Institutional Compliance

Frequently Asked Questions About Human Subjects Research

1. What is the UMass Lowell Institutional Review Board (IRB)?
The UMass Lowell IRB is a committee of faculty from diverse backgrounds and community members who review research protocols involving human subject participants to ensure that the rights of the participants are protected, that they are not subject to unreasonable harm (physical and emotional), and that information about them is kept confidential.

2. What is research?
Research means a systematic investigation, including pilot research, testing and evaluation, designed to develop or contribute to generalizable knowledge. This includes collection of scholarly materials for theses and dissertations done by students, and investigations carried out by faculty and staff for publication and/or presentation.

3. How do I know if I should submit a research protocol to the IRB?
If your project meets the definition of research (including observation, interviews, and surveys) involves human participants, it must be reviewed by the IRB or the Department, if sanctioned to conduct reviews.

4. When should I submit my review request to the IRB?
It is advisable to submit your application for review to the IRB as soon as possible. Approval must be received before any research activities may begin (recruitment or data collection). For a full review, allow at least one month for approval. An estimated timeline is provided in the UMass Lowell Policies and Procedures and recommends submitting your application at least two weeks before the next scheduled monthly meeting.

5. What is informed consent?
Informed consent is usually obtained through a document that fully discloses the nature of the research, explains the risks (both physical and psychological) and benefits and allows the individual to voluntarily decide whether to participate in the research study or not.

6. Who should I contact if I have questions?
Contact either the IRB Administrator at 978 934-4134 or the Director of Institutional Compliance at 978 934-3452 for assistance. This website also contains helpful information.

7. What if I am a student investigator?
Beginning in 2006, students conducting research must have a faculty advisor serve as a PI. Please see the definition of PI to determine who is eligible to sign as PI for IRB applications. Some research projects qualify for review at the Department level, if the department in which you are affiliated has been approved to conduct department-level reviews.

8. What is the difference between anonymous and confidential?
Anonymous means that the data collected by the researcher cannot be linked to the participant. Confidential means that the researcher maybe able to identify a participant’s data but will not reveal the participant’s identity to anyone else. Person-to-person interviews, for example, are never anonymous.

9. Can the Board stop me from conducting my research?
Yes. The IRB has the authority to disapprove, suspend, or terminate research that is not carried out according to its requirements or may be associated with unexpected serious harm to subjects. Any such action will include a statement of the IRB’s reasons for its action and will be reported promptly to the PI, the IO, and the funding agency.

10. Does the IRB serve as a scientific review panel?
No, but if a proposed project appears to lack scientific merit or rigor, or duplicate existing work with more than minimal risk to subjects, the Board is required to consider whether the benefits to individual subjects and society outweigh the potential for harm to them.

11. My research with human subjects is not funded. Do I still have to submit an application to the IRB?
Yes. All research that involves human subject/participants must be reviewed and approved by the IRB.

12. Is IRB approval required for graduate level research involving human subjects?
Yes. Master’s thesis and Doctoral-level dissertation research is considered research and must be approved by the IRB. Failing to obtain approval may result in disqualification of these activities in application towards a degree program.

13. Do student projects that are part of a class requirement have to be submitted to the IRB?
It depends, but typical assignments for a class that are not for generalizable knowledge do not typically need IRB review. Of course, the teaching faculty needs to be aware of the types of information being collected and communicate to students the ethics that guide the collection of information by the students. If there is any question, it is best to contact the Office of Institutional Compliance for guidance before the project is initiated.

14. Do projects involving students in a specific department to meet educational requirements require any additional information in the consent forms?
Yes. If students are required to participate in a subject pool, faculty or other responsible individuals must make clear the terms under which students will receive credit for full or partial participation as subjects, their freedom to not take part in all or any part of the research, and the alternative ways in which they might fulfill their course requirements. In all human-subject activities where sensitive issues of personal behavior, depression, addiction, substance abuse, dietary disorders, suicidal tendencies, sexual disorders might be revealed, the responsible party must include on the consent form sources of professional consultation and care. In addition, efforts must be made to insure that all participants are legally adults. Because many human subject activities, particularly in Psychology and Education, for example, are conducted in the context of both teaching and research, you must provide the students with an oral or written explanation (debriefing) of the nature, design, and implications of the project even if deception is not a part of the experiment. A debriefing script or form must be submitted with the application as an attachment.

15. Who is responsible for reporting any problems that may occur during the conduct of approved human subject research activities?
PIs are responsible for reporting promptly to the IRB Administrator and the Director of Institutional Compliance any serious or continuing noncompliance with federal regulations, university policies, injuring to subjects, unanticipated problems, or changes in research activities. However, anyone who becomes aware of any serious or continuing noncompliance in the conduct of approved research should bring this to the attention of the IRB Administrator and the Director of Institutional Compliance.

16. What should I do if I know of research that has violated ethics?
You should notify the Department Chair or the IRB Administrator. If you have any concerns or are uncertain about what constitutes a violation, contact the IRB Administrator at 978 934-4134.

