The Office for Human Research Protections (OHRP)and the Office of Laboratory Animal Welfare (OLAW) invites all researchers to sign up for their news distribution lists. These act a primary source of news, regulatory changes and updates from the federal perspective.
Go to http://grants1.nih.gov/grants/olaw/references/list.htm to sign up for the OLAW LISTSERV or http://www.hhs.gov/ohrp/news/distributionlist.html for the OHRP distribution list.
19 December 2008
HARPO will be closed
The office will be closed for winter break, beginning December 24, 2008 through January 2, 2009. We'll reopen on January 5, 2009.
Reminder - Next IACUC meetings for 2009
The UMBC IACUC meets four (4) times a year. This allows the committee time for sufficient review of new or renewal protocol applications. The next meetings are scheduled for April, 2009 and July, 2009. Therefore, animal research applications must be submitted to HARPO no later than February 15, 2009 for the April meeting and May 15, 2009 for the July meeting.
Application forms and instructions may be found at http://www.umbc.edu/iacuc/iacucforms.htm.
Application forms and instructions may be found at http://www.umbc.edu/iacuc/iacucforms.htm.
16 December 2008
Student Research Within a Faculty Advisor’s Approved Protocol
Student researchers will, at times, develop ideas for research projects as part of a senior thesis, master’s project or doctoral dissertation. that involve using data collected on a faculty advisor’s IRB approved protocol. The IRB will allow this provided the level of risk does not change, no additional benefits are realized by participants, and the scope of the student’s research project does not significantly differ from the parent protocol.
Rather than burden a student researcher with completing a full application for review and approval, the IRB has developed a Thesis, Masters or Dissertation Research Notification form. This form will assist the IRB in monitoring if the planned activities of the project are already part of a previously IRB approved protocol and/or if there will be any modifications (to risks, consent processes, use of identifiers, etc.) during the course of the research project that will change the provisions of the approved protocol.
If you have a project that falls within this category, download this form (http://www.umbc.edu/irb/tmdr_application.doc) and follow the directions.
Contact HARPO at 5-2737 or HARPO@umbc.edu with any questions.
Rather than burden a student researcher with completing a full application for review and approval, the IRB has developed a Thesis, Masters or Dissertation Research Notification form. This form will assist the IRB in monitoring if the planned activities of the project are already part of a previously IRB approved protocol and/or if there will be any modifications (to risks, consent processes, use of identifiers, etc.) during the course of the research project that will change the provisions of the approved protocol.
If you have a project that falls within this category, download this form (http://www.umbc.edu/irb/tmdr_application.doc) and follow the directions.
Contact HARPO at 5-2737 or HARPO@umbc.edu with any questions.
02 December 2008
International laws, regulations, and guidelines on human subject protections
The Office for Human Research Protections has just released a compendium of human subject protections laws, regulations, and guidelines (almost 1,100 in all) from 92 countries. The list includes web addresses to link directly to the law, regulation, or guideline of interest.
Go to http://www.hhs.gov/ohrp/international/HSPCompilation.pdf for more information.
So, if you're planning an international-based research study, it would behoove you (I like that word!) to investigate whether or not additional research protections are required.
Go to http://www.hhs.gov/ohrp/international/HSPCompilation.pdf for more information.
So, if you're planning an international-based research study, it would behoove you (I like that word!) to investigate whether or not additional research protections are required.
24 November 2008
HARPO will be closed
The office will be closed for Thanksgiving, November 27 and 28, 2008. We'll reopen on December 1, 2008.
14 November 2008
Updated IRB forms and applications
Always remember to keep checking back on the IRB web site for the latest forms and applications that are used by the IRB. The most recent updates include revisions to the Expedited and Full Board Review forms, updates to wording on the Informed Consent form and a new form - a short descriptive form for theses, master's and doctoral dissertation research. This form tracks master's or dissertation students own lines of inquiry that was developed under a faculty mentor’s IRB approved protocol. A seperate, full blown application is not required, but the IRB will want to keep track of any and all research that occurs.
See those updates and new forms at http://www.umbc.edu/irb/irbforms.htm
See those updates and new forms at http://www.umbc.edu/irb/irbforms.htm
04 November 2008
Keep your data (and computer) safe
Words of advice from the Office of Information Technology
Securing Your Laptop Against Physical Theft
Theft of laptops, desktop computers, computer parts and peripherals is a growing problem. According to insurance company figures, there is a 1 in 14 chance of a PC owner being victimized. If you lose your computer, or any part of its system, you've lost more than the cost of the laptop. You have lost your data. The hardware can be replaced, but the loss of work in progress could be devastating.
Click on this link for more information.
People who volunteer to participate in research do so with the understanding that investigators will protect their identity and their information from inadvertent and inappropriate disclosure.
