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3.30 – Human Subjects Research Review

Purpose. It is the responsibility of Lake Superior College to ensure that the rights and welfare of human subjects participating in any research affiliated with the college be adequately protected. It is also the college’s responsibility to ensure that all research participants are fully informed regarding the research and that they participate willingly and are free to withdraw from the study at any time without penalty. Participants must also be guaranteed freedom from coercion and undesirable consequences, and that any identifying information relating to the conduct or the outcomes of the research will be kept confidential. These policies and procedures are intended to protect research subjects from harm by meeting professional, ethical and federal standards without limiting the pursuit of any systematic course of study. Implementation The responsibility for implementation of this regulation is assigned to the Office of Planning and Institutional Effectiveness.

Part 1: Expectations. Human subjects research is any systematic investigation designed to develop or contribute generalizable knowledge based on data obtained from human research subjects. This includes both original studies and
replications of existing studies performed by faculty, students or others. Excluded from this definition are activities whose primary focus is on benefiting the individual(s) involved in the procedure as defined in the attachment.

It is expected that human subjects research proposals will satisfy the following conditions:

    1. Minimal Risk: Research procedures should be designed so that subjects are not exposed to physical, psychological or social risks significantly in excess of that normally encountered in daily life. Any possible risks imposed must be weighed against the scientific importance and the potential benefits of the research.
    2. Confidentiality: Research procedures shall not disclose confidential information, including names and/or salient individual identifying characteristics, to other than the investigator(s) and their research staff. Further, adequate provision must be made to protect the confidentiality of information that is to be retained over an extended period of time.
    3. Informed Consent: Participants will be clearly informed as to the purpose of the study, risks, and benefits associated with participation. Other definitions, descriptions and expectations can be found in an attachment to this policy.

Part 2: Human Subjects Review Board

Part A: Human Subjects Review Board (HSRB) will be established

    1. The membership of this board shall include:
      Vice President of Academic Affairs
      Vice President of Student Services
      Dean of Planning and Institutional Effectiveness
    2. The board’s responsibilities shall be as follows:
      1. develop policies and procedures for the protection of human subjects;
      2. determine the status of exempt and non-exempt research proposals and provide HSRB review of all non-exempt proposals;
      3. when requested, review research procedures affecting human subjects and make recommendations to the investigator;
      4. keep written records of all reviews and decisions of the HSRB; and
      5. establish all operational procedures and policies of the HSRB and the human subjects review process.

Part 3. Research Exemption Categories. Human research activities, except those in which the only involvement of human subjects will be in one or more of the following categories, must be approved by the HSRB.

Subpart A. Research conducted in established or commonly accepted educational settings, involving
normal educational practices such as:

    1. research on regular and special education instructional strategies; or
    2. research on the effectiveness of, or the comparison among, instructional techniques, curricula or classroom management methods.

Subpart B. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of behavior unless:

    1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects (e.g., student identification number or SSN);
    2. 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; and
    3. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Subpart C. 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 through identifiers linked to the subjects.

Subpart D. 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:

    1. public benefit or service programs;
    2. procedures for obtaining benefits or services under those programs;
    3. possible changes in or alternatives to those programs or procedures; or
    4. possible changes in methods or levels of payment for benefits or services under those programs.

Note: According to Federal Regulations, research involving minors can never be exempted under Categories B and C above for studies involving survey or interview procedures.

Part 4: Human Subjects Review Board (HSRB) Review Procedures

Subpart A. Proposals involving research on human subjects are to be submitted to the HSRB in accordance with policies and procedures established by the Board. Data collection may not begin until full HSRB approval has been obtained.

Subpart B. Upon receipt of a proposal the chair will determine whether the proposal requires full review or can be reviewed through an expedited review process.

    1. Criteria for expedited review. Expedited review can be used for proposals in the following categories.
      1. Proposals considered of minimal risk.
      2. Previously approved research programs, which require approval for minor changes.
      3. Research in which the only involvement of human subjects will be in the review categories listed in the attachment.
    2. Expedited reviews are done by the HSRB chair and a member of the Board.
    3. The HSRB member(s) conducting the expedited review may exercise all of the authorities of the HSRB except that the reviewer(s) may not disapprove the research proposal. The reviewer(s) shall refer any research protocol which might have been disapproved to the full HSRB for review. The reviewer(s) may also refer other research proposals to the full HSRB whenever it is believed that a full review is warranted.
    4. When the expedited review procedure is used, the HSRB chair shall inform HSRB members of research proposals that have been approved under this procedure.
    5. Any member of the HSRB may request that a research proposal which has been approved under the expedited procedure be reviewed by the HSRB in accordance with non-expedited procedures. A majority vote of the members shall decide the issue.

Subpart C. The HSRB will meet at regular intervals to assure timely review of research proposals.

Subpart D. Action of the HSRB will be recorded on the approval form, with one copy returned to the investigator and one copy placed in a permanent file under the supervision of the HSRB chair. For further information regarding implementation of this policy click on links; Code of Federal Regulations, Informed Consent, Human Subjects Research Description and Definitions.

Date Implemented: February 3, 2005