17. May deception or misrepresentation be used in studies with human subjects?
Yes, if the benefits outweigh the risks to the subjects for participating in such a study, and if the researcher provides a compelling scientific justification for such experimental manipulation. The participants must be informed that some information is being withheld until the end of their participation. For research where deception or misrepresentation is involved, the subjects must receive an explanation (a debriefing) about the nature of the experiment and why such manipulation was critical to its success. Such a form should be included with the materials submitted for IRB review and approval. All research that involves deception must be approved by the IRB.

18. If I begin my activity that involves human subjects before I receive IRB approval, what action may be taken against me?
Any study will be terminated by the IRB, which could result in loss of funding. Graduate students who begin human subject research before the IRB has approved the research may be denied permission to graduate by either their Department or by the Graduate School.

19. Do I need IRB approval if my activities will be conducted someplace other than the UMass Lowell campus? Do I need IRB approval if my protocol is already approved by another IRB?
Yes. UMass Lowell is still responsible for the activities of its researchers and must comply with federal and university regulations and policies. It is important that the IRB be aware of where and by whom such activities are being conducted, even in another country. The IRB/IEC form can be used to designate that an IRB from another institution will be responsible for oversight but the IRB still needs to be notified of the activity and keep a copy of the form on file.

20. Does the IRB continue to review research once it has been approved?
Yes. The Board conducts annual/continuing reviews of applications at one year intervals for projects that continue for longer than one year. For projects with higher risk, the review may be more frequent.

21. If I make changes in my protocol, does the IRB have to review and approve it again?
Yes. Any changes must be reviewed and approved by the IRB. In most cases, this can be done quickly through the expedited review process or by approval from an authorized IRB representative.

22. How can I speed my application through the IRB?
Carefully read the UMass Lowell IRB Policies and Procedures and complete each section of the application completely, as appropriate. Submit all parts of the application, informed consent, survey questions, recruitment materials, education training certificates, etc. together. Only PIs are qualified to sign the PI Assurance and Signature Page as well as the Informed Consent Form. Call the IRB Administrator if you have any questions during the application process.

23.When do projects require consent?
Consent is required from any human subject in research unless informed consent has been specifically waived by the IRB. The IRB may waive consent if the project involves no more than minimal risk; the waiver does not adversely affect subjects; the research could not practicably be carried out without the waiver; and, where appropriate, subjects are given information about the project afterwards.

24. Does the project require written consent?
The IRB may waive written consent if:
• Signed consent is the only record linking the subject to the research and the greatest risk of the research is a breach of confidentiality; or
• The research presents no more than minimal risk and involves procedures for which consent would not normally be obtained outside of the research context.

25. What consent materials are required for research with minors?
Research activities with minors require completion of a parental consent form and an assent form. To avoid delays in the approval of your application, follow the guidelines for informed consent.

26. What is assent, and is it always required?
Assent refers to the agreement by the minor to participate. Assent must be accompanied by consent from a parent or guardian and must be written in the simplest terms possible. Assent must be sought from a child unless: (1) the child is incapable of providing assent (due to age or condition); or (2) the intervention holds out the prospect of direct benefit to the child and the intervention is available only in the context of the study. In these two situations, consent from parent(s) is sufficient.

27. What is the CITI Human Subjects Protection Training?
Human Subjects Protection training is mandatory and the CITI training is one option the UMass Lowell offers. The training has been customized for UMass Lowell researchers and students and is for anyone engaged in the planning, conduct, or analysis of research (including individuals responsible for obtaining informed consent and those with a major authorship role when the research is reported), whether the research is funded or not. An electronic notification is sent to UMass Lowell to document your completion of the training. The CITI training offers modules for sociobehavioral researchers, biomedical researchers, or IRB members. It is the PIs responsibility to ensure that all key personnel involved in a research project have completed the training requirement. The average learner spends approximately 2 to 3 hours in the Basic Course site and a score of 80% is required to pass.

28. Do I have to renew my training?
Certification is valid for three years from the date of the initial training. CITI also offers a refresher course.

29. I am collaborating with some community members who are primarily Spanish speaking. Is there a training option in Spanish so they can obtain the mandatory education training certification?
Yes, please contact Elaine Major, Director of Institutional Compliance, for guidance on this issue.

30. I have a project that involves evaluating data collected about human subjects from databases. The databases I intend to use do not contain any identifiable information (i.e., the identity of the subjects may not be readily ascertained by the investigator or associated with the information) and I am not going to have any intervention or interaction with human subjects. What type of IRB review would this need?
This is not considered human subject research and does not need to be submitted to the IRB for review. It is important to realize that if you conduct a research project that is considered human subject research and you have not had your project reviewed and approved by the IRB before you start your research project, it may be considered scientific misconduct. In addition, the University may as a consequence impose appropriate academic sanctions, and scholarly journals are unlikely to publish your study. If there is any question, it is always best to contact the Office of Institutional Compliance to verify whether you need to have your project reviewed.