So treat collected data just like your laptop to keep safe and secure. A few helpful tips:
1) train research staff on the proper methods of keeping data secure.
2) de-identify data when saved on the laptop - this means stripping all personal identifiers from the saved data.
3) if the research requires that identifiers be kept, save your data to a removable medium (i.e. external hard drive) and secure that drive under lock and key. You may wish to use an identity key to match various data sets; if so, secure that key as well.
4) sensitive data may be secured using data encryption - the algorithmic transformation of data into an unrecognizable format that can only be recovered using a secret decryption key.
Securing Your Laptop Against Physical Theft
Theft of laptops, desktop computers, computer parts and peripherals is a growing problem. According to insurance company figures, there is a 1 in 14 chance of a PC owner being victimized. If you lose your computer, or any part of its system, you've lost more than the cost of the laptop. You have lost your data. The hardware can be replaced, but the loss of work in progress could be devastating.
Click on this link for more information.
People who volunteer to participate in research do so with the understanding that investigators will protect their identity and their information from inadvertent and inappropriate disclosure.
So treat collected data just like your laptop to keep safe and secure. A few helpful tips:
1) train research staff on the proper methods of keeping data secure.
2) de-identify data when saved on the laptop - this means stripping all personal identifiers from the saved data.
3) if the research requires that identifiers be kept, save your data to a removable medium (i.e. external hard drive) and secure that drive under lock and key. You may wish to use an identity key to match various data sets; if so, secure that key as well.
4) sensitive data may be secured using data encryption - the algorithmic transformation of data into an unrecognizable format that can only be recovered using a secret decryption key.
New IRB members (part 2)
Please welcome additional new members to the UMBC Institutional Review Board who began in the Fall of 2008:
Sarah Chard, Assistant Professor, Anthropology/Sociology
Joseph Clift, Managing Associate/Project Manager, Association for the Study and Development of Community
The updated roster of Board membership is available on the IRB website.
Sarah Chard, Assistant Professor, Anthropology/Sociology
Joseph Clift, Managing Associate/Project Manager, Association for the Study and Development of Community
The updated roster of Board membership is available on the IRB website.
Do surveys created for improving services and programs at UMBC need IRB review?
A question that comes up not only at UMBC, but at other institutions as well. And, is IRB review required? It depends.
Surveys that are for quality improvement/quality assurance or for developing new services or programs for students, employees, or alumni, may not need IRB review. Surveyors should keep in mind that privacy of the participants needs to be protected, the confidentiality of individual responses is maintained, and survey participation is voluntary.
If, at a future date, an opportunity will arise to contribute previously collected survey data to a new project producing generalizable knowledge, an application for IRB review would be required before the data could be released to the new project.
The IRB has developed a QI/QA algorithm to help sort this out.
Surveys that are for quality improvement/quality assurance or for developing new services or programs for students, employees, or alumni, may not need IRB review. Surveyors should keep in mind that privacy of the participants needs to be protected, the confidentiality of individual responses is maintained, and survey participation is voluntary.
If, at a future date, an opportunity will arise to contribute previously collected survey data to a new project producing generalizable knowledge, an application for IRB review would be required before the data could be released to the new project.
The IRB has developed a QI/QA algorithm to help sort this out.
Who signs a consent form?
Federal regulations (45 CFR 46.117) require written informed consent, one that is approved by the IRB and signed by the participant or the participant's legal representative and the principal investigator (or his/her delegate). The delegated responsibility can fall to members of the investigator's “research team”, provided the team members have been trained by the investigator and had also taken the UMBC Collaborative Institutional Training Initiative (CITI) web-based course.
Consent forms should be signed by the person actually administering consent, at the time consent is administered, attesting to the informed consent conversation. At no time should the consent forms be pre-signed by the members of the research team.
Further details about the consent process may be found at http://www.umbc.edu/research/HARPO/IRB/consentassent.html
Consent forms should be signed by the person actually administering consent, at the time consent is administered, attesting to the informed consent conversation. At no time should the consent forms be pre-signed by the members of the research team.
Further details about the consent process may be found at http://www.umbc.edu/research/HARPO/IRB/consentassent.html
10 September 2008
Adding or changing training modules on CITI
So, you've taken the CITI training - thank you! But, your mentor/supervisor has suggested that you take additional training to supplement the work you'll perform the lab or continue with, say, your dissertation research. To change the CITI course registration that will fit your training requirements, you will have to switch "learner groups". All it takes is going through a couple of steps.
1) Log back into CITI (using your username and password). The site that appears will be your "Learner's Menu" page - the one that shows the courses you're enrolled in.
2) Scroll down and look for the link that says "Add a course or update your learner groups for University of Maryland, Baltimore County". Click on that and find the "Update Groups" link.
