Instructions for New IRB Application to Conduct Human Subject Research

1. Instructions for New IRB Application to Conduct Human Subject Research

2. Demographics – Section AThis section provides basic information about the researcher and the proposed project Indicate the Lifespan affiliate(s) where this work will be done Provide contact information for Principal Investigator and Principal Researcher. Be as complete as possible. Provide the complete project title as it appears on the sponsor’s protocol, grant application, or research plan Provide a short title for quick reference Indicate how you will support this project. If this project will use external funds, then you must contact the Grants and Contracts Office and submit the required business forms and budgets for administrative approval. This should be done in parallel with IRB submission because externally funded projects cannot be initiated until committee approval and financial approval (activation) is received.

3. Demographics – Section AThis section provides basic information about the researcher and the proposed project • If external funds (grants/contracts) will not be used, indicate departmental support. Please note: every project involves resources (personnel time, office supplies, etc) • Complete a separate COI registration form for each person listed on your IRB personnel list. Registration forms are available at http://www.lifespan.org/research/sharedcommtteeforms/coiregistrationform.doc • Indicate whether any other review committee considerations apply, such as the use of recombinant DNA or radiation. Please note: If the project will use radioactive material, X-rays or CT scans then you should submit this application simultaneously to the Radiation Safety Officer for review. • PI must sign the application • Obtain Departmental Chief (not Division Chief) signature before submitting to the IRB Office. FOLLOW THE CHECKLIST TO ENSURE YOU HAVE INCLUDED ALL REQUIRED ATTACHMENTS (See Checklist Handout)

4. Research Description-Section BProvides the IRB members with a brief overview of the project Nature and Purpose of Proposed Studies: • Technical Abstract: The technical abstract is directed towards scientists and provides a technical description of the proposed project. The scientific abstract from a grant application can be inserted here. • Lay Summary: The Lay summary is intended for non-scientists. The summary should describe the objectives of this project and the procedures to be used, with an emphasis on what will happen to the subjects. Do not duplicate the technical abstract Performance Site: • Describe where this work will be done in sufficient detail for the IRB to evaluate risk to subjects. • The IRB needs to know if other departments will be impacted by this research. For example, if subjects will be cared for in the hospital or in a clinic, then the medical professionals who provide care for the subjects may need to know about the research. Secondly, if data or specimens will be obtained from another department (such as Pathology), then the “source” department needs to agree to provide the information/specimen.

5. Research Description-Section BProvides the IRB members with a brief overview of the project Performance Site Cont’d: • If the Principal Investigator will be responsible for conducting/overseeing this research at sites outside of Lifespan then the IRB must ensure that appropriate approvals have been obtained from non-Lifespan sites. • If the Lifespan PI is the main PI for all sites in a multi-site trials, then the IRB must ensure that there are adequate plans for sharing data (revisions, adverse events, reports of unanticipated problems, etc) with all sites. Personnel: • indicate how the PI is affiliated with Lifespan • indicate how staff will be trained in the protocol

6. Human Subjects Protection Section CDescribes the research subject population and identifies any special areas of concern that may require additional protections/provisions I. Research Population • Describe your target research subject population. For example, subjects could be defined as having a specific diagnosis/condition or they could comprise a convenience sample of people found at a certain location or event • The IRB is required to make specific determinations if your research will include subjects who are particularly vulnerable so you need to indicate if individuals from any of the specially protected groups will be enrolled and provide additional information requested in the appendices as noted on the form • The IRB must determine that study procedures will protect the rights and welfare of vulnerable research participants. • The IRB must determine that subject selection is equitable and that all relevant ethnic groups, genders, and populations have access to the study as applicable. The IRB must also ensure that ample number of subjects are available to complete the research because research that is started and not finished may put enrolled subjects at risk without any prospect for societal benefit.

7. Human Subjects Protection Section CDescribes the research subject population and identifies any special areas of concern that may require additional protections/provisions II. Subject Recruitment • Describe how you will find potential research subjects III. Informed Consent Process • This section is included to help the IRB determine if the proposed informed consent processes will be adequate. If you will not obtain written informed consent from research subjects, then you will need to apply for a waiver of consent, or an alteration of the consent process. • It is expected that research subjects will be provided with ample time to decide whether or not to take part in this research. Any exceptions must be justified and accepted by the IRB • It is expected that research subjects will not be coerced or unduly influenced to participate, special circumstances must be explained and justified. • Federal regulations specify that the consent process must be done in a language that is understandable to the research subjects. If the research is likely to enroll subjects who do not speak English, then additional provisions must be in place to protect the rights and welfare of enrolled subjects.

8. Human Subjects Protection Section CDescribes the research subject population and identifies any special areas of concern that may require additional protections/provisions IV. Participation Compensation • Describe any compensation provided, including parking vouchers • Privacy and Confidentiality Considerations • The questions posed in this section are intended to describe the procedures that will be used to protect subject privacy and data confidentiality • Common methods used to protect privacy during recruitment include procedures where by initial subject contact is done through an individual who is known to the potential subject (for example, clinical care provider). Research subjects should never have to ask “How did you get my name?” • Common methods to protect confidentiality of data from enrolled subjects includes the use of coding whereby identifiers are separated from the data with a secure code kept in a separate, secure location.

