Preparing for Success: Protocol Start-Up

1. Preparing for Success: Protocol Start-Up Michelle Groy Johnson Quality Improvement Officer Research Integrity Office

2. Most Common Findings • Consent Form Issues • Wrong versions used to consent • Unstamped versions of form used to consent • Missing signatures (PI, person obtaining consent, participant) • Missing dates of signatures

3. Most Common Findings • Protocol Deviations and Violations • Actual practices not described in the protocol • Data collected without consent • Electronic data not encrypted • Data stored with completed consent forms and/or code sheets • Data, consent forms, and/or codes sheets not stored as described • Research team members added and/or removed without IRB approval

4. Most Common Findings • Administrative deficiencies • Missing IRB documentation (e.g. approved protocols, requests for modification, approval certifications) • Lack of file notes • Lack of documentation of PI oversight

5. The Common Denominator Troubled Record Keeping

6. Basics • Administration • Research • Reporting Problems

7. Administrative File • Documents submitted to the IRB (e.g. protocol applications, recruitment materials, instruments, modification requests, continuing review requests, etc.) • Documents approved by the IRB (e.g. consent forms with approval stamps, protocol applications, recruitment materials, instruments, modification requests, continuing review requests, etc., especially if these materials were revised between submission and approval.) • Relevant correspondence to and from the IRB (e.g. approval letters, emails from RIO requesting changes, emails to RIO explaining issues, etc.) • Relevant correspondence to and from other entities (e.g. emails with sponsors, performance sites, or participants that may have bearing on the study. Emails to study team members regarding execution of study procedures, etc.) • File notes (e.g. explanations of time gaps, descriptions of relevant phone conversations, descriptions of study team meetings, etc.)

8. Research File • Completed consent forms: each consent form must be signed and dated by the participant, person obtaining consent and principle investigator. Do not back-date. Make file notes for time gaps. (e.g. the participant signs on Friday, august 3, 2012, and the PI signs, Monday, August 6, 2012, write a note explaining that the PI was the person who obtained consent and was not available to review the consent form for accuracy and to sign it until after the weekend had passed. Consent forms must always be maintained separately from data and code sheets, preferably in a locked space that is separate from the locked spaces where code sheets and data are maintained. Electronic (i.e. scanned) consent forms must be encrypted. • Master code sheets: code sheets must always be maintained separately from data and consent forms, preferably in a locked space that is separate from the locked spaces where consent forms and data are maintained. Electronic code sheets must be encrypted. • Data: data must always be maintained separately from code sheets and consent forms, preferably in a locked space that is separate from the locked spaces where consent forms and code sheets are maintained. Electronic data must be encrypted.

9. Reporting Problems Researchers must follow the protocol as approved and may not implement changes that have not been approved by the IRB. This includes but is not limited to: • Study Procedures • Recruitment Materials • Consent Forms • Instruments • Performance Sites • Study Personnel

10. Reporting Problems If deviations or violations of the approved protocol occur, it must be promptly reported to the IRB. Other considerations that must be promptly reported to the IRB include but are not limited to: • Changes in risks • Invasion of Privacy • Changes in Benefits • Breach of Confidentiality • Complaints • Suspension or Termination

11. Case Study Professor Fit is conducting a study on the effect of exercise on literacy in grades 2 through 5 at a local school. The study will include physical activity and literacy testing on all participants (approximately 400) as well as an additional literacy test on a subset (75). All activities are described in the protocol as research and are not part of the regular curriculum at the school. The protocol indicates that only students with parental permission will be participants in the study. All data will be kept confidential. Prior to data collection, the school principal tells the researchers she wants all of the kids at the school to participate in the physical activities and the general literacy testing. The researchers are happy about this because now their research is “part of the curriculum” and they only need consent from the parents of the kids in the subset. They have already sent out the consent forms and 400 consent forms have been returned, far more than the 75 they need. Almost 800 kids participate in the physical activities and general literacy testing, and the results of the physical testing are given to the teachers to send home. The protocol, data, code sheets, and consent forms are stored together in both paper and electronic formats. The PI is unsure if the code sheets are up to date and believes that the co-investigator may have some additional information relevant to the study. Spanish versions of the consent form were used in the study but had not been submitted to the IRB. None of the consent forms were signed by the PI.

12. Case Study: Issues • Protocol Deviations/Violations • The activities were described in the protocol and approved as research, not curriculum, and the data were used for research purposes. Consequently, • Over 300 children participated in research without parental permission or assent. • Data was released to teachers and families without consent. • Administration • The PI did not know where all of the study information was located. • Data was stored with consent forms and code sheets. • Unapproved materials were used.

13. How to Avoid Being a Case Study • Before you start, design a filing system, and train your research team how to use it. • Event Based seems to work best • Communicate regularly with the research team, especially about changes such as updated consent forms or modifications to the protocol. • Never implement changes without prior approval from the IRB unless the immediate safety of the participants is at stake. If this is the case, report it to the IRB! • Ask for help! RIO offers start-up visits to help you set up your study.

14. Contact The Research Integrity Office 218 Ross Hall ~ Mail Stop 0331Reno, NV 89557-0331 (775) 327-2368