Ithaca College – Sponsored Research All-College Human Subjects Review Board (HSR)

1. Ithaca College – Sponsored ResearchAll-College Human Subjects Review Board (HSR)

2. What is Sponsored Research? • Academic Funding • All-College Human Subjects Review Board (HSR) 3. Institutional Animal Care and Use Committee (IACUC) • Institutional Biosafety Committee (IBC) 5. James J. Whalen Academic Symposium – April 10, 2014

3. Research Involving Human Subjects: HSR Committee Members:

4. Maximize Benefit – Minimize RiskHSR Purposes Protect the rights and welfare of human subjects recruited to participate in research activities conducted under the auspices of Ithaca College

5. Purposes of HSR • Develop and implement College policies and procedures that reflect the ethical principles of the Belmont Report consistent with federal regulation. • Provide the IC community with Human Subjects’ Protections education. • Maintain an accurate system for tracking the status of research protocols.

6. What Does the HSR do? • Primary goal is to ensure that human participants are protected • Committee reviews research proposals that involve the use of human participants • Resource for students and faculty wanting to conduct research involving human participants

7. What an HSR is NOT….. • Group wanting to develop your research design • Group wanting to micromanage your project • Faculty with endless time to give to your project

8. Definition: Research • “A systematic investigation designed to develop or contribute to generalizable knowledge.” (45 CFR 46.102[d]) • In other words: to develop or contribute to the general body of knowledge

9. Types of Applications: • Exempt • Expedited Review • Standard

12. No more than “minimal risk” • Noninvasive data collection • Video, voice and image recordings where risk of breach of confidentiality is minimal • Research involving the evaluation of “normal educational practices” Exempt or Expedited Review

13. Definition: Minimal Risk • Probability of harm no greater than in daily life activities or during routine physical or psychological tests

15. Exempt Projects 1. Research on teaching or instructional methodologies that are conducted in regular education settings. 2. Survey, observational research - as long as the information is recorded so that subjects cannot be directly linked to the data they provide AND you are not asking about sensitive aspects of the subject's behavior that might put them at risk for criminal or civil liability or that might harm their employability, reputation, or financial standing. 3. Observations of public behavior 4. Chart reviews as long as the data are publicly available OR the information is recorded so that subjects cannot be identified.

16. Exempt Projects Human Subjects Research Board (HSR) expedited or standard review is needed for:Projects that are components of a course but are conducted outside of the classroom, laboratory, studio, etc., and use persons not enrolled in the course as subjects. Remember that exempt status is determined by the HSR Board. 

17. Expedited Review Projects qualify for expedited review when research procedures are limited to activities that: • ·incur no more than minimal risk for participants, • ·entail a minor change in previously approved research that involves no additional risk to the research subject.

18. Federally approved includes: • Clinical studies of drugs and medical devices • Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture • Prospective collection of biological specimens for research purposes by noninvasive means • Collection of data through noninvasive procedures • Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes • Collection of data from voice, video, digital, or image recordings made for research purposes • Research on individual or group characteristics or behavior.

19. STANDARD APPLICATION • Projects require standard review when there is greater than minimal risk. • Projects whose subjects are part of a vulnerable population • Research with interviews or deception • Changes in the design of a previously approved study

20. Definition: Vulnerable Populations • Women and fetuses • Prisoners • Children • Mentally Disabled • Economically or Educationally Disadvantaged

22. Recruitment Statement • Needed for all applications EXCEPT Anonymous Surveys • For Anonymous Surveys use a Tear-Off Cover Page

24. Informed Consent Form Needed for ALL Applications EXCEPT Anonymous Surveys For Exempt Applications Only – you can use a Waiver of Informed Consent if: • Having a participant sign would itself be a risk of participation • Minimal risk involving no procedures where signed consent is required

25. Key Elements of Informed Consent • Description of the extent of confidentiality • Compensation ( or lack of) for injury • Whom to contact with questions • Whom to contact in event of injury • Right to refuse to participate • Right to withdraw at any time

26. Incomplete Information Informed consent form Lack of clarity on recruitment procedures Instrument not included Informed Consent Form Errors Ordinary language Transparency Risks not acknowledged Tape recording Age 18+ Committee responses to concerns Substantive comments Consultative comments Committee Actions Tabled Not approved Approved with stipulations Note- Project cannot commence until full approval is granted Approved Common Mistakes in the Application Process

27. CITI Certification Only required of those with federal grants Recommended for all and can be integrated into classes where students are expected to learn research ethics as part of their course work.

29. Q & A