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IRB Survey Results

1. Please rate your level of agreement with each of the following statements:

I was able to easily/intuitively navigate the vIRB system.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
19.6% 50.0% 4.3% 19.6% 6.5% 0.0%

I understood what information I was supposed to put in each protocol section.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
10.9% 54.3% 10.9% 19.6% 4.3% 0.0%

I was able to make the correct choice of review type (exempt, expedited, full committee) based on the vIRB instructions.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
17.4% 54.3% 4.3% 23.9% 0.0% 0.0%

I was able to upload supporting documents such as consent forms and recruitment materials with ease. Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
32.6% 52.2% 8.7% 2.2% 2.2% 2.2%

If your study initially received a "conditional approval" status: The IRB concerns/questions that I needed to address were easy to find within vIRB.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
15.6% 42.2% 13.3% 11.1% 2.2% 15.6%

I received IRB review notification in a timely manner.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
34.8% 37.0% 13.0% 10.9% 4.3% 0.0%

I was able to download documents such as help forms and guidance materials with ease.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
17.4% 37.0% 17.4% 13.0% 2.2% 13.0%

I was able to easily find and take the required human subjects tutorial.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
34.8% 43.5% 6.5% 13.0% 0.0% 2.2%

2. Please your rate level of agreement with each of the following statements: SDSU IRB Members and/or Analysts (office support)...

Appeared to be familiar with the methods used in my field of research.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
22.0% 48.8% 14.6% 9.8% 0.0% 4.9%

Provided clear instructions on what to do at each step of the protocol submission process (i.e., initial submission, responding to conditions, etc.).
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
34.1% 43.9% 4.9% 7.3% 2.4% 7.3%

Were responsive to my questions and concerns.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
53.7% 29.3% 9.8% 2.4% 2.4% 2.4%

Were available to talk about and provide clarification to my questions.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
43.9% 39.0% 7.3% 2.4% 0.0% 7.3%

Reviewed my protocol in a timely manner.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
43.9% 34.1% 4.9% 12.2% 2.4% 2.4%

Provided a rationale for any required changes to my protocol.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
37.5% 27.5% 10.0% 7.5% 5.0% 12.5%

Worked with me to find mutually satisfying solutions to potential ethical problems.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
22.0% 34.1% 2.4% 2.4% 0.0% 39.0%

Were open and pleasant during our interactions (both written and verbal).
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
56.1% 31.7% 2.4% 4.9% 0.0% 4.9%

Respected participants' rights while facilitating the conduct of research.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
41.5% 34.1% 7.3% 0.0% 0.0% 17.1%

Took responsibility for errors or delays in processing my protocol.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
9.8% 19.5% 7.3% 9.8% 0.0% 53.7%

Made comments that negatively impacted my research.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
0.0% 0.0% 9.8% 24.4% 46.3% 19.5%

3. Please rate your level of agreement with each of the following statements:

The IRB views itself as an investigator's ally rather than as a hurdle to clear.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
9.8% 51.2% 12.2% 22.0% 2.4% 2.4%

The IRB views the advancement of science is part of its mission.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
17.1% 43.9% 29.3% 4.9% 0.0% 4.9%

The IRB shows empathy with the difficulties that can present themselves during the design and conduct of research.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
12.2% 46.3% 22.0% 14.6% 0.0% 4.9%

The IRB includes members who are very knowledgeable about IRB procedures and federal policy.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
34.1% 46.3% 12.2% 2.4% 0.0% 4.9%

The IRB conducts a conscientious analysis of potential benefits weighed against potential risks before making decisions.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
19.5% 48.8% 26.8% 0.0% 0.0% 4.9%

The IRB offers information to improve the chances of gaining IRB approval.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
26.8% 43.9% 12.2% 9.8% 2.4% 4.9%

The IRB responds in a timely manner to investigator queries about its processes and decisions.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
39.0% 31.7% 17.1% 9.8% 0.0% 2.4%

The IRB offers consultation during the development of research protocols and grant applications.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
19.5% 34.1% 9.8% 4.9% 2.4% 29.3%

