2006 Important Updates to SBU's Human Subject Protections Program (HSPP)
Released December 11, 2006
Our Human Subject Protection Program (HSPP) has many active participants, including Principal Investigators and their study teams, staff of the Office of Research Compliance (ORC), and the membership of our Institutional Review Boards (IRBs). Our combined efforts continue to help ensure that our HSPP is solid and effective in keeping safe those individuals who volunteer to participate in our research activities at SBU.
The ORC and the IRBs are constantly evaluating the program to assess the need for clarifications of current SBU policies and procedures, promulgation of new policies and procedures, and dissemination of new federal guidance and regulations. The following is a summary of such actions that have been taken or proposed over the past year, including some clarifications of unchanged policies and procedures, since our last update in 2005.
It is extremely important that you review this information with all members of your study team.
I. Doing (or Thinking of Doing) Research on Dietary Supplements? (New Policy)
Research on dietary supplements is an important area of study for obvious reasons, most notably better understanding, through rigorous scientific investigation, of their mechanisms of actions, pharmacokinetic and clinical effects, etc. Over the course of the past year, we have attempted to clarify with various federal and legal entities the types of investigations that cause the dietary supplement to be considered a ‘drug’, therefore requiring compliance with the FDA’s regulations governing Investigational New Drugs (IND; including regulations governing when the IND application requirement to the FDA can be waived). Long story short, we were unsuccessful in clarifying this issue to a level that would enable us to promulgate a policy regarding the often-subtle distinction.
Therefore, in order to ensure that we are conducting such research in a legally compliant manner, the IRB and ORC agree that any new study, and any study undergoing continuing review, in which dietary supplements are being studied, either proof of an approved IND from the FDA, or a written statement from the FDA certifying that an IND is not needed will be required in order to secure approval.
II. Are you a Department Chair, Dean, or a member of a Departmental Review Committee AND a CORIHS PI? (New Policy)
Effective with IRB submissions received after January 1, 2007, if you are a departmental Chair, Dean, or member of a departmental review committee, and you are submitting an IRB application as a principal investigator, you will no longer be permitted to sign both as PI and as Chair/Reviewer/Dean. The preferable individual to attest to the scientific merit of the study and to the competency of the individuals conducting the study and to act as signatory is your Chair (if you are on the review committee), your Dean (if you are the chair), or the VP for Research if you are the Dean. His/her official designees are also acceptable so long as the individual is not a subordinate to you in any way.
III. Investigator Conflict of Interest Unrelated to Current Financial Interest (New Policy)
There are instances where a member of the study team has a vested personal interest in the future commercial success of the drug, device, etc under study (e.g., was involved in discovery, patent, licensing, IND/IDE filings etc.), but does not, at this time, have a financial interest that reaches the level of significant, as defined and discussed in the next section. In this situation, the IRB has determined that, although recruiting or consenting of potential subjects by the affected investigator is acceptable, a section should be added to the consent form that reads:
"Investigator’s Personal Commercial Interest in the Study Drug"
One or more of the investigators on this study has a personal commercial interest in or may financially benefit in the future from the development of the [drug, device, etc] being tested in this study.
IV. IRB Requirements regarding Financial Disclosure from Investigators (Clarification and Revision to Current Policy)
As you are aware, the IRB has been concerned with the issue of potential or real conflicts of interest of its approved investigators for a number of years. Effective November 2002, a policy was put into place requiring that the PI provide the IRB with a yes/no response to a question concerning the presence a significant (personal) financial or commercial interest (e.g., stock, consulting income, honoraria, etc.) for any member of the study team, in the conduct or results of the is study.
New to this policy is the requirement that the specific investigator with the significant interest be named in the required section of the consent form:
The following is an excerpt from part B, Section 24 of the CORIHS Handbook for Investigators, http://www.stonybrook.edu/research/HSG/HSGsec24.html, as revised:
“The CORIHS accepts SBU's definition of Significant Financial Interest in Research per Section III.D of University Policy P-209 http://naples.cc.stonybrook.edu/Admin/policy.nsf/pages/p209
If any of the investigators on the protocol have a significant financial interest as defined above, the IRB requires, as a condition of approval, that:
- the SBU COI committee provides written confirmation that the conflict of interest can be managed.
