whether the subject should or should not participate in the research activity; and (4) not include exculpatory language through which the subject or his/her representative is made to waive or appear to waive any of the subject?s legal rights, or releases or appears to release the researcher, the University or its agents, funding agency/department from liability for negligence.

If applicable, subjects must be advised in the informed consent form that the research activity will involve the use of audio/video recording. Subjects must be advised of how the taped materials will be used and stored, who will have access to the materials other than the researcher, and of any steps that will be taken to prevent the subject from being recognized by others not on the research team who might see the tapes. The researcher must ensure the use of all audio/video recordings comply with the procedures outlined in the informed consent form and must make appropriate arrangements for the storage, erasing, or destroying after a given time period of all audio/video recording tapes.

Additionally, subjects must be advised about the availability or non-availability of medical treatment or monetary compensation for any physical injuries incurred as a result of participating in the research study, especially where the research activity presents risk of physical injury.

In research studies involving minors (individuals under 18 years of age), the informed consent shall include adequate provisions for written assent of the minor (when able, usually 7 years of age or older) or verbal assent by younger children, and permission of the parents or guardians and, when appropriate, to monitor the solicitation of assent and permission. Parental or guardian permission may be waived by the IRB provided that an appropriate mechanism for the protection of the minor is substituted or conditions justifying modification of the waiver exist.

Researchers shall modify the language used on informed consent forms and assent forms to match the abilities of the minors. In research activities involving subjects who are not competent to give legally valid informed consent (e.g., children and individuals who are cognitively impaired), assent of the subject and the written informed consent of the subject?s legal guardian are required before any data collection can be started.

Cover letters and information letters, rather than consent forms, may be used for some categories of exempt research with adults such as research activities involving surveys or interviews. Cover letters and information letters shall provide a statement about the purpose of the research activity; a description of the topic of the research and the content of the research instrument to be used; a statement describing the extent, if any, to which confidentiality or anonymity will be maintained; a statement about the expected duration of the subject?s participation; and a statement about how the participant may obtain additional information about the research activity.

When the human subjects? primary language is other than English, the consent form or cover letter or information letter shall be translated into the appropriate language. If the consent form or cover/information letter is to be translated into a language other than English, the researchers shall submit a copy of the form in that language as well as in English. Researchers should also submit a signed attestation certifying that the translation is an accurate translation of the English version.

Researchers shall be responsible for ensuring that informed consent is documented by the use of a written consent form approved by the IRB and signed by the subject or his/her legally authorized representative, unless the IRB has waived the requirement. Each subject or representative signing the consent form shall be offered a copy of the consent form. When cover letters or information letters are used for some exempt research involving surveys or interviews with adults, the subject?s signature is not necessary because responding to the surveys or interviews indicates a willingness to participate in the research study.

Researchers shall store the signed consent forms in a location approved by the IRB. Researchers must maintain the signed consent forms for a period of three years after completion of the research study in accordance with federal regulations.

Faculty advisors shall be responsible for ensuring compliance with IRB policies and procedures in all research activities conducted by students under their supervision. The consent forms used by students must include the faculty advisor?s name and telephone number so that subjects may be able to contact them with questions about the research study.

Once the IRB has approved the consent form, the researcher will receive a copy of the approved consent form stamped with the approval and expiration date for the research activity.

MODIFICATIONS
A modification is defined as any change to an IRB approved protocol from what was previously approved during the period for which approval was given. It is the IRB?s policy that any changes to an IRB approved protocols must be reviewed and approved prior to their implementation, except when necessary to eliminate apparent immediate hazards to the subject. Changes in research procedures, the informed consent process, and/or the consent/assent document cannot be initiated by the investigator without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.

In order to make any changes, researchers will be required to submit a Request for Modification to Protocol form and any materials relating to the modification request to the Office of Compliance. The Office of Compliance staff will then ensure that the request is reviewed by the IRB in accordance with federal regulations.