3) This is your "Groups" page. Scroll down the page that lists the CITI Course Enrollment Questions. Select the radio button next to "Data or Specimens Only Research" OR "Researchers Conducting Less than Minimal Risk" OR "Social & Behavioral Minimal Risk Research", then continue scrolling to the bottom of the page and hit the submit button.
4) You'll now be back at your "Groups" page. Go to the bottom of the next page and click on the "Go Back to Learner's Main Menu" link.
5) You'll then be back at your "Learner's Menu" page. You’ll see a link that says "Human Research" under My Courses. The original Human Research link should now say "Not Started - Enter". Click on that link and you'll see a list of additional training modules to take. Continue with reviewing the training materials and taking the quizzes. Once completed, you'll have a new certificate showing the completed modules.
Of course, if you have any questions about these steps, contact HARPO at 5-2737 or HARPO@umbc.edu.
1) Log back into CITI (using your username and password). The site that appears will be your "Learner's Menu" page - the one that shows the courses you're enrolled in.
2) Scroll down and look for the link that says "Add a course or update your learner groups for University of Maryland, Baltimore County". Click on that and find the "Update Groups" link.
3) This is your "Groups" page. Scroll down the page that lists the CITI Course Enrollment Questions. Select the radio button next to "Data or Specimens Only Research" OR "Researchers Conducting Less than Minimal Risk" OR "Social & Behavioral Minimal Risk Research", then continue scrolling to the bottom of the page and hit the submit button.
4) You'll now be back at your "Groups" page. Go to the bottom of the next page and click on the "Go Back to Learner's Main Menu" link.
5) You'll then be back at your "Learner's Menu" page. You’ll see a link that says "Human Research" under My Courses. The original Human Research link should now say "Not Started - Enter". Click on that link and you'll see a list of additional training modules to take. Continue with reviewing the training materials and taking the quizzes. Once completed, you'll have a new certificate showing the completed modules.
Of course, if you have any questions about these steps, contact HARPO at 5-2737 or HARPO@umbc.edu.
05 September 2008
How to access the CITI training
As the new semester begins, we at HARPO get quite a few questions on how to access the CITI (or Collaborative Institutional Training Initiative) web based training programs.
First, what is CITI? The CITI program is a web-based subscription training service that provides research ethics education to all members of the research community. UMBC subscribes to this service, but you must register to create your own username and password and gain access to the site.
Now, who needs to take what training? Investigators working with people (that means conducting surveys, interviews, assessments, or looking at a person's data) will take training modules related to the IRB or human research. The modules cover topics dealing with social and behavioral research, high or low risk studies and projects looking at previously collected data or specimens. Investigators working with animals will take training related to animal care and use. There are also modules involving topics of responsible conduct of research, such as research misconduct, conflict of interest, publication practices & responsible authorship.
Finally, how can you access it? Pretty easy - go to HARPO training page (http://www.umbc.edu/HARPO/training.html) and select the training that's appropriate for your research. The important thing to remember is to log into the CITI site when you're ready to begin. Remember this: https://www.citiprogram.org/.
First, what is CITI? The CITI program is a web-based subscription training service that provides research ethics education to all members of the research community. UMBC subscribes to this service, but you must register to create your own username and password and gain access to the site.
Now, who needs to take what training? Investigators working with people (that means conducting surveys, interviews, assessments, or looking at a person's data) will take training modules related to the IRB or human research. The modules cover topics dealing with social and behavioral research, high or low risk studies and projects looking at previously collected data or specimens. Investigators working with animals will take training related to animal care and use. There are also modules involving topics of responsible conduct of research, such as research misconduct, conflict of interest, publication practices & responsible authorship.
Finally, how can you access it? Pretty easy - go to HARPO training page (http://www.umbc.edu/HARPO/training.html) and select the training that's appropriate for your research. The important thing to remember is to log into the CITI site when you're ready to begin. Remember this: https://www.citiprogram.org/.
22 August 2008
CORRECTION! New IRB members
As reported earlier, Satarupa Joardar, was listed as a Graduate student member in Biological Sciences. Correctly, she is a graduate student in the Intercultural Communication program in the Modern Languages and Linguistics department. Mea culpa, Mea culpa.
01 August 2008
What does HARPO do? (a refresher)
HARPO main mission is to assist the UMBC research community in following federal and state compliance regulations, provide guidance on regulatory issues, educate the research community on compliance requirements and serves as the administrative hub of the Institutional Review Board and Institutional Animal Care and Use Committee provides central administration to the Institutional Board (IRB) and the Institutional Care and Use Committee (IACUC).
We do this by communicating with investigators regarding committee decisions, maintaining records and facilitating on-going auditing of approved protocols. We also perform pre-review of protocols and consent forms to identify potential problems and suggest ways to make them better, provide education and training on the protection of research subjects, and provide assistance with the use of IRB and IACUC guidelines and research forms.