- the investigator cannot be involved in the recruitment or consenting of subjects*.
- the investigator cannot place undue pressure on, or offer incentives to, other investigators to enroll subjects.
- a section of the consent form must be added that reads:
Payment to the Investigator:
Dr. ______________, who is one of the investigators conducting this study, has a significant financial interest in the company supporting this study, which means he/she may receive personal financial benefit from the results obtained. Dr. _____________will not be involved in the recruitment or consenting of subjects.*
In addition, as with any study, the consent processes for any or all subjects may be witnessed by an IRB or ORC representative.
The policy and procedures described in this document will be followed, where applicable, in cooperation with the SUNY Policy on Financial Disclosure (current, and as amended).
The IRB requirement described in the section is in addition to the University requirements regarding financial disclosure, as addressed in detail in University Policy P209 (link above).”
*If you are named in the consent form as not involved in recruitment or consenting of subjects, it means that the discussion of any details concerning the research protocol in question must be conducted by an IRB-approved co-investigator. In the case where you may be a patient's treating physician, you may state that there are standard therapies available, as well as research studies that the patient may be interested in hearing about. If the patient is interested in hearing more about his/her research options, referral to the IRB-approved co-investigator must occur.
V. Can you ask patients if it’s acceptable to contact them for future research studies for which they may be eligible? (New Guidance)
Yes. Obviously, the main concern with patients is making sure that the process is compliant with the federal privacy law (HIPAA). Assuming a patient coming into University Hospital signs a Notice of Privacy Practice (NOPP; required of all patients treated at UH), they have the right to agree or object to the use and disclosure of their health information as well.
It is acceptable for you to develop a form that asks for patient name and contact information (phone, cell, e-mail), and also ask:
STONY BROOK UNIVERSITY IS INVOLVED IN MANY CLINICAL RESEARCH PROGRAMS.
WOULD YOU LIKE TO BE CONTACTED REGARDING ANY CLINICAL STUDIES FOR WHICH YOU MAY BE ELIGIBLE TO PARTICIPATE BASED ON YOUR DENTAL AND/OR MEDICAL HISTORY?
The signature of the patient ensures that this method of recruitment will be HIPAA compliant.
Please be aware that a new procedure relevant to this issue has just been implemented at University Hospital. At the time of registration, when a patient is face-to-face with a Central Registration, Off-site Registrar or Admitting Clerk, the question regarding future contact for research is now verbally conveyed to the patient and the response (yes/no) noted on the HIPAA screen of the hospital’s SMS (patient registration and billing) system. Population of this database by this mechanism (and other methods, e.g., postcard mailings to prior patients) will take some time, and the drafting of policies and procedures regarding its use by researchers is in process.
Remember, at this time, only investigators who have a treatment relationship with a potential subject may make contact with that individual for recruitment purposes. Also, as has been the case in the past, all recruitment procedures require prior approval by CORIHS.
VI. Biological Sample Testing (including Genetic Testing) in Research Activities (Revised CORIHS Handbook Section)
CORIHS has revised Section 19 of the Handbook for Investigators, “Biological Specimens in Clinical (including Genetic) Research” in an effort to better assist investigators in drafting ethically compliant protocols and consent forms for research involving collection and analysis of biological specimens. We believe that this revised section will simplify considerations of risk and benefit, and IRB review categories, for these types of studies.
The 2 critical parameters that are considered in the revised section are whether or not the testing involves anonymous or coded samples, and, if coded, whether or not it can provide information that has known clinical significance for diagnosis or prediction of a disease state for either the subject or the subject’s family members.
The revised section also addresses another important aspect of specimen research, i.e., the fact that the information that will be generated from analysis of specimens will likely constitute ‘health information’, therefore requiring that the study be in compliance with privacy regulations, i.e., HIPAA.
