Human Subjects FAQs

Anyone who intends to conduct research that involves people must apply for and receive unconditional IRB approval (approval without contingency) before beginning the research. This applies to ALL research involving people, not just clinical research. Social science, behavioral, educational and linguistic research studies must be reviewed by, and receive approval from, the IRB (this is a representation of likely studies and not an exhaustive list). Review this information, or contact Research Integrity Services (RIS) staff if in doubt about the need for IRB review [Melissa McGee (603) 862-2005, Susan Jalbert (603) 862-3536, or Julie Simpson (603) 862-2003].

Research is broadly defined as a systematic investigation designed to develop or contribute to generalizable knowledge, or investigation designed to test a hypothesis.

The federal regulations state that the following activities are not deemed research:

“(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.” [45 CFR 46.102(l)].

Federal regulations provide the following definitions:

Human subject:  “Human subject means a living individual about whom an investigator (whether professional or student) conducting research:

(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” [45 CFR 46.102(e)(1)].

Identifiable private information: “Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.[45 CFR 46.102(e)(5)].

Using this definition of human subjects, all activities involving prospective collection of information about individuals via intervention/interaction are considered using human subjects and require UNH IRB approval before commencing.

When studies involve the use of secondary/existing data (data/information that exist(s) at the time the research project begins [e.g., previously collected survey data, school records, medical records]) and the secondary/existing data do not contain private information, UNH IRB approval is NOT needed to use such data for research purposes.  Some common examples of secondary/existing data that are not considered private information include, but are not limited to:

Some information on the internet - comments on TripAdvisor; content of public tweets and blogs; information on public Facebook pages; census information; freely-available datasets (whether or not anonymous)

Archives - identifiable information about individuals in a public archive

Datasets - anonymous datasets, whether privately held or publicly available

Researchers should be aware that not all information on the internet is considered publicly available and not all datasets that are characterized as anonymous actually are.  Examples include, but are not limited to: Comments on a non-public chatroom or listserv; restricted-access datasets; or privately held datasets where individuals may be identified, either directly, through a code associated with a name, or through a combination of variables.  As the UNH IRB DOES NOT give post-hoc approval, researchers must be certain that the secondary/existing data do not contain private information before use.  Further, some journals require proof of IRB approval for research projects that the UNH IRB may not consider to involve human subjects (e.g., use of anonymous datasets).  Researchers should check journal requirements before conducting the project and contact the IRB with any questions. 

Yes. Any research study involving human subjects must be submitted to the IRB for review, regardless of funding source.

Aside from potential ethical implications for the subjects and for the researcher, bypassing IRB review brings other risks:

Students:

  • Funding may be withheld. IRB approval is required for UROP, IROP, McNair and other grant programs. These programs will not release funds without IRB approval.
  • Credit may be withheld.  UNH may, at its discretion, refuse to grant students course credit for research conducted without IRB approval.
  • Dissertation or thesis work will not be accepted. Graduate students must present to the Graduate School evidence of IRB approval for their studies involving human subjects. Thesis or dissertation work will not be accepted without it. Degrees will not be awarded for work based on research involving human subjects that was not approved by the IRB.
  • Articles may not be published.  Most professional journals require evidence of IRB approval when considering articles for publication.

Faculty and Staff

  • Funding may be withheld. Federal sponsors, and virtually all private sponsors, require IRB approval as a condition of funding. Sponsors may postpone review of proposals for which review is not complete or pending at the time of proposal submission. Some sponsors will not release funds to UNH for the researcher's use without IRB approval. SPA will not set up accounts for studies lacking necessary IRB approval.
  • Articles may not be published.  Many professional journals require evidence of IRB approval when considering articles for publication.
  • The University will not support unapproved research. Liability issues arising from unapproved research become the responsibility of the researcher. Persons conducting unapproved research are deemed to be acting outside the scope of authority granted them by UNH. UNH will not, therefore, provide a researcher of an unapproved study the resources to answer a liability complaint.

You should check the sponsor requirements for the specific grant/fellowship/ contract for which you are applying to see what the requirements are for timing of obtaining IRB approval. Although many sponsors do not require evidence of IRB approval at the time of proposal submission, most sponsors require evidence of IRB approval before releasing funds to UNH. Even if the sponsor does not specify requirements for IRB approval, UNH Sponsored Programs Administration (SPA) will not set up any accounts for research projects involving human subjects until IRB approval is obtained. With these facts in mind, you should plan on submitting your application to the IRB as soon as you have learned that your proposal has been funded.

