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National Outcomes Performance Assessment of the Collaborative Initiative to Help End Chronic Homelessness

0990-0304Data and Collection Instruments Request

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OMB: 0990-0304

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DATA AND COLLECTION INSTRUEMENTS FOR




EVALUATION OF OHRP EDUCATIONAL ACTIVITIES








Submitted by


Division of Education and Development

Office for Human Research Protections

Rockville, MD



Contact person:

Irene Stith-Coleman
Director
Division of Policy and Assurances
Office for Human Research Protections
1101 Wootton Parkway, Ste. 200
Rockville, MD 20852
ph.240.453.8138
fax.301.402.2071




INSTRUMENT C: Initial Assessment Survey




(Audience: Attendees at OHRP Educational Events where general information about OHRP is provided)




INSTRUMENT C: Initial Assessment Survey



Dear Participant:


The educational event you are attending is funded by the Office for Human Research Protections (OHRP), Division of Education and Development. OHRP is engaged in:


  • establishing criteria for and approving assurances of compliance for the protection of human subjects with institutions engaged in HHS-conducted or -supported human subject research;

  • developing, monitoring, and exercising compliance oversight of HHS regulations for protection of human subjects

  • providing clarification and guidance on involving humans in research;

  • developing and implementing educational programs and resource materials; and

  • promoting the development of approaches to enhance human subject protections.


Completion of the feedback form is voluntary. All information gathered from the form is anonymous. No individual responses are reported.


OHRP intends to use the information gathered from this form to improve the quality of these events.


Please return the completed form to the place designated by the event staff.





Thank you, your help is appreciated.

INSTRUMENT C: Initial Assessment Survey


Answer questions by checking the box or circle corresponding to the appropriate choice.


A. EDUCATIONAL EVENT EVALUATION


A1. Please indicate the degree to which you agree with the following statements about the OHRP education event you just attended. If the event included more than one presenter and/or program, please give the average rating for the entire event.




Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

The topics were well-organized.


The depth of topic coverage was excellent.


The breadth of topic coverage was excellent.


In general, the presenter(s) was effective (e.g. knowledgeable, responsive, interesting, and used appropriate instructional techniques)


Overall the program(s) was of high quality.


The training environment (temperature, acoustics, etc.) was comfortable.


The content covered is relevant to my current job.


The difficulty level of the materials was appropriate to my knowledge level.


For the amount of material covered, the session length was appropriate.



Overall, the OHRP educational event was effective.


I would recommend this educational event to colleagues with roles similar to mine in human research protections.



A2. What was your main reason for attending this OHRP educational event? (Mark only one)


I wanted to learn straight from OHRP

 I wanted to obtain CMEs/CEUs

My attendance was required by my institution

I wanted to gain knowledge and develop my skills

 Other, specify: _______________________________________________



A3. What type of OHRP educational activities have you attended or utilized in the past twelve months (aside from the current training)? (Mark all that apply)


  • I have not participated in any other OHRP educational event in the past twelve months

  • OHRP national conference (comprehensive two-day program)

  • OHRP Regional Community Forum (one-day program)

  • Presentation (OHRP staff participate in conferences, workshops and seminars sponsored by institutions, professional associations, private industry, patient advocacy groups and the federal government)

  • Staff training workshop (OHRP staff train institution staff in human research protections)

  • Quality assurance and quality improvement activity (OHRP staff conduct consultations with a host institution to improve the quality of human research protections program)

  • Website (the OHRP website provides numerous resources regarding human research protections)

  • On-line tutorial (an online module describing written assurances of human subject protections for Institutional Officials, IRB Administrator and IRB Chairs)

  • Other, specify: ________________________________________________________



B. EXPECTED IMPROVEMENTS IN PRACTICE


B1. Were the following topics covered at the Educational Event and if they were, was your understanding of the topic improved as a result of the event?



Topic Covered at Educational Event

If the topic was covered, please indicate the extent to which the OHRP educational event improved your understanding of the topic.

Improved Greatly

Improved Somewhat

Did Not Improve

Don’t Know

History and ethical foundations of human subject protections


HHS regulations overview (45 CFR 46)


Definition of human subjects research


Determining exempt research


Engagement in human subjects research


Composition of IRB (membership)


IRB review: Initial review


IRB review: Continuing review


IRB review: Expedited review


IRB Policies and Procedures/Minutes/Records


Informed consent


Waivers of Informed Consent


Documentation of Informed Consent


Requirements for Emergency Research


Identifying Conflicts of Interest


Reporting unanticipated problems/adverse events


Noncompliance


Federal Wide Assurance


IRB issues involving coded private information

IRB issues involving biological specimens, storage/repositories


IRB issues involving data and data storage


Pregnant women and fetuses in research

Prisoners in research


Children in research


Other vulnerable populations


Privacy/Confidentiality issues


International research involving human subjects


OHRP Quality Improvement Activities


OHRP Activities Update


Other (specify):

_______________________________


_______________________________


Other (specify):

________________________________


________________________________



B2. Think about the topics you just rated and please indicate the extent to which you agree with the following statements:


Participating in this OHRP educational event …


Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

… increased my awareness of issues surrounding human research protections.


