REG 10.10.03 – Human Subject Research

Authority: Vice Chancellor for Research and Innovation

History: First Issued: October 22, 1987. Last Revised: September 30, 2002.

Additional References: 
Department of Health and Human Services, National Institutes of Health, Office for References: Protection from Research Risks, CFR 45, PART 46, Protection of Human Subjects, Revised November 13, 2001, Effective December 13, 2001
Institutional Review Board for the Protection of Human Subjects in Research 
University Requirement for the participation and administration of projects conducted with Human Subjects
Code of Federal Regulations Title 45 – Part 46 – Protection of Human Subjects

OHRP – Office of Human Research Protection
OHRP IRB Guidebook
5 U.S.C. 301; Sec. 474(a), 88 Stat. 352 (42 U.S.C. 2891-3(a))

Contact Info: Regulatory Compliance Administrator, Office of Sponsored Programs and Regulatory Compliance (919-515-4514)

1. General

Federal law and University policy require that all research involving human subjects, conducted by NCSU researchers (faculty, staff or students) must be reviewed and approved by the NCSU Institutional Review Board (IRB) for the Use of Human Subjects in Research. These rules are in place to protect the human subjects, the researchers and the institution.

2. General Principles

All North Carolina State University researchers (faculty, staff, and students) must adhere to strict ethical standards for the use of human subjects in their research. These standards are in place to protect the basic rights of their subjects. Any research that departs from the spirit of these standards violates University policy. Below are some guidelines that the IRB members consider during their reviews to maintain these standards.

2.1. All research procedures minimize the risks to subjects.

2.2. Any risk must be reasonable in relation to the potential benefits from the study.

2.3. Informed consent must be obtained from the subject before participation. This consent must be in writing unless exempted by the committee.

2.4. Subject must be provided with adequate detail regarding the study to make an informed decision regarding their participation. This information should be included on the consent form and should be written in lay language, so that the subjects can make an informed decision regarding participation.

2.5. Subject’s privacy must be maintained.

2.6. Subjects need to be made aware that they participate of their own choice and are free to withdraw from the study at any time

3. Review Categories

There are three categories (or types of review) for projects that are submitted to the IRB. These are as follows:

3.1. Exempt from further review.

3.2. Subject to expedited review.

3.3. Subject to full review.

Determination of the type of review will be made by the chair of the IRB upon consideration of the submitted materials. Expedited review will typically be conducted on those projects that involve no more than minimal risk. Expedited review involves review by two or three committee members. Review of project in the expedited review category may take from 2 to 4 weeks. Full Board Review involves the whole IRB committee and may take from 4 to 6 weeks.

4. Definitions

4.1. Research – A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program, which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

4.2. Human Subject – Means a living individual, about whom an investigator (whether professional or student) conducting research obtains:

4.2.1. Data through intervention or interaction with the individual; or

4.2.2. Identifiable private information

4.2.3. 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.
Interaction includes communication or interpersonal contact between investigator and subject.

4.4.4. Private information includes information about behavior that occurs in a context, in which an individual can reasonably expect that no observation or recording is taking place, and information, which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information), in order for obtaining the information to constitute research involving human subjects.

4.2.5. IRB Approval – the determination of the IRB that the research has been reviewed and may be conducted at NCSU within the constraints set forth by the IRB, and by other institutional and federal requirements.

4.3. Minimal Risk – means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

5. Procedures

Described below is the process by which a principal investigator seeks approval from the NCSU IRB for the Use of Human Subjects in Research.

5.1. In the Annual Faculty Report Form and related forms, the following definitions are used:

5.1.1. Forms – There are four components to a package to be submitted to the IRB for review: the cover sheet, the preliminary questions sheet, the proposal narrative, and the informed consent form.

5.1.1a. Cover Sheet – The cover sheet provides basic information regarding the study under consideration and the principal investigators. For research whose principal investigator is a member of the NCSU faculty, this form should be completed and the NCSU faculty member must sign attesting to their awareness of the University’s policies and procedures for the use of human subjects in research. For research whose principal investigator is not a member of the NCSU faculty, this form should be completed and the principal investigator must sign attesting to their awareness of the University’s policies and procedures for the use of human subjects in research. Further, an NCSU faculty member must sign illustrating that they have reviewed this application thoroughly and will oversee the research in its entirety and acknowledge their role as the principal investigator of record.

5.1.1b. Preliminary Questions Sheet – The responses to these questions will allow the chair to quickly place the study in the appropriate review category (exempt, expedited, or full review). These questions have been developed to decrease the response time of the IRB.

5.1.1c. Proposal Narrative – The proposal narrative is a detailed description of the study. There are seven sections to the narrative that need to be completed: Introduction, Subject Population, Experimental Procedures, Potential Risks, Compensation, Collaborators, Additional Information. Each of these sections needs to be completed, or if a section does not apply write “N/A”. Each of these sections contains critical information that will allow the reviewer to evaluate the study. These sections need to be written in lay language, avoiding jargon and acronyms. Failure to follow these rules will cause delays in processing the submission.

5.1.1d. Informed Consent Form – An important component to any submission to the committee is the informed consent form. This form will be used by the researcher to document that the subject was aware of the requirements of the study and that they were aware that they could refuse to participate or withdraw at anytime. Therefore it is important that this document contain adequate information so that the subjects can make an informed decision regarding participation. As with the proposal narrative, this form should be written in lay language and should avoid jargon and acronyms.

Each of these components needs to be included in the package submitted to the IRB Chair. Incomplete packages will be returned to the principal investigator without review.

6. Review – Two copies of all materials should be sent to the IRB Chair. Upon receipt of a protocol package, the IRB Chair will review the package for completeness and content. If the package is found to be complete, the package will then be reviewed. If there are concerns or needed clarifications, the committee will correspond directly with the principal investigator to resolve these issues. The review process can take anywhere between 2 – 6 weeks, depending on the clarity and complexity of the proposal.

7. Final Notification – Upon receipt of the notification from the IRB reviewers of the acceptability of the experimental protocol, the IRB Chair will send a letter to the principal investigator stating that the research project has been approved for one year (beginning on the date of the letter).

8. Extensions – For those projects that require an extension beyond the one year limitation of the IRB approval, the principal investigator must submit a letter to the IRB Chair stating their intention to continue the research and document any modification to the experimental protocol. The letter should also contain a concise overview of the project to date (# of subjects, significant findings, etc.). Upon receipt of this letter, the IRB will re-review the protocol and if it finds the protocol acceptable will send to the principal investigator a letter of approval.

9. Retention of Documentation – A copy of all records relating to the research project (original submitted protocol, all signed consent forms, correspondence with the IRB, etc.) should be retained for at least three years after the completion of the research.