IRB Procedures for Human Subjects Research
In order to submit new protocols as well as modification/renewals, please follow the process below.
1) Prepare your protocol. Include Aggie Mitchkoski as the administrative contact. It is ESSENTIAL that Aggie be listed as the administrative contact so that she can have access to your protocol in the eprotocol system.
2) When you have completed your protocol, save it but DO NOT HIT SUBMIT....send Aggie an email indicating the study number and name to be reviewed.
3) Aggie will do a review of the Psychology-specific issues that need to be addressed. The checklist to the right lists these issues and the departmental guidelines.
4) Aggie will let you know if there are any issues that need to be fixed. Once the departmental issues are dealt with, Aggie will be the one to submit the protocol to the IRB. The IRB is tracking new submissions to determine that they are coming through Aggie. If you submit something directly to the IRB, it will be sent back to you. If you do not receive a reply email from Aggie within two working days, contact her again to verify that the submission has been received.
5) The IRB will then take over on the review.They will send you feedback as they have always done, and you can send further communications/revision on that protocol, back to them WITHOUT going through Aggie.
6) Please DO submit requests for modifications and renewals of existing protocols through Aggie. Given that modifications often include changes that relate to areas of department policy (SONA, posted flyers, etc.), we need this to be the case. Final Reports do NOT need to go through Aggie.
As long as your study is active with the IRB, has not added any new personnel, nor made any changes to its protocol, no revision or continuation is needed until you reach your renewal date. However, for SONA hours each semester, you must request hours. This can be done by filling out the SONA Hr Request form that is a second sheet to your Lab's Lab Personnel Form or using the Sona Hr Request form to the right on this page.
LAB PERSONNEL FORM
All RAs must complete the CITI online training (see next section.) For Labs involved in tissue sample collection or chemicals, EHS required Safety Training will need to be completed. All undergrad RAs must also complete the Department Ethics training. Each semester and whenever personnel changes occur in your lab/study you need to complete/update a Lab Personnel Form which each Lab has access to on UMASS Apps. Only Personnel needing access to eprotocol should also be listed in the Personnel Info section of your Eprotocol study. After verifying that all necessary training has been completed these logs will be uploaded to your eprotocol study by the Administrator.
All undergrad RAs must also complete the Department's Ethical Training which is offered in the first weeks of each semester. This is required for any undergrad that hopes to work in a Human Subject Lab. There is a place to indicate if this training has been completed or not on the form.
This form can also be used to request keys and SONA Accounts for you lab personnel.
If the RA is a visitor or volunteer, a Volunteer form is required for them to work in your lab. This can also be listed on this form.
CITI ONLINE TRAINING
Everyone involved in your proposal must complete the online CITI Training for Group 2, Social and Behavioral Research Investigators and Key Personnel prior to your IRB submission.
REVISIONS TO YOUR STUDY
Study changes to Eprotocol studies need to be reported via a modification request on the Eprotocol system. Remember you must notify Aggie Mitchkoski that you have new changes ready for submission. She will submit it to the IRB after the departmental review. If you submit it yourself it will be returned to you by the IRB.
Also, when making modifications to the body of eprotocol, leave the original protocol as it is and in the appropriate sections, date and explain the changes being made at the end of the section.
New studies should submit their studies via the new online submission program, E-protocol. Again, remember to notify Aggie Mitchkoski you have a study ready for submission. Do NOT submite it yourself as it will be returned by the IRB.
In order to submit a protocol, you need to get a log-in account and password. You can obtain this by emailing Nancy Swett or call 545-2348. Please note that you will need to have completed your CITI training in order to get your log in information. Provide your netID, your full name, your email address and your position in the department (faculty,grad student post doc,etc.) If you are a grad student, your faculty advisor will also need to submit their information and receive log-in information as they will need to electronically sign off on the protocol. If you are a post-doc, lecturer or adjunct and wish to submit a protocol under your own name without a faculty sponsor, please see Aggie Mitchkoski, Tobin Rm 441 for additional information.
The only other people who will need an E-protocol log in are others you want to have access to your protocol.They would then be added to the Personnel section of Eprotocol. All other RAs and lab personnel should be listed in the Lab Personnel Form which your lab has access to on Umass Apps and do NOT need an E-protocol log in. They do not need to be listed in the Personnel section of Eprotocol. The form will be uploaded into the attachment section when completed by the Human Subject Administrator.
When attaching documents do not use Word 2007 formats as E-protocol does not work well with it. Save the document first as a Word 2003 or pdf. Also, remember to notify Aggie Mitchkoski that you have a protocol ready for review. If you submit the protocol yourself without that review, it will be returned.
When you log in to E-protocol the help function will provide you with the help you will need. If you have other questions, feel free to contact the Human Subject Administrator in Tobin Rm 441. Please be sure to check the following list of items to make sure you include, attach or in some way address these items. If not, the protocol will be returned.
- 99% of all our studies are expedited. Once you choose a review level it cannot be changed.