…increased my interest in the subject matter.


… helped me to consider how I/my institution can improve human research protections.



B3. What was the single best section of the OHRP educational event?

________________________________________________________________________________________________________________________________________________________________________________________________________________________


B4. What was the greatest weakness with the OHRP educational event?

________________________________________________________________________________________________________________________________________________________________________________________________________________________



B5. What changes to the OHRP educational event would you recommend for future similar events? ________________________________________________________________________________________________________________________________________________________________________________________________________________________



B6. Would you recommend this OHRP educational event to others?


  • Yes

 No, please explain:

____________________________________________________________________________________________________________________________________



C. PLEASE TELL US ABOUT YOURSELF



C1. What is your sex/gender?


 Male Female



C2. What is your ethnicity? (Mark all that apply):

 American Indian or Alaska Native Native Hawaiian or Other Pacific Islander

Asian White

Black or African American Other (Specify)_____________________

 Hispanic or Latino



C3. How old are you? ____



C4. What is your highest educational degree?

  • High school

  • Associate’s degree

  • Some college

  • Bachelor’s degree

  • Master’s degree

  • M.D.

  • J.D.

  • Other doctoral degree (Ph.D, Psy.D., Sc.D., etc.)

  • Other, specify: __________________________________________________


C5. What type of institution(s) do you work for? (Mark all that apply)

 Hospital

Academic medical center

University

Private practice

Research institute

Other, specify: _________________________________________________________


C6. What type of human research is conducted in your institution? (Mark all that apply)


Biomedical

Social/behavioral

 None

 Other, specify: ________________________________________________________



C7. For how many years have you been involved with human research?


None

 Less than 1

 1-4 years

5-9 years

10-14 years

15-20 years

20+ years



C8. How would you rate your depth of knowledge of human research protections?


  • Very limited

  • Elementary knowledge of regulations/principles

  • Advanced knowledge in some areas of regulations/principles

  • Advanced knowledge in most areas of regulations/principles


C9. Which of the following describes your current professional position(s)? (Mark all that apply)


  • Faculty

  • Principal investigator

  • Research staff

  • IRB member, staff, administrator or chair

  • Institutional official

  • Compliance officer

  • Legal counsel

  • Clinical staff (nursing, other)

  • Physician

  • Administration

  • Public health official

  • Patient advocate

  • Student

  • Other, specify: ________________________________________________________


C10. What is your primary role in human research protections at your institution? (Please select only one primary role)


  • Institutional official (Assurance Signatory Official)

  • Sponsor agency program official

  • Institutional Review Board staff

  • Institutional Review Board administrator/manager

  • Institutional Review Board chair

  • Institutional Review Board member

If you are an IRB Board member, which of the following do you represent on the board: (Mark only one)

    • Scientific member

    • Nonscientific member

    • Non-affiliated member

    • Don’t know

  • Principal investigator or co-investigator

  • Research coordinator/data collection staff

  • No active Role

  • Other, specify: __________________________________________________


THANK YOU FOR YOUR TIME!


INSTRUMENT C Mod: Initial Assessment Survey




(Audience: Attendees at OHRP Educational Events where education on a specific topic area related to OHRP activities is provided. Slight modification of Instrument C – 6.requests for ratings on general topics are excluded)





Dear Participant:


The educational event you are attending is funded by the Office for Human Research Protections (OHRP), Division of Education and Development. OHRP is engaged in:


  • establishing criteria for and approving assurances of compliance for the protection of human subjects with institutions engaged in HHS-conducted or -supported human subject research;

  • providing clarification and guidance on involving humans in research;

  • developing and implementing educational programs and resource materials; and

  • promoting the development of approaches to enhance human subject protections.


Completion of the feedback form is voluntary. All information gathered from the form is anonymous. No individual responses are reported.


OHRP intends to use the information gathered from this form to improve the quality of these events.


Please return the completed form to the place designated by the event staff.





Thank you, your help is appreciated.

INSTRUMENT C_MOD Initial Assessment Survey


Answer questions by checking the box or circle corresponding to the appropriate choice.


A. EDUCATIONAL EVENT EVALUATION


A1. Please indicate the degree to which you agree with the following statements about the OHRP education event you just attended. If the event included more than one presenter and/or program, please give the average rating for the entire event.




Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

The topics were well-organized.


The depth of topic coverage was excellent.


The breadth of topic coverage was excellent.


In general, the presenter(s) was effective (e.g. knowledgeable, responsive, interesting, and used appropriate instructional techniques)


Overall the program(s) was of high quality.


The training environment (temperature, acoustics, etc.) was comfortable.


The content covered is relevant to my current job.


The difficulty level of the materials was appropriate to my knowledge level.


For the amount of material covered, the session length was appropriate.



Overall, the OHRP educational event was effective.


I would recommend this educational event to colleagues with roles similar to mine in human research protections.



