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Policies & Procedures

office for research protections

The Policy for the Protection of Human Research Participants is available. In addition, a Standard Operating Procedures for Researchers is has been created as a companion document to the Policy. It contains a wealth of information concerning protocol submission and approval as well as coverage of many special topics.

  


Regulatory Changes to the Common Rule



The Office of Research Protection’s mission is to support research at Boston College that conforms to the highest ethical standards. The Institutional Review Board (IRB) is directly concerned with helping the Boston College research community to carry out their work in ways that protect and respect human subjects.

The Revised Common Rule represents significant changes to existing regulations governing research with human subjects. These changes are slated to take effect on January 19th, 2018. There is currently a request under review at the Federal Office of Management and Budget to delay these changes. However, the Office of Research Protections at Boston College (along with most other universities) is proceeding with the understanding that these changes will take effect on January 19th. We are excited to share these changes which will minimize some of the existing administrative burden on researchers and simplify the review process.

 

What is NOT changing?

  • Scope of application: The Revised Common Rule still applies to all research activity conducted by Boston College faculty, staff, and students, regardless of whether the research is federally funded.
  • Definition of research: Research activity requiring contact with the IRB is still defined as the systematic investigation of living humans to produce generalizable knowledge that will be publicly disseminated. The definition of research includes obtaining, storing, using, studying, analyzing, or generating identifiable private information or identifiable biospecimens.
  • Excluded activities that are not considered research: Investigations focused on an individual, rather than producing generalizable knowledge, are still not considered “research” that requires IRB review. This exclusion will still apply to scholarly and journalistic activities such as oral history, journalism, biography, literary criticism, legal research, and historical scholarship including information focused on the specific individuals about whom the information is collected.
  • Who decides whether a project qualifies as exempt, expedited, full board, or “not research”: The IRB will still make the final determination concerning a project’s status. Consulting the IRB staff before submitting a protocol can make the process much more efficient. Feel free to contact us at any time with questions – we are here to assist you through the process!

 

In this section, we describe some of the differences for projects approved before and after the January 19th Common Rule changes.

FOR EXISTING PROTOCOLS APPROVED BEFORE JANUARY 19, 2018

  • Exempt protocols
    • No changes, except that the Boston College ORP has decided that research staff changes no longer require an amendment. Instead, PIs must email a copy of new staff members’ training certificates to the IRB office and indicate the protocols on which they will be working. The process of reporting of any adverse events remains the same.
  • Expedited protocols
    • All existing expedited protocols will be required to undergo one final continuing review. At this point, we may ask you to revise your consent forms in accordance with new policies (see details below on this page – note – see if website design staff can link people to that section of the page). After this final continuing review, you will no longer be required to complete annual continuing reviews in most cases. However, we will check in with you once a year to verify whether your project is still ongoing, or if you would like to close the project. Feel free to contact us with questions about this change.
    • Research staff changes no longer require an amendment. Instead, PIs must email a copy of new staff members’ training certificates to the IRB office and indicate the protocols on which they will be working. The process of reporting of any adverse events remains the same.
  • Full Board protocols
    • Existing full board protocols may be required to update consent forms in accordance with new policies at the time of the next significant amendment or continuing review. Subsequently, annual continuing reviews will not be required if a project no longer involves contact with participants and involves only analysis of existing data.
    • Research staff changes for full board protocols will still require an amendment.

 

