1. Required Training for Research Involving Human Subjects
Under the direction of the Office of the Vice Provost for Research, Northeastern University requires completion of training on the protection of human subjects and the ethical principles of research for all human subject research, regardless of whether or not investigators have received funding to support their project. This training is mandatory for all faculty, staff, and students who conduct/supervise research involving human subjects whether on campus or off-campus, whether funded or unfunded.
Documentation of training must be on file with the Office of Human Subject Research Protection. HSRP will accept documentation of human subject protection training from other institutions. If you have not yet completed some type of human subject protection training, Northeastern University now has an account with CITI for Human Subjects Training. This online CITI course can be accessed at the following url: https://www.citiprogram.org. Once you are on the site, click the “Register” button located on the top right of the page to begin.
Once you have completed the online training course, please forward a copy of your training certificate to Nan Regina, Director of HSRP at email: firstname.lastname@example.org, fax: 617.373.4595, or campus mail stop: 560-177. The certificate can be sent as a screen shot, pdf, via fax or in hard copy.
2. Responsibilities of Investigators
It is the policy of Northeastern University that no activity involving human subjects be undertaken until those activities have been reviewed and approved by the University’s Institutional Review Board (IRB). Accordingly, all university research involving human subjects must first be reviewed by the Office of Human Subject Research Protection.
The principal investigator’s primary responsibility in human subjects’ research is to ensure that the rights and welfare of the participants are protected. Safeguarding the participants from undue risk is the ethical responsibility of each person who is involved, either directly or indirectly, in conducting research at Northeastern University.
Investigators must assure that each member of the research team carries out all research procedures in accordance with ethical principles of research. These principles of Justice, Autonomy and Beneficence are set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research and are codified as regulations in Title 45 Code of Federal Regulations Part 46.
Information regarding necessary guidelines for human research at the University can be found in the manual Policies & Procedures for Human Research Protections. Investigators are responsible for adhering to the guidelines provided there, and should read it prior to submitting an application for review.
3. Classroom Research Assignments
Professors who assign a research project to be conducted by students within the time frame of an academic course should consult the Policy for Classroom Research Involving Faculty and Students and contact HSRP to discuss the project and obtain guidelines for review and approval of such research. This process should be initiated prior to the start of the course.
Arrangements can also be made with HSRP to have someone speak to students who will be conducting research about protection of human subjects in research and the submission and review process.
4. Student Research Proposals
Faculty advisors need to be designated as the principal investigator (PI) for all undergraduate and graduate student projects with human subjects. Advisors are therefore responsible that the research is conducted in accordance with federal regulations and university guidelines, including obtaining approvals. Prior to submission of a student protocol to the Office of Human Subject Research Protection, the advisor should review the application, including any recruitment materials, consent forms and study instruments, if applicable. A signed Assurance (original, not a copy) by the faculty advisor, Department Chair and the student must be submitted with the student’s proposal.
5. Application for Approval
Read the Policies & Procedures for Human Research Protections to understand the procedures for which you are responsible as an investigator and to assist you in completing the Application for Approval.
Please carefully edit and proofread before submitting the application. Applications that are not filled out completely and/or have any missing or incorrect information will be returned to the Principal Investigator.
- Application for Approval for Use of Human Participants in Research
- Assurance of the Principal Investigator Form (must accompany each application)
6. Consent Process
- Sample Consent Forms and Instructions
- Waiver of Documentation of Informed Consent
- Incomplete Disclosure during the Consent Process and Debriefing
Obtaining consent is a process; it is not merely having a person read and sign a statement. The purpose is to ensure that the potential participant has complete understanding of the study and his/her role in it before agreeing to participate. It is the responsibility of the investigator to ensure that the information is presented in a manner that each person can comprehend, that the person understands the risks and benefits, and has the opportunity to ask questions. The investigator must also make it completely clear that the potential participant is free to either participate or not without any negative consequences, and may quit at any time. See 45 CFR 46.116 for the general requirements for informed consent.
- No investigator can involve a person in a research study without the legally effective informed consent of the participant or the participant’s legally authorized representative, unless it has been determined otherwise by the Office of Human Subject Research Protection in accordance with federal regulations.