A2. What was your main reason for attending this OHRP educational event? (Mark only one)


I wanted to learn straight from OHRP

My attendance was required by my institution

I wanted to gain knowledge and develop my skills

 Other, specify: _______________________________________________



A3. What type of OHRP educational activities have you attended or utilized in the past twelve months (aside from the current training)? (Mark all that apply)


  • I have not participated in any other OHRP educational event in the past twelve months

  • OHRP national conference (comprehensive two-day program)

  • OHRP Regional Community Forum (one-day program)

  • Presentation (OHRP staff participate in conferences, workshops and seminars sponsored by institutions, professional associations, private industry, patient advocacy groups and the federal government)

  • Staff training workshop (OHRP staff train institution staff in human research protections)

  • Quality assurance and quality improvement activity (OHRP staff conduct consultations with a host institution to improve the quality of human research protections program)

  • Website (the OHRP website provides numerous resources regarding human research protections)

  • On-line tutorial (an online module describing written assurances of human subject protections for Institutional Officials, IRB Administrator and IRB Chairs)

  • Other, specify: ________________________________________________________



B1. Please indicate the extent to which you agree with the following statements:


Participating in this OHRP educational event …


Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

… increased my awareness of issues surrounding human research protections.


…increased my interest in the subject matter.


… helped me to consider how I/my institution can improve human research protections.



B2. What was the single best section of the OHRP educational event?

______________________________________________________________________________________________________________________________________________________________________________________________________


B3. What was the greatest weakness with the OHRP educational event?


______________________________________________________________________________________________________________________________________________________________________________________________________


B4. What changes to the OHRP educational event would you recommend for future similar events? ______________________________________________________________________________________________________________________________________________________________________________________________________




B5. Would you recommend this OHRP educational event to others?


  • Yes


 No, please explain:

______________________________________________________________________________________________________________________________________________________________________________________________________

C. PLEASE TELL US ABOUT YOURSELF



C1. What is your sex/gender?


 Male Female



C2. What is your ethnicity? (Mark all that apply):

 American Indian or Alaska Native Native Hawaiian or Other Pacific Islander

Asian White

Black or African American Other (Specify)_____________________

 Hispanic or Latino



C3. How old are you? ____



C4. What is your highest educational degree?

  • High school

  • Associate’s degree

  • Some college

  • Bachelor’s degree

  • Master’s degree

  • M.D.

  • J.D.

  • Other doctoral degree (Ph.D, Psy.D., Sc.D., etc.)

  • Other, specify: __________________________________________________


C5. What type of institution(s) do you work for? (Mark all that apply)

 Hospital

Academic medical center

University

Private practice

Research institute

Other, specify: _________________________________________________________



C6. What type of human research is conducted in your institution? (Mark all that apply)


Biomedical

Social/behavioral

 None

 Other, specify: ________________________________________________________



C7. For how many years have you been involved with human research?


None

 Less than 1

 1-4 years

5-9 years

10-14 years

15-20 years

20+ years


C8. How would you rate your depth of knowledge of human research protections?


  • Very limited

  • Elementary knowledge of regulations/principles

  • Advanced knowledge in some areas of regulations/principles

  • Advanced knowledge in most areas of regulations/principles


C9. Which of the following describes your current professional position(s)? (Mark all that apply)


  • Faculty

  • Principal investigator

  • Research staff

  • IRB member, staff, administrator or chair

  • Institutional official

  • Compliance officer

  • Legal counsel

  • Clinical staff (nursing, other)

  • Physician

  • Administration

  • Public health official

  • Patient advocate

  • Student

  • Other, specify: ________________________________________________________



C10. What is your primary role in human research protections at your institution? (Please select only one primary role)


  • Institutional official (Assurance Signatory Official)

  • Sponsor agency program official

  • Institutional Review Board staff

  • Institutional Review Board administrator/manager

  • Institutional Review Board chair

  • Institutional Review Board member

If you are an IRB Board member, which of the following do you represent on the board: (Mark only one)

    • Scientific member

    • Nonscientific member

    • Non-affiliated member

    • Don’t know

  • Principal investigator or co-investigator

  • Research coordinator/data collection staff

  • No active Role

  • Other, specify: __________________________________________________



THANK YOU FOR YOUR TIME!




INSTRUMENT D: Follow-up Assessment Survey



(Audience: Attendees at OHRP Educational Events where general information about OHRP was provided)











Dear Participant:

 

You attended an Office for Human Research Protections (OHRP) educational event approximately three to six months ago, and feedback on the event content was requested at that time.  Now that some time has passed, we would again appreciate your feedback on this educational event.  We are particularly interested in whether you have been able to apply the knowledge gained from that course to your daily routine practices related to human research protections. 

 

OHRP intends to use the information gathered from this effort to improve the quality of their educational events.

 

            Please provide your feedback by completing the form at the following web site: http://_____________.  You may access the site either by pressing ctrl+ enter or by copying the web address and placing it in your browser. Completion of the form will take approximately six minutes and is voluntary.  All information gathered from the form is anonymous.   No individual responses are reported. 