FOR NEW PROTOCOLS APPROVED ON OR AFTER JANUARY 19TH, 2018

  • Exempt protocols
    • There are new categories qualifying as exempt:
      • Research involving benign behavioral interventions in conjunction with the collection of information from adults. This allows data collection via an interaction (e.g., survey, interview, audio/visual recording) from adult subjects with prospective agreement. This new exempt category does NOT allow research with children, deception (unless prior agreement obtained), physiological data collection methods, and linking to additional personally-identifiable data. “Benign behavioral interventions” are brief in duration, painless, not physically invasive, and not likely to have a lasting adverse impact on the subjects. Feel free to contact us for assistance determining whether your research counts as a “benign behavioral intervention.”
      • Storage or maintenance for secondary research use of private information or identifiable biospecimens. This allows for the storage of data and/or specimens in a repository, with identifiers maintained, that were collected under an approved IRB protocol with “broad consent” for future secondary use research. Data do not need to be existing (“on the shelf”) at the time of the research study, as was previously required. The data can be collected prospectively and still be used for exempt research under the revised rule.
      • Research involving the use of private information or identifiable biospecimens that have been stored or maintained for research use. This allows for secondary research use/analysis of identifiable data/biospecimens that were collected under an approved IRB protocol with “broad consent.”
      • Please note: the term “broad consent” as defined by the new regulations applies to consent for storage and secondary research of identifiable private information or biospecimens. This concept must be implemented on an institutional level and requires tracking of individuals who decline to provide consent. Because there is no guidance from OHRP and because of the implications of tracking individuals who do not provide consent and excluding their data from all future research, Boston College is not pursuing broad consent at this time. Many other universities have made the same decision. Investigators can continue to use biospecimens that are coded or to seek waiver of consent for use of biospecimens with identifiers retained consistent with current practices.
    • Exempt protocols will not require annual continuing review, except in certain cases where there may be a need to review the confidentiality of information.
    • The Boston College ORP has decided that research staff changes no longer require an amendment. Instead, PIs must email a copy of new staff members’ training certificates to the IRB office and indicate the protocols on which they will be working. The process of reporting of any adverse events remains the same.
  • Expedited protocols
    • The initial approval process remains unchanged, and there will be no annual continuing reviews unless the IRB specifies a need for an annual review for a specific protocol.
    • Research staff changes no longer require an amendment. Instead, PIs must email a copy of new staff members’ training certificates to the IRB office and indicate the protocols on which they will be working. The process of reporting of any adverse events remains the same.
  • Full Board protocols
    • Continuing reviews will notbe required if a project is in the Data Analysis Only phase, which requires that all contact with subjects has ended.
    • Research staff changes for full board protocols will still require an amendment.

 

Additionally, consent forms may require some changes under the new regulations. Click here to see the new consent form template, and please review the following list of changes:

  • Informed consent forms must begin with a concise and focused presentation of the key information most likely to assist a subject in understanding why he/she may or may not want to participate in the research. Specifically, the revised rule states: “Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.”
  • In many cases, existing consent forms satisfy this requirement for simplicity in their current form, even if the information is presented in different formats. The concise explanation should include the following:
    • The fact that consent is being sought for research, and participation is voluntary
    • The purposes of the research, the expected duration of the prospective student’s participation, and the procedures to be followed
    • The reasonably foreseeable risks or discomforts to the prospective subject, as well as benefits that are reasonably expected
    • Appropriate alternative procedures or treatment, if any, that might be advantageous to the subject  (Note: this mainly applies to medical studies, and is not necessary in most social/behavioral research consent forms)
  • For any clinical trials, there are new provisions requiring consent forms to be posted on a federal website within 60 days from the close of enrollment in the study. The regulatory change also includes a definition of “clinical trial,” which the prior version did not include. Clinical trials are now defined as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.”
  • New regulations also permit researchers to seek broad consent, covering the subject of the investigator’s current research and future unspecified research using the same data or specimens. As described above, Boston College will not be using the broad consent option at this time.

 

For all studies new and old, across all review categories (exempt, expedited, or full board), please note the following:

  • Regardless of whether or not your study will no longer be required to undergo an annual continuing review, PIs are expected to maintain research records for a minimum of 3 years after study completion or the period required by a funding agency, whichever is longer. Records include signed consent forms (if applicable), numbers of enrolled/consented subjects, number of withdrawn subjects (and reason for withdrawal), and any adverse events.
  • We are working on developing a database that will automatically remind researchers when their training certificate is due to expire – we will announce once this system is ready.
  • For studies that will no longer be required to undergo an annual continuing review, we will check in with you annually to verify whether the project is still active, or whether you would like to close the protocol.