Give a us ring or send an email:
Tim Sparklin 410-455-2737 sparklin@umbc.edu
Mary Lilly 410-455-3958 lilly@umbc.edu
Student investigators
How, when and why do student investigators have to apply for human and animal compliance committee (IRB or IACUC) review and approval?
Let's break this down:
How: Both the IRB's and IACUC's protocol submission procedures are found on the web.
The IRB has procedures and guidelines regarding student initiatied research -http://www.umbc.edu/irb/studentinitiatedresearch.htm. While the student may take on the role as the principal investigator of human research study, faculty advisors play an important role is in the student's design and development of human participant research project. The IRB hold the faculty advisor ultimately responsible for the protection of the subjects.
The IACUC's protocol submission procedures do not allow for a student to serve as a principal investigator of an animal research study, but may fully participate as a member of the research team. Review these procedures further at http://www.umbc.edu/iacuc/submissionreviewapproval.htm.
When: Protocols must be submitted as soon as possible to allow time for the members of the committees to adequately and appropriately review and approve the research. A few more specifics:
IRB
Exempt review may be submitted at any time, preferably two (2) weeks before an investigator intends to begin a project
Expedited review may be submitted at any time, preferably four (4) weeks before an investigator intends to begin a project
Full board reviewed research is considered at a convened meeting of the IRB and must be submitted four weeks before a scheduled meeting
IACUC
Animal research protocols are only reviewed at a convened meeting of the IACUC (other conditiions apply) and must be submitted at least 45 days before the scheduled meeting.
Why: In addition to the descriptions above, it's the right thing to do. Being a responsible researcher program encourages integrity in the pursuit of scientific investigation and discourages potential research misconduct and questionable research practices.
Let's break this down:
How: Both the IRB's and IACUC's protocol submission procedures are found on the web.
The IRB has procedures and guidelines regarding student initiatied research -http://www.umbc.edu/irb/studentinitiatedresearch.htm. While the student may take on the role as the principal investigator of human research study, faculty advisors play an important role is in the student's design and development of human participant research project. The IRB hold the faculty advisor ultimately responsible for the protection of the subjects.
The IACUC's protocol submission procedures do not allow for a student to serve as a principal investigator of an animal research study, but may fully participate as a member of the research team. Review these procedures further at http://www.umbc.edu/iacuc/submissionreviewapproval.htm.
When: Protocols must be submitted as soon as possible to allow time for the members of the committees to adequately and appropriately review and approve the research. A few more specifics:
IRB
Exempt review may be submitted at any time, preferably two (2) weeks before an investigator intends to begin a project
Expedited review may be submitted at any time, preferably four (4) weeks before an investigator intends to begin a project
Full board reviewed research is considered at a convened meeting of the IRB and must be submitted four weeks before a scheduled meeting
IACUC
Animal research protocols are only reviewed at a convened meeting of the IACUC (other conditiions apply) and must be submitted at least 45 days before the scheduled meeting.
Why: In addition to the descriptions above, it's the right thing to do. Being a responsible researcher program encourages integrity in the pursuit of scientific investigation and discourages potential research misconduct and questionable research practices.
Reporting and managing conflicts of interest
Have an interest in learning more about the regulations regarding the standards and procedures involving the reporting of financial conflicts of interest? Sure you do! The NIH has compiled answers to the most frequently asked questions regarding the the regulations.
Go to http://grants.nih.gov/grants/policy/coifaq.htm for more information.
Go to http://grants.nih.gov/grants/policy/coifaq.htm for more information.
29 July 2008
Why is training needed?
Investigators conducting research with people are considered "key personnel" who are "engaged in " research with living human beings, using human tissue samples or working with identifiable private information. As such, investigators must be informed about and stay abreast of the regulatory and ethical requirements of such research. UMBC's use of the Collaborative IRB Training Initiative (CITI) is an educational program for the protection of human subjects in research meets that need. The core course in CITI were developed by experts in the IRB community and focuses on studies in sociological, psychological, anthropological or educational phenomena including observational and survey research.
The CITI program also offer training required of all persons using and caring for laboratory animals at UMBC, including scientists, research and animal care personnel. Completion of this training fulfills the IACUC's requirements to conduct studies using specified animals and techniques.
Completing this training is a necessary hoop to jump through before starting a research project - more importantly if external funding from grants or contracts are involved.
See the HARPO training link for more information.
27 June 2008
New IRB members
Please welcome the following new members to the UMBC Institutional Review Board, beginning in the Fall of 2008:
Gina Fitzmaurice, Undergraduate student member, Health Administration & Policy Program
Satarupa Joardar, Graduate student member, Biological Sciences
The updated roster of Board membership is available on the IRB website.
Gina Fitzmaurice, Undergraduate student member, Health Administration & Policy Program
Satarupa Joardar, Graduate student member, Biological Sciences
The updated roster of Board membership is available on the IRB website.
