Policies and Procedures for Human Subjects Research Review

1. Policies and Procedures for Human Subjects Research Review Office of Government and Foundation Relations Siena Hall, 219 Tel.: 782-6558, Fax 782-6550 www.siena.edu/osr Alfredo Medina, Jr., M.S. Human Compliance Officer Joseph Marrone, Ph.D., Chair, Human Subjects Research Review Committee (IRB)

2. LEGAL REQUIREMENTS • The United States Department of Health and Human Services, Office for Protection from Research Risks (Title 45, Part 46 Protection of Human Subjects), requires that “any institution engaging in human subjects research establish an administrative body to protect the rights and welfare of human research subjects recruited to participate in research activities.” • This administrative body is referred to as an Institutional Review Board (IRB).

3. LEGAL REQUIREMENTS • The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both federal regulations and local institutional policy. • Currently, the Siena College Human Subjects Research Review Committee (IRB) consist of ten members: six faculty members from various disciplines, three administrators and an external representative.

4. PURPOSE • The Siena College IRB responds to all research projects involving studies on humans with respect to: 1) The rights and welfare of the individual(s); 2) The methods used to obtain informed consent; and,3) The risk and the potential benefits of the research. • Ensure that all investigators (including students) are in compliance with federal and institutional policies and, most importantly, to protect the rights of the subject(s).

5. IRB REVIEW PROCESS • Before reviewing a protocol, the IRB has to determine whether it has jurisdiction over approval of the research. In other words, is the research subject to IRB review? What is research? Research as defined by the Federal regulations is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”.

6. IRB REVIEW PROCESS What are human subjects? As defined by Federal regulations, human subjects are “ living individuals about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information”. Therefore, any project that fits these two definitions may be subject to IRB review.

7. IRB REVIEW PROCESS At Siena College, there are two (2) types of review: 1. Expedited Review (Minimal risk) 2. Full Review • According to Federal guidelines, 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.” • The form of review that applies to a research project is determined by the IRB, not the investigator.

8. EXPEDITED REVIEW What qualifies for expedited review? The expedited review procedure may be used for research projects that: • Pose no more than minimal risk; • Involves one or more research activities listed in the federal regulations as qualifying for expedited review; and • Propose modifications to previously approved research during the period (one year or less) for which approval has been granted.

9. EXAMPLES OF EXPEDITED REVIEW • Observation of classroomsinvolving no interaction with students or disruption of dailyclassroom work. • Anonymous, non-interactive observation of public behavior. • Research involving nopsychological intervention or deception. • Anonymous telephone or mailquestionnaires on topics oninnocuous topics. • Interviews or surveys onnon-sensitive topic.

10. FULL REVIEW What qualifies for full review? All proposed research that does not meet the criteria for an expedited review must be reviewed by all members of the IRB. This is referred to as full board review. • Full board review may be required for research projects initially submitted for expedited review. That decision rests with the IRB Chair. • An investigator may be asked to be present when his/her application is reviewed by the full board, in order to clarify any uncertainties that may exist in the minds of the IRB members. If the investigator is a student and cannot be present, his or her adviser is welcome to appear in lieu of the investigator.

11. EXAMPLES OF FOR FULL REVIEW • Research thatinvolves interaction with persons under 18 years of age • Research that places humans atpsychological or physiological risk • Research on special populationssuch as prisoners and  mentallyincompetent • Research involving deception • Research involving sensitivetopics

12. IRB APPROVAL PROCESS • All applications should be submitted to the Human Compliance Officer who will log them and then either forward them to the IRB Chair for action or return to the applicant if they are incomplete. • Upon receipt of an application for review, the IRB Chair will determine what form of review applies and inform the investigator by email. Expedited review can usually be completed in 2-3 days. If a full review is required, the IRB Chair will distribute copies of the application to the full committee. It generally will take 2-4 weeks for the IRB to complete a full review of a research plan, so investigators should plan accordingly.

13. SPECIAL POPULATIONS Subjects considered to be “vulnerable” typically are defined as special populations and require special protection. The most common classes of special populations are: • Children (under the age of 18) • Prisoners • Pregnant women • Mentally incompetent individuals • Economically or educationally disadvantaged persons

14. RESEARCH INVOLVING CHILDREN What are some of the basics in conducting research with children? • A child (minor) is anyone under the age of 18. • Assent: a child's affirmative agreement to participate in research must be attained from the child as well as permission from parent(s)/guardian(s). • Permission: means the agreement of parent(s) or guardian to the participation of their child or ward in research.