The IRB Chair of designee will review and approve the modification request, unless the nature of the proposed changes warrant review by the full IRB. Any proposed change that is more than a minor change and that increases the level of risk(s) to the subject(s) in a previously approved research must undergo review by the convened IRB prior to implementation. The principal investigator will be notified in writing of the IRB?s decision by the Office of Compliance.

Should protocol changes be made without prior IRB approval to eliminate apparent hazards to the subject(s), submit a memorandum within 10 working days to the IRB addressing the nature of the change, why it was necessary, and the outcome.

CONTINUING REVIEWS AND CLOSE OUTS
While nonexempt research can be approved for up to one (1) year by the IRB in accordance with federal policy, it requires substantial continuing review. The interval for the continuing review is at the discretion of the IRB but shall occur at least annually. The IRB shall consider the level of risks and benefits of the research activity when determining if the review is required more often than annually.

The principal investigator is responsible for obtaining IRB review for research protocols that last longer than the initial approval period, which is typically one (1) year. Researchers should submit a Continuing Review of Protocol Form when the research activity is to last longer than the approval period. When required by the IRB, the principal investigator shall ensure that progress reports are submitted.

Submission and Review Process
Researchers should submit a Continuing Review of Protocol Form when the research activity is to last longer than the approval period. This form must be submitted to the Office of Compliance no later than approximately 30 days prior to the expiration date of the research protocol to allow sufficient time for the IRB to review the research activity before the expiration date. This will avoid a lapse in the research. The research protocol shall be considered closed if the researcher does not obtain an annual review.

If the research study is active and open to subject enrollment, the principal investigator shall submit a copy of the currently approved informed consent form along with the Continuing Review of Protocol Form. If any changes to the research protocol or the informed consent form are being requested at the time of the continuing review, the principal investigator shall provide an explanation of the requested changes and a copy of the new informed consent form or revised forms instead of the previously approved documents.

The continuing review shall be done in accordance with federal regulations. If the study was originally approved by the convened full IRB, the research protocol must be reviewed by the full IRB which shall assess the risk and determine the appropriate level of review. If the research protocol was originally approved by the convened full IRB but the research activities are limited to data analysis or the research is closed to subject enrollment, then the continuing review can be conducted by expedited review in accordance with federal regulations. If the research protocol was originally approved by expedited review and the researchers propose to continue the research activity for a duration longer than the original approval period, the continuing review can be conducted by expedited review.

A new approval date will be issued for all applications for continuing review that are approved before the expiration date. Applications submitted for continuing review prior to their expiration date, but not formally reviewed and approved by the expiration data will be considered expired studies. All research related activities, including data analysis, must be stopped until formal IRB approval is provided.

If continuing review materials are not submitted on time, the research study will be administratively closed and the principal investigator will be required to submit a new application. All research related activities, including data analysis, must be stopped upon expiration of IRB approval.

The IRB has the authority to observe the conduct of research or to appoint an independent party to act on its behalf including the consent process. The IRB may require verification of the research study procedures during the continuing review when the materials submitted are inconsistent with those previously submitted, inconsistencies cannot be resolved by communications, or when it is determined that additional protections are necessary as part of a corrective action plan when unanticipated problems or adverse events have occurred.

When findings of observational investigations warrant corrective actions, the IRB can terminate or suspend the research study. A researcher may appeal the suspension by submitting a written request to the Office of Compliance.

A nonexempt research study shall be considered complete when data collection and data analysis are finished. At that time, researchers shall submit a Final Report of Research Protocol Form to the Office of Compliance to the attention of the IRB Chair.

REPORTING ADVERSE EVENTS AND UNANTICIPATED PROBLEMS INVOLVING RISKS TO HUMAN SUBJECTS AND OTHERS
Researchers must report all unanticipated problems or unexpected adverse events not included in the original protocol (or subsequent modifications/revisions) and/or consent form, serious adverse events, and expected adverse events, and expected adverse events of moderate or greater severity associated with the research study.

An adverse event is any injury, trauma, or illness experienced by a human subject that required medical or psychological treatment. Adverse events encompass both physical and psychological harms.