24 June 2008
Questions participants should ask before agreeing to participate in a research study
Investigators are always on the look out for participants to enroll in a study; without them, how could you collect valuable data?
When approaching/recruiting potential participants, provide lots of information about your study but also encourage them to ask questions. Full disclosure about the study and honest answers to questions will make life easy for you, the investigator, as well as your participants.
Some questions participants should ask (courtesy of OHRP - http://www.hhs.gov/ohrp/outreach/questions.html):
When approaching/recruiting potential participants, provide lots of information about your study but also encourage them to ask questions. Full disclosure about the study and honest answers to questions will make life easy for you, the investigator, as well as your participants.
Some questions participants should ask (courtesy of OHRP - http://www.hhs.gov/ohrp/outreach/questions.html):
Why is the research being done?
What will be done to me as part of the research?
How will I benefit from the research?
Could the research hurt me?
What will the researcher do with my information?
Will the research cost me anything?
Who pays if I�m unexpectedly injured in the study?
How long will the study last?
What happens if I decide to leave the study early?
Who should I call if I have a question about the research?
06 June 2008
Slide shows that explain CITI compliance training registration
Everyone likes a slide show, right? Except, maybe, for Uncle Harry's bonanza of 400 slides of his trip to the Grand Canyon.
Well, never fear. We at HARPO would rather not put you sleep, but make your introduction and registration with the compliance training programs with the Collaborative Institutional Training Initiative (CITI ) a bit easier.
Currently, there are several compliance training programs to take, including Human Participant Use, Animal Care and Use and Responsible Conduct of Research.
Click on the http://www.umbc.edu/HARPO/training.htm to view the program that interests you or are required to review before conducting research. Select the slide show to view; additional registration instructions are available for download.
Let us know at HARPO@umbc.edu or 410-455-2737 if you have any questions or need more information.
P.S. - we won't tell Uncle Harry you left the room!
Well, never fear. We at HARPO would rather not put you sleep, but make your introduction and registration with the compliance training programs with the Collaborative Institutional Training Initiative (CITI ) a bit easier.
Currently, there are several compliance training programs to take, including Human Participant Use, Animal Care and Use and Responsible Conduct of Research.
Click on the http://www.umbc.edu/HARPO/training.htm to view the program that interests you or are required to review before conducting research. Select the slide show to view; additional registration instructions are available for download.
Let us know at HARPO@umbc.edu or 410-455-2737 if you have any questions or need more information.
P.S. - we won't tell Uncle Harry you left the room!
05 June 2008
Office of Laboratory Animal Welfare IACUC Staff Outreach
The Office of Laboratory Animal Welfare (OLAW) is hosting a series of free online seminar series to help Institutional Animal Care and Use (IACUC) staff understand their responsibilities in the oversight of PHS-funded research involving the use of animals. IACUC members, veterinarians, compliance personnel and animal care staff are also invited to attend the free seminars.
All you need a computer with internet access with Flash software installed.
For more details and registration for this free event (get the free message, right?), go to:
http://grants.nih.gov/grants/olaw/e-seminars.htm
All you need a computer with internet access with Flash software installed.
For more details and registration for this free event (get the free message, right?), go to:
http://grants.nih.gov/grants/olaw/e-seminars.htm
02 June 2008
who should a participant contact
The contact information (telephone, email, address) should be listed for the principal researcher/investigator and HARPO office.
First and foremost, state to the participant in the consent process and on the consent form how they can reach the researcher/investigator at the time of the study and after the study is completed in case they have any questions, concerns, or complaints. List the contact information for a faculty advisor if applicable.
The staff of the HARPO office, who represents the IRB, must also be listed as a contact point to provide assistance to participants to about the IRB review process or that person's rights as a research participant.
The consent form must clearly state who and how to contact both. Use the consent form examples on IRB web site to create this form.
First and foremost, state to the participant in the consent process and on the consent form how they can reach the researcher/investigator at the time of the study and after the study is completed in case they have any questions, concerns, or complaints. List the contact information for a faculty advisor if applicable.
The staff of the HARPO office, who represents the IRB, must also be listed as a contact point to provide assistance to participants to about the IRB review process or that person's rights as a research participant.
The consent form must clearly state who and how to contact both. Use the consent form examples on IRB web site to create this form.
21 May 2008
Animal Welfare Matters fromthe NIH
Animal research news and notes from the NIH Office of Extramural Research
http://nexus.od.nih.gov/nexus/nexus.aspx?ID=44&Month=4&Year=2008
http://nexus.od.nih.gov/nexus/nexus.aspx?ID=44&Month=4&Year=2008
20 May 2008
IRB applications and team members
The applications for IRB review now request that you list the principal investigator, faculty adviser as well as the research team members associated with the research project. The list of all pertinent individuals in the application does two things: 1) it shows the IRB who is associated with the research and that these individuals have completed the CITI training and 2) provides for the necessary documentation in who may be involved in the participant consenting process.