Starting June 1, 2021 studies must be submitted to the UNH IRB for review via Cayuse IRB/Human Ethics.  Information about Cayuse IRB/Human Ethics is available here

The IRB will ask for information about each person working on the study in the application form in Cayuse IRB/Human Ethics.  Only one person, however, can be listed as the Principal Investigator for the study.

Quality improvement studies do not automatically qualify as research and therefore may not require IRB approval. To ascertain whether your proposed quality improvement activity also qualifies as research (thus requiring IRB review), consult the Office of Human Research Protections (OHRP) guidance on quality improvement activities.

Yes, there is.  Applications to the UNH IRB must include for the applicant documentation of completion of the UNH web-based training on human subjects protections.  The training module takes approximately 30 minutes.  Individuals who certify their completion of the module at the end will receive an email that is the documentation/certification of completion of the training to be submitted as part of the IRB application.  The UNH IRB will not review applications missing this documentation.

The UNH IRB uses these terms as follows:

  • Anonymity means that no identifiers can link the information/records/samples to the individual from whom they were obtained.  The presence of a list of codes and associated identifiers (e.g., names) means that data are NOT anonymous.   Further, if a combination of variables collected are likely to identify unique individuals (e.g., a 52 year old female Asian UNH senior), particularly in small, bounded samples, the data should not be described as anonymous.  If data are not anonymous, participation in the research may present risk if there is a breach in confidentiality and identifiable information is released without participants' permission.
  • Confidentiality concerns the treatment of information (data) disclosed in a trust relationship and with the expectation that it will not be divulged to others in ways inconsistent with the understanding of the original disclosure without permission.  Confidentiality is an agreement between parties made via the consent process.  Researchers must keep participants’ contributions to the research confidential unless participants have agreed otherwise (preferably in writing).  Researchers, however, cannot guarantee absolute/complete confidentiality and must inform subjects of this.  For example, in the case of a complaint, the IRB may have to review data.  Further, researchers have to comply with applicable mandatory reporting laws (see the IRB guidance, Information Individuals in New Hampshire are Legally Required to Report), court orders, and/or other legal actions.
  • Privacy is an individual’s control over the extent, timing, and circumstances of sharing him/herself (physically, behaviorally, or intellectually) with others.  Researchers must protect subjects’ privacy. Data must be stored securely and in a form that prevents, where possible, the identification of individuals.

For more information, see the UNH IRB's guidance on Privacy, Confidentiality and Anonymity in Human Subjects Research.

Starting June 1, 2021 studies must be submitted to the UNH IRB for review via Cayuse IRB/Human Ethics.  Information about Cayuse IRB/Human Ethics is available here.   The Cayuse IRB/Human Ethics software routes an application directly to the IRB upon submission and certification.

 

Once the application is received by the IRB staff via Cayuse IRB/Human Ethics, they route it to the IRB for review. There are three levels of IRB review. Researchers are notified of the results of the IRB's review by email via Cayuse IRB/Human Ethics.

PLEASE NOTE! You may not begin your research until the IRB has given your research study written unconditional approval.

Review of Exempt or Expedited studies usually takes about 10-15 working days (allow 15 in the summer). The review process for studies submitted for Full Board review can take up to a month or longer to complete.

You should include sufficient time in your research plan as allowance for any IRB-required changes to the research study. Many revisions resulting from a Full Board study can be considered by the IRB Chair, RIS staff, or a subcommittee of the IRB. Substantive revisions usually require review by the Full Board at a convened meeting.

The IRB generally meets twice each month during the academic year (September through May) and once a month during the summer to review applications that require Full Board review.   A quorum of the IRB must be present for decisions to be "official."

The IRB looks for:

  • A research design that is sound, given the proposed use of human subjects in the study,
  • Equitable selection of subjects,
  • A balance of risks and benefits, and
  • A thoughtful and comprehensive informed consent process

Researchers should complete all the applicable sections of the application form in Cayuse IRB/Human Ethics thoroughly yet succinctly.

The IRB is a standing faculty committee of at least five individuals, including researchers and members of the community at large. Individual experiences and interests cross diverse areas.  Whenever possible, IRB members review applications for disciplines or areas of research in which they have expertise, or with which they are familiar. 

When review of a study requires expertise beyond that available on the IRB, the IRB may seek assistance from qualified individuals outside its membership. While outside experts may inform the IRB's decisions, they do not vote on UNH research studies presented for review.

Generally speaking, no. If the IRB has questions or believes the researcher(s) could provide valuable insight for review, the IRB will set a mutually convenient time to meet with the researcher(s) to discuss the study.

You will receive an email via Cayuse IRB/Human Ethics informing you of the status of your application following IRB review. The IRB will identify any required revisions at that time.

