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PROTECTION OF HUMAN SUBJECTS USED IN RESEARCH
GENERAL GUIDELINES, POLICIES, AND PROCEDURES OF THE TEMPLE
UNIVERSITY INSTITUTIONAL REVIEW BOARD SUBCOMMITTEE B FOR
THE SAFEGUARDING OF THE RIGHTS AND WELFARE OF HUMAN BEINGS
PARTICIPATING IN FUNDED AND NON-FUNDED RESEARCH
Revised: August 2010
TABLE OF CONTENTS
Page
Introduction . . . . . . . . . . . . . . . . . . . . . . . 2
Studies Requiring Review . . . . . . . . . . . . . . . . . 2
Definition of Human Subjects . . . . . . . . . . . . . . . 3
Research Review by the IRB . . . . . . . . . . . . . . . . 3
Exempt Research Proposals . . . . . . . . . . . . . . . 5
Expedited Research Proposals . . . . . . . . . . . . . . 6
Full Committee Review Research Proposals . . . . . . . . 7
Preparation of the Request for Protocol Review . . . . . . 8
Face Sheet . . . . . . . . . . . . . . . . . . . . . . . 8
Part I. . . . . . . . . . . . . . . . . . . . . . . . . 8
Part II. . . . . . . . . . . . . . . . . . . . . . . . 10
Part III. . . . . . . . . . . . . . . . . . . . . . . . 11
Part IV. . . . . . . . . . . . . . . . . . . . . . . . 11
Part V. . . . . . . . . . . . . . . . . . . . . . . . . 14
Part VI. . . . . . . . . . . . . . . . . . . . . . . . 14
Responsibilities of the IRB Subcommittee B Following
the Submission of the Request for
Protocol Review . . . . . . . . . . . . . . . . . . . . 14
Responsibilities of the Investigator(s) Following
the Approval of the Request for Protocol
Review by the IRB . . . . . . . . . . . . . . . . . . . 15
Appendix A: Request for Protocol Review . . . . . . . . . 16
Appendix B: Permission to Videotape . . . . . . . . . . . 22
Permission to Audiotape . . . . . . . . . . . 25
Permission to Photograph . . . . . . . . . . . 28
Appendix C: Sample Consent Forms . . . . . . . . . . . . . 31
Appendix D: Indemnifying Clauses . . . . . . . . . . . . . 40
Appendix E: Application Check List Form . . . . . . . . . 42
INTRODUCTION
Safeguarding the rights and welfare of all human beings (i.e., human subjects) who participate in research projects conducted under the aegis of Temple University is the responsibility of both the University and the investigator(s). The safeguarding of the rights and welfare of human subjects is extended to the intent of the investigator(s) to protect research subjects as well as comply with the specific requirements established by sponsors of its research, the standards established by the Declaration of Helsinki Recommendations Guiding Doctors in Clinical Research in 1964 (revised in 1975), U.S. Department of Health, Education, and Welfare Guidelines in 1971 (revised in 1974), The Nuremburg Code in 1947, The Belmont Report in 1978, and the American Psychological Association codes for pursuit of social and behavioral research published in 1973.
No one such guideline or code is fully adequate to meet all research situations. Concerns that the rights and welfare of human beings are safeguarded from individuals who are conducting research requires federally mandated review processes to assure adequate protection of human subjects used in research protocols. The Institutional Review Board (IRB) Subcommittee B represents most research conducted on the main campus of Temple University and has the responsibility to review in representing the best in ethical concerns for the safeguarding of the rights and welfare of all human subjects used in research protocols. Generally, the IRB Subcommittee B reviews research protocols that are limited to non-medical interventions. Subcommittee A of Temple University School of Medicine and Temple University Hospital will review protocols requiring medical interventions and most research involving human materials.
The length of time required for the review process of submitted Request for Protocol Review to the IRB Subcommittee B is variable. The review process for studies that qualify for expedited review usually require three or more weeks. Request for Protocol Review requiring full committee review may require several months for the review process. The full committee of the IRB Subcommittee B meets approximately every eight weeks for the review of research protocols requiring full committee review.
STUDIES REQUIRING REVIEW
Temple University is charged by federal guidelines and procedures to review all research involving human subjects or human materials carried out by its personnel. There is no distinction between funded and non-funded research activity by either Federal Guidelines and policies and procedures of the IRB of Temple University.
To assure the protection of human subjects and to comply with federal law, Temple University requires that, prior to initiation, all research projects involving human subjects or human materials be reviewed and approved by the IRB. This policy applies to all biomedical and behavioral research involving human subjects or human materials conducted by faculty, staff, and students of Temple University. If the research program or study is a part of an application to a Sponsoring Agency, the human protocol must be submitted for either Subcommittee B's or Subcommittee A's review prior to or when the application is processed by the Office of the Vice President for Research.
DEFINITION OF HUMAN SUBJECTS
Research involving human subject(s) is defined as research involved with any living individual about whom any investigator (whether faculty, staff, or student) conducting research obtains data through an intervention or an interaction with that individual or acquisition of identifiable private information. "Intervention" includes both a manipulation of the human subject's environment or physical acquisition of data performed for research purposes. "Interaction" includes any communication or interpersonal contact between the investigator and the subject for research purposes. "Private information" includes all information about an individual or the behavior of an individual that occurs in a context in which an individual can reasonably expect that no observation is taking place, and/or information which has been provided for specific purposes by an individual who reasonably expected would not be made public. Such information must be individually identifiable by the investigator to constitute research involving human subjects.