The later point is important for, when we in HARPO go and review protocol files, we find that only those associated with a research project are involved in the consent process and have the necessary knowledge to inform participants about the purposes and intent of a study. Plus, it's a good measure for primary investigators to maintain quality control over how the research is being conducted.
So, fill in all names you, as the primary investigator know will be associated with the study. If you don't know at the time of application (waiting for grad students to come on board or are waiting for those helpful undergrads to sign up for study), send an email to the HARPO office (HARPO@umbc.edu) with the names. We'll at the minimum verify these individuals have completed the CITI training.
The later point is important for, when we in HARPO go and review protocol files, we find that only those associated with a research project are involved in the consent process and have the necessary knowledge to inform participants about the purposes and intent of a study. Plus, it's a good measure for primary investigators to maintain quality control over how the research is being conducted.
So, fill in all names you, as the primary investigator know will be associated with the study. If you don't know at the time of application (waiting for grad students to come on board or are waiting for those helpful undergrads to sign up for study), send an email to the HARPO office (HARPO@umbc.edu) with the names. We'll at the minimum verify these individuals have completed the CITI training.
25 April 2008
Meeting the Information Requirements of the Animal Welfare Act
The National Agricultural Library in Beltsville, Maryland if offering for principal investigators, members of IACUCs, information providers, administrators of animal use programs, and veterinarians a workshop about the responsibilites of meeting the requirements of the Animal Welfare Act (AWA).
The AWA require that investigators provide documentation with their applications demonstrating that alternatives to procedures that may cause more than momentary pain or distress to the animals have been considered and that the proposed activities do not unnecessarily duplicate previous experiments.
See the NAL website, http://www.nal.usda.gov/awic/awicworkshops/regform.htm, for registration information for this free workshop.
The AWA require that investigators provide documentation with their applications demonstrating that alternatives to procedures that may cause more than momentary pain or distress to the animals have been considered and that the proposed activities do not unnecessarily duplicate previous experiments.
See the NAL website, http://www.nal.usda.gov/awic/awicworkshops/regform.htm, for registration information for this free workshop.
18 April 2008
IRB Protocol audits (this is not the IRS)
Many faculty and students have received notices over the past several weeks regarding the post approval protocol monitoring (PAPM), or as it may be better known as a "protocol audit".
Because an investigator is chosen for an "audit" or PAPM, it doesn't mean he/she has done anything wrong. UMBC required by federal regulation to exercise "appropriate oversight mechanisms" to make sure the policies and procedures designed for protecting the rights and welfare of human participants are being followed and that participant's well being is safeguarded.
So, in addition to complying with procedures, the PAPM is used to educate researchers about human subject protection issues and improve the quality of research by finding potential errors or omissions as research is performed.
It's good for the researcher and good for the university.
If you get the email or phone call about a PAPM, don't fret; it's all done to make your research experience easier and hopefully less complicated.
Read more about Protocol Audits .
Because an investigator is chosen for an "audit" or PAPM, it doesn't mean he/she has done anything wrong. UMBC required by federal regulation to exercise "appropriate oversight mechanisms" to make sure the policies and procedures designed for protecting the rights and welfare of human participants are being followed and that participant's well being is safeguarded.
So, in addition to complying with procedures, the PAPM is used to educate researchers about human subject protection issues and improve the quality of research by finding potential errors or omissions as research is performed.
It's good for the researcher and good for the university.
If you get the email or phone call about a PAPM, don't fret; it's all done to make your research experience easier and hopefully less complicated.
Read more about Protocol Audits .
The IRB is looking for a few (student) volunteers
The Institutional Review Board (IRB) is currently accepting applications from undergraduate and graduate students to join the IRB. Student members are considered full members of the board, which meets five times a year from 10 am-12 pm on Mondays. The meetings are held during the months of October, December, February, April and June. In addition to meetings, student member review research protocols and vote on issues related to the protection of human subjects.
This is a terrific opportunity to learn about ethical issues related to research; and being a member of the IRB looks good on a CV or resume. Interested students should email Susan Sonnenschein, IRB Chair,
(sonnensc@umbc.edu) to apply. In addition to your CV or resume, describe in your email your research interests and experience.
Additional information about the IRB is found at http://www.umbc.edu/irb/.
This is a terrific opportunity to learn about ethical issues related to research; and being a member of the IRB looks good on a CV or resume. Interested students should email Susan Sonnenschein, IRB Chair,
(sonnensc@umbc.edu) to apply. In addition to your CV or resume, describe in your email your research interests and experience.
Additional information about the IRB is found at http://www.umbc.edu/irb/.
14 March 2008
HARPO will be closed
The Human and Animal Research Protections Office will be closed during UMBC’s spring break, from Monday, March 17, 2008 through Tuesday, March 18, 2008, and will reopen on March 19, 2008.