If the other site has an IRB:
Yes. Many hospitals, universities and other institutions have their own IRBs. If the site of your research has an IRB, the site IRB and the UNH IRB must both approve your study before you start. You may submit your study for review to UNH via Cayuse IRB/Human Ethics at the same time you submit your study to the other institution's IRB for review, or you may submit the study after the other institution's review is completed. For some studies, UNH and the other institution may enter into a formal agreement for UNH to rely on the other institution's IRB review, obviating the need for both IRBs to review the study.  Review this webpage or contact UNH IRB staff for more information about this possibility. Please remember that review and approval requirements may vary among institutions, so you should familiarize yourself with each IRB's policies. You should also plan your research chronology accordingly.

If the other site doesn't have an IRB:
Elementary schools, nursing homes and community centers often serve as research sites, and rarely have IRBs. You should ask the appropriate person in charge at the site (e.g., school principal, director of nursing home, community center director) to provide a letter on letterhead indicating that (s)he has read your research proposal and giving you, the researcher, permission to conduct your research at the site. Alternatively, the person in charge may co-sign with you an invitation-to-participate letter to indicate institutional permission for you to conduct your research at the site. The UNH IRB requires evidence of site permission for its review and approval of your study.

Changes to a research study must be reviewed and approved by the IRB prior to implementation.  Requests for modifications are reviewed at the same level as the original study, i.e., Full Board modifications are reviewed by the IRB at a convened meeting.  

For studies submitted in Cayuse IRB/Human Ethics and approved by the IRB after June 1, 2021, modifications should be submitted to the IRB for review via Cayuse IRB/Human Ethics.  

To request changes to an existing (legacy) study (a study that was approved by the UNH IRB prior to June 1, 2021), researchers need to submit a new application in Cayuse IRB/Human Ethics to replace the existing study (as approved and without any changes).   Once the IRB has approved the study, the IRB will close the existing (legacy) IRB study and researchers can then submit modifications via Cayuse IRB/Human Ethics.  

IRB approval for any study in good standing may be extended.  Researchers who want to request an extension of the IRB approval need to submit a renewal request via Cayuse IRB/Human Ethics.   If a study's approval expires, it will be closed in Cayuse IRB/Human Ethics; once closed, a study cannot be reopened.

  • Researchers who have Expedited with annual continuing review* or Full Board* level studies that were approved by the IRB prior to June 1, 2021 (legacy studies):
    • For those studies in data analysis or interpretation stages and where there will not be any further data collection or future modifications to the protocol, researchers should submit renewal requests via Cayuse IRB/Human Ethics for the existing (legacy) study until they have completed the study.  They should then close the study in Cayuse IRB/Human Ethics.
    • For studies that are in the recruitment or data collection stages or where researchers anticipate submitting modifications in the future, researchers should complete a new application in Cayuse IRB/Human Ethics for the study as approved before the study’s current IRB approval expiration date.  The IRB will treat it as a new application and give it a new IRB number but, unless the PI indicates there are changes from the prior version, will perform a confirmatory review at the previous study’s review level.  The new study will retain the previous study's approval annual renewal date.  At that time, the IRB will close the existing (legacy) study in Cayuse IRB/Human Ethics.

*If you are unsure of your study’s review level, please email IRB staff with the protocol number.

If you closed your IRB file, either by returning the Annual Continuing Review Questionnaire indicating that the study is no longer active, or you let your IRB approval expire, you need to submit a new application to the IRB in Cayuse IRB/Human Ethics in order to re-open the file. 

Information about the requirement for posting clinical trial consent forms for most federally-funded studies is available at https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/index.html.  In short, these consent forms must be posted either on ClinicalTrials.gov or in a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021). The form must be posted after recruitment closes, and no later than 60 days after the last study visit.  

Email Melissa McGee, Susan Jalbert, or Julie Simpson, or call RIS at (603) 862-2005, (603) 862-3536, or (603) 862-2003 for assistance.

View Human Subjects Knowledge Base

The Knowledge Base contains forms, instruction and training material, policies, guidance, tools, and other resources to support your research efforts by topic area.


CONTACT INFORMATION

Melissa McGee, Assistant Director
Research Integrity Services
Service Building Room 107
51 College Road
Durham, NH 03824
Phone: (603) 862-2005
Email: melissa.mcgee@unh.edu

Susan Jalbert, Compliance Officer
Research Integrity Services
Service Building Room 107
51 College Road
Durham, NH 03824
Phone: (603) 862-3536
Email: susan.jalbert@unh.edu

Julie Simpson, Director
Research Integrity Services
Service Building Room 107
51 College Road
Durham, NH 03824
Phone: (603) 862-2003
Email: julie.simpson@unh.edu