- Aggie Mitchkoski is listed as Administrative Contact on all Psychology protocols.
- The recruitment section of E-protocol should contain the following if you are planning on using the SONA system for recruitment.
A. Section 4g. the SONA study name you will use
B. Section 4g. the SONA study description you will post
C. Attachments: If you are using an online study through SONA and/or another survey program be sure to include copies of the survey pages as they will appear online
D. Section 4a. If you are running a multiple part study, clearly identify the number of subjects per section. If you make revisions, leave the old information and add the date and changes being made directly below the original information.
- If the study is an Honor Thesis study for an undergradutate, it should submit with the undergrad as the PI with their faculty sponsor listed.
- Include BOTH how long the individual study session will be and the completed duration of the study protocol (see part 4i in the Protocol Information Section of e-protocol)
- Adding RAs to your proposal is covered above in Personnel Lists
- Upload any other recruiting materials, i.e. fliers, posters as attachments. See this website for what information can be presented in the recruiting materials.
Consent Forms should be called "consent" not "informed consent" form. As some of our studies involve deception and cannot use "informed" we decided to change all the forms so that a deception study could not be isolated because of a different title. Please click here for a template (this is a new template approved by the University IRB) and here for University guidelines. ***Please note that the template includes the word "informed" and needs to be modified for use in our department.
Consent Forms should contain 3 levels of contact, Primary Investigator, a department contact (faculty sponsor or Department Head) and the University IRB contact information (HumanSubjects@ora.umass.edu). Please include them in this order.
Studies which are utilizing audio,video or digital recordings should specify the destruction timeframe as well as who has access to the recordings and where they will be stored. Please refer here for the IRB guidelines for these types of studies.
The consent form must have the following language if the study is for extra credit:
"Your participation in the experiment is voluntary and you can withdraw at any time without penalty. You will still get credit.
Also please include the following in consents for studies for class credit.
"If you are earning experimental credits through your participation, please understand that this is not the only way to do so. You may contact your
instructor who will offer you an appropriate alternative activity."
- Debriefing statements are required for all studies done for credit, for deception studies and for studies involving covert video/audio taping of subjects
- All debriefing statements should be written in non-technical language, taking care to make it clear enough to be understood by 18-year old participants.
- For deception studies subjects must be completely debriefed and offered option to withdraw their data.
- For deception studies subjects must be given information about some mental health resources if they are distressed and want to seek help (e.g., PSC, university health services, etc).
- For deception studies, PIs may include the following Disclosure Disclaimer if desired to the bottom of your Debriefing statement: "Please do not disclose research procedures and hypotheses to anyone who might participate in this study between now and the end of the data collection (insert month, year) as this could affect the results of the study."
- For deception and covert video/audio taping the debriefing should allow the subject to remove their data from the research if they desire it
DEBRIEFING FOR STUDIES OFFERING CLASS CREDIT
Studies for which students are getting research credit must also have a debriefing that is educational. For example:
- What are the questions, hypotheses, and issues that motivate this research?
- What is the general background leading to the research question being studied?
- What's the basic logic underlying the study including the experimental conditions and how they relate to the study's hypotheses?
- How will the data gathered from participants address the hypotheses?
- An accessible reference for further reading. This reference must be found easily by students.
- Ask participants if they wish to be kept informed of the results of the experiment. You can say, "If you would like to receive a report of this research when it is completed (or a summary of the findings), please contact (name) at (email)."
- All debriefing statements should provide your own contact information as well as your Principal Investigator, Dept Chair, and Human Research Protection Office (email@example.com, 545-3428).
USING A DATABASE TO STORE SUBJECTS' CONTACT INFORMATION
All databases that store subjects' contact information should do so after obtaining consent to do so. Consent should include the following:
- What information will be stored
- Where it will be stored and for how long
- Potential risk of confidentiality breach
- Who will have access to it.
- If this database will be used to recruit participants for future studies, ask participants to give separate consent only if they are willing to be contacted in the future.
- If a researcher wants to contact participants in an existing database who haven't consented to being contacted for other studies, the procedure is for the original PI to initiate the contact with information about the new study or s/he should request particpant's permission to share their contact information with another researcher. This recruiting information should be included in the PIs IRB proposal.
Any protocols which might involve shared database use should include this procedure in their protocol to the IRB.
Of course, if all identifying characteristics have been removed from a database, it can be shared without any measures as mentioned above.
RESEARCH IN CLASSROOMS
The department does not allow studies/researchers to directly recruit in classrooms. All recruitment is done via SONA or fliers posted in appropriate bulletin boards in Tobin Hall.
If any projects being done in classrooms could result in new knowledge and/or may be published, instructors should prompt the student(s) involved to file a proposal to the IRB.
Care should also be taken when any potential compromise of identity or risks may be touched on by doing a class survey.If in doubt about whether the classroom research falls under the purview of the IRB, instructors and TAs are encouraged to contact the Psychology Department's IRB committee for guidance.