Summary of Research on Human Subjects

Federal law, based on the principles of individuals' rights to privacy and protection of citizens from  harm by others, has led to clear rules about the conditions under which we may do research using human subjects. Carlow University has convened an Institutional Review Board (IRB) to ensure that all human subject's research is reviewed in advance by responsible, knowledgeable peers to protect these rights. Carlow University is committed to these laws based on moral, ethical, and legal grounds. All research that comes under the aegis of the University must meet the procedures established to ensure the privacy and protection of human subjects. These procedures are followed by faculty in their own research, and by students in any research they conduct regardless of where it is actually conducted.

The procedures are designed to first categorize research as to its degree of potential risk for the subjects on whom the experiments are being conducted. PLEASE REFER TO THE HANDOUT ENTITLED 'DEFINITIONS' THAT DEFINES THESE CATEGORIES (For handouts, please contact Dr. Robert Reed at 412-578-6349 or via E-mail at reedra@carlow.edu).

Those research proposals which the review board judge as being of  minimal or very low potential for harm to human subjects are classified as eligible for EXPEDITED REVIEW. Expedited review is carried out by the IRB Chair and two members of the IRB Committee. Researchers will be notified within 15 to 30 days of submission of the study regarding approval. (Note that the researcher must still meet the criteria of fully informing all subjects that they are part of a study, the likely stresses for them in the study, securing their written consent {or parent/guardian's}, preserving their anonymity with every possible effort, and fully informing the subjects of their right to withdraw from the study at any time with no penalties). Studies that have not been approved by the expedited review process will be reported to the full IRB. Only the full board can disapprove a research protocol.

Protocols that require FULL BOARD REVIEW are distributed to each member of the IRB, and assigned to two members for detailed review. Please refer to Carlow University's Administrative Policies and Procedures for the IRB for details regarding full Board review. The full board meets three times per year (October, January, and March). Proposals should be submitted at least one month in advance of full board review.

Certain categories of research are classified for EXEMPT REVIEW (see 'DEFINITIONS' handout). The IRB requires that research be determined exempt from review by the IRB committee.

The following directions are designed to provide enough information to the IRB so that they can make a fair, informed judgement about the research.

Expedited Review

The IRB may use the expedited review process to review those research studies involving minimal risk to subjects or where minor changes are made in previously approved research during the period of  one year or less for which approval is authorized. A summary of these studies is contained in Docket No. 77N-0350 of the Food and Drug Administration. The investigator must notify the Chairperson or his/her designee requesting an expedited review. The Chairperson will then approve that the study be reviewed by the expedited process. The review may be carried out by the Chairperson and two members of the Committee. In reviewing the research, the reviewers may exercise all of  the authorities of the IRB. Investigators will be notified within 30 days of  submission of the study regarding approval/disapproval. The investigators will be bound to the same requirements for reporting adverse effects, etc. as studies reviewed by the full review process.
Studies that have been approved by expedited review will be reported at the IRB meeting. No research protocol will be disapproved by expedited review. If a question arises, the protocol will be submitted to the full board for review and discussion.

Exempt Review

At 46-101 (b) of Part 45 of the Code of Federal Regulations, a number of categories of research are exempted from federal regulatory requirements. The IRB requires that research be determined as exempt from review by the IRB committee. Any research conducted at Carlow that has not been determined to be exempt from review will be subjected to restriction, suspension, or termination until such a review can be conducted. In cases in which the IRB will decide on exemption, the investigator should submit to the Chairperson the necessary material (see Appendix III for guidelines used to determine exemption). If the research is determined not to be exempt from review, the Chairperson will notify the investigator.

The following guidelines will be used to determine exemptions:

Research Involving Normal Subjects

Section 46.101 (2)(b) of the CFR states that ...Research activities in which the only involvement of human subjects will be in one or more of  the following categories are exempt:

(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (I) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt if: (I) the human subjects are elected or appointed public officials or candidates for election if: (ii) federal statute (s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

(4) 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) Certain demonstration projects that meet federal regulatory criteria can be exempted from IRB review. If such an exemption would be approved by the IRB, it would apply only to the service component of the project. Any research that is conducted in conjunction with the project must have a separate protocol and IRB approval. The IRB may require the use of a consent form for the research component if disclosure of the subject/patients' responses could place the subject at risk of criminal or civil liability, be damaging to the subjects' financial standing, employment or reputation or affect their right to privacy.

(6) Taste and food quality evaluation and consumer acceptance studies, (I) if wholesome foods without additives are consumed; or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Research Involving Children

Although under federal regulations exemptions are permitted where children are participants in research the IRB requires that research involving children be reviewed by the full board except as noted below:

(1) Chart/Medical Record Review

a. A chart/medical record review may be conducted if permission was granted at the time of admission for chart reviews for research purposes, and

b. No identifying information is to be collected from the chart/medical record (i.e.,name, address, phone number...)

(2) Observational Studies

a. Observational studies may be considered exempt as long as videotaping or audio taping in not involved, and no identifying information is recorded.

(3) Educational Studies - See page 1 under summary of Section 46.101 for definition of educational studies.

Note: 'Children' are persons who have not attained the legal age for consent to treatments or procedures involved in research under the applicable law of the jurisdiction on which the research will be conducted. In Pennsylvania the following stipulations apply:

(1) If the minor is between the ages of 13 and 17, the parent or guardian and the child must give informed consent.

(2) If the minor is below the age of 13, the informed consent of the parent or guardian must be obtained and the child must be given an explanation of the research. This may entail the use of a consent form especially prepared to facilitate understanding by a minor of such age.

Use of Consent Forms in Exempt Research

Under Section 46.117, the IRB may waive the requirement for a signed consent form for some or all subjects.

Therefore, the IRB has adopted the following procedure for using consent forms in exempt research:

(1) No consent form is necessary if that document is the only identifier. A subject must, however, be given a consent form to sign if that is his/her wish.

(2) In the event that a consent form is signed, it must be separated from other information that the participant has filled out in order to avoid identification.

(3) Where no consent form is used, an informational sheet must be provided to the participant giving the same information that a signed consent form would (i.e., information about the study, risks, and benefits, etc.).

If there are any questions regarding interpretation of any of the above guidelines or federal regulations, please notify the Chairperson of the IRB.

Full Board Review

Protocols that require Full Board review (those that do not qualify for Expedited or Exempt), are distributed to each member of the IRB and assigned to two members for detailed review. These members lead the discussion at the next meeting. The protocol and consent forms (s) are either:

(1) recommended for approval as is; (2) recommended for approval subject to suggested changes which must be reviewed and approved by the Chairperson or his/her designate; (3) recommended for reconsideration at the next meeting; or (4) recommended for denial of approval.

If the protocol and consent form (s) are to be reconsidered, the comments and suggestions of the board are sent to the investigator.

If the protocol and consent forms(s) are disapproved, written comments are sent to the investigator for possible resubmission at a later date.

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