VII. New Guidance: Outside Entities Proposing Use of SBU Faculty, Staff, Students or Facilities for Research Purposes
There are times when outside entities wish to involve some aspect of our campus community in research activities that don’t otherwise involve SBU. Another university may wish to have our students fill out a survey for a study they are doing on college students. Or a national organization wants to assess undergraduate programs across America and wants to ask our faculty some questions.
When and if you are approached, it is strongly recommended that you contact the Office of Research Compliance to determine if the activity ‘engages’ our institution in the research activity. If we are engaged, then SBU IRB approval is required.
Here are some examples of when SBU does and does not become engaged in research activities:
SBU becomes ‘engaged’, and SBU IRB approval is required, when the proposed activities requested by the outside entity require that an SBU-affiliated individual, e.g.,:
- perform invasive or noninvasive procedures for research purposes (e.g., drawing blood; collecting other biological samples; dispensing drugs; administering other treatments; employing medical technologies; utilizing physical sensors; utilizing other measurement procedures).
- manipulate the environment for research purposes (e.g., controlling environmental light, sound, or temperature; presenting sensory stimuli; orchestrating environmental events or social interactions; making voice, digital, or image recordings).
- interact with living individuals for research purposes (e.g., engaging in protocol-dictated communication or interpersonal contact; conducting research interviews; obtaining informed consent).
- release individually identifiable private information, or permit the outside entity to obtain individually identifiable private information, without subjects' explicit written permission (e.g., releasing student names or e-mails to the outside entity for solicitation as research subjects; permitting the outside entity to record private information from medical records in individually identifiable form).
- obtain, receive, or possess private information that is individually identifiable (either directly or indirectly through coding systems) for research purposes.
Alternatively, SBU is not ‘engaged’, and SBU IRB approval is not required, when the proposed activities require that an SBU affiliated individual only, e.g.,:
- informs prospective subjects about the availability of research;
- provides prospective subjects with written information about research (which may include a copy of the relevant informed consent document and other IRB-approved materials) but do not obtain subjects' consent or act as authoritative representatives of the investigators;
- provides prospective subjects with information about contacting investigators for information or enrollment;
- obtains and appropriately documents prospective subjects' permission for investigators to contact them;
- only releases identifiable private information to the outside entity with the prior written permission of the subject
It is important to note that even if we are not ‘engaged’ in the research activity and IRB approval is not required, approval for the outside entity to come on to campus (e.g., set up a table, post ads, stand in the SAC and hand out flyers etc) will be required by the Office of University Affairs.
VIII. Reminder: Are You Signing IRB (or other compliance) Documents?
Below is an edited version of an article that ran in the OVPR publication, Monday Memo, regarding the implications of your signature on various compliance forms:
“I wanted to take this opportunity to discuss a very important activity that is conducted on this campus every day, sometimes several times a day, by nearly every one of you. The activity is simply that of signing a document, specifically, your attestation that you have reviewed, read and accept responsibility for abiding by the terms of whatever document to which you are affixing your signature. Take, for instance, the incredible responsibility that the Principal Investigator of a research study involving human subjects takes on with just a single signature on the IRB application. The PI’s signature certifies that that s/he will:
- Conduct all aspects of the project as approved by CORIHS,
- Promptly report any revisions or amendments to the research activity for review and approval by CORIHS prior to commencement of the revised protocols,
- Promptly report any unanticipated problems or serious adverse events affecting risk to subjects,
- Assume full responsibility for selecting subjects in strict accordance with the inclusion/exclusion criteria outlined in the application materials,
- Use only CORIHS-approved, stamped consent forms for studies in which consent form(s) have been approved for the research activity, and
- Ensure that all personnel involved with human subjects, or human data and/or biological specimens during the course of this research activity are trained.
It is the PI who takes full responsibility to ensure that the study is being conducted ethically and safely, and in compliance with all policies and procedures associated with research involving human subjects. If the person serving as PI does not know those policies and procedures, s/he should not sign the IRB application until s/he does know them. If non-compliance is subsequently discovered relative to that study, the PI cannot claim ignorance of those policies and procedures if his or her signature is affixed to the applicable IRB application.