- The investigator must obtain consent under circumstances that a) provide the potential participant or representative sufficient opportunity to consider participation and that b) minimize the possibility of coercion or undue influence.
- The information must be written in language that the person, or representative, can easily understand.
- The consent cannot include any language that waives or appears to waive any legal rights of the participant. It cannot include any language that releases the principal investigator, Northeastern University, a sponsoring agency or individuals from liability for negligence.
- For children (under age 18 in MA) to participate in research, including surveys and interviews, signed permission is required from the parent or legal guardian, unless otherwise approved by the Office of Human Subject Research Protection. In some instances, depending upon the ages, maturity, and psychological state of the children involved in the research, documentation of the assent of the child may also be required. See 45 CFR 46.408a.
Once the informed consent document has been approved in its final form by the NU IRB, the Office of Human Subject Research Protection will stamp it and include the IRB tracking number and the dates the consent is valid. Copies of this original stamped version MUST be used to consent participants. No changes to the authorization are permitted without prior approval and a new authorized version by the Office of Human Subject Research Protection. A copy of the consent document must be given to every participant.
7. Recruitment and Advertisements
The IRB must approve all study advertisements and recruitment materials (including posters, flyers, websites, emails, brochures, scripts for telephone recruitment, et cetera) prior to their use. Advertisements should be attached to the Application for Approval.
Advertisements and recruitment materials should be very clear that research participation is what is being solicited and should also contain the following information:
- Names of the investigators and contact information
- Northeastern University’s name and departmental affiliation
- Purpose of the research
- General eligibility criteria
- Location of research
- Time or other commitment required (number of visits, total duration including follow-up visits, et cetera)
- Compensation/Remuneration (if any)
Advertisements should not make extravagant claims, mislead about the purpose of the research, emphasize monetary compensation, use attention-getting techniques, nor pressure readers to participate.
8. Review Process
Protocol reviews are prospective. No retrospective approvals can be granted. Performing research with human subjects without prior IRB approval is unethical, illegal, and may jeopardize the rights and welfare of participants in research. A project that is conducted without IRB approval is subject to termination or other action by the University.
Investigators are responsible for allowing a minimum of 30 business days for the review process. (This means that you should apply at least 5 weeks before your anticipated start date.) Please carefully edit and proof read all application materials before submission to HSRP as incomplete and missing information will cause delays in the protocol application review process.
The NU IRB meets monthly to review protocols. Depending upon the nature of the research, some studies may be reviewed and approved independently by the Chair of the NU IRB. Other studies may require review by the full committee.
For more information about categories of review, please click here.
9. Modifications to an Approved Protocol
After receiving the written approval from the NU IRB to begin a research project, investigators must follow the protocol procedures and use only the versions of the recruitment materials, consent and assent forms and study instruments as approved and on file at the Office of Human Subject Research Protection. However, if you need to make changes to the study, you may do so by requesting a modification in writing to the Office of Human Subject Research Protection (45 CFR 46.110(b)(1)(ii)). The modification must be approved by the NU IRB before you institute the change.
For specific information about how to submit a modification request, please click here.
10. Reporting Adverse Events
Any adverse events involving human subjects must be promptly reported in writing to the Office of Human Subject Research Protection (45 CFR 46.108(4)(i)). In addition to Northeastern University, reporting must be made to any other sites that may be involved.
11. Continuing Review/Study Completion
Federal regulations (45 CFR 46.109(e)) mandate that Full Board and some Expedited Category research studies be reviewed at intervals appropriate to the degree of risk, but not less than once per year from the previous date of approval.
Effective on January 21, 2019, Continuing Review will no longer be required for:
- Most new studies that qualify for the expedited review process.
- Studies that are closed to enrollment with no active or long-term follow-up and activities are limited to final analysis of identifiable data/biospecimens.
The NU IRB will make the final determination on the need for ongoing Continuing Review for all expedited category studies.
Please note that research studies approved via expedited review and governed by the Pre-2018 Rule (prior to January 21, 2019) that are open to enrollment or closed to enrollment with either active or long-term follow-up ongoing still require continuing review.
Projects determined to require continuing review that do not receive written notice of renewed approval from the Office of Human Subject Research Protection may not continue past the expiration date.