DIVISION OF RESEARCH INTEGRITY

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  1. Responsibilities of Investigators
  2. Student Research Proposals
  3. Training
  4. Application for Approval
  5. Consent Process
  6. Advertisements
  7. Categories of Review
  8. Review Process
  9. Modifications to an Approved Protocol
  10. Reporting Adverse Events
  11. Continuing Review/Study Completion
    12.
Ethical Principles of the Belmont Report

1. 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 DRI. For more information or assistance, please contact Nan Clark Regina, Director of the Division of Research Integrity, Northeastern University, 413 Lake Hall, 360 Huntington Ave., Boston, MA 02115-5000; tel. (617) 373-4588 and fax (617) 373-4595.


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 (1991).


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.

2. Student Research Proposals

Faculty advisors are considered 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 DRI, the advisor should review and approve the protocol and any necessary Informed Consent or Informed Consent and Health Information Use and Disclosure Authorization, if applicable. A signed Assurance (original, not a copy) by the faculty advisor and the student must be submitted with the student's proposal.

3. Training

Northeastern University investigators seeking funding from National Institutes of Health (NIH) must satisfy the NIH training requirement before an approved study may be initiated. The NIH Office of Extramural Research web-based tutorial "Protecting Human Research Participants" satisfies the human subjects training requirement for obtaining Federal Funds.


Investigators must include a copy of the certificate of completion for this web-based tutorial with their protocol submissions to the Division of Research Integrity.

4. 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 proof read 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.

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 Principal Investigator (P.I.) 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 P.I .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.

  • 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 DRI 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 DRI. 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, DRI 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 DRI. A copy of the consent document must be given to every participant.
  • Instructions
  • Template 1 - Format for Signed Informed Consent Document
  • Template 2 - Format for Signed Informed Consent and Health Information Use and Disclosure Authorization
  • Template 3 - Format for Unsigned Informed Consent Document
  • Template 4 - Format for Unsigned Informed Consent Document for web-based online surveys

Federal regulations 45 CFR 46.117c allow an IRB to waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

  1. That the only record linking the subject and the research would be the consent document AND the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or


  2. That the research presents no more than minimal risk of harm to subjects AND involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived and the study is allowed to proceed on either the subject's oral consent or in the case of online survey research the subject's implied consent by completion of the survey instrument, the IRB requires the investigator to provide subjects with a written informed consent statement regarding the research.

  • Template 3 - Format for Unsigned Informed Consent Document
  • Template 4 - Format for Unsigned Informed Consent Document for web-based online surveys

The waiver of informed consent by the IRB also includes instances where research involving no more than minimal risk could not practicably be carried out without this waiver. The waiver of informed consent must not adversely affect the rights and welfare of subjects.

Deception of subjects is sometimes a part of the study design of social and behavioral research involving no more than minimal risk. Incomplete disclosure during the consent process and deception of research participants about a study's purpose or procedures must be essential and integral for carrying out the research (45 CFR 46.116(d)). Deception techniques should be used with discretion and may only be employed with the prior approval of the IRB.

Where a waiver of informed consent has been approved by the IRB to allow researchers to proceed with incomplete disclosure and deception, researchers, when appropriate, are required to provide subjects with full disclosure and additional pertinent information after participation (45 CFR 46.116(d)). In some instances, full disclosure is done immediately after the subject has completed the research task(s). In other instances, full disclosure to subjects is held off until the completion of the study's data collection.

The debriefing process usually consists of a written statement given to subjects and discussion with the research team providing a thorough explanation of the incomplete disclosure and deception and the true goals of the research.

6. 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 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.

7. Categories of Review

All research activities must be reviewed by DRI even when categorized as "exempt" status. In addition, please note that "expedited" does not mean "faster" review. It only refers to the federal categories of research that do not require full board review.

FINAL DETERMINATION OF EXEMPT, EXPEDITED AND FULL COMMITTEE STATUS IS MADE BY THE IRB.

  • Exempt Review - review process to determine if the research protocol qualifies for exemption from further institutional review by meeting one or more of the six exempt categories listed at 45 CFR 46 101 (b).


  • Expedited Review - initial review process for research protocols that involve no more than minimal risk to subjects and include activities listed in one or more of nine categories published by the U.S. Department of Health and Human Services.

    Expedited review also includes review of minor changes to previously approved research during the period (of one year or less) for which approval is granted (45 CFR 46 110 (b)). Any proposed modification to previously approved research resulting in greater than minimal risk or having a negative impact on the balance between the risks and benefits of the research will be referred to the full IRB for review.

  • Full Committee Review - review process for research protocols that do not fall under the "exempt" or "expedited" categories, include vulnerable populations, and/or are determined by the IRB to involve greater than minimal risk to subjects (45 CFR 46 111).


  • Continuing Review - federal regulations (45 CFR 46.109(e)) mandate that ongoing Expedited or Full Board 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.

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 four weeks for the review process. (This means that you should apply at least one month before your anticipated start date.) 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 the initial review process, how studies are categorized, IRB actions and time frame for review, please consult Section 7.0 of the Policy and Procedures Manual.

9. Modifications to an Approved Protocol

After you have received written approval for your protocol and Informed Consent or Informed Consent and Health Information Use and Disclosure Authorization, you must follow the protocol procedures and forms as approved and on file at DRI. However, if you need to make changes to the study, you may do so by requesting a modification in writing to DRI (45 CFR 46.110 (b2)). The modification must be approved before you institute the change.


Modifications that require approval include, but are not limited to, changes in Principal Investigator (PI), inclusion/exclusion criteria for subjects, sites of study, recruitment strategy, consent and authorization process, informed consent or Informed Consent and Health Information Use and Disclosure Authorization form, questions on survey/interview/focus groups, testing procedures, confidentiality measures, or safeguards for participants. Conducting a study with unapproved procedures invalidates the approval status.


To request approval for a change, address a memo to DRI that states:

  1. Subject line: Request for Modification
  2. PI name and contact person
  3. Date
  4. Project title and IRB #
  5. Describe the requested modification and the reason for the change
  6. State whether this change affects the level of risk to the participant
  7. If the level of risk is increased, explain the extent of the risk and what procedures will be instituted to minimize it. Explain whether the risk affects current or only future subjects. Make appropriate changes to the consent document. The new consent must be approved as well.

Note: Minimal changes are approved by expedited means and involve little time. Most changes fall in this category. However, if modifications are significant, they will be reviewed by the full IRB.

10. Reporting Adverse Events

Any adverse events involving human subjects must be promptly reported in writing to the Division of Research Integrity (45 CFR 46.103(b5)). Reporting must be made to Northeastern in addition to other sites that may be involved.

11. Continuing Review/Study Completion

A continuing review of research is required at intervals appropriate to the degree of risk, but not less than once per year. (45 CFR 46.109(e)).


For each approved study that has been reviewed under expedited or full committee status, the DRI or IRB assigns a continuing review interval and expiration date. The office sends notification to investigators 4-6 weeks prior to the impending expiration of the study approval. The investigator must complete the accompanying continuing review/study completion form (CRF) and return it at least two weeks before the designated date. The PI is required to complete the CRF whether the study is ongoing, has concluded or never started. Directions for completing the CRF are on the form.


Projects that do not receive written notice of renewed approval from DRI may not continue past the expiration date.



last update: Thursday, July 24, 2008