A serious adverse event is any adverse event that:
$ results in death;
$ is life-threatening (places the subject at immediate risk of death from the event as it occurred);
$ results in inpatient hospitalization or prolongation of existing hospitalization;
$ results in a persistent or significant disability/incapacity;
$ results in a congenital anomaly/birth defect; or
$ based upon appropriate medical judgment, may jeopardize the subject?s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

An unexpected adverse event is any adverse event occurring in one or more subjects participating in a research activity, the nature, severity, or frequency of which is not consistent with either:
$ the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in (a) the protocol-related documents, such as the IRB-approved research protocol, any applicable investigator brochure, and the current IRB-approved informed consent form, and (b) other relevant sources of information, such as product labeling and package inserts; or
$ the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject?s predisposing risk factor profile for the adverse event.

If such events are brought to the researcher?s attention, then the researcher must report them, even if they appear to be unrelated to the research protocol. Unanticipated problems, in general, include any incident, experience, or outcome that meets all of the following criteria:

1. unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;

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 incident, experience, or outcome that meets the above three criteria generally will warrant consideration of substantive changes in the research protocol or informed consent process/document or other corrective actions in order to protect the safety, welfare, or rights of subjects or others. Examples of corrective actions or substantive changes that might need to be considered in response to an unanticipated problem include:

1. changes to the research protocol initiated by the investigator prior to obtaining IRB approval to eliminate apparent immediate hazards to subjects;
2. modification of inclusion or exclusion criteria to mitigate the newly identified risks;
3. implementation of additional procedures for monitoring subjects;
4. suspension of enrollment of new subjects;
5. suspension of research procedures in currently enrolled subjects;
6. modification of informed consent documents to include a description of newly recognized risks; and
7. provision of additional information about newly recognized risks to previously enrolled subjects.

Other types of incidents, experiences, and outcomes that occur during the conduct of research activities involving human subjects represent unanticipated problems but are not considered adverse events. For example, some unanticipated problems involve social or economic harm instead of the physical or psychological harm associated with adverse events. In other cases, unanticipated problems place subjects or others at increased risk of harm, but no harm occurs. Although such unanticipated problems do not involve adverse events, they must be reported to the IRB in accordance with 45 CFR 46.103(a) and 46.103(b)(5).

A reportable event is one in which a participant(s) is/are exposed to an unanticipated harm or risk. An actual injury to the participant is not required. Any social and psychological risk or harm to the participant(s) should be reported. While social harm may result in well-defined events such as loss of employability, loss of insurability, and criminal or civil litigation, usually it disrupts interpersonal relationships by causing embarrassment, humiliation, discrimination, or stigmatization. Social and psychological risk or harm can be caused by such events as a breach of confidentiality, loss of records, or participant information.

If the adverse event that occurred is of serious nature, it must be reported to the IRB within 24 hours of the researcher becoming aware of it. A consulting physician is required. The physician must comment on the severity of the event and the likelihood that it was related to the research protocol. The researcher must use the Unanticipated Problem/Adverse Event Report Form to report the event to the IRB.

All other unanticipated problems or adverse events must be reported to the IRB within 5 working days of the researcher becoming aware of it, if the event occurred at a local site. If the event occurred at another location, it must be reported within 30 days of the researcher becoming aware of it. A consulting physician is not required. The Unanticipated Problem/Adverse Event Report Form must be used to report the event to the IRB.

All problems or adverse events, whether serious, unexpected or neither, must be reported to the IRB, using the Unanticipated Problem/Adverse Event Report Form.

For additional guidance on adverse events and unanticipated problems, researchers are encouraged to consult the document titled, ?Guidance on Reviewing and Reporting Unanticipated Risks to Subjects or Others and Adverse Events,? provided by the Office for Human Research Protections (OHRP).

Submission and Review Process

In accordance with 45 CFR 46.103(a) and 45 CFR 46.103(b)(5), the IRB shall handle all unanticipated problems or adverse events as follows:

1. Researchers must report all unanticipated problems or unexpected adverse events not included in the original protocol (or subsequent modifications/revisions) and/or consent form, serious adverse events, and expected adverse events, and expected adverse events of moderate or greater severity associated with the research study.