31. Do program evaluations that go to NIH or NSF require IRB review?
No. This is not human subject research. Only research proposals that directly involve human subjects are subject to IRB review.

32. How do visiting faculty, adjunct faculty and retired faculty obtain approval to submit research applications as a PI?
A request should be directed to the provost for PI status. The provost makes the determination and issues an email to approve this.

33. What do I need to do if research is conducted in another country and there is no IRB there?
Almost every country has a medical facility or organization that has an IRB. A recent OHRP document provides information about international research legislation or guidelines for 79 countries, 2 confederations, and several international organizations. It can be accessed on the U.S. Department of Health and Human Services website. Check with the appropriate country to ensure that the practices you are proposing are consistent with their culture. You will still need to have IRB review by your sponsoring organization even if you are on sabbatical. It is expected that research carried out in another country will follow UMass Lowell policies or the equivalent. If the setting requires a modification, because of culture or other appropriate necessity, please contact the IRB for advice.

34. I am conducting a survey with no identifiable information – other institutions have allowed me to do so without IRB review but UMass Lowell has requested that it be reviewed. Why?
Research that includes surveys is not always reviewed- it depends on the type of survey, whether any identifiable information is collected, and the purpose of the survey. It is always safest to determine early on as to whether a project needs reviewed. Please feel free to ask the IRB Administrator about your project when you have specific information to describe what you intend to do and he/she can advise you accordingly.

35. What is a “back” translation and why do we need to have a certification for a “back” translation?
A “back” translation is simply taking a document that has been translated into a language other than English and then translating the document in the other language back into English. This allows the IRB to ensure that the information contained in the documents in as close as possible to the original approved English version. This may be necessary for projects that involve populations where English is not the first language. The informed consent form should first be prepared, reviewed, and approved in English. It is recommended that an amendment be submitted for the translated materials to avoid spending resources on translating before the originals are approved. The original documents should then be prepared in the language for which the study is intended. A back translation is then done by a second party, not involved in the research, so that the IRB can be assured that the information is being correctly conveyed in the other language.

36. I routinely get surveys from other institutions, do these need to be approved by our IRB before I participate?
It depends. If the study targeted you as a UMass Lowell student or faculty member, the University’s IRB should have been notified or consulted. If you have been randomly selected, the IRB may not be aware of the study and you would be free to make your own decision about participating. If they are collecting personal information about you or your opinions, then it should have been reviewed by an IRB to ensure that your risk is either minimal or you are informed of any risk from participating. Question the source as to whether the survey received IRB review before answering if you are concerned about risk.

37. I want to publish a picture. Does that require IRB review?
No, that is not human subject research. You should determine if you need a photo release, but that is not an IRB responsibility.

38. Why are elderly included in the vulnerable populations at UMass Lowell? How is “elderly” defined?
The UMass Lowell IRB considers only elderly people with impaired decisional capacity to be members of a vulnerable population and it depends on their individual circumstances. The IRB will try to define what constitutes “elderly,” but as a rule, elderly populations are not considered a vulnerable population. It was added to protect older adults who have cognitive impairment and/or are institutionalized.

39. Are applications that involve any particular discipline funneled to those IRB members that would have the appropriate technical expertise? If not, wouldn’t this be a good idea to improve the review process?
The IRB has not yet initiated this type of process. If a reviewer assigned to do an expedited review considers that the subject requires disciplinary expertise then they can request that another member with the appropriate expertise also review the application.

40. Communicating the idea of a possible risk of disclosure in the informed consent form is difficult to write at a 5th grade level, can you recommend some wording to do so in a way that does not scare off potential research subjects?
The IRB recommends the following statement be included on the informed consent form:
“Every effort will be made to protect your privacy and confidentiality, but there may be a slight risk of your information being released as a result of participating in any research study.”

41.Why does the IRB worry so much about the recruitment document(s)? Some of the requested changes detract from the “appeal” of the brochure. Everything is fully explained in the informed consent form anyway and the purpose of the brochure is to pique interest from potential participants.
The recruitment flyer or advertisement is meant to interest prospective participants but it must provide a rudimentary amount of information that will give a person an understanding of what is to be expected and who is conducting the study, without hype that that raises false expectations.

42. It is difficult to get partners to provide a letter of support for a project that has not yet been reviewed by the IRB, yet the IRB needs the letters before approval is granted. Can you provide some suggestions as to how to accomplish this? It seems like a “catch-22”.
The IRB is interested in ascertaining whether the cooperating partner is agreeable to be a partner in this research effort and that is done by providing a letter from an appropriate authoritative individual at that partner agency. When necessary, the IRB will review an application contingent upon receipt of the needed letter(s).

Note: The U.S. Department of Health and Human Services' frequently updates their online information. For the most uptodate answers about Human Subject Research, visit Human Research Protections FAQs.