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Human Subjects Institutional Review Board

POLICIES AND PROCEDURES

  1. INTRODUCTION

    Nicholls State University has adopted policies and procedures regarding the rights and welfare of human subjects research, training and teaching activities including those supported by grants and contracts from federal, state and local agencies. A Human Subjects Institutional Review board (HSIRB) has been created to determine whether human subjects will be placed at risk (either physical or psychological) and, if so whether:

    1. The risks are outweighed by the sum of the benefits, and therefore warrant the acceptance of the risk.

    2. The protection and respect of the subject's rights and welfare will be addressed to the best of the researcher's ability.

    3. Legally effective informed consent will be obtained by adequate and appropriate methods in accordance with provisions of applicable law, and the conduct and methodology by which the information is obtained will be reviewed at timely intervals.


  2. DISCHARGE OF RESPONSIBILITIES CONCERNING THE PROTECTION OF THE RIGHTS AND WELFARE OF HUMAN SUBJECTS

    In discharging its responsibilities to protect the rights and welfare of human subjects, Nicholls State University adopts the regulations contained in the Federal Register, vol.36 No. 117, June 18, 1991. The establishment of the Human Subjects Institutional Review Board shall be the mechanism for discharging these responsibilities.

  3. COMPOSITION OF THE HUMAN SUBJECTS INSTITUTIONAL REVIEW BOARD (HSIRB)

    1. The HSIRB will be composed of at least 10 members.

      1. One faculty member elected from each academic college, the Freshman Division and the Library:

      2. One representative each from the departments of Psychology and Nursing appointed by the Nicholls State University Research;

      3. One member from the university community at-large appointed by the Vice-President for Academic Affairs;

      4. One member who is not otherwise affiliated with Nicholls State University nor immediately related to anyone affiliated with Nicholls State University to be appointed by the Vice-president for Academic Affairs and approved by the Nicholls State University Research Council.

    2. The HSIRB will include at least one member whose primary concern is in scientific areas (nursing or psychology appointee), and at least one member whose primary concern is in nonscientific areas;

    3. The HSIRB may, at its discretion, invite one or more individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available to the HSIRB. These individuals do not have voting privileges on matters addressed by the HSIRB;

    4. Each elected member will serve for a period of two (2) years beginning with the Fall semester of the year of election. The terms of elected members will be staggered so that one-half of the membership will be elected each academic year. Members may be elected for more than one term of service;

    5. Each appointed member will serve for a period of one year beginning with the Fall semester of the year of appointment. Members may be appointed for more than one term of service;

    6. The HSIRB will select a chairperson and Recording Secretary from its membership at the beginning of each Fall semester

    7. No HSIRB member may participate in the Board's initial or continuing review of any project in which that member has a conflicting interest, except to provide information as requested by the Board.

  4. HSIRB PROCEDURES
    1. Approval, Disapproval, Modification and Termination

      1. The Board shall have the authority to review, approve, require modification(s) in, or disapprove, all research activities/studies or proposed research activities/studies involving human participation;

      2. The meetings of the HSIRB shall be called by the Chairperson as required. The HSIRB shall meet at least once during the Summer, Fall and Spring semesters. Also, meetings will be scheduled at additional times if deemed necessary.

      3. A majority of the HSIRB members will constitute a quorum and include at least one member principally concerned with nonscientific issues;

      4. Official action of the HSIRB members (approval, modification or disapproval) will require the majority of those members present at the meeting.

      5. Notification of official action (approval, modification or disapproval) by the HSIRB shall be sent to each applicant in writing within ten days of the official action. Disapproval of research shall include a statement of the reason(s) for such a decision and give the applicant an opportunity to respond in person or in writing;

      6. The HSIRB shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with HSIRB's requirements or that has been associated with unexpected serious harm to the participants. Such suspension or termination of approval shall include a statement of the reasons for the HSIRB's action and shall be reported promptly in writing to the investigator and appropriate institution of officials.

    2. Review

      1. All projects will receive an annual review. When the element of risk so warrants, more frequent reviews additional information may be requested from the project director or others at the discretion of the Board.

      2. The Chairperson or his/her designer(s) may conduct an Expedited Review of projects (i) presenting a minimal risk to human subjects in accordance with DHHR 45 CFR 46.110 and (ii) containing minor changes in previously approved research. Reviewers may exercise all of the authorities of the activity may be disapproved only after review in accordance with the non-expedited procedure set forth in A.4 above.

    3. Records

      1. Minutes of all meetings, copies of all correspondence to researchers, recommendations to investigators following reviews, notifications of approval and disapproval, will be kept in the office of the Chairperson of the HSIRB for a minimum of 3 years.

  5. INFORMED CONSENT

    No study involving human subjects will be approved unless evidence is presented that legally effective informed consent to participate in the study as been given by the human subjects. This procedure refers to the knowing consent by the participant or his/her authorized representative. Letters of consent or support from the agencies/institutions in which the study will be conducted or the data will be collected will be required. The HSIRB will determine whether knowing consent was given using the following criteria:

    1. The subject was provided with a statement that the study involves research, an explanation of the purposes of the research, the excepted duration of the subject's participation, the procedures to be used in the study and their purpose which may be experimental;

    2. The participant was given a description of any attendant discomforts and risks which could be reasonably expected;

    3. A description of the benefits reasonably to be expected was given to the subject;

    4. Any appropriate alternative procedures that might be advantageous for the participant was disclosed to him/her;

    5. The subject was given an opportunity to have answered any questions concerning the procedures and an address and telephone number to which inquiries could be made;

    6. The participant must be clearly instructed that they are free to withdraw consent and discontinue participation in the investigation at any time. The participants withdrawal must not be looked upon with prejudice.

    7. The subject is provided with a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.

  6. PROCEDURES BY APPLICANT RESEARCHERS

    Investigators using human subjects must submit a completed APPLICATION form well in advance of the initiation of any proposed research or of submission of a grant proposal and at least 10 working days prior to the next meeting of the HSIRB. This ten day period will allow for any modifications recommended by the HSIRB to be incorporated into the final proposal

    If it is impossible for the investigator to submit a completed APPLICATION form in advance of the date for submission a "PENDING REVIEW FORM" will be attached to the proposal, and the review will be carried out at the next HSIRB meeting.

    The investigator should report to the HSIRB any problems and/or proposed procedural changes not included in the original submission. No changes, except those needed to eliminate immediate hazards can be made without the approval of the HSIRB.

    If the applicant is not satisfied with the HSIRB's decision they may request a second review by the HSIRB.

  7. PROCEDURES BY PARTICIPANTS

    If a participant wishes to voice any complaint(s) or concern(s) about their participation in the investigation they should notify the HSIRB chairperson who will then bring it to the attention of the Board. The Board will make a determination of any action to be taken and instruct the chairperson to notify the person that issued the complaint in writing.

    Participants may request a copy of Nicholls State University's policy on Human Subjects Research by contacting the chairperson of the HSIRB.