2. If the adverse event that occurred is of serious nature, it must be reported to the IRB within 24 hours of the researcher becoming aware of it. A consulting physician is required. The physician must comment on the severity of the event and the likelihood that it was related to the research protocol. The researcher must use the Unanticipated Problem/Adverse Event Report Form to report the event to the IRB.

3. All other unanticipated problems or adverse events must be reported to the IRB within 5 working days of the researcher becoming aware of it, if the event occurred at a local site. If the event occurred at another location, it must be reported within 30 days of the researcher becoming aware of it. A consulting physician is not required. The Unanticipated Problem/Adverse Event Report Form must be used to report the event to the IRB.

4. All problems or adverse events, whether serious, unexpected or neither, must be reported to the IRB, using the Unanticipated Problem/Adverse Event Report Form.

5. Upon being notified of any unanticipated problems or adverse events, the IRB Chair or designee will serve as an expedited reviewer using expedited review procedures. If the Chair or designee determines it is not an unanticipated problem/event which involves risk to the subjects or others, he/she will document his/her review by signing the original Unanticipated Problem/Adverse Event Report Form. The Office of Compliance staff will store the original report in the protocol file and send a letter to the PI indicating the review outcome.

6. The unanticipated problem/event will be listed on the IRB agenda for the next convened IRB meeting. Any IRB member may request to review the entire protocol file and the expedited reviewer?s recommendations.

7. The IRB actions may include:

$ acknowledgment/acceptance of the report without further recommendation;
$ a request for further clarification or additional information from the researcher;
$ changes in the protocol (e.g., additional tests or visits to detect similar events in a timely basis);
$ changes in the informed consent form;
$ a requirement to inform subjects already enrolled about additional risks;
$ a change in frequency of the continuation review;
$ recommendation for full review;
$ request for an improvement plan of action or other actions deemed appropriate by the IRB; or
$ suspension of the research study or termination of IRB approval.

8. If the IRB requests further clarification or additional information from the researcher, the Office of Compliance staff will notify the principal investigator in writing of the requests.

9. Upon receiving the principal investigator?s response to the IRB?s request for further clarification or additional information, the Office of Compliance staff will forward the responses to the IRB Chair or designee for further review on behalf of the committee unless the IRB Chair or designee determines the researcher?s response needs further review by the full IRB.

10. If the principal investigator has concerns regarding the IRB decision and/or recommendations, he/she may submit the concerns to the IRB in writing, along with a justification for changing the IRB decision. The IRB will review the request and will make a final determination. The Office of Compliance staff will send a letter to the principal investigator notifying him/her of the IRB?s final determination.

If the IRB Chair or designee determine the unanticipated problem/event involves risks to the subjects or others, the IRB Chair will promptly notify the Institutional Official and the Office of Compliance within 48 hours of making such a determination. The Office of Compliance will notify OHRP and the head of the sponsoring Federal department or agency, if any, of the IRB?s determination within 30 calendar days. After notification has been provided to the appropriate individuals, a convened full IRB meeting will be called by the IRB Chair. The Unanticipated Problem/Adverse Event Report Form and a copy of the original protocol will be provided to each member by the Office of Compliance. Any IRB member may request to review the entire protocol file.

The IRB actions may include:

$ acknowledgment/acceptance of the report without further recommendation;
$ a request for further clarification or additional information from the researcher, in writing, or request the principal investigator attend the convened meeting
$ changes in the protocol (e.g., additional tests or visits to detect similar events in a timely basis);
$ changes in the informed consent form;
$ a requirement to inform subjects already enrolled about additional risks;
$ a change in frequency of the continuation review;
$ recommendation for full review;
$ request for a corrective plan or other actions deemed appropriate by the IRB; or
$ suspension of the research study or termination of IRB approval.