The IRB offers investigators opportunities to be educated about federal research policy.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
12.2% 43.9% 22.0% 2.4% 0.0% 19.5%

The IRB offers helpful editorial suggestions regarding consent documents and protocols (typos, grammar, clarity, etc.).
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
22.0% 24.4% 24.4% 9.8% 2.4% 17.1%

The IRB members fully understand and act within the scope of their function.
Strongly Agree Agree Neutral Disagree Strongly Disagree N/A
22.0% 48.8% 19.5% 7.3% 0.0% 2.4%

4. Did you review the SDSU IRB Guidance Manual prior to developing your IRB protocol?

Yes 83.3%
No 16.7%

5. Was the guidance manual helpful?

Yes 78.6%
No 4.8%

I did not review the guidance manual. 16.7%

6. Did you complete the SDSU IRB Tutorial in advance of preparing your IRB protocol?

Yes 81.0%
No 19.0%

7. After submitting your protocol, how long did it take to receive IRB review comments that indicated what information/clarification was needed to approve your protocol?

Less that One week 14.3%
1-2 weeks 21.4%
2-3 weeks 11.9%
3-4 weeks 21.4%
More than 4 weeks 11.9%
I don't remember 11.9%
Not applicable, I did not receive comments. 7.1%
Other (please specify number of weeks) 0.0%
Other (please specify number of weeks) 0.0%

8. Participants in my study included (check all that apply):

Adults (18+ years) 78.6%
Children and Minors (under 18) 14.3%
Cognitively Impaired Persons 7.1%
Prisoners 4.8%
Elderly/Aged Persons 7.1%
Minorities 31.0%
Students 16.7%
Other (please specify) 7.1% secondary data on individuals (census and survey)
Women
Pre existing data set

9. My research is conducted (check all that apply):

In a lab 19.5%
In a school 19.5%
In a prison 2.4%
In a hospital 7.3%
Over the telephone 9.8%
Through the regular mail 7.3%
On the Internet 14.6%
Other (please specify) 63.4%
Using software SPSS
Mostly from automated, official records of an adult correctional agency.
Their home
Use of existing data
COMMUNITY
Community
I used secondary data.
At SDSU Student Health Services
Community mental health center
community-based sites
in the field
in participants' homes
Using County surveillance data.
AT A RAILROAD COMPANY IN CANADA
in the Geography Computer Lab
Through the interviews at participants' homes.
Existing data
community
face-to-face; in the community
existing data collected in a state welfare agency and from students

10. My most recent protocol submission received the following type of review:

Exempt - existing data 40.5%
Exempt - prospective data collection 14.3%
Expedited 26.2%
Full committee review 19.0%

11. My research involves mainly:

Qualitative methods 4.9%
Quantitative methods 61.0%
Both qualitative and quantitative methods 34.1%
Not Sure 0.0%
Other (please specify) 0.0%

12. Please identify the type of research your most recent protocol involved (check all that apply):

Biomedical 16.7%
Social/Behavioral 90.5%
Educational 7.1%
Other (please specify) 4.8%
Exercise Science
testing web based maps

13. Have you ever been a member of an IRB?

Yes 4.8%
No 95.2%

14. How long have you involved human subjects in your research?

Less than 1 year 29.3%
1 to 4 years 12.2%
4 to 7 years 19.5%
7 to 10 years 4.9%
More than 10 years 34.1%

15. Do you have prior experience using web-based application systems?

Yes 73.2%
No 26.8%

16. Have you ever submitted a protocol to an IRB at an institution other than SDSU?

Yes 57.1%
No 42.9%

17. Did your most recent IRB protocol require review by more than one institution?

Yes 31.0%
No 69.0%

18. Age:

Under 18 0.0%
18-25 17.5%
26-35 37.5%
36-45 15.0%
46-55 25.0%
Over 55 5.0%

19. Gender:

Male 10.0%
Female 90.0%

20. SDSU Position:

Faculty 20.5%
Adjunct Faculty 12.8%
Graduate Student 56.4%
Staff Member 5.1%
Other (please specify) 5.1%
undergraduate student
Research associate