 

 

Thank you, your help is appreciated.


INSTRUMENT D: Follow-up Assessment Survey


Answer questions by checking the box or circle corresponding to the appropriate choice.


  1. EVENT ATTENDED


Location of the OHRP educational event

Host institution: _____________________________


Title: _____________________________________

City: ______________________________________

State: ______________________________________



Date of the OHRP educational event


__ __/ __ __ / __ __

MM DD YY

(Filled out in advance)



A1. Did you complete OHRP’s Initial Assessment Survey at the time of the event? (Mark only one)

 Yes

 No

 Don’t know



B. FOLLOW-UP ASSESSMENT


B1. Please indicate the degree to which you agree with the following statements:



Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

The OHRP educational event was relevant to my current job.


Overall, the OHRP educational event was effective.


Participating in the OHRP educational event improved my ability to carry out human research protections.



C. RECENT IMPROVEMENTS IN PRACTICE


C1. The following is a list of human research protection practices; did you make any changes in the below practices as a result of the OHRP educational event?



Changes Made

No Change Made

Not Applicable

Don’t Know

Application of Threshold Regulatory Definitions (i.e., “research” “human subjects” “engagement”)


Processing and Determining Exempt Research


Process, Content, and Documentation of IRB Review


Informed Consent Process


Reporting Unanticipated Problems and Noncompliance


Determining status and procedures related to research involving biological specimens and data


Application of Subpart B


Application of Subpart C


Application of Subpart D


Institutional Policies and Procedures for Human Subject Protections


Other (specify):

_______________________________


________________________________




D. ENABLING AND CONSTRAINING FACTORS


D1. Which of the following factors have enabled or constrained your ability to make changes in your practices related to human research protections following the OHRP educational event?




ENABLED CHANGE (mark all that apply)

NEUTRAL

CONSTRAINED CHANGE (mark all that apply)

The attitudes of your institution’s human research protections leadership.


The amount of funding available for your institution’s human research protections program.


The knowledge gained at the OHRP educational event.


The degree of support from peers in your institution.


The level of staffing available for your institution’s human research protections program.


The amount of time available to make changes.


Other, Specify:__________

_________________________




D2. Please list any additional comments regarding factors that have enabled or constrained your ability to make changes in your practices related to human research protections:

______________________________________________________________________________________________________________________________________

______________________________________________________________________________________________________________________________________


D3. What do you remember best about the OHRP Educational event?

______________________________________________________________________________________________________________________________________

______________________________________________________________________________________________________________________________________

E. PLEASE TELL US ABOUT YOURSELF


E1. What is your sex/gender?


 Male Female


E2. What is your ethnicity? (Mark all that apply):

 American Indian or Alaska Native Native Hawaiian or Other Pacific Islander

Asian White

Black or African American Other (Specify)_____________________

 Hispanic or Latino


E3. How old are you? ____


E4. What is your highest educational degree?

  • High school

  • Associate’s degree

  • Some college

  • Bachelor’s degree

  • Master’s degree

  • M.D.

  • J.D

  • Other doctoral degree (Ph.D, Psy.D., Sc.D., etc.)

  • Other, specify: __________________________________________________


E5. What type of institution(s) do you work for?

 Hospital

Academic medical center

University

Private practice

Research institute

Other, specify: _________________________________________________________



E6. What type of human research is conducted in your institution? (Mark all that apply)


Biomedical

Social/behavioral

 None

 Other, specify: ________________________________________________________


E7. For how many years have you been involved with human research?


None

 Less than 1

 1-4 years

5-9 years

10-14 years

15-20 years

20+ years



E8. How would you rate your depth of knowledge of human research protections?


  • Very limited

  • Elementary knowledge of regulations/principles

  • Advanced knowledge in some areas of regulations/ principles

  • Advanced knowledge in most areas of regulations/ principles


E9. Which of the following describes your current professional position(s)? (Mark all that apply)


  • Faculty

  • Principal investigator

  • Research staff

  • IRB member, staff, administrator or chair

  • Institutional official

  • Compliance officer

  • Legal counsel

  • Clinical staff (nursing, other)

  • Physician

  • Administration

  • Public health official

  • Patient advocate

  • Student

  • Other, specify: ________________________________________________________



E10. What is your primary role in human research protections at your institution? (Please select only one primary role)


  • Institutional official (Assurance Signatory Official)

  • Sponsor agency program official

  • Institutional Review Board staff

  • Institutional Review Board administrator/manager

  • Institutional Review Board chair

  • Institutional Review Board member

If you are an IRB Board member, which of the following do you represent on the board: (Mark only one)

    • Scientific member

    • Nonscientific member

    • Non-affiliated member

    • Don’t know

  • Principal investigator or co-investigator

  • Research coordinator/data collection staff

  • No active Role

  • Other, specify: __________________________________________________





THANK YOU FOR YOUR TIME!










INSTRUMENT D_Mod: Follow-up Assessment Survey



(Audience: Attendees at OHRP Educational Events where education on a specific topic area related to OHRP activities was provided.)



