Conducting Research

Amendments, Modifications & New Findings

Federal regulations require that any revision to previously approved research involving human subjects receive CPHS approval in advance of implementation except when necessary to eliminate apparent immediate hazards to the subject (45 CFR 46.103 (b)(4)(iii)). If, at any time during the study period, the researcher anticipates changes in the approved protocol, the application, or any informed consent documents, the researcher shall submit a request to amend the protocol.

Minor changes that do not adversely alter the overall risk-benefit profile of the study may receive a Exempt (Level I) review. A modification is defined by the CPHS as a change that does not alter the overall character or purpose of the original project. Examples of minor changes which must be reported:

  1. Changes in contact names, addresses, telephone numbers, ending date, adding a researcher, etc.;

  2. Scientific and/or therapeutic changes that leave the research population the same or lower risk than risk(s) already approved;

  3. Changes in the consent form that reflect changes in scientific/therapeutic changes noted above;

  4. Adding additional subjects of the same type of population indicated in the original protocol;

  5. Changing the title of the protocol.

Major changes (those that may increase the research population’s risk or are of questionable risk), will be reviewed by two reviewers if the original protocol was a Expedited (Level II) or by the full committee it was a Full Board or Convened Meeting Review (Level III). Examples of major changes include:

  1. Adding a subject population different from those already approved;

  2. Adding questions to a questionnaire;

  3. Changing consent procedures;

  4. Changing the location of the research from that which has already been approved for projects other than low risk survey/interview research;

  5. Adding an element that may breech the confidentiality of the subject;

  6. Adding a deceptive element to the research or changing the debriefing procedures for already approved deception;

  7. Changing the way subjects are compensated for participation in research, e.g., increasing the amount, changing from a lottery to cash, using checks instead of cash, etc.

  8. Changes to the consent document to inform subjects of new findings, changes in procedures, risks and benefits to study participation must also be approved by the CPHS. A CPHS approval stamp will be applied to the revised and approved consent form when the modification approval is completed. Procedures used to inform and document consent of previously enrolled subjects affected by the modification should be addressed.

When is a Change Form not required?

To ensure your CPHS approved research remains compliant, it is best to submit all changes you would like to make to an approved protocol for CPHS review. With that said, the following are instances when obtaining approval of a change is not warranted:

  1. Making editorial changes in order to correct typos, grammar, etc.;

  2. Changing service providers of computer applications or survey instruments (such as proposing to use SurveyMonkey and switching to Zoomerang) when the change will not have any effect on the methodology or outcomes.

Adverse Event Reporting

It is the responsibility of the researcher to immediately report to the CPHS any unanticipated and/or adverse problems involving risks to the subjects or others involved in the research. Any undesirable experience associated with the research may be considered an adverse event.

The event is considered serious and should be reported when the subject experiences recurring problems, unanticipated side effects and/or death. If a subject suffers an injury during research, the researcher must take immediate action to assist the subject, and notify of the CPHS in writing of the injury within 48 hours.

Researchers reporting adverse effects of their research must use the CPHS Adverse Event Report. Failure to report an adverse event to the CPHS may result in temporary or permanent suspension of the protocol approval.

Auditing the Status of Enrolled Subjects

It is the responsibility of the researcher to periodically audit the status of enrolled subjects during the course of research to ensure the subject’s original enrollment status has not changed. For example: Studying healthy adults aged 40-50 requires periodic auditing of subject's health status (i.e.: Are they still "healthy").

Should a subject’s status be discovered to have changed, the researcher should temporarily suspend the subject’s participation (unless the suspension would cause harm to the subject) and report the issue to the CPHS using the CPHS Adverse Event Report.

Continuing Review of Approved Protocols (45 CFR 46.109)

The purpose of this process is to revisit the study and verify that the anticipated risks and benefits are reflected in the actual experience of participants. The review will measure safeguards in place at the time of original approval date and evaluate if they are still adequate to ensure the safety and privacy of subjects.

Full Board/Convened Meeting protocols are subject to"…continuing review covered by this policy at intervals appropriate to the degree of risk, but not less than once per year...". Exempt or Expedited reviews, are subject to continuing review at intervals appropriate to the degree of risk but not less than once at completion.

Full Board/Convened Meeting projects lasting more than one year will be reviewed automatically each year. The researcher will submit a CPHS Continuing Review report and attach or follow-up electronic submission with all required supplementary materials. It is the lead researcher's responsibility to complete and return the CPHS Continuing Review report in a timely manner (available on CSUMB's Compliance > Human Subjects Research website).

Continuing Review is required annually until the following is true:

  • All subject specimens, records, data have been collected (i.e., no further collection of data/information from or about living individuals is needed);

  • All recruitment, ongoing informed consent, and/or research-related interactions or interventions with subjects are complete (i.e., no further contact with subjects is necessary or anticipated).

A final, "close-out", Continuing Review report is due at this time, in lieu of the next annually occurring report.

Continuing review may also involve a site visit by a CPHS representative to the research facility. The goal of the site visit is to assess whether the protocol is being carried out as approved by the CPHS. The CPHS may recommend a site visit for research studies that involve vulnerable populations and/or procedures exceeding minimal risk. A site visit may also occur if a serious adverse event has occurred or a complaint has been registered.

In order to assure that the investigation is being conducted in compliance with applicable regulations and university policy, the committee may require continuing reviews to be done at various intervals during the research. This will be done if the committee feels there may be a change in the level of risk. The time of the continuing review may be determined at the time of initial review; however, the committee reserves the right to spot check projects for adherence to approved procedure. The CPHS may ask a committee member or other person(s) to review the research procedure and submit his/her findings in writing. These findings will be presented at a meeting of the full committee.

It is important to note that the study expiration date is crucial for the continuation of the project. If the study is allowed to expire, all data collection must cease and no funds may be spent. Any lapses in approval for the use of human subjects must be defended to the CPHS and to regulatory or funding agencies. A new application and review will be required to reinstate the study if it expires. Only four substantive changes are permitted. The fifth change will require the submission of a new application.

Expedited (Level II) Protocol: If there are no changes proposed to the procedures, the CPHS Chair (or CPHS designee) will review the project review report to determine status for approval. If there are changes proposed, one or two CPHS members will review the request depending upon the type of change (minor or major). Full Board or Convened Meeting Review (Level III) Protocol: The full committee must review and approve any request.

The online CPHS Continuing Review report will be received and processed for review upon submission and receipt of any supplementary materials. Paper submissions should be mailed or delivered to the Committee for the Protection of Human Subjects, c/o Sponsored Programs Office, for processing and review.

§46.109 IRB review of research.

(e) An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year, except as described in §46.109(f).

(f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances:

(i) Research eligible for expedited review in accordance with §46.110;

(ii) Research reviewed by the IRB in accordance with the limited IRB review described in §46.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8);

(iii) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:

(A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or

(B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

(2) [Reserved]

(g) An IRB shall have authority to observe or have a third party observe the consent process and the research.

Suspension or Termination of Approval

The CPHS may suspend or terminate the approval of research that is not being conducted in accordance with the requirements set forth by the committee or that has been associated with unexpected serious harm to subjects (45 CFR 46.109(a)).