RESEARCH REVIEW BY THE IRB
Human research is defined as any activity initiated by Temple University faculty, staff, or student which has the intent of securing information from humans for the purpose of advancing generalized knowledge. There is no distinction whether the activity is funded or non-funded. The IRB of Temple University must review all research protocols involving human subjects. It is assumed by the IRB that the investigator has included in the submission of the research protocol explicit objectives and formal procedures of the research so suitable review can be undertaken.
The IRB has the responsibility of reviewing and the authority to approve, require modification in, or disapprove any or all activities or proposed changes in previously approved research activities. The IRB approves human research based on the IRB's determination that the following requirements are satisfied:
Risks to human subjects are minimized by using research procedures which are consistent with sound research design and which do not unnecessarily expose the subject to risk. Appropriate procedures already being performed on the subjects for diagnostic or treatment purposes are not altered in a way to increase risks to the human subjects.
Risks to subjects must be reasonable in relation to the anticipated benefits, if any, to subjects and the importance of knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB considers only those risks and benefits which may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participation in the research).
Selection of subjects must be equitable. In making this assessment the IRB shall take into account the purpose of the research, the setting in which the research will be conducted, and the population from which the subjects will be recruited. The IRB shall determine if the investigator by knowledge or unknowingly uses coercion for human subjects participation in research. Such coercive actions by an investigator may include using students in his/her class, assigning extra credit for participation in research, waiving other course requirements, etc . All of these actions would require the IRB to disapprove the research protocol unless there were unusual extenuating circumstances.
The IRB must assure that informed consent is sought from each prospective subject or the subject's legally authorized representative, in accordance with law. The informed consent must be appropriately documented.
The IRB must assure that adequate provisions for monitoring the data collection to insure the safety of subjects.
The IRB must assure that adequate provisions for the protection of the privacy of subjects and to maintain the confidentially of data.
The IRB must assure that when a cooperating institution(s), departments, or cooperating research site(s) are to be utilized in the investigator(s) research that appropriate notifications and approvals of use of the institution or site for research have been acquired.
There are three categories of research protocols that are reviewed. These are research proposals which are exempt from review, research proposals which undergo expedited review, and research proposals which require full committee review.
Exempt Research Proposals
The Office of the Vice President for Research of Temple University in consultation with the IRB is responsible for reviewing the preliminary determination of research investigations and for making final institutional determination whether research protocols qualify for exemption. Therefore, the investigator must submit to the IRB a proposal so that a determination for exemption can be made.
The following categories of research are normally exempt from full committee IRB review but must be reported to the IRB for determination of exempt status [Please note that studies using children (i.e., minors) or special populations are ineligible for exempted review]:
Research conducted in established or commonly accepted educational settings, involving normal educational practices.
Research involving educational tests (i.e., cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior. No research will be exempted if the information obtained is recorded in a way that the subject can be identified or through identifiers linked to the subject; or, any disclosure of the human subject's responses outside of research could reasonably place the subject at risk of criminal liability, civil liability, or damage financial standing, employability, or reputation. Further, no human research involving elected or appointed public officials or candidates for public office can be exempted [federal statute(s) require(s) confidentiality without exception of the personally identifiable information will be maintained throughout the research and thereafter].
Research involving existing data or documents that are publicly available or if the information is recorded by the investigator in a manner that human subjects cannot be directly identified or through identifiers linked to the subjects.
Exempt research protocols will be forwarded to the appropriate Sponsoring Agency if deemed exempt by the IRB and the Office of the Vice President for Research. All nonexempt research proposals will be forwarded to the IRB for review.
Expedited Research Proposals
The Office of the Vice President for Research will in consultation with the appropriate IRB Subcommittee chairperson determine whether the research protocol meets the requirements necessary for expedited review process. Other members of the IRB are called upon as necessary to ensure sound judgement of the expedited review. The eligibility of some research for review through the expedited procedure is in no way intended to negate or modify the federal guidelines or procedures.
The IRB uses the expedited review process to review minor changes in previously approved research during the period for which approval is authorized. The only other research for which the IRB uses expedited review procedure is that which involves no more than minimal risk to subjects as demonstrated by the research protocol and indicated by the appropriated IRB Subcommittee chairperson and the Office of the Vice President for Research.
Expedited review is conducted by the appropriate IRB Subcommittee chairperson or by one or more of the experienced IRB members designated by the chairperson to conduct the review and the Office of the Vice President for Research. The IRB member(s) conducting the expedited review exercises have all of the authorities of the IRB except that the reviewer(s) may not disapprove a research protocol. The reviewer(s) shall refer any research protocols which the reviewer would have
disapproved to the full committee for review. The reviewer(s) shall also refer research protocols to the full committee whenever the reviewer(s) believes that full committee review would be warranted.
When the expedited review procedure is used, the appropriate IRB Subcommittee chairperson or member(s) conducting the review inform the full committee in writing of research protocols that have been approved. At a convened IRB meeting, any member may request that any research protocol which has been approved under the expedited procedure be reviewed by the IRB in accordance with non-expedited procedures. A vote of committee members will be taken for review with a simple majority required for full committee review.