INSTRUMENT D: Follow-up Assessment Survey





Dear Participant:

 

You attended an Office for Human Research Protections (OHRP) educational event approximately three to six months ago, and feedback on the event content was requested at that time.  Now that some time has passed, we would again appreciate your feedback on this educational event.  We are particularly interested in whether you have been able to apply the knowledge gained from that course to your daily routine practices related to human research protections. 

 

OHRP intends to use the information gathered from this effort to improve the quality of their educational events.

 

            Please provide your feedback by completing the form at the following web site: http://_____________.  You may access the site either by pressing ctrl+ enter or by copying the web address and placing it in your browser. Completion of the form will take approximately six minutes and is voluntary.  All information gathered from the form is anonymous.   No individual responses are reported. 

 

 

Thank you, your help is appreciated.



INSTRUMENT D: Follow-up Assessment Survey


Answer questions by checking the box or circle corresponding to the appropriate choice.


  1. EVENT ATTENDED


Location of the OHRP educational event

Host institution: _____________________________


Title: _____________________________________

City: ______________________________________

State: ______________________________________



Date of the OHRP educational event


__ __/ __ __ / __ __

MM DD YY

(Filled out in advance)


A1. Did you complete OHRP’s Initial Assessment Survey at the time of the event? (Mark only one)

 Yes

 No

 Don’t know

















B. FOLLOW-UP ASSESSMENT


B1. Please indicate the degree to which you agree with the following statements:



Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

The OHRP educational event was relevant to my current job.


Overall, the OHRP educational event was effective.


Participating in the OHRP educational event improved my ability to carry out human research protections.



C. RECENT IMPROVEMENTS IN PRACTICE


C1. The following is a list of human research protection practices; did you make any changes in the below practices as a result of the OHRP educational event?



Changes Made

No Change Made

Not Applicable

Don’t Know

Institutional Policies and Procedures for Human Subject Protections


IRB Administration


IRB Membership


IRB Minutes and Records


Other (specify):

_______________________________


________________________________




D. ENABLING AND CONSTRAINING FACTORS


D1. Which of the following factors have enabled or constrained your ability to make changes in your practices related to human research protections following the OHRP educational event?




ENABLED CHANGE (mark all that apply)

NEUTRAL

CONSTRAINED CHANGE (mark all that apply)

The attitudes of your institution’s human research protections leadership.


The amount of funding available for your institution’s human research protections program.


The knowledge gained at the OHRP educational event.


The degree of support from peers in your institution.


The level of staffing available for your institution’s human research protections program.


The amount of time available to make changes.


Other, Specify:__________

_________________________




D2. Please list any additional comments regarding factors that have enabled or constrained your ability to make changes in your practices related to human research protections:

______________________________________________________________________________________________________________________________________

______________________________________________________________________________________________________________________________________


D3. What do you remember best about the OHRP Educational event?

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________




E. PLEASE TELL US ABOUT YOURSELF


E1. What is your sex/gender?


 Male Female


E2. What is your ethnicity? (Mark all that apply):

 American Indian or Alaska Native Native Hawaiian or Other Pacific Islander

Asian White

Black or African American Other (Specify)_____________________

 Hispanic or Latino


E3. How old are you? ____


E4. What is your highest educational degree?

  • High school

  • Associate’s degree

  • Some college

  • Bachelor’s degree

  • Master’s degree

  • M.D.

  • J.D

  • Other doctoral degree (Ph.D, Psy.D., Sc.D., etc.)

  • Other, specify: __________________________________________________


E5. What type of institution(s) do you work for?

 Hospital

Academic medical center

University

Private practice

Research institute

Other, specify: _________________________________________________________



E6. What type of human research is conducted in your institution? (Mark all that apply)


Biomedical

Social/behavioral

 None

 Other, specify: ________________________________________________________



E7. For how many years have you been involved with human research?


None

 Less than 1

 1-4 years

5-9 years

10-14 years

15-20 years

20+ years


E8. How would you rate your depth of knowledge of human research protections?


  • Very limited

  • Elementary knowledge of regulations/principles

  • Advanced knowledge in some areas of regulations/ principles

  • Advanced knowledge in most areas of regulations/ principles

E9. Which of the following describes your current professional position(s)? (Mark all that apply)


  • Faculty

  • Principal investigator

  • Research staff

  • IRB member, staff, administrator or chair

  • Institutional official

  • Compliance officer

  • Legal counsel

  • Clinical staff (nursing, other)

  • Physician

  • Administration

  • Public health official

  • Patient advocate

  • Student

  • Other, specify: ________________________________________________________


E10. What is your primary role in human research protections at your institution? (Please select only one primary role)


  • Institutional official (Assurance Signatory Official)

  • Sponsor agency program official

  • Institutional Review Board staff

  • Institutional Review Board administrator/manager

  • Institutional Review Board chair

  • Institutional Review Board member

If you are an IRB Board member, which of the following do you represent on the board: (Mark only one)

    • Scientific member

    • Nonscientific member

    • Non-affiliated member

    • Don’t know

  • Principal investigator or co-investigator

  • Research coordinator/data collection staff

  • No active Role

  • Other, specify: __________________________________________________




THANK YOU FOR YOUR TIME!