9. Human Subjects Protection Section CDescribes the research subject population and identifies any special areas of concern that may require additional protections/provisions • Privacy and Confidentiality Considerations cont’d • At a minimum, PHI and identifiable data must be stored in locked cabinets behind locked doors and electronic data must be stored on password protected computers and/or Lifespan approved devices. • If research data will include sensitive information (such as SSN#, HIV status, records of illegal activity, etc), then additional protections may be required • Researchers must receive a Waiver Preparatory to Research in order to use medical records to search for potential subjects

10. Human Subjects Protection Section CDescribes the research subject population and identifies any special areas of concern that may require additional protections/provisions • Investigational drugs and/or devices • The questions posed in this section are intended to provide the information that is required if drugs and/or devices will be used in this research. • NOTE: If study drug/device is not approved by the FDA, or not approved for the specified use/indication, then an IND# /IDE# or letter of exemption from the FDA is required. • Investigators are required to provide documentation of the FDA IND (for investigational drugs) and/or IDE (for investigational devices) • NOTE: If study device is not approved by the FDA for the specified use and an IDE has not been obtained, then the IRB must make a determination as to whether this is a significant (SR) or non-significant risk (NSR) device. It is imperative the sponsor make the preliminary determination. • Describe procedures to be used for assuring inventory control of the investigational agents. This plan is required to ensure that study agents are only used in the IRB approved manner.

11. Human Subjects Protection Section CDescribes the research subject population and identifies any special areas of concern that may require additional protections/provisions • Safety Considerations • The questions posed in this section are intended to provide sufficient information in order for the IRB to assess risk to subjects • Minimal risk means that the likelihood of harm or discomfort caused by the research is not greater than what is normally experienced in daily life or during the performance of routine physical or psychological examinations or tests. • The Lifespan IRBs require all studies that present greater than minimal risk to include a plan (DSMP) for monitoring subject safety. Please note: a safety plan should not be confused with a DSMB (data safety monitoring board). All studies (greater than minimal risk) require a safety plan, but only some will require a DSMB.Acceptable plans for monitoring subject safety include a description as to how adverse events are evaluated across all performance sites with respect to subject risk and frequently include criteria that would be used to prematurely stop the trial for safety reasons. A description as to how the researchers will submit AE reports to the sponsor is not a safety monitoring plan. The IRB needs to know who will look at these reports as they flow in from multiple sites and how often the reports will be reviewed. Additional guidance is located on the IRB webpage at http://www.lifespan.org/research/irb/irbdatamonitoring.asp

12. Human Subjects Protection Section CDescribes the research subject population and identifies any special areas of concern that may require additional protections/provisions • Safety Considerations cont’d • Explain why the proposed study does not present greater than minimal risk or explain how the study has been designed to minimize risk • For studies that include an intervention, describe what treatments would be provide if the subjects did not enroll in the study • Benefits • The questions posed in this section are intended to provide sufficient information in order for the IRB to determine benefit to subjects. This information is very important because the IRB must determine if risks are reasonable with regard to potential benefit. • Describe any potential benefits to research subjects, science, and/or society

13. ATTACHMENTSADDITIONAL DOCUMENTS ARE REQUIRED AS APPLICABLE • Personnel list, list all personnel who will interact with human subjects or their identifiable data/specimens (See form-handout) • Conflict of Interest Registration form, include a COI registration form for every individual on the personnel list (See form-handout) • Biographical Sketch for the Principal Investigator, this document must be updated annually (See form-handout) • Protocol, attach the complete protocol/grant application/research plan. For grant applications be sure to attach the ENTIRE grant (every page) • Clean copies of the proposed consent forms (required for studies that will use written informed consent). Make sure that the consent form follows the most recent IRB approved template • Clean copies of any ads or recruitment materials that will be used

14. ATTACHMENTSADDITIONAL DOCUMENTS ARE REQUIRED AS APPLICABLE • HIPAA forms as applicable. A request for Review Preparatory to Research is required if you will look at identifiable data before subjects agree to participate. A Waiver of Authorization is required if you will record identifiable information without permission from research subjects. • Investigator Brochure, required for studies that include the use of investigational drugs • Letters of Cooperation are required if other individuals or departments will perform services for this research. Some examples of when you would need a letter of cooperation include: • if a private group allowed you access to their membership lists for recruitment • if a clinical lab will perform research specific assays, or retrieve archived specimens • if a clinical department will perform tests or procedures that are done for research (such as imaging, stress testing, etc) • Nursing services forms are required if Lifespan nurses will administer investigational drugs or devices (See form-handout) • Study Instruments, tools or measures (such as surveys, subject diaries, psychological assessment tools)

15. Questions? If you have any questions, please call • Dawn Roux at 444-7547 for RIH IRB #1, • Adrienne McParlin at 444-3527 for RIH IRB #2 and TMH IRB, • Jacqui Poore at 444-2093 • Pat Houser at 444-2099 • Deb Temple at 444-5843