15. RESEARCH INVOLVING CHILDREN Federal regulations specify four categories of risk to children as subjects: • Minimal risk (requires both assent of the child and permission of parent/guardian). • Greater than minimal risk, but direct benefit to individual subject (requires both assent of the child and permission of parent/guardian). • Greater than minimal risk, with no direct benefit to the individual, but likely to yield generalizable knowledge about the subject’s disorder or condition (requires both).

16. RESEARCH INVOLVING CHILDREN …Continued • Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. • Under Federal and Siena College policy, any research involving children are required to undergo full review.

17. CHILD’S ASSENT • Assent of the child must be obtained if s/he is capable of giving consent. • Elementary school-age children should provide oral assent to participate after the project is explained at their level of understanding. • Middle school-age children and older can provide written assent.

18. INFORMED CONSENT What is informed consent? Informed consent is the process by which prospective human subjects, or their legal representatives, are informed: • Of the nature and purpose of the proposed research, including risks, in a manner appropriate to their level of understanding and in non-technical language; • That they have the right to decline to participate or to withdraw from participation at any time without penalty; and • Given adequate time to decide if they want to participate.

19. INFORMED CONSENT • Informed consent should be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy should be given to the person signing the form. • It is important that the investigator communicate, rather than just provide information. Asking questions in order to elicit questions or comments from the subject(s) is a good way to ascertain that s/he understands what is being proposed.

20. INFORMED CONSENT What exactly is involved in informed consent? • An investigator should cover the essentials of informed consent in his/her oral explanation to the prospective subject. • The investigator should meet with the prospective subject, determine if he or she is capable of giving consent, and then explain the study • To give valid informed consent, a potential subject should truly understand what he or she is giving consent to.

21. BASIC ELEMENTS OF INFORMED CONSENT • Statement that the study involves research and is being conducted through Siena College. • Explanation of the purpose of the research and the expected duration of the subject’s participation. • Description of the procedures to be followed. • Identification of any procedures that are experimental. • Description of any reasonably foreseeable risks or discomfort to the subject. • Description of any benefits to the subject or to others that reasonably may be expected from the research.

22. BASIC ELEMENTS OF INFORMED CONSENT • Statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained • Explanation of whom to contact about: 1. The research project 2. Research subjects’ rights 3. Research-related injury to the subject

23. BASIC ELEMENTS OF INFORMED CONSENT Statement regarding participation: 1. Participation is voluntary. 2. Refusal to participate will not involve a penalty or loss of benefits to which the subject is otherwise entitled 3. Termination of participation at any time will not involve a penalty or loss of benefits to which the subject is otherwise entitled

24. DECEPTION & DEBRIEFING • If deception is involved in a research project, the IRB Chair will determine if the research should undergo full review. • Deception can not be used where there is risk to the subject. • No information can be withheld from subjects that can significantly affect their decision to participate. • Subjects need to be informed about the nature of the research in a way that it does not invalidate the data.

25. DECEPTION & DEBRIEFING All subjects must be debriefed regarding the true nature of the study after their participation. • A debriefing statement should: • Explain all truths not revealed and all falsehoods told to the subjects. • Address why deception was necessary. • Reassure subjects that their reactions to the deceptions were normal.

26. IRB APPLICATION The Siena College IRB review packet consist of five (5) parts: 1.Cover Letter (background information) 2.Criteria for Proposal Review (general guidelines) 3.Application* 4.Informed Consent* (sample and guidelines) 5.Checklist *Documents to be submitted for review

27. USEFUL RESOURCES • The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research http://ohsr.od.nih.gov/mpa/belmont.php3 • Office of Human Subjects Research, NIHhttp://ohsr.od.nih.gov/ • Oklahoma State University IRB Training Quiz http://www.vpr.okstate.edu/irb/quiz/

28. IRB Committee Members, 2006-2007 Joseph Marrone, Ph.D., Chair Gil Brookins, M.S., Marketing and Management Robert Colesante, Ph.D., Education Salvatore Lombardo, Ph.D., Political Science Edward McGlynn, Ph.D., Sociology Alfredo Medina, M.S., ex-officio Jeanne Obermayer, M.A., Student Affairs Robert Rivas, M.S.W., Social Work Carol Sandoval, M.A., Academic Affairs External Representative Russell Moore, Ph.D., Building Principal Shaker Junior High School