INSTRUMENT E: Survey of Institution Representatives


(Audience: Individuals who are directly involved in human research protection activities)





Dear Respondent:


The Office for Human Research Protections (OHRP) is engaged in:


  • establishing criteria for and approving assurances of compliance for the protection of human subjects with institutions engaged in HHS-conducted or -supported human subject research;

  • developing, monitoring, and exercising compliance oversight of HHS regulations for protection of human subjects;

  • providing clarification and guidance on involving humans in research;

  • developing and implementing educational programs and resource materials; and

  • promoting the development of approaches to enhance human subject protections.



Completion of the feedback form is voluntary. All information gathered from the form is anonymous. No individual responses are reported.


OHRP intends to use the information gathered from this form to identify outstanding training needs and to assess the quality of current training activities at the institutional level.


Please return the completed form in the enclosed, self-addressed, stamped envelope.





Thank you, your help is appreciated.


INSTRUMENT E: SURVEY OF INSTITUTION REPRESENTATIVES


Answer questions by checking the box or circle corresponding to the appropriate choice.


A. EDUCATIONAL EXPERIENCE



A1. In fulfilling your human research protections responsibilities, have you used the following education resources? If so, how useful were they?



Did you use this resource?

If yes, how useful was it?

Yes

No

Not Available


Very Useful

Somewhat Useful

Not Useful

Other individuals in my institution



Training developed by my institution



Handbooks, guidelines, and/or standard operating procedures developed by my institution



Model consent form(s) or consent form checklist developed by my institution



Protocol content checklist developed by my institution



Human research protection guidelines for investigators developed by my institution



Other written material developed by my institution (specify):

___________________________________

______________________________________________________________________




Other internal resources (specify):

_________________________________________________________________________________________________________



Books



Newsletters



Journals



OHRP IRB Guidebook



OHRP Telephone Consultation


OHRP e-mail box


“Investigator 101” CD Rom


Other printed material (specify):

_________________________________________________________________________________________________________



Code of Federal Regulations (online)



OHRP website



FDA website



IRB Forum (discussion group)



NIH Training Course



Other Web resources (specify):

_________________________________________________________________________________________________________




A2. Please mark all the following activities that apply to you.


I have…


  • Led a session at a national or regional meeting/workshop on human research protections (e.g., one sponsored by ARENA, PRIM&R, or SAR).

  • Attended a national or regional meeting/workshop on human research protections.

  • Served on a national or regional committee related to human research protections.

  • Authored a paper or published article on human research protections.

  • Submitted a poster session on human research protections.

  • Developed training materials and/or SOPs on human subjects protections

  • None of the above.


B. FORMAL OHRP EDUCATIONAL ACTIVITIES


B1. OHRP conducts educational activities related to human research protection. Which of the following, if any, OHRP educational activities did you attend or use during the past twelve months? (Mark all that apply)




OHRP Educational Activity

Did you attend or use this event/activity?


If yes, how useful was it?

Yes

No

N/A


Very Useful

Somewhat Useful

Not Useful

OHRP national conference (comprehensive two-day program)



OHRP Regional Community Forum (one-day program)



Presentation (OHRP staff participate in conferences, workshops and seminars sponsored by institutions, professional associations, private industry, patient advocacy groups and the federal government)



Staff training workshop (OHRP staff train institution staff in human research protections)



Quality assurance and quality improvement activity (OHRP staff conduct consultations with a host institution to improve the quality of human research protections program)



Website (the OHRP website provides numerous resources regarding human research protections)



On-line tutorial (an online module describing written assurances of human subject protections for Institutional Officials, IRB Administrator and IRB Chairs)



Other (specify):

___________________________________ ___________________________________




B2. Other than in the past 12 months, have you ever participated in OHRP educational activities?


Yes No


C. OPINIONS ABOUT EDUCATION NEEDS


For questions C1-C3, please share your personal opinions based on your experiences with human research protections.


C1. In your opinion, which audiences at your institution are most in need of human research protections education? (Mark all that apply)


  • Institutional official

  • Department chair

  • Principal investigator or co-investigator

  • Clinical research associates

  • Data safety and monitoring committee members

  • Institutional Review Board administrator

  • Institutional Review Board chair

  • Institutional Review Board members

  • Institutional Review Board staff

  • Research coordinator/data collection staff

  • Other members of the research team

  • Other, specify: _________________________________________________

  • None – all have adequate training


C2. From your viewpoint, what are the most effective modes for receiving human research protection education? (Mark up to three)


 Lecture/presentation

 Seminar, workshop

 Case studies

 Panel discussions

 Videoconference

 Teleconference

 Web-based training

 Multi-media (CDs, DVDs, Videotapes)

 Other, specify:_________________________________________________________


C3. Which of the following factors have enabled or constrained your participation in OHRP educational activities?