If you are signing as chair/review committee of the department from which the protocol is coming, it means that you have reviewed and endorsed the proposed study as scientifically meritorious consistent with the University's (and the particular department's) mission. You have reviewed the study personnel and confirm their competency to conduct the study in a safe and ethical manner.”
Bottom line: The significance of what your signature implies becomes most readily apparent, unfortunately, when something goes wrong. Understand the information and the implications of your signature on all documents that you sign.
IX. Reminder and Clarification: Surrogate Permission for Adult Subjects Unable to Consent for Themselves
Those investigators who are proposing, or are approved to conduct research with adults who do not have the ability to consent for themselves must understand that these subjects constitute one of the most vulnerable populations that can be involved in research.
When the IRB is presented with a protocol that proposes use of this population, the committee first asks, ‘Is inclusion of this population consistent with the ethical principle of justice, as discussed in the Belmont Report (http://ohsr.od.nih.gov/guidelines/belmont.html)?’
In other words:
- Must this population be included in order to answer the research question?
- Is the intervention being studied specific to individuals who cannot consent for themselves?
If the answer is ‘yes’ (e.g., stroke or Alzheimer’s treatment studies), then the committee must assess the study’s risk/benefit ratio in relation to scientific design. One factor the IRB considers is the availability of clinical/standard alternatives to the study intervention. Further, adults who cannot consent for themselves cannot, in accordance with SBU policy, be enrolled in research in which the risk is more than minimal, and there is no possibility of direct benefit.
If the study is either minimal risk, or more than minimal risk with the possibility of benefit, then the population may be enrolled, with surrogate permission, as discussed in Section 13 of the CORIHS Handbook for Investigators http://www.stonybrook.edu/research/HSG/HSGsec13.html.
It is important to note that choice of surrogate must be based on determination of presence or absence of a power of attorney, living will, or health care proxy.
X. 2007 Update from OHRP: International Compilation of Human Research Protections
If you are planning on conducting international research, you will want to review OHRP’s updated International Compilation of Human Subject Research Protections, now available at: http://www.hhs.gov/ohrp/international/HSPCompilation.pdf.
Per OHRP:
“The Compilation lists the human subjects research legislation, regulations, or guidelines for 79 countries, two confederations, and several international organizations. This year’s Compilation includes numerous updates over last year and lists the pertinent laws, regulations, and/or guidelines for 8 new countries: Armenia, Croatia, Cyprus, Iran, Malawi, Moldova, Nigeria, and Tajikistan.
“This Compilation was developed for IRBs/Ethics Committees, researchers, funding agencies, and others who are involved in international research. Its purpose is to help these groups familiarize themselves with the laws, regulations, and guidelines where the research will be conducted, to assure that those standards are followed appropriately."
XI. Reminder: Two Alternatives to Review by SBU’s IRBs (CORIHS-A or CORIHS-B)
For those of you who are proposing to conduct industry-sponsored, industry-initiated protocols, don’t forget to consider using Chesapeake Research Review, Inc (CRRI) for your IRB needs.
Details are available at http://www.stonybrook.edu/research/humans/crri.html. Look for a town hall event in the spring for a face-to-face with CRRI representatives who will be there to inform and answer questions for our faculty.
For those of you who conduct, or are interested in conducting, NCI-sponsored oncology protocols (e.g., COG, GOG, ECOG, NSABP, etc.), you will be interested to know that in recent months, SBU has become an active participant in the National Cancer Institute's Central IRB Adult and Pediatrics Initiative. For more information, go to our website, at http://www.stonybrook.edu/research/humans/nci_cirb.html.
XII. Upcoming Changes: Training in Human Subject Protections
As you are aware, our main current training program in human subject protections involves completion of either the basic (for first timers) or refresher (for continuing education) modules on the Collaborative IRB Training Initiative (CITI) web-based program. There are 2 upcoming changes to our web-based process of which you need to be aware:
The CITI group has come up with a new module set for investigators who conduct research under the jurisdiction of FDA, which focuses on Good Clinical Practices.