Please call the Office telephone number at 410-455-2737 if you have any research compliance questions and follow the instructions on the recorded message.
Please call the Office telephone number at 410-455-2737 if you have any research compliance questions and follow the instructions on the recorded message.
11 March 2008
Up to date IRB forms
Application forms are the lifeblood of the IRB as they document procedures, actions and research methodology of the investigator's human participant use. HARPO uses these form to keep members of the IRB informed about the research but also to track what investigators will do. Every once in a while, we tweak these forms to make documentation of the research easier for the IRB to review and for us to put in our database. So, please use the most current forms when submitting applications or reports to the IRB. Using outdated forms may delay the processing of researcher’s requests. The complete list of IRB forms are found at http://www.umbc.edu/irb/irbforms.htm
28 February 2008
IACUC application details
To get your IACUC application reviewed in a timely fashion, and to make life simple for us, follow these steps:
1) Complete the CITI training program. There's no need to send us a copy of your training certificate as we'll have that electronically. But check off the box on the application that you, your advisor and members of your research team, have completed the training.
2) Fax and/or scan the front page of your application. Please only send the signature page by fax or email a scanned copy only. Electronically submit the rest of your application, via email, to iacucsubmissions@umbc.edu. Of course, if there are any parts of your application that cannot be sent electronically to fax or mail to the HARPO office.
3) Check your spelling and grammar. There have been far too many times applications have been submitted with these types of errors. It's best to present to the IACUC a well presented application that not only fully describes your research but also shows you have the adequate know-how and expertise in the areas of animal care and use.
4) Allow yourself sufficient time for review of the research. The review cycle has been created to make sure the folks on the IACUC have adequate time to review, ponder and make any recommendations about your research study. Remember, the IACUC's mission is to ensure that animal use is necessary and that high standards of humane care are observed. They need the time in the review cycle to do this. So, submit as early as you can. The review cycle guidelines are found in the IACUC's Protocol Policy Procedures.
1) Complete the CITI training program. There's no need to send us a copy of your training certificate as we'll have that electronically. But check off the box on the application that you, your advisor and members of your research team, have completed the training.
2) Fax and/or scan the front page of your application. Please only send the signature page by fax or email a scanned copy only. Electronically submit the rest of your application, via email, to iacucsubmissions@umbc.edu. Of course, if there are any parts of your application that cannot be sent electronically to fax or mail to the HARPO office.
3) Check your spelling and grammar. There have been far too many times applications have been submitted with these types of errors. It's best to present to the IACUC a well presented application that not only fully describes your research but also shows you have the adequate know-how and expertise in the areas of animal care and use.
4) Allow yourself sufficient time for review of the research. The review cycle has been created to make sure the folks on the IACUC have adequate time to review, ponder and make any recommendations about your research study. Remember, the IACUC's mission is to ensure that animal use is necessary and that high standards of humane care are observed. They need the time in the review cycle to do this. So, submit as early as you can. The review cycle guidelines are found in the IACUC's Protocol Policy Procedures.
Where in the world is HARPO?
In case you were wondering and would like to visit or drop off any paperwork, the staff of HARPO are located in the UMBC Research Park (bwtech@UMBC) at 5523 Research Park Drive, Suite 310, Baltimore, Maryland 21228.
A map showing our location may be found at http://www.bwtechumbc.com/pdf/bwtech_umbc.pdf.
Give us a call at 410-455-2737 or send an email to HARPO@umbc.edu to let us know you're coming.
A map showing our location may be found at http://www.bwtechumbc.com/pdf/bwtech_umbc.pdf.
Give us a call at 410-455-2737 or send an email to HARPO@umbc.edu to let us know you're coming.
IRB application details
To get your IRB application reviewed in a timely fashion, and to make life simple for us, follow these steps:
1) Complete the CITI training program. There's no need to send us a copy of your training certificate as we'll have that electronically. But check off the box on the application that you, your advisor and members of your research team, have completed the training.
2) Fax and/or scan the front page of your application. Please only send the signature page by fax or email a scanned copy only. Electronically submit the rest of your application, via email, to irbsubmissions@umbc.edu. Of course, if there are any parts of your application that cannot be sent electronically to fax or mail to the HARPO office.
3) Check your spelling and grammar. There have been far too many times applications have been submitted with these types of errors. It's best to present to the IRB a well presented application that not only fully describes your research but also shows you'll be ready to interact with and adequately inform subjects about participation in a research study.
4) Allow yourself sufficient time for review of the research. The review cycle has been created to make sure the folks on the IRB have adequate time to review, ponder and make any recommendations about your research study. Remember, the IRB's mission is to provide oversight on all human participant research, with a focus on protecting individuals from risk and safeguarding their well-being. They need the time in the review cycle to do this. So, submit as early as you can to make sure you won't run into participant scheduling problems or not completing your project before the semester ends. The review cycle guidelines are found in the IRB's Researcher's Guide.