ENABLED PARTICIPATION

(mark all that apply)

CONSTRAINED PARTICIPATION (mark all that apply)


N/A or DON’T KNOW

The attitudes of your institution’s human research protections leadership.


The amount of funding available for your institution’s human research protections program.


The level of staffing available for your institution’s human research protections program.


The amount of time available to make changes.


Other, Specify:__________

_________________________



C4. The following are general topics OHRP might include in training. Please rate how important it is to you to receive training on the following topics.


Training Topic

Importance of Topic

High

Med

Low

Don’t Know

History and ethical foundations of human subject protections


HHS regulations overview (45 CFR 46)


Definition of human subjects research


Determining exempt research


Engagement in human subjects research


Composition of IRB (membership)


IRB review: Initial review


IRB review: Continuing review


IRB review: Expedited review


IRB Policies and Procedures/Minutes/Records


Informed consent


Waivers of Informed Consent


Documentation of Informed Consent


Requirements for Emergency Research


Identifying Conflicts of Interest


Reporting unanticipated problems/adverse events


Noncompliance


Federal Wide Assurance


IRB issues involving coded private information

IRB issues involving biological specimens, storage/repositories


IRB issues involving data and data storage


Pregnant women and fetuses in research


Prisoners in research


Children in research


Other vulnerable populations


Privacy/Confidentiality issues


International research involving human subjects


OHRP Quality Improvement Activities


OHRP Activities Update


Other (specify):

_______________________________________________


_______________________________________________


Other (specify):

_______________________________________________


_______________________________________________



D. PLEASE TELL US ABOUT YOURSELF


D1. What is your sex/gender?


 Male Female



D2. What is your ethnicity? (Mark all that apply):

 American Indian or Alaska Native Native Hawaiian or Other Pacific Islander

Asian White

Black or African American Other (Specify)_____________________

 Hispanic or Latino



D3. How old are you? (in years) _____



D4. What is your highest educational degree?

  • High school

  • Associate’s degree

  • Some college

  • Bachelor’s degree

  • Master’s degree

  • M.D.

  • J.D.

  • Other doctoral degree (Ph.D, Psy.D., Sc.D., etc.)

  • Other, specify: __________________________________________________



D5. What type of institution do you work for?

 Hospital

Academic medical center

University

Private practice

Research institute

Other, specify: _________________________________________________________



D6. What type of human research is conducted in your institution? (Mark all that apply)


 Biomedical

Social/behavioral

Data/specimens

Epidemiological

 Other, specify: _________________________________________________________



D7. For how many years have you been involved with human research?


 None

 Less than 1

 1-4 years

5-9 years

10-14 years

15-20 years

20+ years


D8. How would you rate your depth of knowledge of human research protections?


  • Very limited

  • Elementary knowledge of regulations/principles

  • Advanced knowledge in some areas of regulations/ principles

  • Advanced knowledge in most areas of regulations/ principles


D9. Which of the following best describes your current professional position? (Mark all that apply)


  • Faculty

  • Principal investigator

  • Research staff

  • IRB member, staff, administrator or chair

  • Institutional official

  • Compliance officer

  • Legal counsel

  • Clinical staff (nursing, other)

  • Physician

  • Administration

  • Public health official

  • Patient advocate

  • Student

  • Other, specify: ________________________________________________________


D10. What is your primary role in human research protections at your institution? (Please select only one primary role)


  • Institutional official (Assurance Signatory Official)

  • Institutional Review Board administrator/manager (Please answer D11 below)

  • Institutional Review Board chair (Please answer D12 below)

  • Institutional Review Board member (Please answer D13 below)

If you are an IRB Board member, which of the following do you represent on the board (Mark only one):

    • Scientific member

    • Nonscientific member

    • Non-affiliated member

    • Don’t know

  • Principal investigator or co-investigator (Please answer D14 below)

  • Research coordinator/data collection staff (Please answer D14 below)

  • Other, specify: __________________________________________________


Please answer the following questions that pertain to your primary role only. For example, if your primary role is IRB chair, you only need to answer question D12.


D11. If your primary role is Institutional Review Board administrator/manager, please answer the following questions:


a) What is the total number of IRBs you administer? _____


b) We would like you to think back over the most recently completed year. This might be a calendar year, the academic year, or a state- or institutionally-specified fiscal year. If your institution is not annualized, please use calendar year 2004.


In the most recently completed record year, how many protocols were submitted to your IRB for initial review and, if applicable, for determination or confirmation of exempt status?


Number of protocols submitted _____


c) Is this number an actual number or an estimate ? (Please check one)


D12. If your primary role is Institutional Review Board chair, please answer the following questions:


a) We would like you to think back over the most recently completed year. This might be a calendar year, the academic year, or a state- or institutionally-specified fiscal year. If your institution is not annualized, please use calendar year 2004.


In the most recently completed record year, how many protocols were submitted to your IRB for initial review, continuing review, and, if applicable, for determination or confirmation of exempt status?