21. Indicate the SDSU school/department in which you are affiliated:

Geography
Sociology
Psychology
Graduate School of Public Health
Women's Studies
Public Health &; Psychology
cbeach
ENS
Chicana/o Studies Department
GSPH
GSPH
Health and Human Services--Social Work/Public Health
STE
Psychology
GSPH
College of Education
Psychology
SDSU/UCSD Joint Doctoral Program in Clinical Psychology
Public Health
Public Health
GSPH
GSPH
Psychology
Audiology
GSPH
Clinical psychology
Public Health
SDSU / PSYCHOLOGY
Sciences/Psychology (Joint Doctoral Program in Clinical)
School of Communication
Imperial Valley/ Psychology
Geography
Psychology
Education
Social Work
IVC
Public Health
SLHS
Education
GSPH

22. In my experience, the biggest challenge to working with the IRB is:

Lack of clarification regarding requirements for students in joint doctoral programs

Slowness of response from the IRB. A few glitches in the computer program.

I think the online system should be revised to be more user friendly.

The amount of time it takes to answer all of the questions, although I understand why the process needs to be so thorough. Also, it took awhile to get back (a month?)

Understanding how to use the virtual IRB to respond to comments regarding a conditional approval.

to respect all regulations and still recruit enough subjects

Climate of scrutiny that is handled in a manner that makes one feel they are being led into a trap because the concerns are not discussed in a proactive, above-board manner. If a potential misstep is identified by IRB, it is best for the IRB to be above board rather than followed up by leading questions. Errors can be made in interpretation that can be made more inaccurate by asking questions and the intent of the IRB not discussed.

rewrite the research plan to fit the sections of the IRB, instead of uploading the whole research plan. When receiving an email information saying that I need to look up comments, I need to open many sections to figure out where the comments where. Maybe you need a system where it highlights the sections that IRB has inserted comments then we can go to that section right away.

I think figuring out how to use the on-line IRB took a little getting used to. However, it was easy once I started using it.

Knowing which type of review is necessary

1) Phone call was not returned. 2) The turnaround time for an expedited review seemed too long (more than 3 weeks) after we addressed the responses to a conditional approval. Having a conditional approval delays the start of recruitment of subjects.

Overcoming unreasonable obstacles because I work with people who have disabilities. I do interviews and focus groups and my work is not intrusive--it is helpful to participants because I always provide resources. I am not injecting people with drugs or giving them TB. I do think a full review to engage people in a focus group to discuss their benefits is overkill.

Exempt vs. Expedited I was lucky to have a speaker come to our class to clarify and walk us through each section. Without that, I would have had more trouble.

Unfriendly web-based system; significant changes to the system could be made that would improve the protocol development and submission process. Critical to this would be having the IT development staff (or whoever would handle making the changes to the system) meeting with the investigators who have to use it in order to develop a system that is user-friendly and meets the needs of both investigators and the IRB staff and committee.

nothing was a big challenge.

none, I found SDSU's IRB process to be very simple and effective

Understanding what was necessary for the IRB proposal.

I DIDN'T HAVE ANY CHALLENGES.

The IRB server crashes far too frequently, and it is completely inaccessible at the beginning of semesters. Apparently, the server also "loses" electronic submissions periodically, which seems very odd and is a serious concern.

The comments did not appear on my IRB so I did not know how to change my proposal.

nothing has been too challenging. i've had positive experiences with the sdsu irb

Trying to navigate the website and access it when webportal is down.

to meet the timeline in order to finish the research in time for graduation.

Developing a positive alliance that helps with the application process - especially in the development of appropriate risk/benefit review and measures to address the risks. This was a very helpful process at SDSU

The online submission is not as easy to navigate and complete as it could be. One gets used to it, but it long and sometimes unclear how to complete it.

Timelines. The office is significantly under-staffed for the amount of research that is conducted at SDSU. We need quicker turn-around times, particularly when community members are waiting for us to obtain approval.

glitches in the online system - The system really needs to be revised

Deciding what each section question is actually asking me, since they seem redundant. Also replying to comments appropriately.

navigating the joint IRB review at UCSD and SDSU



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