1) Complete the CITI training program. There's no need to send us a copy of your training certificate as we'll have that electronically. But check off the box on the application that you, your advisor and members of your research team, have completed the training.
2) Fax and/or scan the front page of your application. Please only send the signature page by fax or email a scanned copy only. Electronically submit the rest of your application, via email, to irbsubmissions@umbc.edu. Of course, if there are any parts of your application that cannot be sent electronically to fax or mail to the HARPO office.
3) Check your spelling and grammar. There have been far too many times applications have been submitted with these types of errors. It's best to present to the IRB a well presented application that not only fully describes your research but also shows you'll be ready to interact with and adequately inform subjects about participation in a research study.
4) Allow yourself sufficient time for review of the research. The review cycle has been created to make sure the folks on the IRB have adequate time to review, ponder and make any recommendations about your research study. Remember, the IRB's mission is to provide oversight on all human participant research, with a focus on protecting individuals from risk and safeguarding their well-being. They need the time in the review cycle to do this. So, submit as early as you can to make sure you won't run into participant scheduling problems or not completing your project before the semester ends. The review cycle guidelines are found in the IRB's Researcher's Guide.
18 February 2008
CITI training (part 2)
How would you figure out which is the best human participant training for you? First, think about the level of risk your project entails.
Research protocols that would present a low amount or risk or less than minimal risk to participants most likely will be reviewed by the IRB in any of the six "exempt" review categories. As such, choose the Researchers conducting less than minimal risk research module or the Data or Specimens Only Research module in the CITI training program.
Conversely, research that presents a a minimal risk or higher level of risk will be reviewed in the "expedited" or "full board" review cycles. The module entitled " Social & Behavioral Minimal Risk Research" must be completed by all investigators performing this type of work.
Examples of the type of research in the above review categories can by found on the IRB web site.
If you are unsure of which group to select, or feel your research falls within two of these learner areas, please contact Tim Sparklin in the Human and Animal Research Protections Office at 410-455-2737, email sparklin@umbc.edu or send an IM message to HARPO246.
Research protocols that would present a low amount or risk or less than minimal risk to participants most likely will be reviewed by the IRB in any of the six "exempt" review categories. As such, choose the Researchers conducting less than minimal risk research module or the Data or Specimens Only Research module in the CITI training program.
Conversely, research that presents a a minimal risk or higher level of risk will be reviewed in the "expedited" or "full board" review cycles. The module entitled " Social & Behavioral Minimal Risk Research" must be completed by all investigators performing this type of work.
Examples of the type of research in the above review categories can by found on the IRB web site.
If you are unsure of which group to select, or feel your research falls within two of these learner areas, please contact Tim Sparklin in the Human and Animal Research Protections Office at 410-455-2737, email sparklin@umbc.edu or send an IM message to HARPO246.
14 February 2008
HARPO presentations
The staff from the Human and Animal Research Protections office are available to meet with faculty at departmental meetings or speak to students in informal or formal (research methodology classes) to better educate and inform about research compliance issues. Contact the HARPO office at HARPO@umbc.edu or 410-455-2737 for more information or to schedule a time for your group or class. The current schedule of presentations may be found at this link.
CITI training
Unsure of which learner group to select for the Collaborative Institutional Training Initiative (CITI) web-based courses? Review the below list to determine which best fits your training needs;contact Tim Sparklin if you have any questions. Note that links will open into a new page.
Human Research
Social & Behavioral Minimal Risk Research
This module is designed for faculty, staff, graduate students, and undergraduate students involved in minimal risk research, who plan to submit for expedited review and who have not previously completed the UMBC IRB training program.
Data or Specimens Only Research
This module is designed for faculty, staff, graduate students, and undergraduate students involved in less than minimal risk research that uses pre-existing data, records and/or specimens and when such data may fall within the exempt (subcategory 4) or expedited categories of review (Category 5).
Researchers conducting less than minimal risk research
This module is designed for faculty, staff, graduate students, and undergraduate students involved in less than minimal risk research, which entails no known physical, emotional, psychological, or economic risk, to nonvulnerable subjects. Students who are enrolled in PSYC 332 or related undergraduate research methods courses will take this module for training.
IRB Investigator Refresher Module
These modules are designed for faculty, staff, graduate students, and undergraduate students whose UMBC IRB training certification has expired and are contemplating continuing research with human participants. Investigators will have received a notice from HARPO regarding re-certification and be instructed on the appropriate module to take.
Animal Care and Use
Working with the IACUC – the basic course required for investigators and research staff who plan to use laboratory animals or plan to supervise such work at UMBC. Investigators and research staff are also required to choose appropriate species-specific module.
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