Number of protocols submitted _____


b) Is this number an actual number or an estimate ? (Please check one)



D13. If your primary role is Institutional Review Board member, please answer the following question:


a) In total, how many years have you served on this or any other IRB? (Please include IRB service at other institutions)


Number of years _____



D14. If your primary role is principal investigator, co-investigator, research coordinator or data collection staff, please answer the following questions:


a) In the past three years, how many research projects with human subjects have you worked on?


Number of projects _____


c) Is this number an actual number or an estimate ? (Please check one)





THANK YOU FOR YOUR TIME!








Introductory Letters and Emails



INSTRUMENT C & C_Mod: Initial Assessment Survey



Dear Participant:


The educational event you are attending is funded by the Office for Human Research Protections (OHRP), Division of Education and Development. OHRP is engaged in:


  • establishing criteria for and approving assurances of compliance for the protection of human subjects with institutions engaged in HHS-conducted or -supported human subject research;

  • developing, monitoring, and exercising compliance oversight of HHS regulations for protection of human subjects;

  • providing clarification and guidance on involving humans in research;

  • developing and implementing educational programs and resource materials; and

  • promoting the development of approaches to enhance human subject protections.


Completion of the feedback form is voluntary. All information gathered from the form is anonymous. No individual responses are reported.


OHRP intends to use the information gathered from this form to improve the quality of these events.


Please return the completed form to the place designated by the event staff.





Thank you, your help is appreciated.





INSTRUMENT D and D_Mod: Follow-up Assessment Survey





Dear Participant:

 

You attended an Office for Human Research Protections (OHRP) educational event approximately three to six months ago, and feedback on the event content was requested at that time.  Now that some time has passed, we would again appreciate your feedback on this educational event.  We are particularly interested in whether you have been able to apply the knowledge gained from that course to your daily routine practices related to human research protections. 

 

OHRP intends to use the information gathered from this effort to improve the quality of their educational events.

 

            Please provide your feedback by completing the form at the following web site: http://_____________.  You may access the site either by pressing ctrl+ enter or by copying the web address and placing it in your browser. Completion of the form will take approximately six minutes and is voluntary.  All information gathered from the form is anonymous.   No individual responses are reported. 

 

 

Thank you, your help is appreciated.



INSTRUMENT E: Survey of Institution Representatives




Dear Respondent:


The Office for Human Research Protections (OHRP) is engaged in:


  • establishing criteria for and approving assurances of compliance for the protection of human subjects with institutions engaged in HHS-conducted or -supported human subject research;

  • developing, monitoring, and exercising compliance oversight of HHS regulations for protection of human subjects;

  • providing clarification and guidance on involving humans in research;

  • developing and implementing educational programs and resource materials; and

  • promoting the development of approaches to enhance human subject protections.



Completion of the feedback form is voluntary. All information gathered from the form is anonymous. No individual responses are reported.


OHRP intends to use the information gathered from this form to identify outstanding training needs and to assess the quality of current training activities at the institutional level.


Please return the completed form in the enclosed, self-addressed, stamped envelope.





Thank you, your help is appreciated.











Confidentiality Pledge


As a member of the JBA evaluation team, I recognize the importance of maintaining the confidentiality of data collected and of assuring the right of privacy of persons cooperating in this evaluation activity. To establish safeguards for all involved, I agree to abide by the following principles of conduct:


  1. All information that is collected by me (or other project team members) from participants is confidential. All participants must be informed that their responses to interviews and survey questions will be kept confidential and are for statistical purposes only. All data (and all copies) are property of the project and are not to be shared with anyone. I will not permit any unauthorized person, including members of my own family, to see any completed documents or forms. I will only discuss information obtained about a respondent with authorized project staff.


  1. I agree to treat as confidential and proprietary to the evaluation any and all instruments, materials, and documentation provided or accessed during the course of my service on this evaluation activity. I agree not to copy or duplicate any materials without written permission from the Principal Investigator. I agree to safeguard all study materials and to exercise extreme care to protect them from access by unauthorized persons.


  1. I agree to conduct myself at all times in a manner that will obtain the respect and confidence of all participants and other persons with whom I may come into contact in connection with this project. I agree to report any breach of confidentiality to my supervisor immediately.


  1. I understand that all data collected for this study are the property of OHRP and will not be used for any purpose without prior written permission


By signing below, I acknowledge that I have read and understand the assurances that will be provided to participants. I understand that I am prohibited by both the law and this agreement from disclosing any confidential information which has been obtained by this study to anyone other than an authorized member of JBA or OHRP. I understand that any willful and knowing disclosure in violation of the Privacy Act of 1974 (5 U.S.C. 552a) is a misdemeanor and is punishable by a fine of up to $5,000. I agree to abide by the terms of the assurances of confidentiality set forth here.

Staff Name: ______________________________________________

(PLEASE PRINT)


Signature: _____________________

File Typeapplication/msword
File TitleDATA AND COLLECTION INSTRUEMENTS FOR
Authoristithco
Last Modified ByDHHS
File Modified2006-09-22
File Created2006-09-22

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