8. If the IRB requests further clarification or additional information from the researcher or that the researcher attend the convened meeting, the Office of Compliance staff will notify the principal investigator in writing of the requests.

9. Upon receiving the principal investigator?s response to the IRB?s request for further clarification or additional information, the Office of Compliance staff will forward the responses to the IRB for further review.

10. If the principal investigator has concerns regarding the IRB decision and/or recommendations, he/she may submit the concerns to the IRB in writing, along with a justification for changing the IRB decision. The IRB will review the request and will make a final determination. The Office of Compliance staff will send a letter to the principal investigator notifying him/her of the IRB?s final determination.

REPORTING ANY SERIOUS OR CONTINUING NONCOMPLIANCE WITH 45 CFR PART 46 OR THE REQUIREMENTS OR DETERMINATIONS OF THE IRB

Any research activity that deviates from the federal or state regulations or the policies, procedures, stipulations, or decisions of the IRB are considered to be non-compliant and subject to further inquiry by the IRB. There are three categories of non-compliance: general, serious, and continuing. The three categories are defined as follows:

1. General Non-compliance is any deviation from NMSU?s IRB policies and procedures or federal regulations.
2. Serious Non-compliance is any non-compliance that substantially affects a participant?s rights and/or welfare, or impacts upon the risks or benefits of the research activity.
3. Continuing Non-compliance is a pattern of non-compliance that indicates an inability or unwillingness to comply with the regulations or the requirements or determinations of the IRB.

All reports and complaints of non-compliance shall be directed to the Director of the Office of Compliance. The Office of Compliance will notify the IRB Chair or designee of the allegation of non-compliance within five (5) days of receipt of the report and complaint. If the IRB Chair or designee determine that the non-compliance is clearly neither serious nor continuing and there is a corrective action plan that can be implemented to prevent recurrence, the matter will be filed and no further action will be required. The corrective action plan may involve modification of the research protocol; modification of the consent process; providing past or current subjects with additional information that might affect their willingness to continue their participation in the research; re-consenting participants; or modifying the approval period.

If the IRB Chair or designee determine the non-compliance is serious or continuing, the research may be suspended or terminated while the matter is investigated. If the IRB Chair or designee determine the specified research activities should be immediately suspended, the IRB Chair will send a notice within 48 hours to the principal investigator(s) requesting the immediate suspension of all specified research activities. As required by 45 CFR 46.113, the notice shall include a statement of the reasons for the IRB?s action. The IRB Chair will also notify the Institutional Official and the Office of Compliance within 48 hours of making such a determination. The Office of Compliance will notify OHRP and the head of the sponsoring Federal department or agency, if any, of the IRB?s determination within 30 calendar days.

After notification has been provided to the appropriate individuals, a convened full IRB meeting will be called by the IRB Chair. The Office of Compliance will provide each IRB committee member with a copy of the approved protocol, current consent documents, and all supporting materials. The relevant IRB files will be made available at the meeting. The IRB will assess and vote upon whether the allegations of non-compliance are true and whether the non-compliance is serious or continuing. The IRB may accept or reject the IRB Chair?s initial determination of the non-compliance. If necessary, the IRB may request additional information from the researcher or request appropriate additional consultation and expertise to resolve the matter.

If the IRB requests further clarification or additional information from the researcher or that the researcher attend the convened meeting, the Office of Compliance staff will notify the principal investigator in writing of the requests.

Once the IRB Committee has finalized their review, the IRB Chair will notify the Institutional Official and the Office of Compliance within three (3) days of the IRB?s decision and/or recommendations. Tthe Office of Compliance staff will then send a letter to the principal investigator notifying him/her of the IRB?s decision and/or recommendations. The Office of Compliance will also notify OHRP and the head of the sponsoring Federal department or agency, if any, of the IRB?s determination within 30 calendar days.

If the principal investigator has concerns regarding the IRB decision and/or recommendations, he/she may submit the concerns to the IRB in writing, along with a justification for changing the IRB decision. The IRB will review the request and will make a final determination. The Office of Compliance staff will notify the principal investigator of the IRB?s determination.