For those of you who are social behavioral scientists, there is a complete module set that focuses on the perspective of social behavioral science research.
The CITI webmaster is currently re-programming our site so that these 2 module sets will become active for SBU. When completed, you will receive updated information on new campus requirements for satisfying the initial, and continuing education components of SBU’s human subjects training requirements.
XIII. How are you doing? What is the quality of your own human subject protections program?
Wondering how compliant you've been while conducting your research study now that it has been up and running for a while?
Ever wish you could sit down with me and/or a member of my staff and ask questions or just talk about the myriad rules and regulations impinging upon you as a vital member of the SBU team that protects human subjects participating in research at our Institution?
Don’t forget the wildly successful Investigator Quality Assessment/Quality Improvement Program for the Protection of Human Subjects, available free of charge from the Office of Research Compliance. Many have been conducted since the program was first introduced 2 years ago, all have benefited from the experience, and YOU TOO can experience the comfort in receiving confirmation that you are conducting compliant research, and protecting your research subjects.
All QAs to date have occurred over 2 days. Specifically, an initial interview/discussion with you and key members of your research team is scheduled. Then the QA/QI team reviews your subject and IRB records from one or more of your active CORIHS studies. You will then receive correspondence that discusses your strengths and weaknesses with respect to compliance with SBU’s policies for conducting human subjects research, and more importantly, to assess where improvements can be made.
Please contact the Office of Research Compliance (2-9036) to begin participation in this important program. In conjunction with investigator-requested visits, ORC will also initiate scheduling these QA/QI visits with investigators as well (as we’ve said in the past, if you don't call us, we'll call you!).
XIV. New (Federal) Guidance: The Federal Office of Human Research Protections (OHRP) Frequently Asked Questions (and Answers) Page now on OHRP’s Website
The Office for Human Research Protections (OHRP) has Frequently Asked Questions (FAQ’s) page on its website. These FAQs provide guidance on OHRP's current thinking on these topics and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required.
Where there are discrepancies between OHRP guidance, and CORIHS’s Handbook for Investigators, the latter is to be followed. Remember, the federal regulations provide the basic premise for human subject protections, while our Handbook represents the “best practices” that SBU has adopted for our institution. For example, at our institution, proposed use of anonymous/anonymized human data/tissue must still receive approval via the exemption process; the federal guidance on this topic does not require that this process be in place.
The FAQ page can be accessed at: http://www.hhs.gov/ohrp/ by clicking the Frequently Asked Questions (FAQ) tab (5th) in the left margin.
XV. Important Continuing Education for EVERYONE: The Belmont Report and our Federal Wide Assurance (FWA)
When is the last time you reviewed the Belmont Report, the 1977 landmark document that is the basis for all federal regulations that govern clinical research? Take a moment and review it now (everything will be much clearer to you if you do): http://ohsr.od.nih.gov/guidelines/belmont.html
Now, back in 2001, we were granted a Federal Wide Assurance (FWA #00000125) by the federal Office for Human Research Protections, in which we promised that we would abide by all federal regulations for all research involving human subjects. Probably one of the most significant promises we made was that one of our institution’s IRB would review the human subjects research conducted by any faculty, staff, or student of SBU regardless of where it is conducted, and regardless of source or status of funding. The only exception to that promise is where our institution enters into a documented agreement with another to allow one IRB to review for both entities.
Here now, in detail, are the terms of our assurance: http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm. It is imperative that all participants in our research program be familiar with these terms, as we all must have a part in upholding them.
XVI. As always, the ORC Website has all the current information and current applications you need:
http://www.stonybrook.edu/research/humans/humansubjects.html
As you can see from this update, our Human Subject Protection Program (HSPP) is always undergoing review to ensure that SBU is following the best possible practices in protecting our subjects. The best way to stay up to date with changes made to our HSPP is to visit the website often. When you need to complete an application or form, always download it directly from the web, to ensure you are using the most current version.
If you have any questions about any of the information above, please feel free to contact me at jmatuk@notes.cc.sunysb.edu, phone (631) 632-9036.